Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2025-12-24 @ 12:35 PM
Study NCT ID:
NCT01293461
Status:
COMPLETED
Last Update Posted:
2013-03-01
First Post:
2011-02-08
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Pharmacokinetics of CBX129801 in Patients With Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000608079', 'term': 'CBX129801'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'dispFirstSubmitDate': '2013-02-25', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-25', 'studyFirstSubmitDate': '2011-02-08', 'dispFirstSubmitQcDate': '2013-02-25', 'studyFirstSubmitQcDate': '2011-02-09', 'dispFirstPostDateStruct': {'date': '2013-03-01', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-03-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the single and multiple dose pharmacokinetics of plasma CBX129801 after subcutaneous (SC) administration of CBX129801 by estimating parameters of Cmax, Tmax, Cmin, AUClast, AUCinf, Tlag, Cav, CL/F, Vz/F, and half life.', 'timeFrame': 'For duration of study / 16 months', 'description': 'Plasma CBX129801 will be used to assess the concentration versus time profiles and PK of CBX129801.'}, {'measure': 'To assess the safety and tolerability of CBX129801 when administered SC by adverse events, injection site assessments, clinical laboratory tests, vital signs, physical examinations, and electrocardiograms.', 'timeFrame': 'For duration of study / 16 months'}], 'secondaryOutcomes': [{'measure': 'To evaluate the technique of sensory nerve conduction velocity (SNCV) in the sural nerves in patients with type 1 diabetes mellitus.', 'timeFrame': 'Predose and 6 and 12 weeks postdose'}, {'measure': 'To assess the immunogenicity of CBX129801 by occurrence of anti-CBX129801 antibody formation.', 'timeFrame': 'For duration of study / 16 months'}, {'measure': 'To evaluate the technique of motor nerve conduction velocity (MNCV) in the peroneal nerves in patients with type 1 diabetes mellitus.', 'timeFrame': 'Predose and 6 and 12 weeks postdose'}, {'measure': 'To evaluate the technique of vibration perception threshold (VPT) in patients with type 1 diabetes (Part 2 only)', 'timeFrame': 'Predose and 12 weeks postdose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes', 'Diabetes Mellitus', 'Peripheral Diabetic Neuropathy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess safety and tolerability and determine the pharmacokinetics of subcutaneous single and multiple (up to 12) dose administration of CBX129801 (long-acting synthetic C-peptide) in type 1 diabetes patients.', 'detailedDescription': 'This study will be conducted in two parts (Part 1 and Part 2). Part 1 will be conducted in three sequential dose cohorts with dose level escalated for each successive cohort. In Part 2 of the study, a dose regimen determined from the pharmacokinetic data from Part 1 will be administered in up to 40 additional subjects to achieve a target plasma concentration range that represents the most commonly observed physiological C-peptide levels in healthy, non-diabetic individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Give informed consent\n* Aged 18 to 55 years (Part 1), Ages 18 to 65 years (Part 2)\n* Stable type 1 diabetes mellitus (T1DM) for a minimum of 5 years\n* Body mass index of 18-35 kg/m2\n* Be C-peptide deficient (assessed by fasting concentration level)\n* Normal renal function (assessed by serum creatinine)\n* Be in good general health (besides T1DM)\n* Have abnormal sural nerve conduction velocity observed bilaterally (Part 2 only)\n\nKey Exclusion Criteria:\n\n* Any significant cardiovascular, hematological, renal, hepatic, pulmonary, endocrine (except for diabetes mellitus), central nervous, or gastrointestinal condition or disease\n* Unstable glucose control\n* Have had a islet cell, kidney, and/or pancreas transplant\n* Blood loss or blood donation within 56 days\n* Drug or alcohol abuse (within 2 years) or recreational drug use (within 3 months)\n* History or positive test result for Hepatitis B, C, and/or HIV\n* Treatment with medication for peripheral neuropathy within 30 days'}, 'identificationModule': {'nctId': 'NCT01293461', 'briefTitle': 'Safety and Pharmacokinetics of CBX129801 in Patients With Type 1 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cebix Incorporated'}, 'officialTitle': 'A Randomized, Blinded, Placebo-Controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of CBX129801 (Long-Acting Synthetic C-Peptide) After Subcutaneous Administration in Patients With Type 1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'CBX129801-PK-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CBX129801', 'interventionNames': ['Drug: CBX129801']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'CBX129801', 'type': 'DRUG', 'description': 'Subcutaneous injection', 'armGroupLabels': ['CBX129801']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Subcutaneous injection', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Escondido', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'city': 'Tustin', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.74585, 'lon': -117.82617}}, {'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'city': 'Butte', 'state': 'Montana', 'country': 'United States', 'geoPoint': {'lat': 46.00382, 'lon': -112.53474}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Olympia', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.04491, 'lon': -122.90169}}, {'city': 'Renton', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.48288, 'lon': -122.21707}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cebix Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}