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

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
Haisco-USA Pharmaceuticals, Inc.
Study ID
NCT07404306
Phase
PHASE1
Status
Completed

Conditions

  • General Anesthesia

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • HSK3486 — DRUG
    HSK3486 for induction of general anesthesia
  • propofol — DRUG
    Propofol for induction of general anesthesia
  • Placebo — DRUG
    Intralipid

Study Details

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.

Key Dates

Start date
Aug 16, 2022
Status verified
Feb 2026
Primary completion
Oct 3, 2023
Completion
Oct 3, 2023

Study Design

Enrollment
43 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: HSK3486 0.1 mg/kg
    HSK3486 (IV bolus over 30 seconds \[+5 seconds\] from a syringe)
  • Experimental: HSK3486 0.125 mg/kg
    HSK3486 (IV bolus over 30 seconds \[+5 seconds\] from a syringe)
  • Experimental: HSK3486 0.15 mg/kg
    HSK3486 (IV bolus over 30 seconds \[+5 seconds\] from a syringe)
  • Experimental: HSK3486 0.175 mg/kg
    HSK3486 (IV bolus over 30 seconds \[+5 seconds\] from a syringe)
  • Experimental: HSK3486 0.2 mg/kg
    HSK3486 (IV bolus over 30 seconds \[+5 seconds\] from a syringe)
  • Experimental: HSK3486 0.225 mg/kg
    HSK3486 (IV bolus over 30 seconds \[+5 seconds\] from a syringe)
  • Active Comparator: Propofol 0.5 mg/kg
    Propofol (IV bolus over 30 seconds \[+5 seconds\] from a syringe)
  • Active Comparator: Propofol 0.625 mg/kg
    Propofol (IV bolus over 30 seconds \[+5 seconds\] from a syringe)
  • Active Comparator: Propofol 0.675 mg/kg
    Propofol (IV bolus over 30 seconds \[+5 seconds\] from a syringe)
  • Active Comparator: Propofol 0.725 mg/kg
    Propofol (IV bolus over 30 seconds \[+5 seconds\] from a syringe)
  • Active Comparator: Propofol 0.775 mg/kg
    Propofol (IV bolus over 30 seconds \[+5 seconds\] from a syringe)
  • Placebo Comparator: Placebo
    Intralipid (IV bolus over 30 seconds \[+5 seconds\] from a syringe)

Primary Outcome Measure

Dose Determination for use in part 2 [ Time Frame: 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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
ICON (LPRA) - Salt LakeSalt Lake CityUtah84124-

Find similar trials in Salt Lake City, UT

By research site
ICON (LPRA) - Salt Lake· Salt Lake City, UT

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