Actively Recruiting
Phase 1a/1b Study of TRB-061 in Healthy Participants & Atopic Dermatitis Patients
Led by TRex Bio, Inc. · Updated on 2026-03-02
115
Participants Needed
14
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Phase 1a/1b Study of TRB-061 in Healthy Participants & Atopic Dermatitis Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 to 70 years, inclusive, at the time of informed consent.
- Body weight 6550 kg and body mass index (BMI) between 18.5 and 35.0 kg/m8, 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 6545 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 6516,
- BSA affected 6510%,
- vIGA-AD score 653, and
- Pruritus NRS score 653.
You will not qualify if you...
- 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.
- History of alcohol or drug abuse within the past year.
- Use of tobacco/nicotine products beyond protocol-allowed limits.
- Positive cotinine test at check-in (SAD/MAD only).
- Any other reason, in the opinion of the investigator or sponsor, that would make the participant unsuitable for participation in the study.
- 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.
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Paratus Clinical Research - Canberra Trial Clinic
Belconnen, Australian Capital Territory, Australia, 2617
Not Yet Recruiting
2
Paratus Clinical Brisbane Pty Ltd
Albion, Brisbane, Australia, 4010
Not Yet Recruiting
3
Paratus Clinical Research Western Sydney
Blacktown, New South Wales, Australia, 2148
Not Yet Recruiting
4
Paratus Clinical Research Central Coast
Kanwal, New South Wales, Australia, 2259
Not Yet Recruiting
5
Cornerstone Centre for Clinical Research
Coorparoo, Queensland, Australia, 4151
Not Yet Recruiting
6
CMAX Clinical Research Pty Ltd
Adelaide, South Australia, Australia, 5000
Actively Recruiting
7
Paratus Clinical Research Melbourne
Melbourne, Victoria, Australia, 3070
Not Yet Recruiting
8
Momentum Clinical Research Pukekohe
Pukekohe, Auckland, New Zealand, 2120
Not Yet Recruiting
9
Momentum Clinical Research Dunedin
Dunedin, Otago, New Zealand, 9016
Not Yet Recruiting
10
Pacific Clinical Research Network-Tasman
Nelson, Tasman District, New Zealand, 7011
Not Yet Recruiting
11
Medical Research Institute of New Zealand
Newtown, Wellington Region, New Zealand, 6021
Not Yet Recruiting
12
Pacific Clinical Research Network-Wellington
Upper Hutt, Wellington Region, New Zealand, 5018
Not Yet Recruiting
13
Momentum Clinical Research Kapiti
Waikanae, Wellington Region, New Zealand, 5036
Not Yet Recruiting
14
Pacific Clinical Research Network-West Auckland
Auckland, New Zealand, 0600
Not Yet Recruiting
Research Team
S
Study Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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