NCT06589219

Study to Assess CMR316 in Healthy Volunteers and Patients With Idiopathic Pulmonary Fibrosis

A Phase 1/1B Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Nebulized CMR316 in Healthy Volunteers and Patients With Idiopathic Pulmonary Fibrosis

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 106 (estimated)
• Sponsor: Calibr, a division of Scripps Research · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pulmonary Fibroses, Idiopathic

Interventions

Type	Name	Description
DRUG	CMR316	CMR316 administered via nebulization at single or multiple dose(s) assigned by cohort
DRUG	Placebo	Placebo administered via nebulization at single or multiple dose(s) to match CMR316 administration

Timeline

• Start date: 2024-08-19
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2024-09-19
• Last updated: 2025-04-23

Locations

1 site across 1 country: Germany