Ignite Creation Date:
2024-07-17 @ 10:45 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06496620
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-07-03
Brief Title:
A Study to Evaluate Solrikitug in Participants With COPD ZION
Sponsor:
Uniquity One UNI
Organization:
Uniquity One UNI
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Multiple Dose-Ranging Study to Assess the Safety Tolerability Pharmacokinetics and Pharmacodynamics of Solrikitug in Participants With Chronic Obstructive Pulmonary Disease ZION
Status:
RECRUITING
Status Verified Date:
2024-09
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:
ZION
Brief Summary:
A Randomized Double-blind Placebo-controlled Multiple Dose-Ranging Study to Assess the Safety Tolerability Pharmacokinetics and Pharmacodynamics of Solrikitug in Participants with Chronic Obstructive Pulmonary Disease COPD
Detailed Description:
This is a 12-week randomized double-blind placebo-controlled clinical study to evaluate the safety tolerability PK immunogenicity and pharmacodynamics of 2 dose levels of solrikitug versus placebo on top of standard of care in participants with COPD
Approximately 135 eligible participants with COPD will be randomized at approximately 30 sites Participants will receive solrikitug or placebo administered via subcutaneous injection at the study site over a 12-week treatment period The study also includes a post-treatment follow-up period of 16 weeks
Approximately 135 eligible participants with COPD will be randomized at approximately 30 sites Participants will receive solrikitug or placebo administered via subcutaneous injection at the study site over a 12-week treatment period The study also includes a post-treatment follow-up period of 16 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?:
None