Ph 1a/1b Single Ascending Dose and Multiple Ascending Dose Study of ARQ-234
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorArcutis Biotherapeutics, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
Able and willing to provide written informed consent.
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).
Contraception requirements: Females of childbearing potential: negative pregnancy tests at screening and baseline and agree to use highly effective contraception (plus barrier method) during the study and for 4 months after last dose. Males if sexually active with a pregnant partner or a female of childbearing potential, agree to condom use during the study and for 4 months after last dose.
Disqualifiers
Any clinically significant medical or psychiatric condition that could increase risk, interfere with participation, or confound results (per investigator).
Significant renal impairment or clinically significant hepatic impairment (per protocol/part-specific definitions).
Clinically significant cytopenias or clinically significant abnormal liver tests at screening (per protocol).
History of anaphylaxis/serious hypersensitivity (including significant hypersensitivity to local anesthetics).
Trial design
Treatments tested in this trial
- ARQ-234
- Placebo
Treatment groups
125 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov