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

NCT Number	NCT06934252
Lead Sponsor	TRex Bio, Inc.
Conditions	Moderate-to-severe Atopic Dermatitis
Enrollment	115 participants
Start Date	2025-05-02
Primary Completion	2027-09-02 (estimated)
Study Completion	2028-02-29 (estimated)
Updated on ClinicalTrials.gov	2026-08-13