Phase I Study of DS-2741a in Healthy Volunteers and Participants With Atopic Dermatitis

• Status: Terminated
• Trial end date: 2020-12-18
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 1, single-center, first-in-human study to assess the safety, pharmacokinetics and pharmacodynamics of DS-2741a after subcutaneous injection in healthy Japanese male volunteers and Japanese participants with moderate to severe atopic dermatitis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Daiichi Sankyo Co., Ltd.

Criteria

Inclusion Criteria:

• For Part 1 and Part 3:

• Japanese healthy male subjects.

• Age ≥20 and ≤45 years upon providing informed consent.

• Body mass index (BMI) ≥18.5 and <25.0 kg/m^2 at screening.

• For Part 2:

• Japanese Male or female, Age ≥20 upon providing informed consent.

• Diagnosed with chronic atopic dermatitis (AD) at least 3 years before screening and by the criteria of Hannifin and Rajka at screening.

Exclusion Criteria:

• For 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.

• For Part 2:

• Having an active dermatological disease other than AD, which, in the investigator's opinion, would affect study assessments.

• Having a history of serious disease in the study potentially endangering the participant, as judged by the investigator or sub-investigator.

• Having a chronic or acute infection requiring treatment within 28 days before screening.

• Having superficial skin infections within 7 days before screening.

• Having a history of recurrent oral herpes and recurrent genital herpes.

• Having a history of parasitic infection or invasive, opportunistic infection such as histoplasmosis despite infection resolution, etc.