Trial Condition(s):
Psoriasis
BAY1003803 Single and multiple dose escalation, safety, tolerability and pharmacokinetics study
Bayer Identifier:
17014
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
Systemic safety following single and multiple dermal administration of BAY1003803
Inclusion Criteria
- Healthy male subject
- Age: 18 to 64 years (inclusive) at the first screening visit
- Body mass index (BMI): above or equal 18 and below or equal 30 kg / m² at the first screening visit
- Non-smoker at least 3 months prior to study start and during the study
- Healthy skin on which reddening can be easily recognizedExclusion Criteria
- A history of relevant diseases, especially incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, excretion and effect of the study drugs will not be normal, dermal diseases, diseases which present a risk for subjects to be treated with glucocorticoid receptor agonists (e.g. gastric ulcers, cornea ulcer, colitis ulcerosa, severe infections, glaucoma, diabetes, myocardial infarction, thromboembolic disease, hypertension, thyroid disease, tuberculosis, myasthenia gravis, osteoporosis, psychiatric diseases)
- Infections and febrile illness within 4 week before the first study drug administration
- Use of systemic or topical medicines or substances which oppose the study objectives or which might influence them
- Inoculations with live vaccine within 8 weeks before the first study drug administration
- Signs of irritation or folliculitis or any other dermatological conditions in the test areas that would interfere with the planned assessments as judged by the Investigators
- Human leukocyte antigen-DR (HLA-DR) < 15000 AB/monocyteTrial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Hamburg, Germany, 20251 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Trial Design
Escalating dose study for safety, tolerability and pharmacokinetics after single and multiple dermal administration of two BAY1003803 formulation types with two concentrations each in healthy male volunteers, applying a double-blind, vehicle-controlled design and including a positive control group
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- Cortisol serum levels for safetyTimeframe: Up to 2 weeks
- Frequency of treatment-emergent adverse events (TEAEs)Timeframe: Up to 2 weeks
- Nature of treatment-emergent adverse events (TEAEs)Timeframe: Up to 2 weeks
Secondary Outcome
- Monocytic human leukocyte antigen-DR (HLA-DR) expression (Part 1, single dose)Timeframe: Day 1 to 3 at 8:00 am
- Monocytic human leukocyte antigen-DR (HLA-DR) expression (Part 2, multiple dose)Timeframe: Day 1 to 8 at 8:00 am
- Maximum plasma concentration (Cmax) after single dose of BAY1003803Timeframe: 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 BAY1003803Timeframe: 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 BAY1003803Timeframe: At pre-dose, 1.5, 3, 5, 7, 9, 11, 13, 15, 21, 22 hours
- Maximum plasma concentration (Cmax,md) after multiple dose of BAY1003803Timeframe: 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 BAY1003803Timeframe: 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)
Additional Information
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