Phase 1a/1b Study of TRB-061 in Healthy Participants & Patients With Atopic Dermatitis (NCT06934252) | Clinical Trial Compass
RecruitingPhase 1
Phase 1a/1b Study of TRB-061 in Healthy Participants & Patients With Atopic Dermatitis
Australia, New Zealand115 participantsStarted 2025-05-02
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female participants aged 18 to 70 years, inclusive, at the time of informed consent.
. Body weight ≥50 kg and a 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 (SAD and MAD): no clinically significant abnormalities in ECGs at screening.
. For participants in Phase 1b: 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: From Screening to Day 85 (SAD), Up to Day 127 (MAD); up to Day 253 (Phase 1b)
. Must be a non-smoker or ≤5 cigarettes per week for the past 6 months (SAD/MAD only).
. For participants in Phase 1b: Moderate-to-severe AD at Screening and at Day 1 visit
Exclusion criteria
. 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 prior 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.