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

PHASE1RECRUITING

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 details:

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.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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 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 (Parts 1 and 2): no clinically significant abnormalities in laboratory results, ECGs, or physical exams at screening.
  5. For participants in Part 3: diagnosis of moderate-to-severe atopic dermatitis for at least 12 months before 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.

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 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. History of malignancy (except treated and cured non-melanoma skin cancers or cervical carcinoma in situ).
  10. Pregnant or breastfeeding women, or women planning to become pregnant during the study or within a specified time after the last dose.
  11. Clinically significant ECG abnormalities (e.g., QTcF >470 ms) or other cardiac risk factors.
  12. Abnormal laboratory values at screening.
  13. Use of live vaccines within 4 weeks before Day 1.
  14. Use of systemic corticosteroids, immunosuppressants, or immunomodulatory drugs within protocol-defined washout periods.
  15. Active COVID-19 infection or symptoms, or positive COVID-19 test at screening.
  16. History of alcohol or drug abuse within the past year.
  17. Use of tobacco/nicotine products beyond protocol-allowed limits.
  18. Positive cotinine test at check-in.
  19. Any other reason, in the opinion of the investigator or sponsor, that would make the participant unsuitable for participation in the study.

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    PHASE1

trial

Study ID

NCT06934252

Intervention or treatment

DRUG: TRB-061

DRUG: TRB-061

DRUG: TRB-061

DRUG: Placebo

Conditions

  • Moderate-to-severe Atopic Dermatitis

  • Condition: Moderate-to-severe Atopic Dermatitis

  • DRUG: TRB-061 and other drugs

  • Adelaide, South Australia, Australia

  • Sponsor: TRex Bio, Inc.

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Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

CMAX Clinical Research Pty Ltd

Select from list below to view details:

  • CMAX Clinical Research Pty Ltd

    Adelaide, South Australia, Australia

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Who is running the clinical trial?

TBI

TRex Bio, Inc.

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?

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: SAD - TRB-061
  • Single ascending subcutaneous doses of TRB-061 in healthy participants
Drug: TRB-061
    EXPERIMENTAL: MAD - TRB-061
    • Multiple subcutaneous doses (Q4W for 8 weeks) in healthy participants
    Drug: TRB-061
      EXPERIMENTAL: Phase 1b - TRB-061
      • Multiple subcutaneous doses (Q4W for 12 weeks) in patients with moderate-to-severe AD
      Drug: TRB-061
        PLACEBO_COMPARATOR: Placebo Comparator
        • Subcutaneous placebo (matching TRB-061 in each study part)
        Drug: Placebo

          What is the study measuring?

          Primary Outcome

          MeasureDescriptionTime Frame
          Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)Not SpecifiedFrom Screening to Day 85 (Part 1), Up to Day 127 (Part 2); up to Week 49 (Part 3)

          Secondary Outcome

          MeasureDescriptionTime Frame
          Pharmacokinetic (Maximum Observed Plasma Concentration, Cmax)Not SpecifiedUp to Day 85 (Part 1), Up to Day 127 (Part 2); up to Week 49 (Part 3)
          Are you running this trial?If you're a clinic or sponsor, you can claim this study.
          Claim this trial

          References

          Clinical Trials Gov: Phase 1a/1b Study of TRB-061 in Healthy Participants & Atopic Dermatitis Patients

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