A First-in-Human Study of RPT193 in Healthy Volunteers and Patients With Atopic Dermatitis

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-dose Escalation, Multiple-dose Escalation, and Food Effect Study of RPT193 in Healthy Subjects and Patients With Moderate to Severe Atopic Dermatitis

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04271514

Enrollment

103

Registered

2020-02-17

Start date

2019-08-12

Completion date

2021-04-26

Last updated

2021-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Brief summary

This study is a first-in-human, 3-part, multi-center, Phase 1, randomized, double-blind, placebo-controlled study with RPT193 in up to 64 healthy male and female subjects and 30 male and female patients with atopic dermatitis. RPT193 is an orally-available, potent, and selective antagonist of CCR4.

Interventions

DRUGRPT193

Antagonist of the CCR4 chemokine receptor

DRUGPlacebo

Matching placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

Selected Inclusion Criteria: Parts A & B (COMPLETED ENROLLMENT): * Healthy male or female * 18-55 years of age, inclusive * At least 50 kg in weight * BMI: 18.0-30.0 kg/m2, inclusive Part C (COMPLETED ENROLLMENT): * Male or female with atopic dermatitis * 18-65 years of age, inclusive * BMI between 18.0 (inclusive) and \<40.0 kg/m2 * Body surface area (BSA) with AD involvement ≥10% * Eczema Area and Severity Index (EASI) score ≥12 * Validated Investigator's Global Assessment (vIGA) ≥3 * History of inadequate response to treatment with topical medications, such as corticosteroids or calcineurin inhibitors, or patients for whom topical treatments are otherwise medically inadvisable Selected

Exclusion criteria

Parts A & B (COMPLETED ENROLLMENT): * Use of tobacco products within 60 days prior to drug administration * History of alcohol abuse or drug addiction * Positive drug and alcohol screen * Participation in a drug study within 60 days prior to drug administration * Donation or loss of more than 100 mL of blood within 60 days prior to drug administration. * Donation or loss of more than 1.5 liters of blood (for male subjects) / more than 1.0 liters of blood (for female subjects) in the 10 months prior to drug administration. Part C (COMPLETED ENROLLMENT): * Any serious and/or uncontrolled medical condition * History of alcohol abuse or drug addiction * Positive drug and alcohol screen

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Treatment Emergent Adverse Events	up to Day 16 (Part A: SAD); up to Day 22 (Part B: MAD); up to Day 43 (Part C)	Number of participants with abnormal laboratory values and/or adverse events that are related to treatment

Countries

Netherlands, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026