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

NCT ID: NCT04211415

Last Updated: 2021-06-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-13
• Study Completion Date: 2020-12-18

Brief 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.

Detailed Description

This study consists of three parts. Part 1 and Part 3 are a single ascending and multiple dose study to assess the safety, pharmacokinetics and pharmacodynamics of DS-2741a after subcutaneous injection in healthy Japanese male participants. Part 2 is a single-dose study to assess the pharmacokinetics, safety, pharmacodynamics and efficacy of DS-2741a after subcutaneous injection in Japanese participants with moderate to severe atopic dermatitis.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Part 1: DS-2741a Cohort 1, 5 mg

Participants will be randomized to receive a single, subcutaneous injection of DS-2741a 5 mg.

Group Type: EXPERIMENTAL

DS-2741a

Intervention Type: DRUG

Single, subcutaneous injection (upper arm, upper part of the thigh, or abdominal wall in principle) administered weekly for 4 weeks

Part 1: DS-2741a Cohort 2, 15 mg

Participants will be randomized to receive a single, subcutaneous injection of DS-2741a 15 mg.

Group Type: EXPERIMENTAL

DS-2741a

Intervention Type: DRUG

Single, subcutaneous injection (upper arm, upper part of the thigh, or abdominal wall in principle) administered weekly for 4 weeks

Part 1: DS-2741a Cohort 3, 50 mg

Participants will be randomized to receive a single, subcutaneous injection of DS-2741a 50 mg.

Group Type: EXPERIMENTAL

DS-2741a

Intervention Type: DRUG

Single, subcutaneous injection (upper arm, upper part of the thigh, or abdominal wall in principle) administered weekly for 4 weeks

Part 1: DS-2741a Cohort 4, 150 mg

Participants will be randomized to receive a single, subcutaneous injection of DS-2741a 150 mg.

Group Type: EXPERIMENTAL

DS-2741a

Intervention Type: DRUG

Single, subcutaneous injection (upper arm, upper part of the thigh, or abdominal wall in principle) administered weekly for 4 weeks

Part 1: DS-2741a Cohort 5, 500 mg

Participants will be randomized to receive a single, subcutaneous injection of DS-2741a 500 mg.

Group Type: EXPERIMENTAL

DS-2741a

Intervention Type: DRUG

Single, subcutaneous injection (upper arm, upper part of the thigh, or abdominal wall in principle) administered weekly for 4 weeks

Part 1: DS-2741a Cohort 6, 1000 mg

Participants will be randomized to receive a single, subcutaneous injection of DS-2741a 1000 mg.

Group Type: EXPERIMENTAL

DS-2741a

Intervention Type: DRUG

Single, subcutaneous injection (upper arm, upper part of the thigh, or abdominal wall in principle) administered weekly for 4 weeks

Part 1: Placebo

Participants will be randomized to receive a single, subcutaneous injection of placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Single, subcutaneous injection administered weekly for 4 weeks

Part 2: DS-2741a Cohort 1, X mg (based on results of Part 1)

Participants will receive a single, subcutaneous injection of DS-2741a X mg, where X mg will be based on the maximum tolerated dose identified in Part 1.

Group Type: EXPERIMENTAL

DS-2741a

Intervention Type: DRUG

Single, subcutaneous injection (upper arm, upper part of the thigh, or abdominal wall in principle) administered weekly for 4 weeks

Part 2: DS-2741a Cohort 1, Y mg (based on results of Part 1)

Participants will receive a single, subcutaneous injection of DS-2741a Y mg, where Y mg will be based on the maximum tolerated dose identified in Part 1.

Group Type: EXPERIMENTAL

DS-2741a

Intervention Type: DRUG

Single, subcutaneous injection (upper arm, upper part of the thigh, or abdominal wall in principle) administered weekly for 4 weeks

Part 3: DS-2741a Cohort 1, Z mg (based on results of Part 1)

Participants will be randomized to receive a receive a single, subcutaneous injection of DS-2741a Z mg, where Z mg will be based on the maximum tolerated dose identified in Part 1.

Group Type: EXPERIMENTAL

DS-2741a

Intervention Type: DRUG

Single, subcutaneous injection (upper arm, upper part of the thigh, or abdominal wall in principle) administered weekly for 4 weeks

Part 3: Placebo

Participants will be randomized to receive a single, subcutaneous injection of placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Single, subcutaneous injection administered weekly for 4 weeks

Interventions

DS-2741a

Single, subcutaneous injection (upper arm, upper part of the thigh, or abdominal wall in principle) administered weekly for 4 weeks

Intervention Type: DRUG

Placebo

Single, subcutaneous injection administered weekly for 4 weeks

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Daiichi Sankyo Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Study Leader

Role: STUDY_DIRECTOR

Daiichi Sankyo

Locations

Osaka Pharmacology Clinical Research Hospital

Osaka, , Japan

Countries

Japan

Other Identifiers

195071

Identifier Type: OTHER

Identifier Source: secondary_id

DS2741-A-J101

Identifier Type: -

Identifier Source: org_study_id