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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RIST4721 300mg | Experimental | RIST4721 as once-daily 300mg oral solution for 6 days with a placebo crossover. |
|
| RIST4721 150mg | Experimental | RIST4721 as once-daily 150mg oral solution for 6 days with a placebo crossover. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RIST4721 | Drug | RIST4721 oral solution |
| |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MAC Clinical Research | Manchester | M13 9NQ | United Kingdom |
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| Placebo |
| Drug |
Placebo oral solution |
|