NCT07285122

Brief Summary

This is a 4-part, randomised, double-blind, placebo-controlled, first in human study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of inhaled RB042.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P75+ for phase_1 healthy

Timeline
12mo left

Started Feb 2026

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
Feb 2026Oct 2027

First Submitted

Initial submission to the registry

December 3, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 16, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

February 16, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

August 12, 2026

Status Verified

August 1, 2026

Enrollment Period

1.6 years

First QC Date

December 3, 2025

Last Update Submit

August 10, 2026

Conditions

HealthyHealthy SmokerCOPD (Chronic Obstructive Pulmonary Disease)COPD

Keywords

COPDChronic Obstructive Pulmonary DiseaseHealthy smokerHealthy volunteer

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, healthy adult smokers and patients with moderate to severe stable COPD.

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

Secondary Outcomes (5)

  • Maximum concentration (Cmax)

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

  • Time to maximum concentration (Tmax)

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

  • Terminal elimination half-life (t½)

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

  • 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 B and D)

  • Trough concentration

    On Days 7, 14, and 21

Study Arms (10)

Cohort A1

EXPERIMENTAL

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

Drug: RB042Drug: Placebo inhalation solution

Cohort A2

EXPERIMENTAL

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

Drug: RB042Drug: Placebo inhalation solution

Cohort A3

EXPERIMENTAL

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

Drug: RB042Drug: Placebo inhalation solution

Cohort A4

EXPERIMENTAL

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

Drug: RB042Drug: Placebo inhalation solution

Cohort B1

EXPERIMENTAL

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

Drug: RB042Drug: Placebo inhalation solution

Cohort B2

EXPERIMENTAL

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

Drug: RB042Drug: Placebo inhalation solution

Cohort B3

EXPERIMENTAL

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

Drug: RB042Drug: Placebo inhalation solution

Cohort B4

EXPERIMENTAL

Participants will receive RB042 (Dose Level B4) or matching placebo on Days 1, 8, 15, and 22.

Drug: RB042Drug: Placebo inhalation solution

Cohort C1

EXPERIMENTAL

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

Drug: RB042Drug: Placebo inhalation solution

Cohort D1

EXPERIMENTAL

Participants will receive RB042 (Dose Level D1) or matching placebo on Days 1, 8, 15, and 22.

Drug: RB042Drug: Placebo inhalation solution

Interventions

RB042DRUG

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

Cohort A1Cohort A2Cohort A3Cohort A4Cohort B1Cohort B2Cohort B3Cohort B4Cohort C1Cohort D1
Placebo inhalation solutionDRUG

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

Cohort A1Cohort A2Cohort A3Cohort A4Cohort B1Cohort B2Cohort B3Cohort B4Cohort C1Cohort D1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Part A, B, C only: Participants must be 18 to 55 years of age inclusive.
  • Part D only: Patients must be 40 to 80 years of age inclusive.
  • Part A, B, C only: 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.
  • Part D only: Former smokers (smoked a total of 100 or more cigarettes in their lifetime but has not smoked in the past 6 months to over a year).
  • Part A, B, C only: Have forced expiratory volume (FEV1) ≥80% predicted and FEV1 to FVC ratio (FEV1/FVC) ≥0.7 at Screening and on Day -1.
  • Part D only: Have forced expiratory volume (FEV1) between ≥30% and \<80% predicted and FEV1 to FVC ratio (FEV1/FVC) \<0.7 post-bronchodilation at Screening.
  • Part D only: Documented clinical diagnosis of COPD per 2026 Global Initiative for Chronic Obstructive Lung Disease (GOLD) for greater than ≥1 year and a history of chronic bronchitis as evidenced by frequent productive cough in the 2-year period immediately before Screening.
  • Part D only: Have clinically stable COPD with no moderate to severe exacerbations in the past 3 months.
  • Part D only: Must be on stable assigned maintenance COPD therapy.
  • 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:

  • Part A, B and C only: 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.
  • Part D only: Current unstable 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.
  • Part A, B and C only: Chronic or active respiratory disease (e.g., asthma, COPD) or history of angioedema within 3 years.
  • Part D only: Patients with other respiratory conditions other than COPD (for example, clinically significant asthma, active tuberculosis, pulmonary fibrosis) are excluded if these conditions are the primary cause of their respiratory symptoms.
  • 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, B and D 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.
  • Part B and C only: Contraindication to, or unwillingness to undergo, bronchoscopy.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linear Clinical Research

Nedlands, Western Australia, 6009, Australia

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Chief Medical Officer

CONTACT

1800312514clinicaltrialdisclosure@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)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

August 12, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)