A First-in-Human Study of RPT193 in Healthy Volunteers and Patients With Atopic Dermatitis
- Registration Number
- NCT04271514
- Lead Sponsor
- RAPT Therapeutics, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 103
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description COMPLETED ENROLLMENT -- Multiple Dose Escalation Part B - placebo Placebo Matching placebo will be administered once/day for 7 days to healthy volunteers COMPLETED ENROLLMENT -- Single Dose Escalation Part A - placebo Placebo Matching placebo will be administered to healthy volunteers COMPLETED ENROLLMENT -- Expansion Part C - active RPT193 RPT193 will be administered daily for 28 days to patients with atopic dermatitis COMPLETED ENROLLMENT -- Single Dose Escalation Part A - active RPT193 Increasing doses of RPT193 will be administered to healthy volunteers COMPLETED ENROLLMENT -- Expansion Part C - placebo Placebo Matching placebo will be administered daily for 28 days to patients with atopic dermatitis COMPLETED ENROLLMENT -- Multiple Dose Escalation Part B - active RPT193 Increasing doses of RPT193 will be administered once/day for 7 days to healthy volunteers
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
Lenus Research & Medical Group
🇺🇸Miami, Florida, United States
Clinical Trials Management,LLC
🇺🇸Metairie, Louisiana, United States
PRA
🇳🇱Groningen, Netherlands
Perseverance Research Center LLC
🇺🇸Scottsdale, Arizona, United States
University Clinical Trials, Inc
🇺🇸San Diego, California, United States
Pinnacle Research Group, LLC
🇺🇸Anniston, Alabama, United States
ForCare Clinical Research
🇺🇸Tampa, Florida, United States
Dawes Fretzin Clinical Research Group, LLC
🇺🇸Indianapolis, Indiana, United States
Sadick Research Group LLC
🇺🇸New York, New York, United States
MetroBoston Clinical Partners LLC
🇺🇸Brighton, Massachusetts, United States
Progressive Clinical Research PA
🇺🇸San Antonio, Texas, United States
DermResearch, Inc.
🇺🇸Austin, Texas, United States
DelRicht Research
🇺🇸Baton Rouge, Louisiana, United States
Central Sooner Research
🇺🇸Norman, Oklahoma, United States