Status:
RECRUITING
Phase 1a/1b Study of TRB-061 in Healthy Participants & Atopic Dermatitis Patients
Lead Sponsor:
TRex Bio, Inc.
Conditions:
Moderate-to-severe Atopic Dermatitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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...
Detailed Description
The study comprises three sequential parts: Part 1 (SAD): Healthy adults will receive single-ascending doses of TRB-061 or placebo in cohorts of 8 (6 active, 2 placebo). Safety data will be reviewed ...
Eligibility Criteria
Inclusion
- 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: diagnosis of moderate-to-severe atopic dermatitis for at least 12 months before 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.
Exclusion
- 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.
- 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.
- Any other reason, in the opinion of the investigator or sponsor, that would make the participant unsuitable for participation in the study.
Key Trial Info
Start Date :
May 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 22 2027
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT06934252
Start Date
May 2 2025
End Date
June 22 2027
Last Update
August 11 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
CMAX Clinical Research Pty Ltd
Adelaide, South Australia, Australia, 5000