A Study to Investigate the Effects of RIST4721 on the Inflammatory Response in Healthy Male Subjects Using a Blister Model

Aristea Therapeutics, Inc.32 enrolled

Overview

A Randomised, Single-Blind, Placebo-Controlled, Crossover Study to Investigate the Effects of RIST4721, a Novel CXCR2 Inhibitor, on the Inflammatory Response in Healthy Male Subjects Using a Standardized Blister Model

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Inflammatory Response

Interventions

RIST4721DRUG

RIST4721 oral solution

PlaceboDRUG

Placebo oral solution

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subject is male, with Fitzpatrick skin types 1 to 3 * Subject is aged between 18 to 55 years, inclusive * Subject has a body mass index (BMI) of 18 to 32 kg/m2, inclusive * Healthy as determined by a responsible physician, based on medical evaluation * Must be willing to use birth control as indicated Exclusion Criteria: * Subject is known to have immune deficiency or is immunocompromised * Subject has had a recent acute infection or chronic infection * Subject has a known or suspected allergy or contraindications to cantharidin (blister induction method), RIST4721 or any component of the study drug * Clinically relevant history of abnormal physical or mental health (including \[but not limited to\], neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder)

Locations (1)

MAC Clinical Research

Manchester, United Kingdom

Outcomes

Primary Outcomes

Absolute neutrophil count in blister fluid at 24 hours post-blister formation compared to placebo

Blister fluid will be harvested at 24, 30, and 36 hours post-blister formation and neutrophil count will be assessed at each time point and compared to placebo control

Time frame: Blister formation to Hour 24

Absolute neutrophil count in blister fluid at 30 hours post-blister formation compared to placebo

Blister fluid will be harvested at 24, 30, and 36 hours post-blister formation and neutrophil count will be assessed at each time point and compared to placebo control

Time frame: Blister formation to Hour 30

Absolute neutrophil count in blister fluid at 36 hours post-blister formation compared to placebo

Blister fluid will be harvested at 24, 30, and 36 hours post-blister formation and neutrophil count will be assessed at each time point and compared to placebo control

Time frame: Blister formation to Hour 36

Data from ClinicalTrials.gov

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