A single center trial to evaluate the effect of POLB 001 on inflammatory responses following an intradermal LPS challenge in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
Centre for Human Drug Research
Leiden, Netherlands
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 16 days
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