Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
Phase 1: testing ARQ-234 for Atopic Dermatitis (AD)
This is a first-in-human, Phase 1, neither you nor the study doctors know who gets the real treatment, randomly assigned, compared with a dummy treatment, 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).
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are ARQ-234, or Placebo. The registry lists allocation as randomized. This is a first-in-human, Phase 1, neither you nor the study doctors know who gets the real treatment, randomly assigned, compared with a dummy treatment, dose-escalation study evaluating ARQ-234.
They plan to enroll about 125 people at 7 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.
Official title (unrewritten)
A Phase 1a/1b, Double-Blind, Randomized, Placebo-Controlled, Single Ascending Dose and Multiple Ascending Dose Study of ARQ-234 in Healthy Volunteers and Subjects With Moderate to Severe Atopic Dermatitis.
Interventions: ARQ-234, Placebo
Primary outcome (registry wording): Number and percentage of participants who experience an adverse event (AE) or serious adverse event (SAE)
Who it is for (from inclusion criteria)
Ages 18 Years to 65 Years
(All Participants):
Adults 18-65 years (inclusive) at consent
Generally healthy at screening/baseline (no clinically significant findings on medical history, exam, vitals, ECG, or safety labs, per investigator)
Body weight by study part: Part A (SAD) \& Part B (MAD): 50-100 kg (inclusive), Part C (POC): 50-125 kg (inclusive)
who can join for atopic dermatitis (AD) Participants (Parts A Cohorts 6-7, Part B, Part C):
Diagnosis of moderate-to-severe atopic dermatitis for ≥ 6 months prior to screening
Meets minimum disease severity at baseline: Part A Cohorts 6-7: BSA ≥7%, vIGA-AD 3-4, EASI ≥10 at Baseline, Parts B and C: BSA ≥10%, vIGA-AD 3-4, EASI ≥16 at Baseline
Who the registry excludes
(All Participants):
Any clinically significant medical or psychiatric condition that could increase risk, interfere with participation, or confound results (per investigator)
Clinically significant cytopenias or clinically significant abnormal liver tests at screening (per protocol)
History of anaphylaxis/serious hypersensitivity (including significant hypersensitivity to local anesthetics)
History of attempted suicide or significant current risk, per investigator)
Chronic or significant infection history or positive screening tests for hepatitis B, hepatitis C, HIV, or tuberculosis (including positive QuantiFERON or history of active/latent TB)
This is a tissue, urine, and blood banking protocol for cutaneous t-cell lymphoma (CTCL), eczema, and atopic dermatitis patients for current and future research.
This study will examine microbes (e.g., bacteria, fungi, viruses) that live on human skin and how microbes contribute to health and disease. It will analyze healthy human skin and how the these microorganisms might change in patients with atopic dermatitis (AD), a skin condition also known as eczema.
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07453602?
Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07453602?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.