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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
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• Healthy men or non-pregnant, non-lactating healthy women of non-childbearing potential, 18-60 years of age.

• Must agree to use a highly effective method of contraception.

• Body Mass Index (BMI) 18-33 kg/m2 as measured at screening.

• Weight ≤100 kg at screening.

• Normal lung function, defined as: FVC and FEV1 \> 80% predicted (based on age, height, race, sex, SaO2 \> 95% on room air.

• Heart rate between 50 and 90 beats per minute (BPM).

• Good state of health (mentally and physically) as indicated by a comprehensive clinical assessment (detailed medical history and a complete physical examination) and screening safety procedures.

• Diagnosis of IPF by American Thoracic Society/ERS (European Respiratory Society)/JRS (Japanese Respiratory Society)/ALAT (Latin America Thoracic Society) 2011 criteria within five years prior to consent.

• Men or non-pregnant, non-lactating women of non-childbearing potential.

• Age ≥ 40 years.

• Mild to moderate IPF as defined by predicted FVC ≥ 55% of normal and predicted DLCO \> 40% of normal at Screening.

• Subjects receiving oral pirfenidone or nintedanib for treatment of IPF may participate if they have been on treatment with a stable, well-tolerated dose (as determined by the investigator), for at least 8 weeks prior to consent with no changes to therapy dose and schedule anticipated during the course of study participation.

• Must be able to understand a written informed consent, which must be obtained prior to any study procedures.

• Must be willing and able to comply with all study requirements

Locations
Other Locations
Germany
Fraunhofer Institute for Toxicology and Experimental Medicine ITEM
RECRUITING
Hanover
Contact Information
Primary
Nathalie Luis
nluis@scripps.edu
Backup
Alex Brooks
abrooks@scripps.edu
858-242-1000
Time Frame
Start Date: 2024-08-19
Estimated Completion Date: 2026-03
Participants
Target number of participants: 106
Treatments
Active_comparator: Part 1 SAD CMR316
Single ascending dose, nebulized administration of CMR316
Placebo_comparator: Part 1 SAD Placebo
Single ascending dose, nebulized administration of matching placebo
Active_comparator: Part 2 MAD CMR316
Multiple ascending dose, nebulized administration of CMR316 once weekly for 4 weeks
Placebo_comparator: Part 2 MAD Placebo
Multiple ascending dose, nebulized administration of matching placebo once weekly for 4 weeks
Experimental: Part 3 IPF Patients
Open-label, nebulized administration of CMR316 once weekly for 4 weeks for patients with IPF
Sponsors
Leads: Calibr, a division of Scripps Research

This content was sourced from clinicaltrials.gov