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
1 other identifier
interventional
103
2 countries
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2019
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 12, 2019
CompletedFirst Submitted
Initial submission to the registry
February 13, 2020
CompletedFirst Posted
Study publicly available on registry
February 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 26, 2021
CompletedSeptember 30, 2021
September 1, 2021
1.7 years
February 13, 2020
September 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (6)
COMPLETED ENROLLMENT -- Single Dose Escalation Part A - active
EXPERIMENTALIncreasing doses of RPT193 will be administered to healthy volunteers
COMPLETED ENROLLMENT -- Single Dose Escalation Part A - placebo
PLACEBO COMPARATORMatching placebo will be administered to healthy volunteers
COMPLETED ENROLLMENT -- Multiple Dose Escalation Part B - active
EXPERIMENTALIncreasing doses of RPT193 will be administered once/day for 7 days to healthy volunteers
COMPLETED ENROLLMENT -- Multiple Dose Escalation Part B - placebo
PLACEBO COMPARATORMatching placebo will be administered once/day for 7 days to healthy volunteers
COMPLETED ENROLLMENT -- Expansion Part C - active
EXPERIMENTALRPT193 will be administered daily for 28 days to patients with atopic dermatitis
COMPLETED ENROLLMENT -- Expansion Part C - placebo
PLACEBO COMPARATORMatching placebo will be administered daily for 28 days to patients with atopic dermatitis
Interventions
Antagonist of the CCR4 chemokine receptor
Matching placebo
Eligibility Criteria
You may qualify if:
- Parts A \& B (COMPLETED ENROLLMENT):
- Healthy male or female
- 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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Pinnacle Research Group, LLC
Anniston, Alabama, 36207, United States
Perseverance Research Center LLC
Scottsdale, Arizona, 85254, United States
University Clinical Trials, Inc
San Diego, California, 92123, United States
Lenus Research & Medical Group
Miami, Florida, 33172, United States
ForCare Clinical Research
Tampa, Florida, 33613, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250, United States
DelRicht Research
Baton Rouge, Louisiana, 70809, United States
Clinical Trials Management,LLC
Metairie, Louisiana, 70006, United States
MetroBoston Clinical Partners LLC
Brighton, Massachusetts, 02135, United States
Sadick Research Group LLC
New York, New York, 10075, United States
Central Sooner Research
Norman, Oklahoma, 73071, United States
DermResearch, Inc.
Austin, Texas, 78759, United States
Progressive Clinical Research PA
San Antonio, Texas, 78213, United States
PRA
Groningen, 9728 NZ, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Laurence Cheng, MD, PhD
RAPT Therepeutics, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2020
First Posted
February 17, 2020
Study Start
August 12, 2019
Primary Completion
April 26, 2021
Study Completion
April 26, 2021
Last Updated
September 30, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share