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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
115
Single subcutaneous injection of TRB-061 at escalating doses
Subcutaneous TRB-061 administered every 4 weeks for a total of 4 doses
Subcutaneous TRB-061 administered every 4 weeks for 3 doses
Single and multiple subcutaneous doses of placebo matching TRB-061 in patients
Paratus Clinical Research - Canberra Trial Clinic
Belconnen, Australian Capital Territory, Australia
RECRUITINGParatus Clinical Brisbane Pty Ltd
Albion, Brisbane, Australia
RECRUITINGParatus Clinical Research Western Sydney
Blacktown, New South Wales, Australia
RECRUITINGParatus Clinical Research Central Coast
Kanwal, New South Wales, Australia
RECRUITINGCornerstone Centre for Clinical Research
Coorparoo, Queensland, Australia
RECRUITINGCMAX Clinical Research Pty Ltd
Adelaide, South Australia, Australia
ACTIVE_NOT_RECRUITINGParatus Clinical Research Melbourne
Melbourne, Victoria, Australia
RECRUITINGAlfred Health
Melbourne, Australia
NOT_YET_RECRUITINGMCR Sunshine
Saint Albans, Australia
NOT_YET_RECRUITINGMomentum Clinical Research Pukekohe
Pukekohe, Auckland, New Zealand
RECRUITING...and 9 more locations
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Screening to Day 85 (SAD), Up to Day 127 (MAD); up to Day 253 (Phase 1b)
Pharmacokinetic (Maximum Observed Plasma Concentration, Cmax)
Time frame: Up to Day 85 (SAD), Up to Day 127 (MAD); up to Week 37 (Phase 1b)
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