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A single center trial to evaluate the effect of POLB 001 on inflammatory responses following an intradermal LPS challenge in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| POLB 001 30 mg | Active Comparator |
| |
| POLB 001 70 mg | Active Comparator |
| |
| POLB 001 150 mg | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| POLB 001 | Drug | Investigational Medicinal Product |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of intradermal LPS challenge | To evaluate the effect of POLB 001 on inflammatory responses following an intradermal LPS challenge in healthy volunteers Endpoints: Skin response by imaging - Erythema (multispectral imaging) (Clinician's Erythema Assessment (CEA) Scale) | 16 days |
| Effect of intradermal LPS challenge | To evaluate the effect of POLB 001 on inflammatory responses following an intradermal LPS challenge in healthy volunteers Endpoints: Blister exudate analysis - Flow cytometry (neutrophils, monocyte subsets, T cells, B cells, NK cells, dendritic cells) (10*9/L) | 16 days |
| Effect of intradermal LPS challenge | To evaluate the effect of POLB 001 on inflammatory responses following an intradermal LPS challenge in healthy volunteers Endpoints: Blister exudate analysis - Cytokines (IL-6, IL-8, TNF, IL-1β) (pg/mL) | 16 days |
| Effect of intravenous LPS challenge | To evaluate the effect of POLB 001 on inflammatory responses following an intravenous LPS challenge in healthy volunteers Endpoints: Blood - Cytokines (IL-6, IL-8, IL-10, TNF, IL-1β) (pg/mL) | 16 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Human Drug Research | Leiden | 2333 CL | Netherlands |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| Placebo | Drug | Matching Placebo |
|
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |