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Part 1: Dose-Finding of HSK3486 Injection In Nondependent, Recreational Central Nervous System Depressant Users | Clinical Trials | Clareo Health

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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

NCT07404306•Haisco-USA Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•The following criteria must be met for a subject to be eligible for inclusion in the study:
•1. Willing to participate in the study, give written informed consent, and comply with the study restrictions.
•2. Gender: male or female; females may be of childbearing potential, of nonchildbearing potential, or postmenopausal.
•3. Age: 18 years to 55 years, inclusive, at Screening.
•4. Body mass index (BMI): 18.0 kg/m2 to 30.0 kg/m2, inclusive.
•5. Weight: ≥50 kg, inclusive.
•6. Healthy subject, defined by the absence of evidence of any clinically significant, in the opinion of the Investigator, active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology, and urinalysis.
•7. Subject must be a nondependent, nontreatment-seeking recreational CNS depressant user, defined as follows:
•1. ≥10 lifetime nontherapeutic experiences (i.e., for psychoactive effects) with CNS depressants (e.g., benzodiazepines, barbiturates, opiates, zolpidem, zopiclone, propofol/fospropofol, gamma-hydroxybutyrate).
•2. ≥1 nontherapeutic use of a CNS depressant within the 8 weeks prior to screening.
+9 more criteria

Exclusion Criteria

•A subject who meets any of the following criteria will not be eligible for inclusion in the study:
•1. An employee of the Sponsor or research site personnel directly affiliated with this study or their immediate family member (defined as a spouse, parent, child, or sibling, whether biological or legally adopted).
•2. Drug or alcohol dependence within the 2 years prior to Screening (except nicotine and caffeine), as defined by the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision (DSM-IV-TR), and/or has ever participated or plans to participate in a substance or alcohol rehabilitation program to treat their substance or alcohol dependence.
•3. Opioid dependence as judged by the Investigator after a naloxone challenge.
•4. Women who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 90 days of last study drug administration.
•5. Males with female partners who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 90 days of last study drug administration.
•6. Positive drug and alcohol screen (tetrahydrocannabinol \[THC\], morphine/opiates, methadone, oxycodone, phencyclidine, cocaine, amphetamines, methamphetamines, ecstasy, barbiturates, benzodiazepines, tricyclic antidepressants, and alcohol) at each admission to the CRU. For THC, subjects should ideally test negative. However, eligibility decision with regards to THC use will be considered on a case by case basis, at the discretion of the Investigator.
•7. Treatment with an investigational drug or device within 5 times the elimination half-life, if known (e.g., a marketed product) or within 30 days (if the elimination half-life is unknown) prior to first drug administration or is concurrently enrolled in any research judged not to be scientifically or medically compatible with this study. An exception may be made for subjects who participated in Part 1 of the study.
•8. History or presence of clinically significant abnormality (e.g., obstructive sleep apnea) as assessed by physical examination, medical history, ECG, vital signs, or laboratory values, which, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.
•9. Any disease which, in the opinion of the Investigator, poses an unacceptable risk to the subjects.
+25 more criteria

Locations (1)

ICON (LPRA) - Salt Lake

Salt Lake City, Utah, United States

Key Dates

Start Date

August 16, 2022

Primary Completion Date

October 3, 2023

Completion Date

October 3, 2023

Last Updated

February 23, 2026

Enrollment

ACTUAL participants

Conditions

General Anesthesia

Interventions

HSK3486

DRUG

propofol

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 23, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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