Trial Outcomes & Findings for Effects of HSK3486 on Cardiac Repolarization in Health Subjects (TQT) (NCT NCT06795204)
NCT ID: NCT06795204
Last Updated: 2026-01-13
Results Overview
Corrected for HR using the individual QT correction method (QTcI) - ΔQTcI
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
From the base line ECG (D-2) to end of the period, up to 24 hours post-dose
Results posted on
2026-01-13
Participant Flow
A total of 175 subjects were screened in this study, 112 subjects failed screening, 3 subjects did not complete all procedures or assessments for inclusion and exclusion criteria, 48 subjects were randomized, and all 48 subjects completed the study.
Participant milestones
| Measure |
Sequence 1: C-B-A
C: HSK3486 0.4 mg/kg (Study drug) B: Moxifloxacin hydrochloride tablet 0.4g (Positive control) A: Placebo (HSK3486 simulator) (Negative control)
|
Sequence 2: A-B-C
A: Placebo (HSK3486 simulator) (Negative control) B: Moxifloxacin hydrochloride tablet 0.4g (Positive control) C: HSK3486 0.4 mg/kg (Study drug)
|
Sequence 3: B-C-A
B: Moxifloxacin hydrochloride tablet 0.4g (Positive control) C: HSK3486 0.4 mg/kg (Study drug) A: Placebo (HSK3486 simulator) (Negative control)
|
Sequence 4: C-A-B
C: HSK3486 0.4 mg/kg (Study drug) A: Placebo (HSK3486 simulator) (Negative control) B: Moxifloxacin hydrochloride tablet 0.4g (Positive control)
|
Sequence 5: A-C-B
A: Placebo (HSK3486 simulator) (Negative control) C: HSK3486 0.4 mg/kg (Study drug) B: Moxifloxacin hydrochloride tablet 0.4g (Positive control)
|
Sequence 6: B-A-C
B: Moxifloxacin hydrochloride tablet 0.4g (Positive control) A: Placebo (HSK3486 simulator) (Negative control) C: HSK3486 0.4 mg/kg (Study drug)
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of HSK3486 on Cardiac Repolarization in Health Subjects (TQT)
Baseline characteristics by cohort
| Measure |
Sequence 1: C-B-A
n=8 Participants
C: HSK3486 0.4 mg/kg (Study drug) B: Moxifloxacin hydrochloride tablet 0.4g (Positive control) A: Placebo (HSK3486 simulator) (Negative control)
|
Sequence 2: A-B-C
n=8 Participants
A: Placebo (HSK3486 simulator) (Negative control) B: Moxifloxacin hydrochloride tablet 0.4g (Positive control) C: HSK3486 0.4 mg/kg (Study drug)
|
Sequence 3: B-C-A
n=8 Participants
B: Moxifloxacin hydrochloride tablet 0.4g (Positive control) C: HSK3486 0.4 mg/kg (Study drug) A: Placebo (HSK3486 simulator) (Negative control)
|
Sequence 4: C-A-B
n=8 Participants
C: HSK3486 0.4 mg/kg (Study drug) A: Placebo (HSK3486 simulator) (Negative control) B: Moxifloxacin hydrochloride tablet 0.4g (Positive control)
|
Sequence 5: A-C-B
n=8 Participants
A: Placebo (HSK3486 simulator) (Negative control) C: HSK3486 0.4 mg/kg (Study drug) B: Moxifloxacin hydrochloride tablet 0.4g (Positive control)
|
Sequence 6: B-A-C
n=8 Participants
B: Moxifloxacin hydrochloride tablet 0.4g (Positive control) A: Placebo (HSK3486 simulator) (Negative control) C: HSK3486 0.4 mg/kg (Study drug)
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
Age (Years)
|
34.3 Years
STANDARD_DEVIATION 4.77 • n=210 Participants
|
31.1 Years
STANDARD_DEVIATION 4.94 • n=19 Participants
|
30.9 Years
STANDARD_DEVIATION 3.56 • n=123 Participants
|
31.0 Years
STANDARD_DEVIATION 5.76 • n=123 Participants
|
31.6 Years
STANDARD_DEVIATION 5.26 • n=615 Participants
|
34.9 Years
STANDARD_DEVIATION 5.00 • n=20 Participants
|
32.3 Years
STANDARD_DEVIATION 4.94 • n=13 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=210 Participants
|
2 Participants
n=19 Participants
|
1 Participants
n=123 Participants
|
1 Participants
n=123 Participants
|
0 Participants
n=615 Participants
|
2 Participants
n=20 Participants
|
8 Participants
n=13 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=210 Participants
|
6 Participants
n=19 Participants
|
7 Participants
n=123 Participants
|
7 Participants
n=123 Participants
|
8 Participants
n=615 Participants
|
6 Participants
n=20 Participants
|
40 Participants
n=13 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=615 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=210 Participants
|
8 Participants
n=19 Participants
|
8 Participants
n=123 Participants
|
8 Participants
n=123 Participants
|
8 Participants
n=615 Participants
|
8 Participants
n=20 Participants
|
48 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=615 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=615 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=615 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=615 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=615 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=13 Participants
|
|
Baseline BMI
|
22.74 kg/m2
STANDARD_DEVIATION 0.964 • n=210 Participants
|
22.81 kg/m2
STANDARD_DEVIATION 2.017 • n=19 Participants
|
22.88 kg/m2
STANDARD_DEVIATION 1.429 • n=123 Participants
|
21.41 kg/m2
STANDARD_DEVIATION 0.777 • n=123 Participants
|
23.58 kg/m2
STANDARD_DEVIATION 1.296 • n=615 Participants
|
22.70 kg/m2
STANDARD_DEVIATION 1.9777 • n=20 Participants
|
22.69 kg/m2
STANDARD_DEVIATION 1.546 • n=13 Participants
|
PRIMARY outcome
Timeframe: From the base line ECG (D-2) to end of the period, up to 24 hours post-doseCorrected for HR using the individual QT correction method (QTcI) - ΔQTcI
Outcome measures
| Measure |
C (Study Drug)
n=48 Participants
HSK3486 0.4 mg/kg (Study drug)
|
B (Positive Control)
n=48 Participants
Moxifloxacin hydrochloride tablet 0.4g (Positive control)
|
A (Placebo)
n=48 Participants
(HSK3486 simulator) (Negative control)
|
|---|---|---|---|
|
Change-from-baseline in QTc Interval
5 min post-dose
|
4.4 ms
Interval 3.33 to 5.46
|
-3.0 ms
Interval -4.05 to -1.93
|
0.4 ms
Interval -0.7 to 1.41
|
|
Change-from-baseline in QTc Interval
8 min post-dose
|
5.1 ms
Interval 3.97 to 6.23
|
-1.3 ms
Interval -2.42 to -0.19
|
1.0 ms
Interval -0.13 to 2.11
|
|
Change-from-baseline in QTc Interval
10 min post-dose
|
4.7 ms
Interval 3.51 to 5.82
|
-2.9 ms
Interval -4.06 to -1.78
|
0.8 ms
Interval -0.3 to 1.99
|
|
Change-from-baseline in QTc Interval
15 min post-dose
|
3.3 ms
Interval 2.33 to 4.26
|
-3.7 ms
Interval -4.63 to -2.72
|
0.6 ms
Interval -0.33 to 1.59
|
|
Change-from-baseline in QTc Interval
30 min post-dose
|
1.0 ms
Interval 0.16 to 1.82
|
-1.6 ms
Interval -2.4 to -0.76
|
0.4 ms
Interval -0.38 to 1.25
|
|
Change-from-baseline in QTc Interval
1 h post-dose
|
-0.1 ms
Interval -1.22 to 1.12
|
5.2 ms
Interval 4.06 to 6.38
|
0.5 ms
Interval -0.62 to 1.7
|
|
Change-from-baseline in QTc Interval
2 h post-dose
|
1.1 ms
Interval -0.07 to 2.34
|
10.0 ms
Interval 8.8 to 11.2
|
1.3 ms
Interval 0.08 to 2.46
|
|
Change-from-baseline in QTc Interval
4h post-dose
|
2.6 ms
Interval 1.3 to 3.84
|
14.8 ms
Interval 13.55 to 16.09
|
3.0 ms
Interval 1.75 to 4.27
|
|
Change-from-baseline in QTc Interval
6h post-dose
|
-1.0 ms
Interval -2.98 to 0.93
|
8.0 ms
Interval 6.1 to 9.97
|
-0.9 ms
Interval -2.86 to 1.03
|
|
Change-from-baseline in QTc Interval
8h post-dose
|
-1.7 ms
Interval -3.58 to 0.17
|
7.4 ms
Interval 5.58 to 9.29
|
1.12 ms
Interval -2.41 to 1.3
|
|
Change-from-baseline in QTc Interval
