Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-30 @ 3:50 AM
Study NCT ID:
NCT04037657
Status:
COMPLETED
Last Update Posted:
2019-07-31
First Post:
2019-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Safety, Pharmacodynamics and Pharmacokinetics of HSK3486 in Healthy Female Subjects.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000730813', 'term': 'HSK3486'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-11-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-29', 'studyFirstSubmitDate': '2019-07-20', 'studyFirstSubmitQcDate': '2019-07-29', 'lastUpdatePostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety by measurement of Adverse Events', 'timeFrame': 'First dose of study drug on day 1'}, {'measure': 'Bispectral index （BIS）', 'timeFrame': 'From first dose of study drug until fully alert on day 1'}, {'measure': "Modified observer's assessment of alertness/sedation（MOAA/S）", 'timeFrame': 'Time Frame: From first dose of study drug until fully alert on day 1', 'description': "Observe the change of modified observer's assessment of alert /sedation during the whole trial"}], 'secondaryOutcomes': [{'measure': 'Median effective dose (ED50)', 'timeFrame': 'From first dose of study drug until fully alert on day 1'}, {'measure': 'Peak concentration (Cmax)', 'timeFrame': 'From the start of administration to 48 hours after administration'}, {'measure': 'Time to plasma peak concentration(Tmax)', 'timeFrame': 'From the start of administration to 48 hours after administration'}, {'measure': 'Area Under the Curve (AUC0-30min, AUC0-1h, AUC0-last, and AUC0-inf)', 'timeFrame': 'From the start of administration to 48 hours after administration'}, {'measure': 'Total clearance (CL)', 'timeFrame': 'From the start of administration to 48 hours after administration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia', 'Sedation']}, 'descriptionModule': {'briefSummary': 'This study was a single-center positive-controlled, randomized, dose-escalation study of HSK3486 in healthy female subjects administered as a single IV bolus dose.Subjects were confined to the study unit from the evening of Day -1 until the morning of Day 2, then were required to return for a follow up visit on Day 5. Intensive safety, PD and PK assessments were performed prior to dosing on Day 1 until 24 hours post-dose (Day 2).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Female, aged 18 - 49 years (inclusive)\n* Women of child-bearing potential agreed to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy\n* Negative serum pregnancy test\n* In general good health without CS medical history\n* American Society of Anesthesiologists (ASA) Physical Status Classification of I or II\n* Body Mass Index (BMI) between 18 and 30 kg/m2 (inclusive)\n* Negative screen for drugs of abuse, alcohol, hepatitis B surface antigen (HBs-Ag), hepatitis C virus antibody (HCV-Ab) and Human Immunodeficiency Virus (HIV) at screening; and drugs of abuse, alcohol pre dose on Day -1\n* Normal or non-CS findings on a physical examination, 12-lead Electrocardiogram (ECG) and vital signs (respiratory rate between 12 and 20 breaths per minute, blood pressure (BP) between 100-140/60-90 mmHg, heart rate between 50-99 beats per minute, temperature between 35.8°C and 37.5°C and pulse oximetry values \\> 95% on room air)\n* Clinical laboratory values within the normal limits as defined by the clinical laboratory, unless the PI decided that out-of-range values were not CS\n* Able to provide written informed consent\n* Willing and able to follow study instructions and likely to complete all study requirements\n* Suitable venous and arterial access\n\nExclusion Criteria:\n\n* History of allergy or sensitivity to: propofol, components of Fresofol 1% MCT/LCT propofol, or HSK3486 (excipients soy bean oil, glycerine, triglycerides, purified egg phospholipids, sodium oleate and sodium hydroxide), or plain lignocaine\n* History of CS problems with general anesthesia\n* Current smoker, or a history of regular (more than weekly) use of tobacco- or nicotine-containing products within 2 months prior to screening\n* History of excessive alcohol intake (more than four standard drinks daily, on average) or use of recreational drugs within the last 3 months CONFIDENTIAL HSK3486 SAD\\_02 Sichuan Haisco Pharmaceutical Co., Ltd Version: 13 Nov 2015 Page 19 of 513\n* Use of prescription or over the counter medications within 7 days of Investigational Product administration, with the exception of contraceptive medications, paracetamol, oral non-steroidal anti-inflammatory agents, topical over the counter preparations and routine vitamins (if they do not exceed an intake of 20 to 600 times the recommended daily dose), unless agreed as non-clinically relevant by the PI and Sponsor.\n* Standard donation of blood within 30 days of the study\n* Donation of plasma or participation in a plasmapheresis program within 7 days preceding this study\n* Receipt of any investigational study drug within 30 days prior to screening\n* Unable to fast for the 6 hours prior to Investigational Product administration\n* CS (as judged by the Investigator) presence of acute illness (e.g. gastrointestinal illness, infection such as influenza, upper respiratory tract infection) at admission to the clinical study unit\n* Anticipated need for surgery or hospitalization during the study\n* Anatomical abnormality that would potentially interfere with airway management under unconscious sedation or anesthesia\n* History of posture-related gastric reflux more than twice weekly\n* History of seizures or epilepsy\n* History of ischaemic heart disease\n* History of brady- or tachy-dysrhythmias requiring medical care\n* History of asthma, with bronchospasm requiring treatment in the last 3 months\n* Any condition, which in the Investigator's opinion, puts the subject at significant risk, could confound the study results or may interfere significantly with the subject's participation in the study."}, 'identificationModule': {'nctId': 'NCT04037657', 'briefTitle': 'Evaluating the Safety, Pharmacodynamics and Pharmacokinetics of HSK3486 in Healthy Female Subjects.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Haisco Pharmaceutical Group Co., Ltd.'}, 'officialTitle': 'A Phase 1b, Positive-controlled, Dose-escalation Study to Determine the Safety, Pharmacodynamics and Pharmacokinetics of a Single Intravenous Dose of HSK3486 in Healthy Female Subjects.', 'orgStudyIdInfo': {'id': 'HSK3486-Australian-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HSK3486', 'description': '0.288 mg/kg ，0.432 mg/kg ，0.540 mg/kg ，0.648 mg/kg，0.810 mg/kg There were five cohorts of six subjects per cohort (5 HSK3486:1 propofol).', 'interventionNames': ['Drug: HSK3486']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Propofol', 'description': '2.5 mg propofol', 'interventionNames': ['Drug: Propofol']}], 'interventions': [{'name': 'HSK3486', 'type': 'DRUG', 'description': 'HSK3486 was administered as a single dose over a 1 minute infusion period. There were five cohorts of six subjects per cohort (5 HSK3486:1 propofol).', 'armGroupLabels': ['HSK3486']}, {'name': 'Propofol', 'type': 'DRUG', 'description': 'Propofol, at a dose of 2.5 mg/kg, was administered as a 1 minute infusion at a constant rate via infusion pump.', 'armGroupLabels': ['Propofol']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sichuan Haisco Pharmaceutical Group Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}