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Treatment A: HSK3486 dose 1 for General Anesthesia

Phase 1
Waitlist Available
Research Sponsored by Haisco-USA Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening between day -28 and day -5; confinement period 9 days in clinic from day -4 (admission) to 24 hours after study drug administration in period 4; follow-up 3 to 7 days after study drug administration
Awards & highlights

Study Summary

This trial will study the safety of two intravenous drugs and their potential for abuse in healthy recreational drug users.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening between day -28 and day -2; confinement period 2 days in clinic from day -1 (admission) to 24 hours after study drug administration; follow-up 3 to 7 days after study drug administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening between day -28 and day -2; confinement period 2 days in clinic from day -1 (admission) to 24 hours after study drug administration; follow-up 3 to 7 days after study drug administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1
Part 2
Secondary outcome measures
To evaluate the safety and tolerability of HSK3486 in healthy, nondependent, recreational CNS depressant drug users
Propofol

Side effects data

From 2022 Phase 3 trial • 255 Patients • NCT04711837
28%
Hypotension
27%
Nausea
19%
Procedural Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
HSK3486
Propofol

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Treatment B: HSK3486 dose 2Experimental Treatment1 Intervention
Treatment B: HSK3486 dose 2 (IV bolus over 30 seconds [+5 seconds] from a syringe; dose to be determined in Part 1)
Group II: Treatment A: HSK3486 dose 1Experimental Treatment1 Intervention
Treatment A: HSK3486 dose 1 (IV bolus over 30 seconds [+5 seconds] from a syringe; dose to be determined in Part 1)
Group III: Treatment C: PropofolActive Control1 Intervention
Treatment C: Propofol (IV bolus over 30 seconds [+5 seconds] from a syringe; dose to be determined in Part 1)
Group IV: Treatment D: PlaceboPlacebo Group1 Intervention
Treatment D: Placebo (Treatment A matched) (IV bolus over 30 seconds [+5 seconds] from a syringe)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HSK3486
2019
Completed Phase 3
~1630

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Haisco-USA Pharmaceuticals, Inc.Lead Sponsor
3 Previous Clinical Trials
1,055 Total Patients Enrolled
2 Trials studying General Anesthesia
800 Patients Enrolled for General Anesthesia
~15 spots leftby Jun 2025
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