Phase 1a/1b Study of TRB-061 in Healthy Participants & Patients With Atopic Dermatitis
Eligible age
18–70 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
Yes
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About this study
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.
Sponsor: TRex Bio, Inc.
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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.
Source: ClinicalTrials.gov · NCT06934252 · last updated 2026-06-16