Phase 1a/1b Study of TRB-061 in Healthy Participants & Patients With Atopic Dermatitis
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
TRex Bio, Inc.
115 participants
May 2, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Single subcutaneous injection of TRB-061 at escalating doses
Subcutaneous TRB-061 administered every 4 weeks for a total of 4 doses
Subcutaneous TRB-061 administered every 4 weeks for 3 doses
Single and multiple subcutaneous doses of placebo matching TRB-061 in patients
Locations(15)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06934252