Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2026-01-01 @ 2:55 AM
Study NCT ID:
NCT05715333
Status:
COMPLETED
Last Update Posted:
2024-11-08
First Post:
2023-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of CM326 Injection in Healthy Subjects
Sponsor:
Keymed Biosciences Co.Ltd
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Immunogenicity of CM326 Injection in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2023-03
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 a single-center, randomized, double-blind, placebo-controlled, dose-increasing phase I clinical study.
Detailed Description:
The purpose of this study is to evaluate the safety, tolerance, pharmacokinetics and immunogenicity of single and multiple subcutaneous administration of CM326 at different doses in healthy male subjects.
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?: