臨床研究等提出・公開システム

Japanese

Date of registration	Dec. 12, 2019
Last modified on	Dec. 10, 2021
Trial ID	jRCT2080224983

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

Scientific Title

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.

Public Title

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

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	DAIICHI SANKYO Co.,Ltd.
	Address
	Phone Number
	E-mail Address	dsclinicaltrial@daiichisankyo.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	DAIICHI SANKYO Co.,Ltd.
	Address
	Phone Number
	E-mail Address	dsclinicaltrial@daiichisankyo.co.jp

Recruitment Status	terminated

Date of First Enrolment		Jan. 13, 2020
Target Sample Size		75
Study Type		Interventional
Study Design	Study Design	A single-center, randomized, double-blind, placebo-controlled study
Study Design	Objective	treatment purpose
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	< 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.
	Exclusion Criteria	< 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.
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Healthy volunteers and Japanese subjects with moderate to severe atopic dermatitis.
Intervention(s)		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
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety pharmacokinetics Part 1 and Part 3: Safety Part 2: Pharmacokinetics (PK)
Secondary Outcome		safety pharmacokinetics other Part 1 and Part 3: PK, Anti-Drug Antibody (ADA) Part 2: Safety, ADA

Primary Sponsor	DAIICHI SANKYO Co., LTD.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	Medical Corporation Heishinkai OPHAC Hospital IRB
Address of IRB	4-1-29, Miyahara, Osaka Shi Yodogawa Ku, Osaka Fu, 532-0003, Japan
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Dec. 13, 2019

Secondary ID No.	NCT04211415
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-195071
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
5	Dec. 10, 2021	(this page)	Changes
4	June. 18, 2021	Detail	Changes
3	Aug. 20, 2020	Detail	Changes
2	Jan. 10, 2020	Detail	Changes
1	Dec. 12, 2019	Detail

List of change history