NCT07453602

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.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: Arcutis Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study consists of 3 parts with staggered initiation: * Part A - Phase 1a SAD: ARQ-234 will be assessed in single ascending dose cohorts in healthy volunteer participants and participants with atopic dermatitis. * Part B - Phase 1b MAD: ARQ-234 will be assessed in multiple ascending cohorts in participants with atopic dermatitis. * Part C - Phase 1b POC Expansion: ARQ-234 will be assessed in participants with atopic dermatitis.

Conditions

• Atopic Dermatitis (AD)
• Eczema

Interventions

Type	Name	Description
BIOLOGICAL	ARQ-234	ARQ-234 subcutaneous injectable solution
DRUG	Placebo	Placebo subcutaneous injectable solution

Timeline

• Start date: 2026-03-02
• Primary completion: 2028-04-01
• Completion: 2028-04-01
• First posted: 2026-03-06
• Last updated: 2026-03-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study