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

NCT06934252 | Recruiting Phase 1

• 1 other identifier: TRB061-AD-101
• Study Type: interventional
• Target: 115
• Locations: 2 countries
• Sites: 14

Brief 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

Moderate-to-severe Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  From Screening to Day 85 (Part 1), Up to Day 127 (Part 2); up to Day 337 (Part 3)

Secondary Outcomes (1)

• Pharmacokinetic (Maximum Observed Plasma Concentration, Cmax)

  Up to Day 85 (Part 1), Up to Day 127 (Part 2); up to Week 49 (Part 3)

Study Arms (4)

SAD - TRB-061

EXPERIMENTAL

Single ascending subcutaneous doses of TRB-061 in healthy participants

Drug: TRB-061

MAD - TRB-061

EXPERIMENTAL

Multiple subcutaneous doses (Q4W for 8 weeks) in healthy participants

Drug: TRB-061

Part 3 Phase 1b - TRB-061

EXPERIMENTAL

Multiple subcutaneous doses (Q4W for 12 weeks) in patients with moderate-to-severe AD

Drug: TRB-061

Placebo Comparator

PLACEBO COMPARATOR

Subcutaneous placebo (matching TRB-061 in each study part)

Drug: Placebo

Interventions

TRB-061 DRUG

Single subcutaneous injection of TRB-061 at escalating doses

SAD - TRB-061

Placebo DRUG

Single and multiple subcutaneous doses of placebo matching TRB-061 in patients

Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants aged 18 to 70 years, inclusive, at the time of informed consent.
• Body weight ≥50 kg and 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 (Parts 1 and 2): no clinically significant abnormalities in laboratory results, ECGs, or physical exams at screening.
• For participants in Part 3: 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).
• Moderate-to-severe AD at Screening and at Day 1 visit as defined by:
• EASI score ≥16,
• BSA affected ≥10%,
• vIGA-AD score ≥3, and
• Pruritus NRS score ≥3.

You may not qualify if:

• 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 investigational product (whichever is longer) before Day 1.
• History of hypersensitivity or allergic reaction to any component of the study drug or 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).
• Active infection or history of serious infections within 4 weeks prior to Day 1.
• History of malignancy (except treated and cured non-melanoma skin cancers or cervical carcinoma in situ).
• Pregnant or breastfeeding women, or women planning to become pregnant during the study or within a specified time after the last dose.
• Clinically significant ECG abnormalities (e.g., QTcF \>470 ms) or other cardiac risk factors.
• Abnormal laboratory values at screening.
• Use of live vaccines within 4 weeks before Day 1.
• Use of systemic corticosteroids, immunosuppressants, or immunomodulatory drugs within protocol-defined washout periods (Part 3 Phase 1b only).
• Active COVID-19 infection or symptoms, or positive COVID-19 test at screening.

Sponsors & Collaborators

• TRex Bio, Inc.: lead

Study Sites (14)

Paratus Clinical Research - Canberra Trial Clinic

Belconnen, Australian Capital Territory, 2617, Australia

NOT YET RECRUITING

Paratus Clinical Brisbane Pty Ltd

Albion, Brisbane, 4010, Australia

NOT YET RECRUITING

Paratus Clinical Research Western Sydney

Blacktown, New South Wales, 2148, Australia

NOT YET RECRUITING

Paratus Clinical Research Central Coast

Kanwal, New South Wales, 2259, Australia

NOT YET RECRUITING

Cornerstone Centre for Clinical Research

Coorparoo, Queensland, 4151, Australia

NOT YET RECRUITING

CMAX Clinical Research Pty Ltd

Adelaide, South Australia, 5000, Australia

RECRUITING

Paratus Clinical Research Melbourne

Melbourne, Victoria, 3070, Australia

NOT YET RECRUITING

Momentum Clinical Research Pukekohe

Pukekohe, Auckland, 2120, New Zealand

NOT YET RECRUITING

Momentum Clinical Research Dunedin

Dunedin, Otago, 9016, New Zealand

NOT YET RECRUITING

Pacific Clinical Research Network-Tasman

Nelson, Tasman District, 7011, New Zealand

NOT YET RECRUITING

Medical Research Institute of New Zealand

Newtown, Wellington Region, 6021, New Zealand

NOT YET RECRUITING

Pacific Clinical Research Network-Wellington

Upper Hutt, Wellington Region, 5018, New Zealand

NOT YET RECRUITING

Momentum Clinical Research Kapiti

Waikanae, Wellington Region, 5036, New Zealand

NOT YET RECRUITING

Pacific Clinical Research Network-West Auckland

Auckland, 0600, New Zealand

NOT YET RECRUITING

Central Study Contacts

Study Director

CONTACT

+1 (650) 567-5582; clinicaltrials@trex.bio

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 18, 2025
• Study Start: May 2, 2025
• Primary Completion (Estimated): September 2, 2027
• Study Completion (Estimated): February 29, 2028
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (7); AU (7)