BAY1003803 Single and Multiple Dose Escalation, Safety, Tolerability and Pharmacokinetics Study

• Status: Terminated
• Trial end date: 2017-10-16
• Target enrollment: 0
• Participant gender: Male

Summary

Systemic safety following single and multiple dermal administration of BAY1003803

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer
• Treatments: Clobetasol

Criteria

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 recognized

Exclusion 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/monocyte