Status:
COMPLETED
A First-in-Human Study of RPT193 in Healthy Volunteers and Patients With Atopic Dermatitis
Lead Sponsor:
RAPT Therapeutics, Inc.
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 patien...
Eligibility Criteria
Inclusion
- Selected
- 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
- 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
Key Trial Info
Start Date :
August 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 26 2021
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT04271514
Start Date
August 12 2019
End Date
April 26 2021
Last Update
September 30 2021
Active Locations (14)
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1
Pinnacle Research Group, LLC
Anniston, Alabama, United States, 36207
2
Perseverance Research Center LLC
Scottsdale, Arizona, United States, 85254
3
University Clinical Trials, Inc
San Diego, California, United States, 92123
4
Lenus Research & Medical Group
Miami, Florida, United States, 33172