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

Study Overview
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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

Official Title
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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

Conditions
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Inflammatory Response

Intervention / Treatment
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* Drug: RIST4721
* Drug: Placebo


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RIST4721 300mg<br>RIST4721 as once-daily 300mg oral solution for 6 days with a placebo crossover. | Drug: RIST4721<br>* RIST4721 oral solution<br>Drug: Placebo<br>* Placebo oral solution<br>|
| Experimental: RIST4721 150mg<br>RIST4721 as once-daily 150mg oral solution for 6 days with a placebo crossover. | Drug: RIST4721<br>* RIST4721 oral solution<br>Drug: Placebo<br>* Placebo oral solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | Blister formation to Hour 36 |