Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06547333
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
A Study of CM310 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of CM310 Recombinant Humanized Monoclonal Antibody Injection in Subjects With Moderate to Severe Chronic Obstructive Pulmonary DiseaseCOPD
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a multi-center randomized double-blind placebo-controlled Phase ⅡⅢ clinical study to evaluate the efficacy safety PK characteristics PD effects and immunogenicity of CM310 in subjects with moderate to severe Chronic Obstructive Pulmonary DiseaseCOPD
The study has two parts Each part consists of three periods including an up to 4-week screening period a 52-week randomized treatment period and a 8-week safety follow-up period
The study has two parts Each part consists of three periods including an up to 4-week screening period a 52-week randomized treatment period and a 8-week safety follow-up period
Detailed Description:
The study has two parts Each part consists of three periods including an up to 4-week screening period a 52-week randomized treatment period and a 8-week safety follow-up period During the first part patients who meet eligibility criteria will be randomized 111 to receive either CM310 300 mg CM310 150mg or matched placebo subcutaneously every two weeks Q2W for a total of 26 times at the double-blind treatment period An interim analysis will be performed and an optimal dose will be recommended During the second part patients will be randomized 11 to receive either CM310 optimal dose or matched placebo subcutaneously at the double-blind treatment period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None