Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT00493220
Status:
COMPLETED
Last Update Posted:
2011-12-02
First Post:
2007-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pharmacokinetic and Safety Study of HYLENEX Recombinant-Augmented Subcutaneous Ceftriaxone Administration
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'interventionBrowseModule': {'meshes': [{'id': 'D002443', 'term': 'Ceftriaxone'}, {'id': 'D006821', 'term': 'Hyaluronoglucosaminidase'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D002439', 'term': 'Cefotaxime'}, {'id': 'D002505', 'term': 'Cephacetrile'}, {'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006026', 'term': 'Glycoside Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D011133', 'term': 'Polysaccharide-Lyases'}, {'id': 'D019757', 'term': 'Carbon-Oxygen Lyases'}, {'id': 'D008190', 'term': 'Lyases'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'george_harb@baxter.com', 'title': 'George Harb, MD, MPH', 'organization': 'Baxter Healthcare Corporation'}, 'certainAgreement': {'otherDetails': 'For this study, Baxter requires a review of any planned PI results communications (eg, for confidential information) up to 90 days prior to submission or communication. Baxter may request an additional delay of up to 60 days (eg, to allow for intellectual property protection).', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'from time of start of intervention administration through 7 days after intervention administered', 'description': 'Infusion site reaction assessments performed at baseline (shortly before study drug administration) and at 5, 30 and 45 minutes, and 1, 4, 6, 24, 36 and 48 hours after completion of study drug administration. Other adverse events were to be recorded whenever reported by the participant or observed by study staff.', 'eventGroups': [{'id': 'EG000', 'title': 'HYLENEX SC', 'description': 'All participants administered subcutaneous HYLENEX and ceftriaxone', 'otherNumAtRisk': 30, 'otherNumAffected': 30, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo SC', 'description': 'All participants administered subcutaneous placebo and ceftriaxone', 'otherNumAtRisk': 30, 'otherNumAffected': 30, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Intravenous', 'description': 'All participants administered intravenous ceftriaxone', 'otherNumAtRisk': 29, 'otherNumAffected': 22, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Infusion site anaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Infusion site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 29, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Infusion site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 29, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Infusion site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Infusion site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 29, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Infusion site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Infusion site reaction', 'notes': 'Reported term = "muscle twitching"', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Infusion site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Vessel puncture site bruise', 'notes': 'Refers to site of placement of catheter for PK plasma sample collection, not study drug administration site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'HYLENEX SC', 'description': 'All per-protocol participants administered subcutaneous hylenex and ceftriaxone'}, {'id': 'OG001', 'title': 'Placebo SC', 'description': 'All per-protocol participants administered subcutaneous placebo and ceftriaxone'}, {'id': 'OG002', 'title': 'Intravenous', 'description': 'All per-protocol participants administered intravenous ceftriaxone'}], 'classes': [{'categories': [{'measurements': [{'value': '92.0', 'spread': '15.1', 'groupId': 'OG000'}, {'value': '82.2', 'spread': '13.5', 'groupId': 'OG001'}, {'value': '150', 'spread': '19.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM ratio (natural log-transformed)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '111.79', 'ciLowerLimit': '108.57', 'ciUpperLimit': '115.12', 'estimateComment': 'HYLENEX SC/Placebo SC', 'statisticalMethod': 'Schuirmann two one-sided tests procedure', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM ratio (natural log-transformed)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '60.81', 'ciLowerLimit': '59.06', 'ciUpperLimit': '62.62', 'estimateComment': 'HYLENEX SC/Intravenous', 'statisticalMethod': 'Schuirmann two one-sided tests procedure', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM ratio (%; ln-transformed)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '54.40', 'ciLowerLimit': '52.82', 'ciUpperLimit': '56.01', 'estimateComment': 'Placebo SC/Intravenous', 'statisticalMethod': 'Schuirmann two one-sided tests procedure', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%'}], 'paramType': 'MEAN', 'timeFrame': 'at the time of the highest measured plasma ceftriaxone concentration', 'description': 'Maximum measured plasma ceftriaxone concentration', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol (excludes one participant that did not receive intravenous ceftriaxone intervention)'}, {'type': 'SECONDARY', 'title': 'Tmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'HYLENEX SC', 'description': 'All per-protocol participants administered subcutaneous HYLENEX and ceftriaxone'}, {'id': 'OG001', 'title': 'Placebo SC', 'description': 'All per-protocol participants administered subcutaneous placebo and ceftriaxone'}, {'id': 'OG002', 'title': 'Intravenous', 'description': 'All per-protocol participant administered intravenous ceftriaxone'}], 'classes': [{'categories': [{'measurements': [{'value': '2.02', 'groupId': 'OG000', 'lowerLimit': '1.02', 'upperLimit': '3.01'}, {'value': '3.02', 'groupId': 'OG001', 'lowerLimit': '1.52', 'upperLimit': '4.04'}, {'value': '0.502', 'groupId': 'OG002', 'lowerLimit': '0.501', 'upperLimit': '0.611'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.00', 'ciLowerLimit': '-1.25', 'ciUpperLimit': '-0.75', 'estimateComment': 'HYLENEX SC minus Placebo SC', 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.01', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.52', 'ciLowerLimit': '1.27', 'ciUpperLimit': '1.71', 'estimateComment': 'Placebo SC minus Intravenous', 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.01', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.52', 'ciLowerLimit': '2.26', 'ciUpperLimit': '2.76', 'estimateComment': 'Placebo SC minus Intravenous', 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'from start of ceftriaxone administration until time of maximum measured plasma ceftriaxone concentration', 'description': 'Time to maximum measured plasma ceftriaxone concentration', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol (excludes one participant that did not receive intravenous ceftriaxone intervention)'}, {'type': 'PRIMARY', 'title': 'AUC0-t', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'HYLENEX SC', 'description': 'All per-protocol participants administered subcutaneous HYLENEX and ceftriaxone'}, {'id': 'OG001', 'title': 'Placebo SC', 'description': 'All per-protocol participants administered subcutaneous placebo and ceftriaxone'}, {'id': 'OG002', 'title': 'Intravenous', 'description': 'All per-protocol participants administered intravenous ceftriaxone'}], 'classes': [{'categories': [{'measurements': [{'value': '1139.3', 'spread': '200.30', 'groupId': 'OG000'}, {'value': '1115.6', 'spread': '180.55', 'groupId': 'OG001'}, {'value': '1065.3', 'spread': '176.07', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM ratio (%; ln-transformed)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '101.99', 'ciLowerLimit': '98.95', 'ciUpperLimit': '105.12', 'estimateComment': 'HYLENEX SC/Placebo SC', 'statisticalMethod': 'Schuirmann two one-sided tests procedure', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM ratio (%; ln-transformed)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '106.79', 'ciLowerLimit': '103.61', 'ciUpperLimit': '110.07', 'estimateComment': 