TRB-061 injections for healthy adults and people with moderate-to-severe atopic dermatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled Phase 1a/1b program includes single-ascending dose (SAD) and multiple-ascending dose (MAD) parts in healthy volunteers and a Phase 1b repeat-dosing part in patients with moderate-to-severe atopic dermatitis. In SAD healthy volunteers are dosed in cohorts of 8 (6 active, 2 placebo) with safety review before escalation; MAD healthy volunteers receive three doses Q4W over 8 weeks. The Phase 1b patient portion randomizes participants 1:1:1 to two active dose levels or placebo for four doses over 12 weeks, with an option for placebo recipients to receive active treatment after the primary period. Follow-up periods of roughly 10–12 weeks are included to monitor safety, pharmacokinetics, and pharmacodynamics.

Why it matters

Who can join: the full rules

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

Where it's running

• Paratus Clinical Research - Canberra Trial Clinic
  Deakin, Australian Capital Territory, Australia Recruiting
• Paratus Clinical Brisbane Pty Ltd
  Albion, Brisbane, Australia Recruiting
• Paratus Clinical Research Western Sydney
  Blacktown, New South Wales, Australia Recruiting
• Paratus Clinical Research Central Coast
  Kanwal, New South Wales, Australia Recruiting
• Cornerstone Centre for Clinical Research
  Coorparoo, Queensland, Australia Recruiting
• Paratus Clinical Research Melbourne
  Melbourne, Victoria, Australia Recruiting

Study contacts

• Study coordinator: Study Director
• Email: clinicaltrials@trex.bio
• Phone: +1 (650) 567-5582

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• A Phase 3 test of Rezpegaldesleukin (NKTR-358) for moderate-to-severe atopic dermatitis in patients 12 years and older

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  Recruiting at 13 sites Phase 3 Nektar Therapeutics · Birmingham, Alabama and 12 other locations · NCT07711418

• Rezpegaldesleukin for moderate-to-severe atopic dermatitis in people 12 and older

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• Nemolizumab for infants with moderate-to-severe atopic dermatitis

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• SYX-5219 in healthy adults and adults with moderate-to-severe atopic dermatitis

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• Oral LW402 for moderate-to-severe atopic dermatitis

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  Recruiting Phase 3 Shanghai Longwood Biopharmaceuticals Co., Ltd. · Beijing · NCT07370909

• SHR-1905 treatment for moderate-to-severe atopic dermatitis

  This trial will test whether SHR-1905 injections help adults aged 18–75 who have moderate-to-severe atopic dermatitis.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.