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

NCT07404306 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: HSK3486-110 Dose Finding
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

General Anesthesia

Outcome Measures

Primary Outcomes (1)

• Dose Determination for use in part 2

  To determine the doses of IV HSK3486 and propofol for use in Part 2, the abuse potential part of the study

  Screening between Day -28 and Day -2; confinement period 3 days in clinic from Day -1 (admission) to 24 hours after study drug administration; follow-up 3 to 7 days after study drug administration

Study Arms (12)

HSK3486 0.1 mg/kg

EXPERIMENTAL

HSK3486 (IV bolus over 30 seconds \[+5 seconds\] from a syringe)

Drug: HSK3486

HSK3486 0.125 mg/kg

EXPERIMENTAL

HSK3486 (IV bolus over 30 seconds \[+5 seconds\] from a syringe)

Drug: HSK3486

HSK3486 0.15 mg/kg

EXPERIMENTAL

HSK3486 (IV bolus over 30 seconds \[+5 seconds\] from a syringe)

Drug: HSK3486

HSK3486 0.175 mg/kg

EXPERIMENTAL

HSK3486 (IV bolus over 30 seconds \[+5 seconds\] from a syringe)

Drug: HSK3486

HSK3486 0.2 mg/kg

EXPERIMENTAL

HSK3486 (IV bolus over 30 seconds \[+5 seconds\] from a syringe)

Drug: HSK3486

HSK3486 0.225 mg/kg

EXPERIMENTAL

HSK3486 (IV bolus over 30 seconds \[+5 seconds\] from a syringe)

Drug: HSK3486

Propofol 0.5 mg/kg

ACTIVE COMPARATOR

Propofol (IV bolus over 30 seconds \[+5 seconds\] from a syringe)

Drug: propofol

Propofol 0.625 mg/kg

ACTIVE COMPARATOR

Propofol (IV bolus over 30 seconds \[+5 seconds\] from a syringe)

Drug: propofol

Propofol 0.675 mg/kg

ACTIVE COMPARATOR

Propofol (IV bolus over 30 seconds \[+5 seconds\] from a syringe)

Drug: propofol

Propofol 0.725 mg/kg

ACTIVE COMPARATOR

Propofol (IV bolus over 30 seconds \[+5 seconds\] from a syringe)

Drug: propofol

Propofol 0.775 mg/kg

ACTIVE COMPARATOR

Propofol (IV bolus over 30 seconds \[+5 seconds\] from a syringe)

Drug: propofol

Placebo

PLACEBO COMPARATOR

Intralipid (IV bolus over 30 seconds \[+5 seconds\] from a syringe)

Drug: Placebo

Interventions

HSK3486 DRUG

HSK3486 for induction of general anesthesia

HSK3486 0.1 mg/kg; HSK3486 0.125 mg/kg; HSK3486 0.15 mg/kg; HSK3486 0.175 mg/kg; HSK3486 0.2 mg/kg; HSK3486 0.225 mg/kg

propofol DRUG

Propofol for induction of general anesthesia

Propofol 0.5 mg/kg; Propofol 0.625 mg/kg; Propofol 0.675 mg/kg; Propofol 0.725 mg/kg; Propofol 0.775 mg/kg

Placebo DRUG

Intralipid

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Willing to participate in the study, give written informed consent, and comply with the study restrictions.
• Gender: male or female; females may be of childbearing potential, of nonchildbearing potential, or postmenopausal.
• Age: 18 years to 55 years, inclusive, at Screening.
• Body mass index (BMI): 18.0 kg/m2 to 30.0 kg/m2, inclusive.
• Weight: ≥50 kg, inclusive.
• 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.
• Subject must be a nondependent, nontreatment-seeking recreational CNS depressant user, defined as follows:
• ≥10 lifetime nontherapeutic experiences (i.e., for psychoactive effects) with CNS depressants (e.g., benzodiazepines, barbiturates, opiates, zolpidem, zopiclone, propofol/fospropofol, gamma-hydroxybutyrate).
• ≥1 nontherapeutic use of a CNS depressant within the 8 weeks prior to screening.
• ≥1 nontherapeutic use of benzodiazepines within the 12 months prior to screening.
• Ability and willingness to abstain from alcohol-, caffeine-, and xanthine-containing beverages or food (e.g., coffee, tea, cola, chocolate, energy drinks) from 48 hours (2 days) prior to first admission to the CRU, throughout the entire study, and until discharge.
• All values for hematology and clinical chemistry tests of blood and urine within the normal range or show no clinically relevant deviations, as judged by the Investigator.
• Females of childbearing potential, and males with female partner(s) of childbearing potential, as judged by the Investigator, must agree to use 2 forms of contraception, 1 of which must be a barrier method, during the study and for 90 days after the last drug administration. Acceptable barrier forms of contraception are condom, cervical cap, and diaphragm. Acceptable non barrier forms of contraception for this study are an intrauterine device (IUD) including hormonal IUDs, oral contraceptives (used for ≥30 days prior to dosing any study treatment), and/or spermicide.
• For females: a negative pregnancy test at Screening and Admission.
• Postmenopausal females: defined as 12 months with no menses prior to Screening and a serum follicle stimulating hormone (FSH) \>40 IU/L at Screening.

You may not qualify if:

• 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).
• 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.
• Opioid dependence as judged by the Investigator after a naloxone challenge.
• Women who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 90 days of last study drug administration.
• 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.
• 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.
• 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.
• 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.
• Any disease which, in the opinion of the Investigator, poses an unacceptable risk to the subjects.
• Mallampati intubation score \>2.
• History of clinically significant drug allergy diagnosed by a physician. Confirmatory circumstances would include treatment with epinephrine or in an emergency department.
• Any personal or family history of issues with succinylcholine, such as malignant hyperthermia or pseudocholinesterase deficiency.
• History of allergy, adverse reaction (including significant agitation, etc.), or hypersensitivity to propofol, lidocaine, other injected anesthetic agents, or related drugs.
• History of allergy to eggs, egg products, soybeans or soy products.
• Heavy smoker (\>20 cigarettes per day) and/or is unable to abstain from smoking and/or the use of prohibited nicotine-containing products (including e-cigarettes, pipes, cigars, chewing tobacco, nicotine topical patches, nicotine gum, or nicotine lozenges) from 2 hours prior to dosing until at least 4 hours postdose during the in-clinic periods.

Sponsors & Collaborators

• Haisco-USA Pharmaceuticals, Inc.: lead

Study Sites (1)

ICON (LPRA) - Salt Lake

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Interventions

HSK3486; Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: All subjects will receive a 2 cc pre-treatment of 1% lidocaine at the injection site to minimize pain associated with study drug administration prior to administration of either HSK3486 or propofol.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: For HSK3486 and propofol dose determination, groups of 4 eligible subjects will receive 1 dose of study drug or propofol. On Day 1, subjects in the first group will receive IV HSK3486 0.1 mg/kg (starting dose) or propofol 0.5 mg/kg (starting dose) administered as a bolus over 30 seconds (+5 seconds) from a syringe. The dose used for succeeding groups will be based on the pharmacodynamic (PD) and safety results of the prior group. The dose used in the next group may be increased, decreased or repeated.

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 11, 2026
• Study Start: August 16, 2022
• Primary Completion: October 3, 2023
• Study Completion: October 3, 2023
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

US (1)