Inhaled RB042 in Healthy Adult Volunteers, Healthy Adult Smokers and Patients With Chronic Obstructive Pulmonary Disease

August 10, 2026 updated by: Atisama Therapeutics

A Phase 1a/1b, 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, Healthy Adult Smokers and Patients With Chronic Obstructive Pulmonary Disease

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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, healthy adult smokers and patients with moderate to severe chronic obstructive pulmonary disease.

Study details include:

  • Overall study duration of up to 19 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 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 in Part C will be required to visit the study site for assessments on 10 occasions, including in-house stays between Day -1 to 2, Day 7 to 8, Day 14 to 15, Day 21 to 23 over 5 months.
  • Patients in Part D will be required to visit the study site for assessments on 10 occasions over 5 months.
  • Participants will be administered a single dose (Part A) or multiple doses (Parts B, C and D) of study intervention.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
105

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Recruiting
        • Linear Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Any psychiatric or medical condition that, in the investigator's opinion, could compromise safety or compliance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort A1
Participants will receive RB042 (Dose Level A1) or matching placebo on Day 1.
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.
Experimental: Cohort A2
Participants will receive RB042 (Dose Level A2) or matching placebo on Day 1.
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.
Experimental: Cohort A3
Participants will receive RB042 (Dose Level A3) or matching placebo on Day 1.
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.
Experimental: Cohort A4
Participants will receive RB042 (Dose Level A4) or matching placebo on Day 1.
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.
Experimental: Cohort B1
Participants will receive RB042 (Dose Level B1) or matching placebo on Days 1, 8, 15, and 22.
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.
Experimental: Cohort B2
Participants will receive RB042 (Dose Level B2) or matching placebo on Days 1, 8, 15, and 22.
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.
Experimental: Cohort B3
Participants will receive RB042 (Dose Level B3) or matching placebo on Days 1, 8, 15, and 22.
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.
Experimental: Cohort C1
Participants will receive RB042 (Dose Level C1) or matching placebo on Days 1, 8, 15, and 22.
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.
Experimental: Cohort B4
Participants will receive RB042 (Dose Level B4) or matching placebo on Days 1, 8, 15, and 22.
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.
Experimental: Cohort D1
Participants will receive RB042 (Dose Level D1) or matching placebo on Days 1, 8, 15, and 22.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 B and D)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum concentration (Cmax)
Time Frame: From Day 1 until the end of the study (Day 85 for Part A; Day 106 for Parts B and D)
To characterize the Cmax of RB042 following single and multiple doses of RB042 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)
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 B and D)
To characterize the Tmax of RB042 following single and multiple doses of RB042 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)
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 B and D)
To characterize the t½ of RB042 following single and multiple doses of RB042 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)
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 B and D)
To characterize the AUC of RB042 following single and multiple doses of RB042 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)
Trough concentration
Time Frame: On Days 7, 14, and 21
To characterize the AUC of RB042 following multiple doses of RB042 administered via a nebuliser to healthy adult volunteers, healthy adult smokers and patients with moderate to severe stable COPD.
On Days 7, 14, and 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Atisama Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 16, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RB042_1001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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