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RPT193

Phase 1

Atopic Dermatitis | Small molecule | Dermatology |RAPT Therapeutics, Inc.|Last Updated: Sep 30, 2021

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment103
FDA Designations
No designations recorded
Clinical trial landscape

RPT193 · 1 trial · 1 indication

Phase 1 1
NCT04271514A First-in-Human Study of RPT193 in Healthy Volunteers and Patients With Atopic DermatitisAtopic Dermatitis
COMPLETED103 Analytics
PHASE1COMPLETED
A First-in-Human Study of RPT193 in Healthy Volunteers and Patients With Atopic Dermatitis
Atopic DermatitisUnlock trial analytics
Study Endpoints
Primary Endpoints
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

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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
COMPLETED ENROLLMENT -- Single Dose Escalation Part A - activeEXPERIMENTALIncreasing doses of RPT193 will be administered to healthy volunteers
COMPLETED ENROLLMENT -- Single Dose Escalation Part A - placeboPLACEBO_COMPARATORMatching placebo will be administered to healthy volunteers
COMPLETED ENROLLMENT -- Multiple Dose Escalation Part B - activeEXPERIMENTALIncreasing doses of RPT193 will be administered once/day for 7 days to healthy volunteers
COMPLETED ENROLLMENT -- Multiple Dose Escalation Part B - placeboPLACEBO_COMPARATORMatching placebo will be administered once/day for 7 days to healthy volunteers
COMPLETED ENROLLMENT -- Expansion Part C - activeEXPERIMENTALRPT193 will be administered daily for 28 days to patients with atopic dermatitis
COMPLETED ENROLLMENT -- Expansion Part C - placeboPLACEBO_COMPARATORMatching placebo will be administered daily for 28 days to patients with atopic dermatitis
Interventions
NameTypeDescription
RPT193DRUGAntagonist of the CCR4 chemokine receptor
PlaceboDRUGMatching placebo
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Eligibility Criteria
Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites14

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 bet...

Countries:United StatesNetherlands
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