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New eczema drug TRB-061 enters first human trials

NCT ID NCT06934252

Disease control Sponsor: TRex Bio, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 14, 2026 · Updated 2 times

Summary

This early-stage trial tests a new drug called TRB-061 in healthy adults and people with moderate-to-severe atopic dermatitis (eczema). The study checks for safety, side effects, and how the drug moves through the body. Participants receive either TRB-061 or a placebo as injections under the skin. The goal is to see if TRB-061 is safe enough to study further for treating eczema.

What this could mean

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

Active substance
TRB-061
What this could lead to
If successful, this could point toward a new treatment option for moderate-to-severe atopic dermatitis, potentially reducing symptoms and flare-ups.
What could go wrong
This is an early Phase 1 trial focused on safety, not effectiveness. The drug may not work in larger studies or could have side effects. Results are years away from any possible use.

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 115 people

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

Started

May 2025

Expected to finish

Feb 2028

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 70 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: 1. Male or female participants aged 18 to 70 years, inclusive, at the time of informed consent. 2. Body weight ≥50 kg and a body mass index (BMI)between 18.5 and 35.0 kg/m², inclusive. 3. Participant is in good general health as determined by the investigator, based on medical history, physical examination, and clinical laboratory tests. 4. For healthy participants (SAD and MAD): no clinically significant abnormalities in ECGs at screening. 5. For participants in Phase 1b: Confirmed diagnosis of AD with onset of symptoms at least 1 year prior to Screening. 6. Must be nonpregnant and nonlactating with negative pregnancy tests at screening and prior to dosing. 7. Must be a non-smoker or ≤5 cigarettes per week for the past 6 months (SAD/MAD only). 8. For participants in Phase 1b: Moderate-to-severe AD at Screening and at Day 1 visit 9. Agrees to abstain from the use of tetrahydrocannabinol (THC)-containing products while on study. Exclusion Criteria: 1. History of any clinically significant disease or disorder which, in the opinion of the investigator, may put the participant at risk or interfere with study results. 2. History or presence of any condition requiring systemic immunosuppressive or immunomodulatory therapy within a defined period before screening. 3. Use of any biologic agent (e.g., monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) before Day 1. 4. Participation in another investigational drug trial within 30 days or 5 half-lives of the prior investigational product (whichever is longer) before Day 1. 5. History of hypersensitivity or allergic reaction to any component of the study drug or placebo formulation. 6. Known active or latent tuberculosis (TB) infection. or history of incomplete TB treatment. 7. Positive test at screening for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) RNA, or human immunodeficiency virus (HIV). 8. Active infection or history of serious infections within 4 weeks prior to Day 1. 9. Clinically significant ECG abnormalities (e.g., QTcF\>470 ms) or other cardiac risk factors. 10. Abnormal and clinically significant laboratory values at screening. 11. Use of live vaccines within 4 weeks before Day 1. 12. Use of systemic corticosteroids, immunosuppressants, or immunomodulatory drugs within protocol-defined washout periods (Part 3 only). 13. Recent history of alcohol or drug abuse as defined per protocol. 14. Use of tobacco/nicotine products beyond protocol-allowed limits (SAD and MAD). 15. Positive cotinine test at check-in (SAD/MAD only). 16. Any other reason, in the opinion of the investigator or sponsor, that would make the participant unsuitable for participation in the study. 17. Any medical or psychiatric condition that, in the opinion of the Investigator or Sponsor's medical monitor, would place the participant at risk, interfere with study participation, or interfere with the interpretation of study results. 18. Surgery within the past 90 days prior to dosing as determined by the Investigator or Sponsor's medical monitor to be clinically relevant or planned surgery to be performed during the study and 30 days after the last dose of study drug

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Conditions

The condition(s) this trial relates to.

atopic eczema

As listed by the trial registrant

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

Moderate-to-severe atopic dermatitis

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

    18 sites in 2 countries. 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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Alfred Health

    NOT_YET_RECRUITING

    Melbourne, 3004, Australia

  • CMAX Clinical Research Pty Ltd

    ACTIVE_NOT_RECRUITING

    Adelaide, South Australia, 5000, Australia

  • Clinical Trials New Zealand Ltd

    RECRUITING

    Hamilton, Waikato Region, 3204, New Zealand

  • Cornerstone Centre for Clinical Research

    RECRUITING

    Coorparoo, Queensland, 4151, Australia

  • MCR Christchurch

    RECRUITING

    Christchurch, 8013, New Zealand

  • MCR Palmerston North

    NOT_YET_RECRUITING

    Palmerston North, 4414, New Zealand

  • MCR Sunshine

    NOT_YET_RECRUITING

    Saint Albans, 3021, Australia

  • Medical Research Institute of New Zealand

    RECRUITING

    Newtown, Wellington Region, 6021, New Zealand

  • Momentum Clinical Research Dunedin

    RECRUITING

    Dunedin, Otago, 9016, New Zealand

  • Momentum Clinical Research Kapiti

    RECRUITING

    Waikanae, Wellington Region, 5036, New Zealand

  • Momentum Clinical Research Pukekohe

    RECRUITING

    Pukekohe, Auckland, 2120, New Zealand

  • Pacific Clinical Research Network-Tasman

    RECRUITING

    Nelson, Tasman District, 7011, New Zealand

  • Pacific Clinical Research Network-Wellington

    RECRUITING

    Upper Hutt, Wellington Region, 5018, New Zealand

  • Pacific Clinical Research Network-West Auckland

    RECRUITING

    Auckland, 0600, New Zealand

  • Paratus Clinical Brisbane Pty Ltd

    RECRUITING

    Albion, Brisbane, 4010, Australia

  • Paratus Clinical Research - Canberra Trial Clinic

    RECRUITING

    Belconnen, Australian Capital Territory, 2617, Australia

  • Paratus Clinical Research Central Coast

    RECRUITING

    Kanwal, New South Wales, 2259, Australia

  • Paratus Clinical Research Melbourne

    RECRUITING

    Melbourne, Victoria, 3070, Australia

  • Paratus Clinical Research Western Sydney

    RECRUITING

    Blacktown, New South Wales, 2148, Australia

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