NCT07404306

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

A 2-Part, Dose-Finding and Human Abuse Potential Study Of HSK3486 Injection In Nondependent, Recreational Central Nervous System Depressant Users

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Haisco-USA Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This single center study will consist of 2 parts. Part 1 will be an open-label, dose-finding study of HSK3486 and propofol conducted in up to 48 recreational users of CNS depressants to determine the appropriate doses to be used in Part 2 of the study. Part 2 will be a randomized, double-blind, placebo- and active-controlled 4-period, 4 way crossover, in approximately 42 healthy volunteers with prior recreational CNS depressant exposure. Both Part 1 and Part 2 of the study will consist of an outpatient Screening Visit, an in-clinic Treatment Phase, and Follow-up; Part 2 will also include a Qualification Phase.

Conditions

• General Anesthesia

Interventions

Type	Name	Description
DRUG	HSK3486	HSK3486 for induction of general anesthesia
DRUG	propofol	Propofol for induction of general anesthesia
DRUG	Placebo	Intralipid

Timeline

• Start date: 2022-08-16
• Primary completion: 2023-10-03
• Completion: 2023-10-03
• First posted: 2026-02-11
• Last updated: 2026-02-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study