12h post-dose
|
-0.9 ms
Interval -2.7 to 0.91
|
6.2 ms
Interval 4.36 to 7.95
|
0.8 ms
Interval -1.03 to 2.55
|
|
Change-from-baseline in QTc Interval
24h post-dose
|
-0.7 ms
Interval -2.18 to 0.72
|
7.3 ms
Interval 5.85 to 8.74
|
0.1 ms
Interval -1.35 to 1.52
|
|
Change-from-baseline in QTc Interval
1 min post-dose
|
4.1 ms
Interval 2.07 to 6.12
|
-4.4 ms
Interval -6.46 to -2.42
|
0.0 ms
Interval -1.89 to 1.96
|
|
Change-from-baseline in QTc Interval
2 min post-dose
|
-3.1 ms
Interval -4.24 to -1.9
|
-7.7 ms
Interval -8.88 to -6.56
|
-3.1 ms
Interval -4.24 to -1.91
|
|
Change-from-baseline in QTc Interval
3 min post-dose
|
-0.1 ms
Interval -1.24 to 0.97
|
-4.4 ms
Interval -5.51 to -3.33
|
-0.9 ms
Interval -2.02 to 0.15
|
|
Change-from-baseline in QTc Interval
3h post-dose
|
0.5 ms
Interval -0.75 to 1.77
|
13.2 ms
Interval 11.99 to 14.5
|
0.9 ms
Interval -0.38 to 2.11
|
|
Change-from-baseline in QTc Interval
30s post-dose
|
2.1 ms
Interval 0.46 to 3.74
|
5.1 ms
Interval 2.96 to 7.29
|
-0.1 ms
Interval -1.7 to 1.41
|
Adverse Events
HSK3486( Study Drug)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Moxifloxacin Hydrochloride
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
HSK3486( Study Drug)
n=48 participants at risk
One time, 0.4 mg/kg, IV bolus administration for 30 (±5) seconds
|
Placebo
n=48 participants at risk
One time, IV bolus administration for 30 (±5) seconds
|
Moxifloxacin Hydrochloride
n=48 participants at risk
One time, 0.4 g oral administration with 240 mL of warm water on an empty stomach.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/48 • From Screen period ( day -21) to 7±1 day after the last dose
|
0.00%
0/48 • From Screen period ( day -21) to 7±1 day after the last dose
|
2.1%
1/48 • From Screen period ( day -21) to 7±1 day after the last dose
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/48 • From Screen period ( day -21) to 7±1 day after the last dose
|
0.00%
0/48 • From Screen period ( day -21) to 7±1 day after the last dose
|
2.1%
1/48 • From Screen period ( day -21) to 7±1 day after the last dose
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/48 • From Screen period ( day -21) to 7±1 day after the last dose
|
0.00%
0/48 • From Screen period ( day -21) to 7±1 day after the last dose
|
2.1%
1/48 • From Screen period ( day -21) to 7±1 day after the last dose
|
|
Investigations
White blood cell counts decreased
|
2.1%
1/48 • From Screen period ( day -21) to 7±1 day after the last dose
|
0.00%
0/48 • From Screen period ( day -21) to 7±1 day after the last dose
|
0.00%
0/48 • From Screen period ( day -21) to 7±1 day after the last dose
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/48 • From Screen period ( day -21) to 7±1 day after the last dose
|
0.00%
0/48 • From Screen period ( day -21) to 7±1 day after the last dose
|
2.1%
1/48 • From Screen period ( day -21) to 7±1 day after the last dose
|
|
Investigations
Alanine aminotransferase increased
|
2.1%
1/48 • From Screen period ( day -21) to 7±1 day after the last dose
|
0.00%
0/48 • From Screen period ( day -21) to 7±1 day after the last dose
|
0.00%
0/48 • From Screen period ( day -21) to 7±1 day after the last dose
|
|
Investigations
Neutrophil count decreased
|
4.2%
2/48 • From Screen period ( day -21) to 7±1 day after the last dose
|
0.00%
0/48 • From Screen period ( day -21) to 7±1 day after the last dose
|
2.1%
1/48 • From Screen period ( day -21) to 7±1 day after the last dose
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place