Inhaled RB042 in Healthy Adult Volunteers and Healthy Adult Smokers
Trial Parameters
Brief Summary
This is a 3-part, randomised, double-blind, placebo-controlled, first in human study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of inhaled RB042.
Eligibility Criteria
Inclusion Criteria: * Participants must be overtly healthy as determined by medical evaluation * Part C only: have a ≥10 pack years smoking history, have smoked tobacco products (cigarettes, cigars, or equivalent) regularly for the past 12 months, and currently smoke daily. * Have forced expiratory volume (FEV1) ≥80% predicted and FEV1 to FVC ratio (FEV1/FVC) ≥0.7 at Screening and on Day -1 * Body weight at least 50 kg and have a body mass index (BMI) within the range 18.0 and 32.0 kg/m2 (inclusive) * Women of childbearing potential (WOCBP) must have a negative pregnancy test and must not be lactating. * Participants must agree to use an approved method(s) of highly effective contraception as defined in the protocol. Exclusion Criteria: * Clinically significant history or presence of gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine, neurologic, hematologic, metabolic, autoimmune, or oncologic disorders that may affect safety or study outcomes. * Chronic or activ