Phase I study of DS-2741a in Healthy Volunteers and Subjects with Atopic Dermatitis
- Conditions
- Healthy volunteers and Japanese subjects with moderate to severe atopic dermatitis.
- Registration Number
- JPRN-jRCT2080224983
- Lead Sponsor
- DAIICHI SANKYO Co., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- terminated
- Sex
- All
- Target Recruitment
- 75
< Part 1 and Part 3 >
1. Japanese healthy male subjects.
2. Age >=20 and <=45 years upon providing informed consent.
3. Body mass index (BMI) >=18.5 and <=25.0 kg/m2 at screening.
< Part 2 >
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.
< Part 1 and Part 3 >
- 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.
< Part 2 >
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>pharmacokinetics<br>Part 1 and Part 3: Safety<br>Part 2: Pharmacokinetics (PK)
- Secondary Outcome Measures
Name Time Method safety<br>pharmacokinetics<br>other<br>Part 1 and Part 3: PK, Anti-Drug Antibody (ADA)<br>Part 2: Safety, ADA