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

Part of paid clinical trials in Fair Lawn, New Jersey.

Sponsor
Arcutis Biotherapeutics, Inc.
Study ID
NCT07453602
Phase
PHASE1
Status
Recruiting
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Conditions

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

Start date
Mar 2, 2026
Status verified
May 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

Locations (1)

FacilityCityStateZIPSite coordinators
Clinical Site 101Fair LawnNew Jersey07410
Clinical Site 101
[email protected]
1-844-692-6729

Find similar trials in Fair Lawn, NJ

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Clinical· Fair Lawn, NJ

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