Ignite Creation Date:
2025-12-24 @ 4:48 PM
Ignite Modification Date:
2025-12-28 @ 5:21 PM
Study NCT ID:
NCT07119450
Status:
COMPLETED
Last Update Posted:
2025-11-21
First Post:
2025-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Study of [14C] GZR18
Sponsor:
Gan & Lee Pharmaceuticals.
Organization:
Study Overview
Official Title:
A Mass Balance Study of [14C] GZR18 in Chinese Overweight or Obese Male Subjects
Status:
COMPLETED
Status Verified Date:
2025-10
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 trial is a Single-center, non-randomized, open-label, single-dose Mass Balance Study.
The study period of each subject consists of a screening period (D-21 to D-2), a baseline period (D-2 to D-1), a dosing and routine collection period (D1 to D36) and an intermittent collection and follow-up period (D36 to D78, during which subjects should visit the hospital once a week, 6 visits in total).
The study period of each subject consists of a screening period (D-21 to D-2), a baseline period (D-2 to D-1), a dosing and routine collection period (D1 to D36) and an intermittent collection and follow-up period (D36 to D78, during which subjects should visit the hospital once a week, 6 visits in total).
Detailed Description:
None
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?: