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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.
Healthy adults will receive a single-ascending dose (SAD) of placebo or TRB-061 in cohorts of 8 (6 active, 2 placebo). Safety data will be reviewed before dosing the remaining participants. Follow-up lasts 12 weeks post-dosing. Treatment in the multiple-ascending dose (MAD) phase will be initiated after SAD cohort safety review is completed. Healthy adults will receive 3 doses of TRB-061 or placebo every 4 weeks (Q4W) over 8 weeks. Follow-up lasts 10 weeks post-last dose.
Participants with moderate-to-severe AD (Phase 1b) will be randomized to receive one of two dose levels of TRB-061 or placebo for 12 weeks (Q4W) in Period 1. In Period 2, participants will have the option to consent to a cross over treatment where those who previously received placebo will receive TRB-061 and those who received TRB-061 will receive placebo Q4W for 12 weeks followed by a Follow Up period through End of Study (EOS). Participants who do not consent to receive crossover treatment will continue study visits including efficacy and safety assessments through the EOS visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD - TRB-061 | Experimental | Single ascending subcutaneous doses of TRB-061 in healthy participants |
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| MAD - TRB-061 | Experimental | Multiple subcutaneous doses (Q4W for 8 weeks) in healthy participants |
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| Phase 1b - TRB-061 | Experimental | Multiple subcutaneous doses (Q4W for 12 weeks) in patients with moderate-to-severe AD |
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| Placebo Comparator | Placebo Comparator | Subcutaneous placebo (matching TRB-061 in each study part) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRB-061 | Drug | Single subcutaneous injection of TRB-061 at escalating doses |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (Maximum Observed Plasma Concentration, Cmax) | Up to Day 85 (SAD), Up to Day 127 (MAD); up to Week 37 (Phase 1b) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Contact | +1 (650) 567-5582 | clinicaltrials@trex.bio |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paratus Clinical Research - Canberra Trial Clinic | Recruiting | Belconnen | Australian Capital Territory | 2617 | Australia |
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| TRB-061 |
| Drug |
Subcutaneous TRB-061 administered every 4 weeks for a total of 4 doses |
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| TRB-061 | Drug | Subcutaneous TRB-061 administered every 4 weeks for 3 doses |
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| Placebo | Drug | Single and multiple subcutaneous doses of placebo matching TRB-061 in patients |
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| Paratus Clinical Brisbane Pty Ltd | Recruiting | Albion | Brisbane | 4010 | Australia |
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| Paratus Clinical Research Western Sydney | Recruiting | Blacktown | New South Wales | 2148 | Australia |
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| Paratus Clinical Research Central Coast | Recruiting | Kanwal | New South Wales | 2259 | Australia |
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| Cornerstone Centre for Clinical Research | Recruiting | Coorparoo | Queensland | 4151 | Australia |
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| CMAX Clinical Research Pty Ltd | Active, not recruiting | Adelaide | South Australia | 5000 | Australia |
| Paratus Clinical Research Melbourne | Recruiting | Melbourne | Victoria | 3070 | Australia |
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| Momentum Clinical Research Pukekohe | Recruiting | Pukekohe | Auckland | 2120 | New Zealand |
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| Momentum Clinical Research Dunedin | Recruiting | Dunedin | Otago | 9016 | New Zealand |
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| Pacific Clinical Research Network-Tasman | Recruiting | Nelson | Tasman District | 7011 | New Zealand |
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| Clinical Trials New Zealand Ltd | Recruiting | Hamilton | Waikato Region | 3204 | New Zealand |
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| Medical Research Institute of New Zealand | Recruiting | Newtown | Wellington Region | 6021 | New Zealand |
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| Pacific Clinical Research Network-Wellington | Recruiting | Upper Hutt | Wellington Region | 5018 | New Zealand |
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| Momentum Clinical Research Kapiti | Recruiting | Waikanae | Wellington Region | 5036 | New Zealand |
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| Pacific Clinical Research Network-West Auckland | Recruiting | Auckland | 0600 | New Zealand |
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