A Phase 1a/1b, Double-Blind, Randomized, Placebo-Controlled, Single Ascending Dose and Multiple Ascending Dose Study of ARQ-234 in Healthy Volunteers and Subjects With Moderate to Severe Atopic Dermatitis.
This is a first-in-human, Phase 1, double-blind, randomized, placebo-controlled, dose-escalation study evaluating ARQ-234. The study is designed to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ARQ-234 in two populations: healthy volunteers and participants with moderate to severe atopic dermatitis (AD). Healthy volunteers will participate in Single Ascending Dose (SAD) Cohorts 1-5. Participants with moderate to severe AD will be enrolled in SAD Cohorts 6-7, Multiple Ascending Dose (MAD) Cohorts, and a Proof-of-Concept (POC) expansion cohort.
• Able and willing to provide written informed consent.
• Adults 18-65 years (inclusive) at consent.
• Generally healthy at screening/baseline (no clinically significant findings on medical history, exam, vitals, ECG, or safety labs, per investigator).
• Contraception requirements: Females of childbearing potential: negative pregnancy tests at screening and baseline and agree to use highly effective contraception (plus barrier method) during the study and for 4 months after last dose. Males if sexually active with a pregnant partner or a female of childbearing potential, agree to condom use during the study and for 4 months after last dose.
• Body weight by study part: Part A (SAD) \& Part B (MAD): 50-100 kg (inclusive), Part C (POC): 50-125 kg (inclusive)
• Diagnosis of moderate-to-severe atopic dermatitis for ≥ 6 months prior to screening.
• Meets minimum disease severity at baseline: Part A Cohorts 6-7: BSA ≥7%, IGA-AD 3-4, EASI ≥10 at Baseline, Parts B and C: BSA ≥10%, IGA-AD 3-4, EASI ≥16 at Baseline.
• Inadequate response, intolerance, or medical inappropriateness of topical AD therapies (and/or prior systemic AD therapy failure within the last year may qualify as inadequate response).