Inhaled RB042 in Healthy Adult Volunteers and Healthy Adult Smokers

NCT ID: NCT07285122

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2027-02-28

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.

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.

Conditions

Healthy; Healthy Smoker

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cohort A1

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

Group Type: EXPERIMENTAL

RB042

Intervention Type: DRUG

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

Placebo inhalation solution

Intervention Type: DRUG

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

Cohort A2

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

Group Type: EXPERIMENTAL

RB042

Intervention Type: DRUG

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

Placebo inhalation solution

Intervention Type: DRUG

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

Cohort A3

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

Group Type: EXPERIMENTAL

RB042

Intervention Type: DRUG

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

Placebo inhalation solution

Intervention Type: DRUG

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

Cohort A4

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

Group Type: EXPERIMENTAL

RB042

Intervention Type: DRUG

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

Placebo inhalation solution

Intervention Type: DRUG

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

Cohort B1

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

Group Type: EXPERIMENTAL

RB042

Intervention Type: DRUG

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

Placebo inhalation solution

Intervention Type: DRUG

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

Cohort B2

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

Group Type: EXPERIMENTAL

RB042

Intervention Type: DRUG

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

Placebo inhalation solution

Intervention Type: DRUG

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

Cohort B3

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

Group Type: EXPERIMENTAL

RB042

Intervention Type: DRUG

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

Placebo inhalation solution

Intervention Type: DRUG

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

Cohort C1

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

Group Type: EXPERIMENTAL

RB042

Intervention Type: DRUG

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

Placebo inhalation solution

Intervention Type: DRUG

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

Interventions

RB042

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

Intervention Type: DRUG

Placebo inhalation solution

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

Intervention Type: DRUG

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.
• Evidence of complement activation (C3a, C5a, or Bb above the upper limit of normal).
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

RAGE Bio

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Chief Medical Officer

Role: CONTACT

Phone: 1800312514

Email: clinicaltrialdisclosure@ragebio.com

Other Identifiers

RB042_1001

Identifier Type: -

Identifier Source: org_study_id