'HYLENEX SC/Intravenous', 'statisticalMethod': 'Schuirmann two one-sided tests procedure', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM ratio (%; ln-transformed)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '104.71', 'ciLowerLimit': '101.59', 'ciUpperLimit': '107.92', 'estimateComment': 'Placebo SC/Intravenous', 'statisticalMethod': 'Schuirmann two one-sided tests procedure', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%'}], 'paramType': 'MEAN', 'timeFrame': 'Start of ceftriaxone administration through time of last measureable plasma ceftriaxone concentration', 'description': 'Area under the drug concentration-time curve from time zero to the time of the last measurable concentration (calculated by the linear trapezoidal method)', 'unitOfMeasure': 'μg*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol (excludes one participant that did not receive intravenous ceftriaxone intervention)'}, {'type': 'PRIMARY', 'title': 'AUC0-inf', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'HYLENEX SC', 'description': 'All per-protocol participants administered subcutaneous HYLENEX and ceftriaxone'}, {'id': 'OG001', 'title': 'Placebo SC', 'description': 'All per-protocol participants administered subcutaneous placebo and ceftriaxone'}, {'id': 'OG002', 'title': 'Intravenous', 'description': 'All per-protocol participants administered intravenous ceftriaxone'}], 'classes': [{'categories': [{'measurements': [{'value': '1162.6', 'spread': '210.36', 'groupId': 'OG000'}, {'value': '1141.3', 'spread': '192.86', 'groupId': 'OG001'}, {'value': '1085.8', 'spread': '187.50', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM ratio (%; ln-transformed)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '101.76', 'ciLowerLimit': '98.64', 'ciUpperLimit': '104.98', 'estimateComment': 'HYLENEX SC/Placebo SC', 'statisticalMethod': 'Schuirmann two one-sided tests procedure', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bioequivalence = 95% confidence interval of least squares mean (LSM) within 80%-125%'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM ratio (%; ln-transformed)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '106.95', 'ciLowerLimit': '103.67', 'ciUpperLimit': '110.33', 'estimateComment': 'HYLENEX SC/Intravenous', 'statisticalMethod': 'Schuirmann two one-sided tests procedure', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM ratio (%; ln-transformed)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '105.10', 'ciLowerLimit': '101.87', 'ciUpperLimit': '108.42', 'estimateComment': 'Placebo SC/Intravenous', 'statisticalMethod': 'Schuirmann two one-sided tests procedure', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%'}], 'paramType': 'MEAN', 'timeFrame': 'from the start of ceftriaxone administration to infinity', 'description': 'Area under the drug concentration-time curve from time zero to infinity, calculated as AUC0-t + Ct/kel (Ct = time of last measurable concentration; kel = terminal elimination rate constant)', 'unitOfMeasure': 'µg*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol (excludes one participant that did not receive intravenous ceftriaxone intervention)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HYLENEX SC, Placebo SC, IV', 'description': 'subcutaneous HYLENEX and ceftriaxone as first intervention, subcutaneous placebo and ceftriaxone as second intervention, intravenous ceftriaxone as third intervention'}, {'id': 'FG001', 'title': 'HYLENEX SC, IV, Placebo SC', 'description': 'subcutaneous HYLENEX and ceftriaxone as first intervention, intravenous ceftriaxone as second intervention, subcutaneous placebo and ceftriaxone as third intervention'}, {'id': 'FG002', 'title': 'Placebo SC, HYLENEX SC, IV', 'description': 'subcutaneous placebo and ceftriaxone as first intervention, subcutaneous HYLENEX and ceftriaxone as second intervention, intravenous ceftriaxone as third intervention'}, {'id': 'FG003', 'title': 'Placebo SC, IV, HYLENEX SC', 'description': 'subcutaneous placebo and ceftriaxone as first intervention, intravenous ceftriaxone