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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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are helping researchers by being a part of this trial?

"Yes, according to the latest information from clinicaltrials.gov, this study is still looking for volunteers. The trial was first posted on August 16th, 2022 and updated November 7th, 2022. They are seeking 42 individuals at a single location."

Answered by AI

Does this experiment only allow young people to participate?

"This study is looking for patients who are younger than 55 and older than 18."

Answered by AI

Are there any potential dangers in taking HSK3486 at a dose of 2?

"Because this is a Phase 1 trial, there is limited data supporting safety and efficacy. Our team rates the safety of Treatment B: HSK3486 dose 2 as a 1."

Answered by AI

Could I possibly qualify to be a subject in this experiment?

"This study is looking for 42 participants that will receive general anesthesia. The age range for candidates is 18 to 55 years old. To be eligible, potential patients must: - Be male or female (females must not be of childbearing potential, postmenopausal, or pregnant) - Have a Body Mass Index between 18 and 30 kg/m2 - Weigh at least 50 kg - Not have any evidence of clinically significant active or chronic disease following medical and surgical history, physical examination including vital signs and 12-lead ECG, hematology, blood chemistry, serology,"

Answered by AI

Are there any enrollees still needed for this experiment?

"The listing on clinicaltrials.gov says that the research team is still enrolling patients for this study. It was first announced on 8/16/2022 and has been updated as recently as 11/7/2022. 1 site will be admitting a total of 42 people into the trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Dose-Finding and Human Abuse Potential Study Of HSK3486 Injection In Nondependent, Recreational Central Nervous System Depressant Users
2022. "Dose-Finding and Human Abuse Potential Study Of HSK3486 Injection In Nondependent, Recreational Central Nervous System Depressant Users". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05614544.
~16 spots leftby Apr 2025
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