New inhaled drug RB042 enters first human safety tests

NCT ID NCT07285122

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 2 times

Summary

This early-stage study is testing an inhaled drug called RB042 for the first time in humans. Researchers want to see if it is safe and how the body handles it. The study includes 90 healthy adults, some of whom are smokers. Participants will receive either RB042 or a placebo through a nebulizer. This research does not aim to treat any disease but to gather essential safety data.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RB042
What could go wrong
This is a very early phase 1 study in healthy people, not patients. It only tests safety and how the drug moves through the body, not whether it works for any disease. Many drugs fail at this stage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 105 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Linear Clinical Research

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

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