as second intervention, subcutaneous HYLENEX and ceftriaxone as third intervention'}, {'id': 'FG004', 'title': 'IV, HYLENEX SC, Placebo SC', 'description': 'intravenous ceftriaxone as first intervention, subcutaneous HYLENEX and ceftriaxone as second intervention, subcutaneous placebo and ceftriaxone as third intervention'}, {'id': 'FG005', 'title': 'IV, Placebo SC, HYLENEX SC', 'description': 'intravenous ceftriaxone as first intervention, subcutaneous placebo and ceftriaxone as second intervention, subcutaneous HYLENEX and ceftriaxone as third intervention'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'First 7-Day Washout & Safety Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Second 7-Day Washout & Safety Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Third Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Final 7-Day Safety Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Healthy volunteers recruited via subject-initiated telephone or internet contacts or visits to Phase I unit. Those considered potentially eligible were, after obtaining consent, screened in detail to determine eligibility against protocol eligibility criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'HYLENEX SC, Placebo SC, IV', 'description': 'subcutaneous HYLENEX and ceftriaxone as first intervention, subcutaneous placebo and ceftriaxone as second intervention, intravenous ceftriaxone as third intervention'}, {'id': 'BG001', 'title': 'HYLENEX SC, IV, Placebo SC', 'description': 'subcutaneous HYLENEX and ceftriaxone as first intervention, intravenous ceftriaxone as second intervention, subcutaneous placebo and ceftriaxone as third intervention'}, {'id': 'BG002', 'title': 'Placebo SC, HYLENEX SC, IV', 'description': 'subcutaneous placebo and ceftriaxone as first intervention, subcutaneous HYLENEX and ceftriaxone as second intervention, intravenous ceftriaxone as third intervention'}, {'id': 'BG003', 'title': 'Placebo SC, IV, HYLENEX SC', 'description': 'subcutaneous placebo and ceftriaxone as first intervention, intravenous ceftriaxone as second intervention, subcutaneous HYLENEX and ceftriaxone as third intervention'}, {'id': 'BG004', 'title': 'IV, HYLENEX SC, Placebo SC', 'description': 'intravenous ceftriaxone as first intervention, subcutaneous HYLENEX and ceftriaxone as second intervention, subcutaneous placebo and ceftriaxone as third intervention'}, {'id': 'BG005', 'title': 'IV, Placebo SC, HYLENEX SC', 'description': 'intravenous ceftriaxone as first intervention, subcutaneous placebo and ceftriaxone as second intervention, subcutaneous HYLENEX and ceftriaxone as third intervention'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.2', 'spread': '10.6', 'groupId': 'BG000'}, {'value': '37.6', 'spread': '4.0', 'groupId': 'BG001'}, {'value': '34.2', 'spread': '11.5', 'groupId': 'BG002'}, {'value': '34.8', 'spread': '17.5', 'groupId': 'BG003'}, {'value': '34.8', 'spread': '11.0', 'groupId': 'BG004'}, {'value': '33.2', 'spread': '8.0', 'groupId': 'BG005'}, {'value': '34.5', 'spread': '10.3', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '25', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-24', 'studyFirstSubmitDate': '2007-06-26', 'resultsFirstSubmitDate': '2011-09-12', 'studyFirstSubmitQcDate': '2007-06-27', 'lastUpdatePostDateStruct': {'date': '2011-12-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-10-24', 'studyFirstPostDateStruct': {'date': '2007-06-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC0-t', 'timeFrame': 'Start of ceftriaxone administration through time of last measureable plasma ceftriaxone concentration', 'description': 'Area under the drug concentration-time curve from time zero to the time of the last measurable concentration (calculated by the linear trapezoidal method)'}, {'measure': 'AUC0-inf', 'timeFrame': 'from the start of ceftriaxone administration to infinity', 'description': 'Area under the drug concentration-time curve from time zero to infinity, calculated as AUC0-t + Ct/kel (Ct = time of last measurable concentration; kel = terminal elimination rate