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

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Atopic Dermatitis (AD)
• Eczema

Eligibility basics and study details

Study type

Interventional

Phase

Phase 1

Ages

18 to 65 years

Sex

All

Healthy volunteers

Accepted

Sponsor

Arcutis Biotherapeutics, Inc.

Last updated on ClinicalTrials.gov

October 5, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites