NCT06934252

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 115 (estimated)
• Sponsor: TRex Bio, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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 or Part 2. 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.

Detailed description

Healthy adults will receive a single-ascending dose (SAD) of placebo or TRB-061 in cohorts of 8 (6 active, 2 placebo). Safety data will be reviewed before dosing the remaining participants. Follow-up lasts 12 weeks post-dosing. Treatment in the multiple-ascending dose (MAD) phase will be initiated after SAD cohort safety review is completed. Healthy adults will receive 3 doses of TRB-061 or placebo every 4 weeks (Q4W) over 8 weeks. Follow-up lasts 10 weeks post-last dose. Participants with moderate-to-severe AD (Phase 1b) will be randomized (1:1:1) to receive one of two dose levels of TRB-061 or placebo for 12 weeks (Q4W), followed by a follow up period. There will be an option for subjects who received placebo to receive active treatment following the primary study period.

Conditions

• Moderate-to-severe Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	TRB-061	Single subcutaneous injection of TRB-061 at escalating doses
DRUG	TRB-061	Subcutaneous TRB-061 administered every 4 weeks for a total of 4 doses
DRUG	TRB-061	Subcutaneous TRB-061 administered every 4 weeks for 3 doses
DRUG	Placebo	Single and multiple subcutaneous doses of placebo matching TRB-061 in patients

Timeline

• Start date: 2025-05-02
• Primary completion: 2027-09-02
• Completion: 2028-02-29
• First posted: 2025-04-18
• Last updated: 2026-03-02

Locations

14 sites across 2 countries: Australia, New Zealand