Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06329401
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-03-12
Brief Title:
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Sponsor:
Avalyn Pharma Inc
Organization:
Avalyn Pharma Inc
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Phase 2b Study Evaluating the Safety and Efficacy of Pirfenidone Solution for Inhalation AP01 in Participants With PPF
Status:
RECRUITING
Status Verified Date:
2024-04
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:
A randomized double-blind placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of inhaled pirfenidone AP01 versus placebo on top of standard of care in participants with PPF over 52 weeks
Detailed Description:
This is a randomized double-blind placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of AP01 pirfenidone solution for inhalation versus placebo on top of standard of care in participants with PPF over 52 weeks Up to 300 eligible participants will be randomized to 1 of 3 treatment arms AP01 high dose AP01 low dose or placebo
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