Clinical trial NCT04271514: A First-in-Human Study of RPT193 in Healthy Volunteers and Patients With Atopic Dermatitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atopic Dermatitis
Lead sponsor: RAPT Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-02-17
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 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 Criteria:

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

Primary outcomes:
measure: Incidence of Treatment Emergent Adverse Events
timeFrame: up to Day 16 (Part A: SAD); up to Day 22 (Part B: MAD); up to Day 43 (Part C)
Secondary outcomes:
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group, LLC
state: Alabama
city: Scottsdale
country: United States
facility: Perseverance Research Center LLC
state: Arizona
city: San Diego
country: United States
facility: University Clinical Trials, Inc
state: California
city: Miami
country: United States
facility: Lenus Research & Medical Group
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Baton Rouge
country: United States
facility: DelRicht Research
state: Louisiana
city: Metairie
country: United States
facility: Clinical Trials Management,LLC
state: Louisiana
city: Brighton
country: United States
facility: MetroBoston Clinical Partners LLC
state: Massachusetts
city: New York
country: United States
facility: Sadick Research Group LLC
state: New York
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research PA
state: Texas
city: Groningen
country: Netherlands
facility: PRA
Study officials:
affiliation: RAPT Therepeutics, Inc.
name: Laurence Cheng, MD, PhD
role: STUDY_DIRECTOR
References: