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Recruiting Phase 1

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

NCT06934252 · tracked via the Priya Life Science Australia tracker
Sponsor
TRex Bio, Inc
Phase
Phase 1
Started
2025-05-02
Last updated
2026-08-13

Condition(s) studied

Moderate-to-severe Atopic Dermatitis

Investigational drug(s) / intervention(s)

TRB-061TRB-061TRB-061Placebo

TRB-061: Single subcutaneous injection of TRB-061 at escalating doses

TRB-061: Subcutaneous TRB-061 administered every 4 weeks for a total of 4 doses

TRB-061: Subcutaneous TRB-061 administered every 4 weeks for 3 doses

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

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 (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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. Male or female participants aged 18 to 70 years, inclusive, at the time of informed consent. 2. Body weight ≥50 kg and a body mass index (BMI)between 18.5 and 35.0 kg/m², inclusive. 3. Participant is in good general health as determined by the investigator, based on medical history, physical examination, and clinical laboratory tests. 4. For healthy participants (SAD and MAD): no clinically significant abnormalities in ECGs at screening. 5. For participants in Phase 1b: Confirmed diagnosis of AD with onset of symptoms at least 1 year prior to Screening. 6. Must be nonpregnant and nonlactating with negative pregnancy tests at screening and prior to dosing. 7. Must be a non-smoker or ≤5 cigarettes per week for the past 6 months (SAD/MAD only). 8. For participants in Phase 1b: Moderate-to-severe AD at Screening and at Day 1 visit 9. Agrees to abstain from the use of tetrahydrocannabinol (THC)-containing products while on study. Exclusion Criteria: 1. 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. 2. History or presence of any condition requiring systemic immunosuppressive or immunomodulatory therapy within a defined period before screening. 3. Use of any biologic agent (e.g., monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) before Day 1. 4. Participation in another investigational drug trial within 30 days or 5 half-lives of the prior investigational product (whichever is longer) before Day 1. 5. History of hypersensitivity or allergic reaction to any component of the study drug or placebo formulation. 6. Known active or latent tuberculosis (TB) infection. or history of incomplete TB treatment. 7. Positive test at screening for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) RNA, or human immunodeficiency virus (HIV). 8. Active infection or history of serious infections within 4 weeks prior to Day 1. 9. Clinically significant ECG abnormalities (e.g., QTcF\>470 ms) or other cardiac risk factors. 10. Abnormal and clinically significant laboratory values at screening. 11. Use of live vaccines within 4 weeks before Day 1. 12. Use of systemic corticosteroids, immunosuppressants, or immunomodulatory drugs within protocol-defined washout periods (Part 3 only). 13. Recent history of alcohol or drug abuse as defined per protocol. 14. Use of tobacco/nicotine products beyond protocol-allowed limits (SAD and MAD). 15. Positive cotinine test at check-in (SAD/MAD only). 16. Any other reason, in the opinion of the investigator or sponsor, that would make the participant unsuitable for participation in the study. 17. Any medical or psychiatric condition that, in the opinion of the Investigator or Sponsor's medical monitor, would place the participant at risk, interfere with study participation, or interfere with the interpretation of study results. 18. Surgery within the past 90 days prior to dosing as determined by the Investigator or Sponsor's medical monitor to be clinically relevant or planned surgery to be performed during the study and 30 days after the last dose of study drug

Primary outcome measure(s)

  • Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) — From Screening to Day 85 (SAD), Up to Day 127 (MAD); up to Day 253 (Phase 1b)

Trial sites (19)

FacilityCityRegionStatus
Paratus Clinical Research - Canberra Trial Clinic Belconnen Australian Capital Territory Recruiting
Paratus Clinical Brisbane Pty Ltd Albion Brisbane Recruiting
Paratus Clinical Research Western Sydney Blacktown New South Wales Recruiting
Paratus Clinical Research Central Coast Kanwal New South Wales Recruiting
Cornerstone Centre for Clinical Research Coorparoo Queensland Recruiting
CMAX Clinical Research Pty Ltd Adelaide South Australia Active Not Recruiting
Paratus Clinical Research Melbourne Melbourne Victoria Recruiting
Alfred Health Melbourne Australia Not Yet Recruiting
MCR Sunshine Saint Albans Australia Not Yet Recruiting
Momentum Clinical Research Pukekohe Pukekohe Auckland Recruiting
Momentum Clinical Research Dunedin Dunedin Otago Recruiting
Pacific Clinical Research Network-Tasman Nelson Tasman District Recruiting
Clinical Trials New Zealand Ltd Hamilton Waikato Region Recruiting
Medical Research Institute of New Zealand Newtown Wellington Region Recruiting
Pacific Clinical Research Network-Wellington Upper Hutt Wellington Region Recruiting
Momentum Clinical Research Kapiti Waikanae Wellington Region Recruiting
Pacific Clinical Research Network-West Auckland Auckland New Zealand Recruiting
MCR Christchurch Christchurch New Zealand Recruiting
MCR Palmerston North Palmerston North New Zealand Not Yet Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06934252 on ClinicalTrials.gov ↗ ← All trials in Australia