HSK3486 for general anesthesia induction for General Anesthesia

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
General Anesthesia
HSK3486 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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.

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 15 minutes from end of drug administration

15 minutes from end of drug administration
Proportion of subjects with successful induction who maintain the desired depth of anesthesia for general elective surgery, AND without significant cardiac and respiratory depression
From start of the drug administration to MOAA/S ≤1 (up to 3 minutes)
Proportion of subjects with any injection-site pain on Numeric Rating Scale
From the time of study drug administration to desired depth of anesthesia to MOAA/S≤1( up to 5 minutes)
Success rate of general anesthesia induction

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Propofol for general anesthesia induction
1 of 2
HSK3486 for general anesthesia induction
1 of 2
Active Control
Experimental Treatment

399 Total Participants · 2 Treatment Groups

Primary Treatment: HSK3486 for general anesthesia induction · No Placebo Group · Phase 3

HSK3486 for general anesthesia induction
Drug
Experimental Group · 1 Intervention: HSK3486 · Intervention Types: Drug
Propofol for general anesthesia induction
Drug
ActiveComparator Group · 1 Intervention: Propofol · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HSK3486
2019
Completed Phase 3
~1630

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 15 minutes from end of drug administration

Who is running the clinical trial?

Haisco-USA Pharmaceuticals, Inc.Lead Sponsor
3 Previous Clinical Trials
702 Total Patients Enrolled
2 Trials studying General Anesthesia
441 Patients Enrolled for General Anesthesia

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Patients aged 18 to 65 years old, with ASA-PS I to IV (Appendix6)
You are of childbearing potential and are willing to use birth control for 30 days post study drug administration.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 17th, 2021

Last Reviewed: October 9th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.