Systemic safety following single and multiple dermal administration of BAY1003803
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
32
Topical administration for 22 h per day
Topical administration for 22 h per day
Topical administration for 22 h per day
Unnamed facility
Hamburg, Germany
Cortisol serum levels for safety
Time frame: Up to 2 weeks
Frequency of treatment-emergent adverse events (TEAEs)
Time frame: Up to 2 weeks
Nature of treatment-emergent adverse events (TEAEs)
Time frame: Up to 2 weeks
Monocytic human leukocyte antigen-DR (HLA-DR) expression (Part 1, single dose)
Time frame: Day 1 to 3 at 8:00 am
Monocytic human leukocyte antigen-DR (HLA-DR) expression (Part 2, multiple dose)
Time frame: Day 1 to 8 at 8:00 am
Maximum plasma concentration (Cmax) after single dose of BAY1003803
Time frame: At pre-dose, 1.5, 3, 5, 7, 9, 11, 13, 15, 21, 22, 23, 24 hours
Area under the plasma concentration vs. time curve from zero to infinity (AUC) after single dose of BAY1003803
Time frame: At pre-dose, 1.5, 3, 5, 7, 9, 11, 13, 15, 21, 22, 23, 24, 27, 31, 35, 39, 47 hours
Area under the curve from time zero to 22 hours [AUC(0-22)] after single dose of BAY1003803
Time frame: At pre-dose, 1.5, 3, 5, 7, 9, 11, 13, 15, 21, 22 hours
Maximum plasma concentration (Cmax,md) after multiple dose of BAY1003803
Time frame: At pre-dose, 3, 7, 9, 11, 13, 22, 23 hours (Day 1); At pre-dose, 3, 7, 9, 11, 13, 22, 23, 24 hours (Day 2 and Day 6)
Area under the curve from time zero to 24 hours [AUC(0-24)md] after multiple dose of BAY1003803
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Topical administration for 22 h per day
Topical administration for 22 h per day
Topical administration for 22 h per day
Topical administration for 22 h per day
Time frame: At pre-dose, 3, 7, 9, 11, 13, 22, 23 hours (Day 1); At pre-dose, 3, 7, 9, 11, 13, 22, 23, 24 hours (Day 2 and Day 6)