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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COMPLETED ENROLLMENT -- Single Dose Escalation Part A - active | Experimental | Increasing doses of RPT193 will be administered to healthy volunteers |
|
| COMPLETED ENROLLMENT -- Single Dose Escalation Part A - placebo | Placebo Comparator | Matching placebo will be administered to healthy volunteers |
|
| COMPLETED ENROLLMENT -- Multiple Dose Escalation Part B - active | Experimental | Increasing doses of RPT193 will be administered once/day for 7 days to healthy volunteers |
|
| COMPLETED ENROLLMENT -- Multiple Dose Escalation Part B - placebo | Placebo Comparator | Matching placebo will be administered once/day for 7 days to healthy volunteers |
|
| COMPLETED ENROLLMENT -- Expansion Part C - active | Experimental | RPT193 will be administered daily for 28 days to patients with atopic dermatitis |
|
| COMPLETED ENROLLMENT -- Expansion Part C - placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RPT193 | Drug | Antagonist of the CCR4 chemokine receptor |
|
| 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) |
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Selected Inclusion Criteria:
Parts A & B (COMPLETED ENROLLMENT):
Part C (COMPLETED ENROLLMENT):
Selected Exclusion Criteria:
Parts A & B (COMPLETED ENROLLMENT):
Part C (COMPLETED ENROLLMENT):
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| Name | Affiliation | Role |
|---|---|---|
| Laurence Cheng, MD, PhD | RAPT Therepeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinnacle Research Group, LLC | Anniston | Alabama | 36207 | United States | ||
| Perseverance Research Center LLC |
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| Placebo Comparator |
Matching placebo will be administered daily for 28 days to patients with atopic dermatitis |
|
| Placebo | Drug | Matching placebo |
|
| 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 |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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