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Recruiting NCT07285122

Inhaled RB042 in Healthy Adult Volunteers and Healthy Adult Smokers

Conditions: Healthy, Healthy Smoker

Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 90
Sponsor: Atisama Therapeutics

Location: Linear Clinical Research Nedlands Western Australia

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 active respiratory disease (e.g., asthma, COPD) or history of angioedema within 3 years. * Active or chronic liver disease, or abnormal liver function tests (ALT, AST, or bilirubin outside reference range, except Gilbert's syndrome). * QTcF \>450 msec (males) or \>470 msec (females). * Renal impairment (creatinine clearance \21 drinks/week for males or \>14 for females). * History of severe drug reaction or anaphylaxis. * Contraindication to, or unwillingness to undergo, bronchoscopy. * Any psychiatric or medical condition that, in the investigator's opinion, could compromise safety or compliance.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07285122). StuddyBuddy aggregates publicly available trial information.