A Phase 1/1B Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Nebulized CMR316 in Healthy Volunteers and Patients With Idiopathic Pulmonary Fibrosis
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).
• 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