臨床研究等提出・公開システム

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.

Phase I study of DS-2741a in Healthy Volunteers and Subjects with Atopic Dermatitis

Inoguchi Akihiro

DAIICHI SANKYO Co.,Ltd.

1-2-58, Hiromachi, Shinagawa-ku, Tokyo

dsclinicaltrial_jp@daiichisankyo.com

Contact for Clinical Trial Information

DAIICHI SANKYO Co.,Ltd.

1-2-58, Hiromachi, Shinagawa-ku, Tokyo

+81-3-6225-1111

dsclinicaltrial_jp@daiichisankyo.com

terminated

Jan. 13, 2020

Interventional

A single-center, randomized, double-blind, placebo-controlled study

treatment purpose

1

< 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.

Both

Healthy volunteers and Japanese subjects with moderate to severe atopic dermatitis.

investigational material(s)
Generic name etc : DS-2741
INN of investigational material : -
Therapeutic category code : 449 Other antiallergic agents
Dosage and Administration for Investigational material : SUBCUTANEOUS

control material(s)
Generic name etc : Placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : SUBCUTANEOUS

safety
pharmacokinetics
Part 1 and Part 3: Safety
Part 2: Pharmacokinetics (PK)

safety
pharmacokinetics
other
Part 1 and Part 3: PK, Anti-Drug Antibody (ADA)
Part 2: Safety, ADA

Dec. 13, 2019