RecruitingPhase 1interventionalRules rewrite

Phase 1: testing TRB-061 for Moderate-to-severe Atopic Dermatitis

This Phase 1a/1b randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment 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).

Official registry: https://clinicaltrials.gov/study/NCT06934252 · TRex Bio, Inc. · enrollment listed as 115

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are TRB-061, TRB-061, or TRB-061. The registry lists allocation as randomized. This Phase 1a/1b randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment 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).

They plan to enroll about 115 people at 19 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: TRB-061, TRB-061, TRB-061, Placebo

Primary outcome (registry wording): Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Who it is for (from inclusion criteria)

Ages 18 Years to 70 Years
Body weight ≥50 kg and a body mass index (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

Who the registry excludes

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 dummy treatment (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)

Public study contact (from the registry)

Study Director

+1 (650) 567-5582

clinicaltrials@trex.bio

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

19 listed

Paratus Clinical Research - Canberra Trial Clinic — Deakin, Australian Capital Territory, Australia (recruiting)
Paratus Clinical Brisbane Pty Ltd — Albion, Brisbane, Australia (recruiting)
Paratus Clinical Research Western Sydney — Blacktown, New South Wales, Australia (recruiting)
Paratus Clinical Research Central Coast — Kanwal, New South Wales, Australia (recruiting)
Cornerstone Centre for Clinical Research — Coorparoo, Queensland, Australia (recruiting)
CMAX Clinical Research Pty Ltd — Adelaide, South Australia, Australia (active_not_recruiting)
Paratus Clinical Research Melbourne — Melbourne, Victoria, Australia (recruiting)
Alfred Health — Melbourne, Australia (recruiting)
MCR Sunshine — Saint Albans, Australia (recruiting)
Momentum Clinical Research Pukekohe — Pukekohe, Auckland, New Zealand (recruiting)
Momentum Clinical Research Dunedin — Dunedin, Otago, New Zealand (recruiting)
Pacific Clinical Research Network-Tasman — Nelson, Tasman District, New Zealand (recruiting)

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FAQ about this NCT record

Is NCT06934252 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06934252?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06934252?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary