DS-2741a Phase I Study- A three-part first-in-human study: single ascending dose and multiple dose study to assess the safety, pharmacokinetics and pharmacodynamics of DS-2741a after subcutaneous injection in healthy Japanese male subjects, and single dose study to assess the pharmacokinetics, safety, pharmacodynamics and efficacy of DS-2741a after subcutaneous injection in Japanese subjects with moderate to severe atopic dermatitis.

DAIICHI SANKYO Co., LTD.0 个研究点目标入组 75 人开始时间: 2019年12月12日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•< 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
•< 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.

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