Ph 1a/1b Single Ascending Dose and Multiple Ascending Dose Study of ARQ-234
Eligible age
18–65 yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
Yes
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About this study
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.
Sponsor: Arcutis Biotherapeutics, Inc.
You may qualify if…
- ✓ 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%, vIGA-AD 3-4, EASI ≥10 at Baseline, Parts B and C: BSA ≥10%, vIGA-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).
You may not qualify if…
- ✕ Any clinically significant medical or psychiatric condition that could increase risk, interfere with participation, or confound results (per investigator).
- ✕ Significant renal impairment or clinically significant hepatic impairment (per protocol/part-specific definitions).
- ✕ Clinically significant cytopenias or clinically significant abnormal liver tests at screening (per protocol).
- ✕ History of anaphylaxis/serious hypersensitivity (including significant hypersensitivity to local anesthetics).
- ✕ History of attempted suicide or significant current risk, per investigator).
- ✕ Chronic or significant infection history or positive screening tests for hepatitis B, hepatitis C, HIV, or tuberculosis (including positive QuantiFERON or history of active/latent TB).
- ✕ Known/suspected immunosuppression or history of invasive opportunistic infections or unusually frequent/recurrent/prolonged infections (per investigator).
- ✕ Recent herpes zoster that poses risk or may affect interpretation (per investigator).
Where it's recruiting
Fair Lawn
College Station
Source: ClinicalTrials.gov · NCT07453602 · last updated 2026-08-17