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

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Moderate-to-severe Atopic Dermatitis

In brief

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.

Key facts

Study ID

NCT06934252

Run by

TRex Bio, Inc.

People needed

115

Starts

2025-05-02

Expected to finish

2028-02-29

Last updated by the study team

2026-06-16

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female participants aged 18 to 70 years, inclusive, at the time of informed consent.
• Body weight ≥50 kg and a body mass index (BMI)between 18.5 and 35.0 kg/m², inclusive.
• Participant is in good general health as determined by the investigator, based on medical history, physical examination, and clinical laboratory tests.
• For healthy participants (SAD and MAD): no clinically significant abnormalities in ECGs at screening.
• For participants in Phase 1b: Confirmed diagnosis of AD with onset of symptoms at least 1 year prior to Screening.
• Must be nonpregnant and nonlactating with negative pregnancy tests at screening and prior to dosing.
• Must be a non-smoker or ≤5 cigarettes per week for the past 6 months (SAD/MAD only).
• For participants in Phase 1b: Moderate-to-severe AD at Screening and at Day 1 visit
• Agrees to abstain from the use of tetrahydrocannabinol (THC)-containing products while on study.

You may not qualify if…

• 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.
• History or presence of any condition requiring systemic immunosuppressive or immunomodulatory therapy within a defined period before screening.
• Use of any biologic agent (e.g., monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) before Day 1.
• Participation in another investigational drug trial within 30 days or 5 half-lives of the prior investigational product (whichever is longer) before Day 1.
• History of hypersensitivity or allergic reaction to any component of the study drug or placebo formulation.
• Known active or latent tuberculosis (TB) infection. or history of incomplete TB treatment.
• Positive test at screening for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) RNA, or human immunodeficiency virus (HIV).
• Active infection or history of serious infections within 4 weeks prior to Day 1.
• Clinically significant ECG abnormalities (e.g., QTcF>470 ms) or other cardiac risk factors.
• Abnormal and clinically significant laboratory values at screening.
• Use of live vaccines within 4 weeks before Day 1.
• Use of systemic corticosteroids, immunosuppressants, or immunomodulatory drugs within protocol-defined washout periods (Part 3 only).
• Recent history of alcohol or drug abuse as defined per protocol.
• Use of tobacco/nicotine products beyond protocol-allowed limits (SAD and MAD).
• Positive cotinine test at check-in (SAD/MAD only).
• Any other reason, in the opinion of the investigator or sponsor, that would make the participant unsuitable for participation in the study.
• 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.
• 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

Where it is running

• Pacific Clinical Research Network-West Auckland — Auckland, New Zealand (enrolling)
• Paratus Clinical Brisbane Pty Ltd — Albion, Brisbane, Australia (enrolling)
• Paratus Clinical Research Western Sydney — Blacktown, New South Wales, Australia (enrolling)
• Paratus Clinical Research Central Coast — Kanwal, New South Wales, Australia (enrolling)
• Cornerstone Centre for Clinical Research — Coorparoo, Queensland, Australia (enrolling)
• Paratus Clinical Research - Canberra Trial Clinic — Belconnen, Australian Capital Territory, Australia (enrolling)
• Paratus Clinical Research Melbourne — Melbourne, Victoria, Australia (enrolling)
• Momentum Clinical Research Pukekohe — Pukekohe, Auckland, New Zealand (enrolling)
• Momentum Clinical Research Dunedin — Dunedin, Otago, New Zealand (enrolling)
• Pacific Clinical Research Network-Tasman — Nelson, Tasman District, New Zealand (enrolling)
• Clinical Trials New Zealand Ltd — Hamilton, Waikato Region, New Zealand (enrolling)
• Medical Research Institute of New Zealand — Newtown, Wellington Region, New Zealand (enrolling)
• Pacific Clinical Research Network-Wellington — Upper Hutt, Wellington Region, New Zealand (enrolling)
• Momentum Clinical Research Kapiti — Waikanae, Wellington Region, New Zealand (enrolling)
• CMAX Clinical Research Pty Ltd — Adelaide, South Australia, Australia

Full record on ClinicalTrials.gov

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