Phase 1a/1b Study of TRB-061 in Healthy Participants & Patients With Atopic Dermatitis

May 27, 2026 updated by: TRex Bio, Inc.

A Phase 1a/1b Randomized, Double-Blind, Placebo-Controlled, 3-Part Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Subcutaneous Doses of TRB-061 in Healthy Participants and in Patients With Moderate-to-Severe Atopic Dermatitis

This Phase 1a/1b randomized, double-blind, placebo-controlled study evaluates the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneously (SC) administered TRB-061 in healthy adults and patients with moderate-to-severe atopic dermatitis (AD). The number of dosing cohorts may be increased or decreased in Part 1 (SAD) or Part 2 (MAD).

Part 1 (SAD): Healthy participants receiving single doses of TRB-061 or placebo.

Part 2 (MAD): Healthy participants receiving multiple doses (3 doses over 8 weeks) of TRB-061 or placebo.

Part 3 (Phase 1b): Participants with moderate-to-severe AD receiving repeated doses (4 doses over 12 weeks) of TRB-061 or placebo.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Healthy adults will receive a single-ascending dose (SAD) of placebo or TRB-061 in cohorts of 8 (6 active, 2 placebo). Safety data will be reviewed before dosing the remaining participants. Follow-up lasts 12 weeks post-dosing. Treatment in the multiple-ascending dose (MAD) phase will be initiated after SAD cohort safety review is completed. Healthy adults will receive 3 doses of TRB-061 or placebo every 4 weeks (Q4W) over 8 weeks. Follow-up lasts 10 weeks post-last dose.

Participants with moderate-to-severe AD (Phase 1b) will be randomized to receive one of two dose levels of TRB-061 or placebo for 12 weeks (Q4W) in Period 1. In Period 2, participants will have the option to consent to a cross over treatment where those who previously received placebo will receive TRB-061 and those who received TRB-061 will receive placebo Q4W for 12 weeks followed by a Follow Up period through End of Study (EOS). Participants who do not consent to receive crossover treatment will continue study visits including efficacy and safety assessments through the EOS visit.

Study Type

Interventional

Enrollment (Estimated)

115

Phase

  • 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 Locations

  • Australia
    • Australian Capital Territory
      • Belconnen, Australian Capital Territory, Australia, 2617
        • Recruiting
        • Paratus Clinical Research - Canberra Trial Clinic
        • Contact:
    • Brisbane
      • Albion, Brisbane, Australia, 4010
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
      • Kanwal, New South Wales, Australia, 2259
    • Queensland
      • Coorparoo, Queensland, Australia, 4151
        • Recruiting
        • Cornerstone Centre for Clinical Research
        • Contact:
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Active, not recruiting
        • CMAX Clinical Research Pty Ltd
    • Victoria
  • New Zealand
      • Auckland, New Zealand, 0600
        • Recruiting
        • Pacific Clinical Research Network-West Auckland
        • Contact:
    • Auckland
    • Otago
    • Tasman District
      • Nelson, Tasman District, New Zealand, 7011
        • Recruiting
        • Pacific Clinical Research Network-Tasman
        • Contact:
    • Waikato Region
      • Hamilton, Waikato Region, New Zealand, 3204
        • Not yet recruiting
        • Clinical Trials New Zealand Ltd
        • Contact:
    • Wellington Region
      • Newtown, Wellington Region, New Zealand, 6021
        • Recruiting
        • Medical Research Institute of New Zealand
        • Contact:
      • Upper Hutt, Wellington Region, New Zealand, 5018
      • Waikanae, Wellington Region, New Zealand, 5036

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

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
Intervention / Treatment
Experimental: MAD - TRB-061
Multiple subcutaneous doses (Q4W for 8 weeks) in healthy participants
Drug: TRB-061
Single subcutaneous injection of TRB-061 at escalating doses
Drug: TRB-061
Subcutaneous TRB-061 administered every 4 weeks for a total of 4 doses
Drug: TRB-061
Subcutaneous TRB-061 administered every 4 weeks for 3 doses
Experimental: SAD - TRB-061
Single ascending subcutaneous doses of TRB-061 in healthy participants
Drug: TRB-061
Single subcutaneous injection of TRB-061 at escalating doses
Drug: TRB-061
Subcutaneous TRB-061 administered every 4 weeks for a total of 4 doses
Drug: TRB-061
Subcutaneous TRB-061 administered every 4 weeks for 3 doses
Placebo Comparator: Placebo Comparator
Subcutaneous placebo (matching TRB-061 in each study part)
Drug: Placebo
Single and multiple subcutaneous doses of placebo matching TRB-061 in patients
Experimental: Phase 1b - TRB-061
Multiple subcutaneous doses (Q4W for 12 weeks) in patients with moderate-to-severe AD
Drug: TRB-061
Single subcutaneous injection of TRB-061 at escalating doses
Drug: TRB-061
Subcutaneous TRB-061 administered every 4 weeks for a total of 4 doses
Drug: TRB-061
Subcutaneous TRB-061 administered every 4 weeks for 3 doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: From Screening to Day 85 (SAD), Up to Day 127 (MAD); up to Day 253 (Phase 1b)
From Screening to Day 85 (SAD), Up to Day 127 (MAD); up to Day 253 (Phase 1b)

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic (Maximum Observed Plasma Concentration, Cmax)
Time Frame: Up to Day 85 (SAD), Up to Day 127 (MAD); up to Week 37 (Phase 1b)
Up to Day 85 (SAD), Up to Day 127 (MAD); up to Week 37 (Phase 1b)

Collaborators and Investigators

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

Sponsor

TRex Bio, Inc.

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)

May 2, 2025

Primary Completion (Estimated)

September 2, 2027

Study Completion (Estimated)

February 29, 2028

Study Registration Dates

First Submitted

April 11, 2025

First Submitted That Met QC Criteria

April 11, 2025

First Posted (Actual)

April 18, 2025

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRB061-AD-101

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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