Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2026-01-11 @ 5:29 AM
Study NCT ID:
NCT06830395
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-19
First Post:
2025-02-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of CM313 in Subject With IgA Nephropathy
Sponsor:
Keymed Biosciences Co.Ltd
Organization:
Study Overview
Official Title:
A Phase II Clinical Study to Evaluate the Safety and Efficacy of CM313 (SC) Injection in Subjects With Primary IgA Nephropathy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
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 divided into two parts (Part A and Part B). This study aims to evaluate the safety and efficacy of CM313 in subjects with primary Immunoglobulin A nephropathy(IgAN), while also observing its Pharmacokinetics(PK) characteristics, Pharmacokinetics(PD) effects, and immunogenicity.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?: