BridgeMD
New treatment option for Healthy
Official title Inhaled RB042 in Healthy Adult Volunteers and Healthy Adult Smokers
ClinicalTrials.gov ID: NCT07285122
What this study is testing
What is RB042?
RB042 is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for healthy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a 3-part, randomised, double-blind, placebo-controlled, first in human study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of inhaled RB042.
- Phase 1: an early, usually small safety study
- Time commitment: about 5 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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.
You likely can't join if
- Clinically significant history or presence of gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine, neurologic, hematologic...
- 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 \<90 mL/min) or thrombocytopenia (\<150 × 10⁹/L).
- Positive test for hepatitis B surface or core antigen, hepatitis C (unless HCV-RNA negative), or HIV.
See the full eligibility 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.
- Clinically significant history or presence of gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine, neurologic, hematologic, metabolic, autoimmune, or oncologic disorders that may affect safety or...
- 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 \<90 mL/min) or thrombocytopenia (\<150 × 10⁹/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 concurrent 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 \>400 mL within 30 days.
- Parts A and B only: Regular smoking (≥1 day per week) within 6 months prior to dosing, or a positive urine cotinine test at screening or Day -1.
- Excessive alcohol consumption (\>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.
The study team makes the final eligibility decision.
Where it's taking place
- Nedlands, Western Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nedlands, Western Australia, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.