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drugset / Trial / NCT04037657

Evaluating the Safety, Pharmacodynamics and Pharmacokinetics of HSK3486 in Healthy Female Subjects.

NCT04037657 ↗

Phase 1 Completed 25 enrolled Sichuan Haisco Pharmaceutical Group Co., Ltd
RandomizedParallel-groupDouble-blindTreatment

Summary

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).

Timeline

Start
2015-04-22
Primary completion
2015-06-09
Completion
2015-11-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Cipepofol Small molecule 0.288 mg/kg Intravenous
Subject Cipepofol Small molecule 0.432 mg/kg Intravenous
Subject Cipepofol Small molecule 0.54 mg/kg Intravenous
Subject Cipepofol Small molecule 0.648 mg/kg Intravenous
Subject Cipepofol Small molecule 0.81 mg/kg Intravenous
Comparator Propofol Small molecule 2.5 mg/kg —

Indications

No indication recorded.