A Phase 1a/1b Randomized, Double-Blind, Placebo-Controlled, 3-Part Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Subcutaneous Doses of TRB-061 in Healthy Participants and in Patients With Moderate-to-Severe Atopic Dermatitis
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.
• 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.
• 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
• Agrees to abstain from the use of tetrahydrocannabinol (THC)-containing products while on study.