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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-25

Study Completion Date

2019-12-09

Brief Summary

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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

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Detailed Description

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Conditions

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Inflammatory Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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RIST4721 300mg

RIST4721 as once-daily 300mg oral solution for 6 days with a placebo crossover.

Group Type EXPERIMENTAL

RIST4721

Intervention Type DRUG

RIST4721 oral solution

Placebo

Intervention Type DRUG

Placebo oral solution

RIST4721 150mg

RIST4721 as once-daily 150mg oral solution for 6 days with a placebo crossover.

Group Type EXPERIMENTAL

RIST4721

Intervention Type DRUG

RIST4721 oral solution

Placebo

Intervention Type DRUG

Placebo oral solution

Interventions

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RIST4721

RIST4721 oral solution

Intervention Type DRUG

Placebo

Placebo oral solution

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes