Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-01-16 @ 10:47 PM
Study NCT ID:
NCT06547502
Status:
COMPLETED
Last Update Posted:
2024-12-09
First Post:
2024-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics and Safety Profile of a Single Dose GZR4 in Subjects with Renal Impairment
Sponsor:
Gan and Lee Pharmaceuticals, USA
Organization:
Study Overview
Official Title:
The Study of Pharmacokinetics and Safety of a Single Dose of GZR4 Injection in Subjects with Mild to Moderate Renal Impairment and Subjects with Normal Renal Function
Status:
COMPLETED
Status Verified Date:
2024-12
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 will be conducted to investigated the effect of decreased kidney function on PK and safety of GZR4 and to guide dosing recommendations in people with kidney impairment.
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?:
False
Is an FDA AA801 Violation?: