Actively Recruiting
Inhaled RB042 in Healthy Adult Volunteers and Healthy Adult Smokers
Led by RAGE Bio · Updated on 2026-02-23
90
Participants Needed
1
Research Sites
50 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a 3-part, randomised, double-blind, placebo-controlled, first in human study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of inhaled RB042.
CONDITIONS
Official Title
Inhaled RB042 in Healthy Adult Volunteers and Healthy Adult Smokers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be overtly healthy as determined by medical evaluation
- For Part C only: Participants must have a smoking history of at least 10 pack years, have smoked tobacco regularly for the past 12 months, and currently smoke daily
- Forced expiratory volume (FEV1) must be at least 80% predicted and FEV1 to FVC ratio must be at least 0.7 at Screening and on Day -1
- Body weight must be at least 50 kg with a body mass index (BMI) between 18.0 and 32.0 inclusive
- Women of childbearing potential must have a negative pregnancy test and must not be lactating
- Participants must agree to use an approved highly effective method of contraception as defined in the protocol
You will not qualify if you...
- Clinically significant history or presence of gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine, neurologic, hematologic, metabolic, autoimmune, or oncologic disorders that could affect safety or study outcomes
- Chronic or active respiratory disease such as asthma or COPD, or history of angioedema within 3 years
- Active or chronic liver disease, or abnormal liver function tests outside reference range except Gilbert's syndrome
- QTcF greater than 450 msec for males or greater than 470 msec for females
- Renal impairment with creatinine clearance less than 90 mL/min or thrombocytopenia less than 150 x 10^9/L
- Positive test for hepatitis B surface or core antigen, hepatitis C (unless HCV-RNA negative), or HIV
- Active respiratory infection within 5 days before study start
- Recent or current use of medications, herbal supplements, vaccines, or blood products that could interfere with study safety or interpretation
- Participation in another investigational study within 30 days, or blood donation over 400 mL within 30 days
- For Parts A and B only: Regular smoking of at least 1 day per week within 6 months prior to dosing, or positive urine cotinine test at screening or Day -1
- Excessive alcohol consumption over 21 drinks per week for males or over 14 for females
- History of severe drug reaction or anaphylaxis
- Contraindication to or unwillingness to undergo bronchoscopy
- Any psychiatric or medical condition that could compromise safety or compliance according to the investigator's opinion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Linear Clinical Research
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
Research Team
C
Chief Medical Officer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
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