HealthyPhase 1NCT07285122
Inhaled RB042 in Healthy Adult Volunteers, Healthy Adult Smokers and Patients With Chronic Obstructive Pulmonary Disease
A Phase 1 study testing RB042 in people with Healthy and Healthy Smoker, run by Atisama Therapeutics at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Healthy Smoker, COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- RB042
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteAustralia
- Study dates
- 16 Feb 2026to Oct 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Linear Clinical Research
Nedlands, Western Australia, 6009
About this study
Official title: 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.
Read the 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.
- Being tested
- RB042, Placebo inhalation solution
- Keywords
- COPD, Chronic Obstructive Pulmonary Disease, Healthy smoker, Healthy volunteer
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RB042Drug
A single or multiple doses of RB042 will be administered via a nebuliser.
Placebo inhalation solutionDrug
A single or multiple doses of placebo will be administered via a nebuliser.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A1 | Experimental | Participants will receive RB042 (Dose Level A1) or matching placebo on Day 1. Receives: Drug: RB042; Drug: Placebo inhalation solution |
| Cohort A2 | Experimental | Participants will receive RB042 (Dose Level A2) or matching placebo on Day 1. Receives: Drug: RB042; Drug: Placebo inhalation solution |
| Cohort A3 | Experimental | Participants will receive RB042 (Dose Level A3) or matching placebo on Day 1. Receives: Drug: RB042; Drug: Placebo inhalation solution |
| Cohort A4 | Experimental | Participants will receive RB042 (Dose Level A4) or matching placebo on Day 1. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: RB042; Drug: Placebo inhalation solution |
| Cohort B4 | Experimental | Participants will receive RB042 (Dose Level B4) or matching placebo on Days 1, 8, 15, and 22. Receives: 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. Receives: Drug: RB042; Drug: Placebo inhalation solution |
| Cohort D1 | Experimental | Participants will receive RB042 (Dose Level D1) or matching placebo on Days 1, 8, 15, and 22. Receives: Drug: RB042; Drug: Placebo inhalation solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: From Day 1 until the end of the study (Day 85 for Part A; Day 106 for Parts B and D)
Trough concentration
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.
Measured: On Days 7, 14, and 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start16 Feb 2026
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atisama Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07285122
- Sponsor's protocol ID
- RB042_1001
- Status last verified
- Aug 2026
- First submitted
- 3 Dec 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07285122
- Acronym / sponsor ID
- RB042_1001
- Keywords
- COPD, Chronic Obstructive Pulmonary Disease, Healthy smoker, Healthy volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Atisama TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Cohort A1 | Experimental | Drug: RB042, Drug: Placebo inhalation solutionParticipants will receive RB042 (Dose Level A1) or matching placebo on Day 1. |
| Cohort A2 | Experimental | Drug: RB042, Drug: Placebo inhalation solutionParticipants will receive RB042 (Dose Level A2) or matching placebo on Day 1. |
| Cohort A3 | Experimental | Drug: RB042, Drug: Placebo inhalation solutionParticipants will receive RB042 (Dose Level A3) or matching placebo on Day 1. |
| Cohort A4 | Experimental | Drug: RB042, Drug: Placebo inhalation solutionParticipants will receive RB042 (Dose Level A4) or matching placebo on Day 1. |
| Cohort B1 | Experimental | Drug: RB042, Drug: Placebo inhalation solutionParticipants will receive RB042 (Dose Level B1) or matching placebo on Days 1, 8, 15, and 22. |
| Cohort B2 | Experimental | Drug: RB042, Drug: Placebo inhalation solutionParticipants will receive RB042 (Dose Level B2) or matching placebo on Days 1, 8, 15, and 22. |
| Cohort B3 | Experimental | Drug: RB042, Drug: Placebo inhalation solutionParticipants will receive RB042 (Dose Level B3) or matching placebo on Days 1, 8, 15, and 22. |
| Cohort B4 | Experimental | Drug: RB042, Drug: Placebo inhalation solutionParticipants will receive RB042 (Dose Level B4) or matching placebo on Days 1, 8, 15, and 22. |
| Cohort C1 | Experimental | Drug: RB042, Drug: Placebo inhalation solutionParticipants will receive RB042 (Dose Level C1) or matching placebo on Days 1, 8, 15, and 22. |
| Cohort D1 | Experimental | Drug: RB042, Drug: Placebo inhalation solutionParticipants will receive RB042 (Dose Level D1) or matching placebo on Days 1, 8, 15, and 22. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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).
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RB042A single or multiple doses of RB042 will be administered via a nebuliser. | Drug | Cohort A1, Cohort A2, Cohort A3, Cohort A4, Cohort B1, Cohort B2, Cohort B3, Cohort B4, Cohort C1, Cohort D1 |
| Placebo inhalation solutionA single or multiple doses of placebo will be administered via a nebuliser. | Drug | Cohort A1, Cohort A2, Cohort A3, Cohort A4, Cohort B1, Cohort B2, Cohort B3, Cohort B4, Cohort C1, Cohort D1 |
Primary outcome
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.
5 secondary outcomes
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)
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)
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)
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)
Trough concentration
Time frame: On Days 7, 14, and 21
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RB042 in people with Healthy and Healthy Smoker, run by Atisama Therapeutics at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chief Medical Officer (1800312514, clinicaltrialdisclosure@ragebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.