Phase 1a/1b Study of TRB-061 in Healthy Participants & Patients With Atopic Dermatitis
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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
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