Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06589219
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Study to Assess CMR316 in Healthy Volunteers and Patients With Idiopathic Pulmonary Fibrosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 11B Study to Assess Safety Tolerability Pharmacokinetics and Pharmacodynamics of Nebulized CMR316 in Healthy Volunteers and Patients With Idiopathic Pulmonary Fibrosis
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:
None
Brief Summary:
The purpose of this study is to assess the safety tolerability and pharmacokinetics single and multiple inhaled doses of CMR316 in healthy volunteers and patients with Idiopathic Pulmonary Fibrosis IPF
Detailed Description:
This is a 3-part single-center study Part 1 will evaluate single ascending doses SAD and Part 2 will evaluate multiple ascending doses MAD once weekly dosing for 4 weeks of nebulized CMR316 or placebo in healthy male and female subjects Part 3 will assess multiple doses once weekly dosing for 4 weeks of nebulized CMR316 open-label in subjects with IPF
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