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

Conditions

• Atopic Dermatitis (AD)
• Eczema

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Accepted

Interventions

• ARQ-234 — BIOLOGICAL
  ARQ-234 subcutaneous injectable solution
• Placebo — DRUG
  Placebo subcutaneous injectable solution

Study Details

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.

Key Dates

First listed

Mar 6, 2026

Start date

Mar 2, 2026

Status verified

Aug 2026

Primary completion

Apr 30, 2028

Completion

Apr 30, 2028

Study Design

Enrollment

125 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: ARQ-234
• Placebo Comparator: Placebo

Primary Outcome Measure

Number and percentage of participants who experience an adverse event (AE) or serious adverse event (SAE) [ Time Frame: From screening to the last follow up visit for each study part (Part A: 16 weeks, Part B: 30 weeks, Part C: 30 weeks) ]

Central Contacts

• Arcutis Medical Information
  1-844-692-6729
  [email protected]

Locations (2)

Find similar trials in Fair Lawn, NJ

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