NCT06795204

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

Completed Phase 1 Results posted Last updated 13 January 2026

What this trial tests

Phase 1 trial testing HSK3486 in Anesthesia; Adverse Effect in 48 participants. Completed in 26 November 2024.

Timeline

9 April 2024

Primary endpoint
19 May 2024

26 November 2024

Quick facts

Lead sponsor	Haisco-USA Pharmaceuticals, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	48
Start date	9 April 2024
Primary completion	19 May 2024
Estimated completion	26 November 2024
Sites	1 location across China

Drugs / interventions tested

• HSK3486 — full drug profile →
• Moxifloxacin Hydrochloride — full drug profile →
• Placebo

Conditions studied

• Anesthesia; Adverse Effect — all drugs for Anesthesia; Adverse Effect →
• Cardiac Arrhythmia — all drugs for Cardiac Arrhythmia →

Sponsor

Haisco-USA Pharmaceuticals, Inc. — full company profile →

Who can join

Adults 18 to 45, any sex, with Anesthesia; Adverse Effect or Cardiac Arrhythmia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change-from-baseline in QTc Interval Primary · From the base line ECG (D-2) to end of the period, up to 24 hours post-dose

Corrected for HR using the individual QT correction method (QTcI) - ΔQTcI

30s post-dose

Group	Value	95% CI
C (Study Drug)	2.1	0.46 – 3.74
B (Positive Control)	5.1	2.96 – 7.29
A (Placebo)	-0.1	-1.70 – 1.41

1 min post-dose

Group	Value	95% CI
C (Study Drug)	4.1	2.07 – 6.12
B (Positive Control)	-4.4	-6.46 – -2.42
A (Placebo)	0.0	-1.89 – 1.96

2 min post-dose

Group	Value	95% CI
C (Study Drug)	-3.1	-4.24 – -1.90
B (Positive Control)	-7.7	-8.88 – -6.56
A (Placebo)	-3.1	-4.24 – -1.91

3 min post-dose

Group	Value	95% CI
C (Study Drug)	-0.1	-1.24 – 0.97
B (Positive Control)	-4.4	-5.51 – -3.33
A (Placebo)	-0.9	-2.02 – 0.15

5 min post-dose

Group	Value	95% CI
C (Study Drug)	4.4	3.33 – 5.46
B (Positive Control)	-3.0	-4.05 – -1.93
A (Placebo)	0.4	-0.70 – 1.41

8 min post-dose

Group	Value	95% CI
C (Study Drug)	5.1	3.97 – 6.23
B (Positive Control)	-1.3	-2.42 – -0.19
A (Placebo)	1.0	-0.13 – 2.11

10 min post-dose

Group	Value	95% CI
C (Study Drug)	4.7	3.51 – 5.82
B (Positive Control)	-2.9	-4.06 – -1.78
A (Placebo)	0.8	-0.30 – 1.99

15 min post-dose

Group	Value	95% CI
C (Study Drug)	3.3	2.33 – 4.26
B (Positive Control)	-3.7	-4.63 – -2.72
A (Placebo)	0.6	-0.33 – 1.59

Adverse events — posted to ClinicalTrials.gov

Time frame: From Screen period ( day -21) to 7±1 day after the last dose. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

HSK3486( Study Drug)

Serious: 0/48 (0%)

Deaths: 0/48

Placebo

Serious: 0/48 (0%)

Deaths: 0/48

Moxifloxacin Hydrochloride

Serious: 0/48 (0%)

Deaths: 0/48

Other adverse events (7 terms — click to expand)

Reaction	System	HSK3486( Study Drug)	Placebo	Moxifloxacin Hydrochloride
Neutrophil count decreased	Investigations	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—
White blood cell counts decreased	Investigations	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Blood creatine phosphokinase increased	Investigations	—	—	—
Blood thyroid stimulating hormone decreased	Investigations	—	—	—

Data from ClinicalTrials.gov NCT06795204 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.