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