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

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.

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080224983
Enrollment
75
Registered
2019-12-12
Start date
2020-01-13
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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

Sponsors

DAIICHI SANKYO Co., LTD.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Japanese healthy male subjects. 2. Age >=20 and =18.5 and 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.

Exclusion criteria

Exclusion criteria: - 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. 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.

Design outcomes

Primary

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

Secondary

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

Countries

Japan

Contacts

Public ContactContact for Clinical Trial Information

DAIICHI SANKYO Co.,Ltd.

dsclinicaltrial_jp@daiichisankyo.com+81-3-6225-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026