Inhaled RB042 in Healthy Adult Volunteers and Healthy Adult Smokers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RB042, Placebo inhalation solution.
- Who it may be relevant to
- Registry conditions: Healthy, Healthy Smoker. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase I, Randomised, Double Blind, Placebo-controlled, Dose-escalating Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of RB042 Administered Via Inhalation to Healthy Adult Volunteers and Healthy Adult Smokers
Overview
This is a 3-part, randomised, double-blind, placebo-controlled, first in human study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of inhaled RB042.
Detailed description
The purpose of this study is to measure the safety, tolerability, PK, and PD of inhaled RB042 compared with inhaled placebo in healthy adult volunteers and healthy adult smokers.
Study details include:
* Overall study duration of up to 14 months. * Participants in Part A (healthy adult volunteers) will be required to visit the study site for assessments on 11 occasions, including a 4-day in-house stay, over 4 months. * Participants in Parts B (healthy adult volunteers) and C (healthy adult smokers) will be required to visit the study site for assessments on 13 occasions, including a 17-day (Day -1 to 16) and 3-day (Day 21 to 24) in-house stay, over 5 months. * Participants will be administered a single dose (Part A) or multiple doses (Parts B and C) of study intervention.
Interventions
- Drug RB042
A single or multiple doses of RB042 will be administered via a nebuliser. - Drug Placebo inhalation solution
A single or multiple doses of placebo will be administered via a nebuliser.
Primary outcome measures
- Number and frequency of treatment-emergent adverse events (TEAEs) [Time frame: From Day 1 until the end of the study (Day 85 for Part A; Day 106 for Parts A and B)]
Secondary outcome measures (5)
- Maximum concentration (Cmax) [Time frame: From Day 1 until the end of the study (Day 85 for Part A; Day 106 for Parts A and B)]
- Time to maximum concentration (Tmax) [Time frame: From Day 1 until the end of the study (Day 85 for Part A; Day 106 for Parts A and B)]
- Terminal elimination half-life (t½) [Time frame: From Day 1 until the end of the study (Day 85 for Part A; Day 106 for Parts A and B)]
- Area under the concentration-time curve (AUC) [Time frame: From Day 1 until the end of the study (Day 85 for Part A; Day 106 for Parts A and B)]
- Trough concentration [Time frame: On Days 7, 14, and 21]
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 <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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Australia · 1 center
- Linear Clinical Research — Nedlands
Identifiers
NCT: NCT07285122 · RB042_1001