Actively Recruiting
Study to Assess CMR316 in Healthy Volunteers and Patients With Idiopathic Pulmonary Fibrosis
Led by Calibr, a division of Scripps Research · Updated on 2025-04-23
106
Participants Needed
1
Research Sites
79 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Study to Assess CMR316 in Healthy Volunteers and Patients With Idiopathic Pulmonary Fibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy men or non-pregnant, non-lactating healthy women of non-childbearing potential, aged 18 to 60 years
- Agree to use a highly effective method of contraception
- Body Mass Index (BMI) between 18 and 33 kg/m2
- Weight 100 kg or less at screening
- Normal lung function with FVC and FEV1 above 80% predicted and oxygen saturation above 95% on room air
- Heart rate between 50 and 90 beats per minute
- Good mental and physical health as confirmed by medical history and physical exam
- Diagnosis of IPF within five years prior to consent for Part 3
- Age 40 years or older for Part 3
- Mild to moderate IPF with predicted FVC 55% or more and DLCO above 40% at screening
- Stable treatment with oral pirfenidone or nintedanib for at least 8 weeks prior to consent for Part 3
- Able to understand and willing to comply with study requirements
You will not qualify if you...
- Serious adverse reaction or hypersensitivity to any drug or formulation ingredients
- History of significant allergies or hypersensitivity reactions
- Clinically significant cardiovascular, skin, kidney, liver, lung, gastrointestinal, neurological, or psychiatric illness within 30 days prior to dosing
- Poor venous access limiting blood draws
- Elevated liver enzymes or bilirubin above normal limits except Gilbert Syndrome
- Positive tests for hepatitis B, hepatitis C, or HIV
- Renal impairment with creatinine clearance below 90 mL/min for Parts 1 and 2 or below 50 mL/min for Part 3
- Corrected QT interval above 450 msec at screening
- Positive pregnancy test or currently pregnant or lactating
- Participation in another clinical trial within 30 days or 5 half-lives prior to dosing
- Recent use of over-the-counter or prescribed medications that conflict with study requirements
- History of substance or alcohol use disorder in past two years
- Regular alcohol use exceeding defined limits
- Current smokers or recent smoking history exceeding 10 pack-years
- Use of e-cigarettes or nicotine replacement within last 12 months
- Positive drug abuse screening
- Men with pregnant or lactating partners
- Recent blood or plasma donation
- Employees or immediate family of study site or sponsor
- Active respiratory infection requiring antibiotics within 4 weeks prior to consent
- Clinically significant deterioration or uncontrolled illness for Part 3
- Use of supplemental oxygen for resting hypoxemia
- Life expectancy less than one year or listed for lung transplant
- Hospitalization or serious illness within 3 months prior to consent
- Alternative lung fibrosis causes or connective tissue diseases
- Active asthma, COPD, or infection
- Severe liver impairment or high liver enzymes
- Use of medications posing risk of adverse interaction with study drug
- Smoking within one year prior to consent for Part 3
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fraunhofer Institute for Toxicology and Experimental Medicine ITEM
Hanover, Germany, 30625
Actively Recruiting
Research Team
N
Nathalie Luis
CONTACT
A
Alex Brooks
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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