Effects of HSK3486 on Cardiac Repolarization in Health Subjects (TQT)

Phase 1 Completed 48 enrolled Haisco-USA Pharmaceuticals, Inc.

RandomizedCrossoverQuadruple-blindTreatment

Summary

To assess the effects of a single IV bolus of HSK3486 single dose on cardiac repolarization (QTc interval of the electrocardiogram, and to evaluate the safety and tolerability of a single IV bolus of HSK3486 in healthy subjects

Timeline

Start: 2024-04-09
Primary completion: 2024-05-19
Completion: 2024-11-26

Outcome

Met primary endpoint

paper The upper bound of the two-sided 90% confidence interval for ΔΔQTcI interval remained < 10 milliseconds at all post-dose timepoints. PMID 41858914 ↗

registry analysis (non-inferiority test); C (Study Drug) vs A (Placebo); p <0.05; Mean Difference (Final Values) 4.10 (90% CI 1.29 to 6.82); Mixed Models Analysis NCT06795204 ↗

Publications

Kleiman R, Rudo T, Daley W, Hu M, Yan P, Zhou R, Hou J. Effects of Cipepofol on Cardiac Depolarization and Repolarization in Healthy Subjects: A Single-Center, Randomized, Placebo and Positive-Controlled Thorough QT Study. Drug Des Devel Ther. 2026 Jan 14;20:565051. doi: 10.2147/DDDT.S565051. eCollection 2026.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cipepofol	Small molecule	0.4 mg/kg	Intravenous
Comparator	Moxifloxacin	Small molecule	0.4 g	Oral