constant)'}], 'secondaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'at the time of the highest measured plasma ceftriaxone concentration', 'description': 'Maximum measured plasma ceftriaxone concentration'}, {'measure': 'Tmax', 'timeFrame': 'from start of ceftriaxone administration until time of maximum measured plasma ceftriaxone concentration', 'description': 'Time to maximum measured plasma ceftriaxone concentration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ceftriaxone', 'cephalosporins', 'pharmacokinetics', 'subcutaneous', 'hyaluronoglucosaminidase', 'hyaluronidase', 'hyaluronan', 'rHuPH20'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '19947907', 'type': 'RESULT', 'citation': 'Harb G, Lebel F, Battikha J, Thackara JW. Safety and pharmacokinetics of subcutaneous ceftriaxone administered with or without recombinant human hyaluronidase (rHuPH20) versus intravenous ceftriaxone administration in adult volunteers. Curr Med Res Opin. 2010 Feb;26(2):279-88. doi: 10.1185/03007990903432900.'}]}, 'descriptionModule': {'briefSummary': 'The objectives of this study are:\n\n* to establish the safety of subcutaneous administration of ceftriaxone at different concentrations, with and without HYLENEX recombinant, and to determine the maximum tolerated concentration;\n* and to establish the pharmacokinetic comparability of subcutaneous administration of ceftriaxone with HYLENEX recombinant to subcutaneous administration without HYLENEX recombinant and to IV administration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, 18-65 years of age\n* If female: non-lactating; non-pregnant; and incapable of becoming pregnant, or taking specific precautions to avoid becoming pregnant before and during study\n* Normal clinical laboratory parameters\n* Adequate venous access in both upper extremities\n* Agreeing to refrain from smoking and from ingesting any alcohol or caffeine-containing products before and during the study\n* Good health based on medical history, physical examination and laboratory tests\n* Non-smoking; or smoking less than 10 cigarettes per day and willing to refrain from use of nicotine products before and during study\n\nExclusion Criteria:\n\n* Received a cephalosporin within the 21 days prior to study or anticipated to receive non-study cephalosporin during study\n* Pregnant or breast-feeding.\n* Previously exposed to a hyaluronidase drug product\n* Medical condition presenting unacceptable safety risk or likely to prevent completion of study\n* Known hypersensitivity to hyaluronidase or any other ingredient in HYLENEX recombinant\n* Contraindication to ceftriaxone, including known allergy to beta-lactam antibiotics\n* Local condition precluding subcutaneous injection or injection site evaluation\n* History of gastrointestinal disease (in particular colitis)\n* Consumption of caffeine- or other methylxanthine-containing beverage within 24 hours before and/or during the PK sampling period\n* Participation in study of any investigational drug or device within 30 days before this study\n* Serum hemoglobin \\<12 g/dL.\n* Blood donation or significant loss of blood within 56 days, or plasma donation within 7 days, prior to study\n* Medical history/condition, screening physical examination finding or clinical laboratory result precluding safe participation in study, or which might adversely effect interpretation of study results\n* History of drug or alcohol abuse within 2 years prior to study'}, 'identificationModule': {'nctId': 'NCT00493220', 'acronym': 'INFUSE-Cftrx', 'briefTitle': 'Pharmacokinetic and Safety Study of HYLENEX Recombinant-Augmented Subcutaneous Ceftriaxone Administration', 'organization': {'class': 'INDUSTRY', 'fullName': 'Baxter Healthcare Corporation'}, 'officialTitle': 'INcreased Flow Utilizing Subcutaneously-Enabled Ceftriaxone (INFUSE-Ceftriaxone) Study: A Phase I Study Comparing the Safety and Pharmacokinetics of Ceftriaxone Administered Subcutaneously With and Without Human Recombinant Hyaluronidase (HYLENEX Recombinant) and Intravenously in Human Volunteers', 