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NCT05478174 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of HSK3486 Compared to Propofol for Adults Undergoing Elective Surgery With General Anesthesia
A Phase 3 study, sponsored by Haisco-USA Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 400
- Enrollment target
NCT05478174: Completed Phase 3 study, sponsored by Haisco-USA Pharmaceuticals.
NCT05478174 is a Phase 3 study that has completed, run by Haisco-USA Pharmaceuticals. The registered enrollment target is 400 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05478174, a Phase 3 study, has completed, sponsored by Haisco-USA Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 400 participants
- Enrollment target
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.
Primary Outcome
1. Induction success (MOAA/S ≤1) after administration of the study drug, and 2. One or less top-up doses required without using any rescue drugs.
Interventions
- DRUG Propofol
- DRUG HSK3486
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2022-07-26 |
| Est. Completion | 2023-11-14 |
| Phase | Phase 3 |
What the finished NCT05478174 record still lists
NCT05478174 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 2 interventions - of which Propofol is the first listed.
NCT05478174 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05478174 about?
NCT05478174 is a clinical study titled "Efficacy and Safety of HSK3486 Compared to Propofol for Adults Undergoing Elective Surgery With General Anesthesia". 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 nee...
What is the current status of trial NCT05478174?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2022-07-26. Estimated completion is 2023-11-14.
What interventions are being tested in trial NCT05478174?
The interventions under investigation include: Propofol (DRUG), HSK3486 (DRUG).
Who is sponsoring clinical trial NCT05478174?
This trial is sponsored by Haisco-USA Pharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05478174's enrollment target sits among peer trials
400 922nd of 2000 higher than 1,039 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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