Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07453602
Brief 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.
Study:
NCT07453602
Study Brief:
Protocol Section:
NCT07453602