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

Daiichi Sankyo

Status and phase: Terminated; Phase 1

Conditions: Atopic Dermatitis

Treatments: Drug: DS-2741a; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04211415

DS2741-A-J101

195071 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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8 participants in 11 patient groups, including a placebo group

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

Experimental group

Description:

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

Treatment:

Drug: DS-2741a

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

Experimental group

Description:

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

Treatment:

Drug: DS-2741a

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

Experimental group

Description:

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

Treatment:

Drug: DS-2741a

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

Experimental group

Description:

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

Treatment:

Drug: DS-2741a

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

Experimental group

Description:

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

Treatment:

Drug: DS-2741a

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

Experimental group

Description:

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

Treatment:

Drug: DS-2741a

Part 1: Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

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

Experimental group

Description:

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.

Treatment:

Drug: DS-2741a

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

Experimental group

Description:

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.

Treatment:

Drug: DS-2741a

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

Experimental group

Description:

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.

Treatment:

Drug: DS-2741a

Part 3: Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo