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.
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.
Sequential
CMR316
DrugCMR316 administered via nebulization at single or multiple dose(s) assigned by cohort
Placebo
DrugPlacebo administered via nebulization at single or multiple dose(s) to match CMR316 administration
Number of participants with adverse events
Adverse events will be analyzed for severity and potential relationship to CMR316 to determine safety and tolerability of CMR316
Number of participants with clinically significant abnormal physical exam and vital signs
Vital signs will include evaluation of systolic and/or diastolic blood pressure (mmHg), heart rate (beats/min), temperature (Celsius), and respiratory rate (breaths/minute).
Number of patients with reduced pulmonary function
Pulse oximeter will analyze oxygen saturation, spirometry will include evaluation of FEV1, FVC, and FEV1/FVC, and DLCO
Number of participants with abnormal electrocardiogram readings
Electrocardiogram will include an evaluation of QTcF interval, ventricular rate, PR interval, QRS duration and QRS axis
Assess pharmacokinetics, AUC, as available
Area under the concentration-time curve (AUC) from time of administration
Assess pharmacokinetics, Cmax, as available
Maximum drug concentration observed
Assess pharmacodynamics, characterize enzymatic activity
Change from pre-dose baseline and % inhibition in enzymatic activity
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