'orgStudyIdInfo': {'id': '1838-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HYLENEX SC, Placebo SC, IV', 'description': 'subcutaneous HYLENEX and ceftriaxone as 1st intervention, subcutaneous placebo and ceftriaxone as 2nd intervention, IV ceftriaxone as 3rd intervention', 'interventionNames': ['Drug: SC HYLENEX and Ceftriaxone', 'Drug: SC Placebo and Ceftriaxone', 'Drug: IV Ceftriaxone']}, {'type': 'EXPERIMENTAL', 'label': 'HYLENEX SC, IV, Placebo SC', 'description': 'subcutaneous HYLENEX and ceftriaxone as 1st intervention, IV ceftriaxone as 2nd intervention, subcutaneous placebo and ceftriaxone as 3rd intervention', 'interventionNames': ['Drug: SC HYLENEX and Ceftriaxone', 'Drug: SC Placebo and Ceftriaxone', 'Drug: IV Ceftriaxone']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo SC, HYLENEX SC, IV', 'description': 'subcutaneous placebo and ceftriaxone as 1st intervention, subcutaneous HYLENEX and ceftriaxone as 2nd intervention, IV ceftriaxone as 3rd intervention', 'interventionNames': ['Drug: SC HYLENEX and Ceftriaxone', 'Drug: SC Placebo and Ceftriaxone', 'Drug: IV Ceftriaxone']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo SC, IV, HYLENEX SC', 'description': 'subcutaneous placebo and ceftriaxone as 1st intervention, IV ceftriaxone as 2nd intervention, subcutaneous HYLENEX and ceftriaxone as 3rd intervention', 'interventionNames': ['Drug: SC HYLENEX and Ceftriaxone', 'Drug: SC Placebo and Ceftriaxone', 'Drug: IV Ceftriaxone']}, {'type': 'EXPERIMENTAL', 'label': 'IV, HYLENEX SC, Placebo SC', 'description': 'IV ceftriaxone as 1st intervention, subcutaneous HYLENEX and ceftriaxone as 2nd intervention, subcutaneous placebo and ceftriaxone as 3rd intervention', 'interventionNames': ['Drug: SC HYLENEX and Ceftriaxone', 'Drug: SC Placebo and Ceftriaxone', 'Drug: IV Ceftriaxone']}, {'type': 'EXPERIMENTAL', 'label': 'IV, Placebo SC, HYLENEX SC', 'description': 'IV ceftriaxone as 1st intervention, subcutaneous placebo and ceftriaxone as 2nd intervention, subcutaneous HYLENEX and ceftriaxone as 3rd intervention', 'interventionNames': ['Drug: SC HYLENEX and Ceftriaxone', 'Drug: SC Placebo and Ceftriaxone', 'Drug: IV Ceftriaxone']}], 'interventions': [{'name': 'SC HYLENEX and Ceftriaxone', 'type': 'DRUG', 'otherNames': ['HYLENEX recombinant', 'hyaluronoglucosaminidase', 'hyaluronidase', 'rHuPH20'], 'description': 'single, subcutaneous, 150 U dose of HYLENEX; followed by single, subcutaneous, 1 gm dose of ceftriaxone (350 mg/mL solution administered at 2.5 mL/min over 1.14 minutes)', 'armGroupLabels': ['HYLENEX SC, IV, Placebo SC', 'HYLENEX SC, Placebo SC, IV', 'IV, HYLENEX SC, Placebo SC', 'IV, Placebo SC, HYLENEX SC', 'Placebo SC, HYLENEX SC, IV', 'Placebo SC, IV, HYLENEX SC']}, {'name': 'SC Placebo and Ceftriaxone', 'type': 'DRUG', 'otherNames': ['saline', 'normal saline', '0.9% sodium chloride injection'], 'description': 'single, subcutaneous injection of 1 mL 0.9% sodium chloride solution; followed by single, subcutaneous, 1 gm dose of ceftriaxone (350 mg/mL solution administered at 2.5 mL/min over 1.14 minutes)', 'armGroupLabels': ['HYLENEX SC, IV, Placebo SC', 'HYLENEX SC, Placebo SC, IV', 'IV, HYLENEX SC, Placebo SC', 'IV, Placebo SC, HYLENEX SC', 'Placebo SC, HYLENEX SC, IV', 'Placebo SC, IV, HYLENEX SC']}, {'name': 'IV Ceftriaxone', 'type': 'DRUG', 'otherNames': ['ceftriaxone'], 'description': 'single, intravenous infusion of 1 gm ceftriaxone (40 mg/mL solution administered at 0.83 mL/min over 30 minutes)', 'armGroupLabels': ['HYLENEX SC, IV, Placebo SC', 'HYLENEX SC, Placebo SC, IV', 'IV, HYLENEX SC, Placebo SC', 'IV, Placebo SC, HYLENEX SC', 'Placebo SC, HYLENEX SC, IV', 'Placebo SC, IV, HYLENEX SC']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'George E Harb, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Baxter Healthcare Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baxter Healthcare Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Halozyme Therapeutics', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Geroge E. Harb, MD', 'oldOrganization': 'Baxter Healthcare Corporation'}}}}