drugset / Trial / NCT07453602

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

NCT07453602 ↗

Phase 1 Recruiting 125 enrolled Arcutis Biotherapeutics, Inc.
RandomizedSequentialQuadruple-blindTreatment

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.

Timeline

Start
2026-03-02
Primary completion
2028-04
Completion
2028-04

Drugs

EvaluationDrugModalityDoseRoute
Subject ARQ-234 Unknown — Subcutaneous

Indications