drugset
drugset / Trial / NCT04054063

A Study Evaluating Safety, Pharmacodynamics and Pharmacokinetics of HSK3486 and Etomidate for Induction of Anesthesia in Healthy Male Subjects

NCT04054063 ↗

Phase 1 Completed 25 enrolled Sichuan Haisco Pharmaceutical Group Co., Ltd
NaSingle-groupOpen-labelTreatment

Summary

This study is designed as an open label, single dose combination of HSK3486 and etomidate in healthy adult male subjects. The study will evaluate the anesthetic/sedation effect of the combination of the 2 drugs and the safety profile including pain on injection, hypotension, tachycardia or bradycardia effects (HSK3486), and involuntary muscle movements, nausea and vomiting potential and adrenal suppression (etomidate). All subjects will be administered HSK3486 plus etomidate. Subjects will be confined to the study unit from the evening of Day -1 until the morning of Day 2, then will be required to return for a follow up visit on Day 7. Intensive PD, PK, safety and tolerability and assessments will be performed prior to dosing on Day 1 until 24 hours post-dose (Day 2).

Timeline

Start
2016-11-30
Primary completion
2016-12-21
Completion
2017-06-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Cipepofol Small molecule 0.216 mg/kg Intravenous
Subject Cipepofol Small molecule 0.324 mg/kg Intravenous
Subject Cipepofol Small molecule 0.432 mg/kg Intravenous
Subject Etomidate Small molecule 0.1 mg/kg Intravenous
Subject Etomidate Small molecule 0.15 mg/kg Intravenous
Subject Etomidate Small molecule 0.2 mg/kg Intravenous

Indications

No indication recorded.