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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: RPT193
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COMPLETED ENROLLMENT -- Single Dose Escalation Part A - active<br>Increasing doses of RPT193 will be administered to healthy volunteers | Drug: RPT193<br>* Antagonist of the CCR4 chemokine receptor<br>|
| Placebo Comparator: COMPLETED ENROLLMENT -- Single Dose Escalation Part A - placebo<br>Matching placebo will be administered to healthy volunteers | Drug: Placebo<br>* Matching placebo<br>|
| Experimental: COMPLETED ENROLLMENT -- Multiple Dose Escalation Part B - active<br>Increasing doses of RPT193 will be administered once/day for 7 days to healthy volunteers | Drug: RPT193<br>* Antagonist of the CCR4 chemokine receptor<br>|
| Placebo Comparator: COMPLETED ENROLLMENT -- Multiple Dose Escalation Part B - placebo<br>Matching placebo will be administered once/day for 7 days to healthy volunteers | Drug: Placebo<br>* Matching placebo<br>|
| Experimental: COMPLETED ENROLLMENT -- Expansion Part C - active<br>RPT193 will be administered daily for 28 days to patients with atopic dermatitis | Drug: RPT193<br>* Antagonist of the CCR4 chemokine receptor<br>|
| Placebo Comparator: COMPLETED ENROLLMENT -- Expansion Part C - placebo<br>Matching placebo will be administered daily for 28 days to patients with atopic dermatitis | Drug: Placebo<br>* Matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

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