RecruitingPhase 1NCT07453602

Ph 1a/1b Single Ascending Dose and Multiple Ascending Dose Study of ARQ-234

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.


Sponsor

Arcutis Biotherapeutics, Inc.

Enrollment

125 participants

Start Date

Mar 2, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called ARQ-234 and a drug called Placebo for people with atopic dermatitis (ad) and eczema. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALARQ-234

ARQ-234 subcutaneous injectable solution

DRUGPlacebo

Placebo subcutaneous injectable solution


Locations(1)

Clinical Site 101

Fair Lawn, New Jersey, United States

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NCT07453602


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