NCT06795204

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

A Randomized, Positive and Placebo-Controlled Study to Evaluate the Effects of HSK3486 Administration on Cardiac Repolarization in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Haisco-USA Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Detailed description

This is a single-center, randomized, blinded (except moxifloxacin hydrochloride tablet), placebo and positive controlled study with a 6-sequence, three-period crossover design in healthy subjects. A blinded design is used for administration of HSK3486 and placebo, and an open-label design is used for moxifloxacin hydrochloride tablet. Subjects meet the including criteria and none of exclusion criteria are randomized in equal proportion to one of 6 dosing sequences (see Table 2 for dosing sequences), and the study procedure consisted of 3 periods, with washout period of 5 days between periods. Subjects are closely monitored on vital sign checking, 12-lead ECG, and Holter collection through out each treatment period.

Conditions

• Anesthesia; Adverse Effect
• Cardiac Arrhythmia

Interventions

Type	Name	Description
DRUG	HSK3486	Study Drug
DRUG	Moxifloxacin Hydrochloride	Positive Control
DRUG	Placebo	Negative Control

Timeline

• Start date: 2024-04-09
• Primary completion: 2024-05-19
• Completion: 2024-11-26
• First posted: 2025-01-27
• Last updated: 2026-01-13
• Results posted: 2026-01-13

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study