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

Bayer

Status and phase: Terminated; Phase 1

Conditions: Psoriasis

Treatments: Drug: BAY1003803 0.01% lipophilic cream; Drug: Ointment vehicle; Drug: Lipophilic cream vehicle; Drug: BAY1003803 0.1% ointment; Drug: Clobetasol propionate; Drug: BAY1003803 0.01% ointment; Drug: BAY1003803 0.1% lipophilic cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT02936492

17014

Details and patient eligibility

About

Systemic safety following single and multiple dermal administration of BAY1003803

Enrollment: 32 patients

Sex: Male

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 3 patient groups, including a placebo group

BAY1003803

Experimental group

Description:

Topical treatment: dose escalating in 9 steps from 0.13 mg to 61.7 mg per subject

Treatment:

Drug: BAY1003803 0.1% lipophilic cream

Drug: BAY1003803 0.01% lipophilic cream

Drug: BAY1003803 0.01% ointment

Drug: BAY1003803 0.1% ointment

Placebo

Placebo Comparator group

Description:

Topical treatment using matching amount of placebo

Treatment:

Drug: Ointment vehicle

Drug: Lipophilic cream vehicle

Clobetasol propionate

Active Comparator group

Description:

Topical treatment using 16.5 mg of clobetasol propionate per subject

Treatment:

Drug: Clobetasol propionate