drugset
drugset / Trial / NCT04033939

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

NCT04033939 ↗

Phase 1 Completed 48 enrolled Sichuan Haisco Pharmaceutical Group Co., Ltd
RandomizedParallel-groupOpen-labelTreatment

Summary

This is the first clinical trial of HSK3486 and will be conducted in healthy volunteers to determine the safety, tolerability (including pain on injection), and PK(only to be assessed for subjects who are randomized to HSK3486 in Cohorts 3 to 8)and PD and profiles of HSK3486 administered as a single IV injection. Results from this study will supports further clinical development of HSK3486. This study will be performed in compliance with the protocol, International Conference on Harmonization Good Clinical Practice (ICH GCP) and local regulatory requirements. Aspects of the study concerned with the investigational product will meet the requirements of Good Manufacturing Practice (GMP).

Timeline

Start
2014-04-13
Primary completion
2014-11-11
Completion
2015-05-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Cipepofol Small molecule 0.016 mg/kg Intravenous
Subject Cipepofol Small molecule 0.064 mg/kg Intravenous
Subject Cipepofol Small molecule 0.128 mg/kg Intravenous
Subject Cipepofol Small molecule 0.192 mg/kg Intravenous
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 Intravenous

Indications

No indication recorded.