Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 5:37 AM
Study NCT ID:
NCT07358858
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-22
First Post:
2026-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Food Effect Study of QLS1410 in Healthy Chinese Adults
Sponsor:
Qilu Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
A Randomized, Open-label, Two-period, Crossover Food Effect Study of QLS1410 in Healthy Chinese Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-01
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:
This study is aimed to evaluate the effect of food on pharmacokinetics of QLS1410 in healthy Chinese adults.
Detailed Description:
All the qualified participants will be randomized (1:1) to two treatment sequences (fed/fasting and fasting/fed). In each period, participants will receive a single dosing of QLS1410 tablets either with or without a high-fat breakfast. There will be a one-week washout period in this study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: