drugset / Trial / NCT07404306

Part 1: Dose-Finding of HSK3486 Injection In Nondependent, Recreational Central Nervous System Depressant Users

NCT07404306

Phase 1 Completed 43 enrolled Haisco-USA Pharmaceuticals, Inc.
RandomizedSequentialSingle-blindTreatment

Summary

Part 1: To determine the doses of IV HSK3486 and propofol for use in Part 2, the abuse potential part of the study. Part 2: To evaluate the abuse potential of HSK3486 compared with propofol when administered IV to healthy nondependent, recreational CNS depressant drug users.

Timeline

Start
2022-08-16
Primary completion
2023-10-03
Completion
2023-10-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Cipepofol Small molecule 0.1 mg/kg Intravenous
Subject Cipepofol Small molecule 0.125 mg/kg Intravenous
Subject Cipepofol Small molecule 0.15 mg/kg Intravenous
Subject Cipepofol Small molecule 0.175 mg/kg Intravenous
Subject Cipepofol Small molecule 0.2 mg/kg Intravenous
Subject Cipepofol Small molecule 0.225 mg/kg Intravenous
Comparator Propofol Small molecule 0.5 mg/kg Intravenous
Comparator Propofol Small molecule 0.625 mg/kg Intravenous
Comparator Propofol Small molecule 0.675 mg/kg Intravenous
Comparator Propofol Small molecule 0.725 mg/kg Intravenous
Comparator Propofol Small molecule 0.775 mg/kg Intravenous

Indications

No indication recorded.