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

NCT ID: NCT02936492

Last Updated: 2017-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-24

Study Completion Date

2017-10-16

Brief Summary

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Systemic safety following single and multiple dermal administration of BAY1003803

Detailed Description

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Conditions

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Psoriasis

Keywords

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Phase I Healthy volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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BAY1003803

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

Group Type EXPERIMENTAL

BAY1003803 0.01% lipophilic cream

Intervention Type DRUG

Topical administration for 22 h per day

BAY1003803 0.1% lipophilic cream

Intervention Type DRUG

Topical administration for 22 h per day

BAY1003803 0.01% ointment

Intervention Type DRUG

Topical administration for 22 h per day

BAY1003803 0.1% ointment

Intervention Type DRUG

Topical administration for 22 h per day

Placebo

Topical treatment using matching amount of placebo

Group Type PLACEBO_COMPARATOR

Lipophilic cream vehicle

Intervention Type DRUG

Topical administration for 22 h per day

Ointment vehicle

Intervention Type DRUG

Topical administration for 22 h per day

Clobetasol propionate

Topical treatment using 16.5 mg of clobetasol propionate per subject

Group Type ACTIVE_COMPARATOR

Clobetasol propionate

Intervention Type DRUG

Topical administration for 22 h per day

Interventions

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BAY1003803 0.01% lipophilic cream

Topical administration for 22 h per day

Intervention Type DRUG

BAY1003803 0.1% lipophilic cream

Topical administration for 22 h per day

Intervention Type DRUG

BAY1003803 0.01% ointment

Topical administration for 22 h per day

Intervention Type DRUG

BAY1003803 0.1% ointment

Topical administration for 22 h per day

Intervention Type DRUG

Lipophilic cream vehicle

Topical administration for 22 h per day

Intervention Type DRUG

Ointment vehicle

Topical administration for 22 h per day

Intervention Type DRUG

Clobetasol propionate

Topical administration for 22 h per day

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Hamburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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17014

Identifier Type: -

Identifier Source: org_study_id