About this trial
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 criteria
Qualifiers
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.
Disqualifiers
Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.
Presence or history of clinically significant hypersensitivity (e.g., anaphylaxis, angioedema, Stevens-Johnson syndrome) or allergy as judged by the investigator. Subjects with a history of seasonal rhinitis (hay fever) or childhood asthma may participate if these conditions are not active or expected to be active during the subject's participation.
History of clinically significant cardiovascular, skin, renal, hepatic, respiratory or gastrointestinal disease (except cholecystectomy), neurological or psychiatric disorder, illness/infection/hospitalization, or surgical procedure within 30 days prior to first dose of study drug. Subjects with a history of pancreatitis, heart failure, acute renal failure, bullous pemphigoid, or severe and disabling arthritis, conditions associated with postmarketing safety reports of oral gliptins, are excluded.
Have poor venous access that limits phlebotomy.
Trial design
Treatments tested in this trial
- CMR316
- Placebo