Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Haisco-USA Pharmaceuticals, Inc.
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?To demonstrate HSK3486 0.4/0.2 mg/kg (0.4 mg/kg intravenous \[IV\] slow injection over 30 \[±5\] seconds for the first dose, an additional 0.2 mg/kg if needed) is non-inferior to Propofol 2.0/1.0 mg/kg (2.0 mg/kg IV slow injection over 30 \[±5\] seconds for first dose, an additional 1.0 mg/kg if needed) in success of induction of general anesthesia in adults undergoing elective surgery.
Eligibility Criteria
Adults aged 18+ needing elective surgery with general anesthesia can join. They must be in stable health (ASA-PS I to IV), not pregnant, and agree to use birth control. Excluded are those with recent heart attacks, uncontrolled conditions, severe allergies, or drug abuse.Treatment Details
The trial is testing HSK3486 against Propofol for inducing anesthesia in adults before surgery. Participants will receive an initial dose followed by an additional dose if needed to see if HSK3486 is as effective as Propofol.
2Treatment groups
Experimental Treatment
Active Control
Group I: HSK3486 for general anesthesia inductionExperimental Treatment1 Intervention
HSK3486 for induction of general anesthesia
Group II: Propofol for general anesthesia inductionActive Control1 Intervention
Propofol for induction of general anesthesia
Find a clinic near you
Research locations nearbySelect from list below to view details:
Minnesota Clinical Study CenterMinneapolis, MN
UPMC - Presbyterian/MontefiorePittsburgh, PA
Brigham & Women's HospitalBoston, MA
HD ResearchCarrollton, TX
More Trial Locations
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Who is running the clinical trial?
Haisco-USA Pharmaceuticals, Inc.Lead Sponsor