Inhaled RB042 in Healthy Adult Volunteers and Healthy Adult Smokers

NCT07285122 | Recruiting Phase 1 DMC

• 1 other identifier: RB042_1001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy; Healthy Smoker

Outcome Measures

Primary Outcomes (1)

• Number and frequency of treatment-emergent adverse events (TEAEs)

  To assess the safety and tolerability of single and multiple doses of RB042 when administered via a nebuliser to healthy adult volunteers and healthy adult smokers

  From Day 1 until the end of the study (Day 85 for Part A; Day 106 for Parts A and B)

Secondary Outcomes (5)

• Maximum concentration (Cmax)

  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)

  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)

  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)

  From Day 1 until the end of the study (Day 85 for Part A; Day 106 for Parts A and B)

• Trough concentration

  On Days 7, 14, and 21

Study Arms (8)

Cohort A1

EXPERIMENTAL

Participants will receive RB042 (Dose Level A1) or matching placebo on Day 1.

Drug: RB042; Drug: Placebo inhalation solution

Cohort A2

EXPERIMENTAL

Participants will receive RB042 (Dose Level A2) or matching placebo on Day 1.

Drug: RB042; Drug: Placebo inhalation solution

Cohort A3

EXPERIMENTAL

Participants will receive RB042 (Dose Level A3) or matching placebo on Day 1.

Drug: RB042; Drug: Placebo inhalation solution

Cohort A4

EXPERIMENTAL

Participants will receive RB042 (Dose Level A4) or matching placebo on Day 1.

Drug: RB042; Drug: Placebo inhalation solution

Cohort B1

EXPERIMENTAL

Participants will receive RB042 (Dose Level B1) or matching placebo on Days 1, 8, 15, and 22.

Drug: RB042; Drug: Placebo inhalation solution

Cohort B2

EXPERIMENTAL

Participants will receive RB042 (Dose Level B2) or matching placebo on Days 1, 8, 15, and 22.

Drug: RB042; Drug: Placebo inhalation solution

Cohort B3

EXPERIMENTAL

Participants will receive RB042 (Dose Level B3) or matching placebo on Days 1, 8, 15, and 22.

Drug: RB042; Drug: Placebo inhalation solution

Cohort C1

EXPERIMENTAL

Participants will receive RB042 (Dose Level C1) or matching placebo on Days 1, 8, 15, and 22.

Drug: RB042; Drug: Placebo inhalation solution

Interventions

RB042 DRUG

A single or multiple doses of RB042 will be administered via a nebuliser.

Cohort A1; Cohort A2; Cohort A3; Cohort A4; Cohort B1; Cohort B2; Cohort B3; Cohort C1

Placebo inhalation solution DRUG

A single or multiple doses of placebo will be administered via a nebuliser.

Cohort A1; Cohort A2; Cohort A3; Cohort A4; Cohort B1; Cohort B2; Cohort B3; Cohort C1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RAGE Bio: lead

Study Sites (1)

Linear Clinical Research

Nedlands, Western Australia, 6009, Australia

RECRUITING

Central Study Contacts

Chief Medical Officer

CONTACT

1800312514; clinicaltrialdisclosure@ragebio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 16, 2025
• Study Start: February 16, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)