Healthy volunteers and Japanese subjects with moderate to severe atopic dermatitis.
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Japanese healthy male subjects. 2. Age >=20 and =18.5 and 1. Japanese male or female, age >=20 upon providing informed consent. 2. Diagnosed with chronic atopic dermatitis at least 3 years before screening and by the criteria of Hannifin and Rajka at screening.
Exclusion criteria
Exclusion criteria: - Having a history of atopic dermatitis - Having a history of hypersensitivity to drugs or other substances or being idiosyncratic - Having alcohol or drug dependence etc. 1. Having an active dermatological disease other than atopic dermatitis, which, in the investigator's opinion, would affect study assessments. 2. Having a history of serious disease in the study potentially endangering the subject, as judged by the investigator or sub-investigator. 3. Having a chronic or acute infection requiring treatment within 28 days before screening. 4. Having superficial skin infections within 7 days before screening. 5. Having a history of recurrent oral herpes and recurrent genital herpes. 6. Having a history of parasitic infection or invasive, opportunistic infection such as histoplasmosis despite infection resolution. etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety pharmacokinetics Part 1 and Part 3: Safety Part 2: Pharmacokinetics (PK) | — |
Secondary
| Measure | Time frame |
|---|---|
| safety pharmacokinetics other Part 1 and Part 3: PK, Anti-Drug Antibody (ADA) Part 2: Safety, ADA | — |
Countries
Japan
Contacts
DAIICHI SANKYO Co.,Ltd.