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

NCT06934252 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2026-03-02

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • TRex Bio, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-02
Primary Completion
2027-09-02
Completion
2028-02-29

Countries

  • Australia
  • New Zealand

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06934252 on ClinicalTrials.gov