BAY1003803 Single and Multiple Dose Escalation, Safety, Tolerability and Pharmacokinetics Study
NCT02936492 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2017-11-08
Summary
Systemic safety following single and multiple dermal administration of BAY1003803
Conditions
Interventions
- DRUG
-
BAY1003803 0.01% lipophilic cream
Topical administration for 22 h per day
- DRUG
-
BAY1003803 0.1% lipophilic cream
Topical administration for 22 h per day
- DRUG
-
BAY1003803 0.01% ointment
Topical administration for 22 h per day
- DRUG
-
BAY1003803 0.1% ointment
Topical administration for 22 h per day
- DRUG
-
Lipophilic cream vehicle
Topical administration for 22 h per day
- DRUG
-
Ointment vehicle
Topical administration for 22 h per day
- DRUG
-
Clobetasol propionate
Topical administration for 22 h per day
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bayer Study Director · Bayer
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 64 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-10-24
- Primary Completion
- 2017-04-18
- Completion
- 2017-10-16
Countries
- Germany
Study Locations
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