A phase 1/2 study of E6005 in Japanese patients with atopic dermatitis
Phase 1
- Conditions
- Atopic dermatits
- Registration Number
- JPRN-jRCT2080221229
- Lead Sponsor
- Eisai Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Male
- Target Recruitment
- 40
Inclusion Criteria
Japanese adult male patients with a confirmed diagnosis of atopic dermatitis according to Guidelines for Management of Atopic Dermatitis by the Japanese Dermatological Association.
Exclusion Criteria
-Patients complicated with eye symptoms (e.g., cataract, retinal detachment), Kaposi varicelliform eruption, and molluscum contagiosum or impetigo contagiosa.
-Patients who had or have a severe allergy such as anaphylactic shock, anaphylactic reaction and anaphylactoid reaction or allergy/hypersensitivity to E6005 or any of their excipients.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety will be assessed by adverse events, clinical laboratory results, vital signs, 12-lead ECGs, and ophthalmology. Pharmacokinetic characteristics of E6005 and metabolite will be evaluated using plasma concentration data.
- Secondary Outcome Measures
Name Time Method