Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT06795204
Status:
COMPLETED
Last Update Posted:
2025-01-30
First Post:
2025-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of HSK3486 on Cardiac Repolarization in Health Subjects (TQT)
Sponsor:
Haisco-USA Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
A Randomized, Positive and Placebo-Controlled Study to Evaluate the Effects of HSK3486 Administration on Cardiac Repolarization in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: