Study to Assess CMR316 in Healthy Volunteers and Patients With Idiopathic Pulmonary Fibrosis
Trial Parameters
Brief 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 Criteria
Inclusion Criteria: Part 1 \& 2 * 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. Inclusion Criteria: Part 3 * 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.