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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorCalibr, a division of Scripps Research

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

Treatment groups

106 Participants
are divided into 5 treatment groups