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Completed

NCT Number: NCT04271514

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA, Groningen, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RPT193

Drug

Antagonist of the CCR4 chemokine receptor

Placebo

Drug

Matching placebo

Primary outcomes

  1. Incidence of Treatment Emergent Adverse Events

    Time frame: 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

Sponsors and collaborators

Lead sponsor

RAPT Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 17, 2020
Registry last updated
Sep 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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