臨床研究等提出・公開システム

Date of registration	Nov. 07, 2023
Last modified on	April. 13, 2026
Trial ID	jRCT2071230085

Scientific Title	Phase I Study of AK1910 in Healthy Japanese Subjects, Healthy Caucasian Subjects, Patients with Systemic Lupus Erythematosus (Single Dose and Multiple Dose Study)
Public Title	Phase I Study of AK1910 in Healthy Japanese Subjects, Healthy Caucasian Subjects, Patients with Systemic Lupus Erythematosus (Single Dose and Multiple Dose Study)

Contact for Scientific Queries	Name	Shirae Shinichiro
	Affiliation	ASAHI KASEI THERAPEUTICS CORPORATION
	Address	1-1-2 Yurakucho, Chiyoda-ku, Tokyo
	Telephone	+81-3-6699-3600
	E-mail	ct-info@om.asahi-kasei.co.jp
Contact for Public Queries	Name	Contact for Clinical Trial Information
	Affiliation	ASAHI KASEI THERAPEUTICS CORPORATION
	Address	1-1-2 Yurakucho, Chiyoda-ku, Tokyo
	Telephone	+81-3-6699-3600
	E-mail	ct-info@om.asahi-kasei.co.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Nov. 08, 2023
Target sample size		120
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	<Part 1> [1] Japanese healthy men and women or Caucasian healthy men [2] Individuals >=18 to <45 years of age at the time of informed consent [3] Individuals who fully understand the details of the study and who are capable of providing written informed consent <Part 2> [1] Patients who meet the EULAR/ACR 2019 SLE classification criteria and have a diagnosis of SLE [2] Individuals >=18 years to < 75 years at the time of informed consent [3] Individuals who fully understand the details of the study and who are capable of providing written informed consent
	Exclusion Criteria	<Part 1> [1] Past history of disease in organsystems considered unsuitable for this study [2] Past history of allergy or anaphylaxis to drugs or other substances [3] Other protocol defined exclusion criteria could apply <Part 2> [1] Patients with active central nervouslupus or systemic autoimmune diseases other than systemic lupus erythematosus [2] Patients with history or complications of serious diseases considered unsuitable for this study [3] Patients with history or complications of infections that may affect safety and efficacy evaluation
	Age Minimum	18age old over
	Age Maximum	75age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Systemic Lupus Erythematosus
Intervention(s)		<Part 1> A single administration of AK1910 <Part 2> A single or repeated administration of AK1910
Primary Outcome(s)		Plasma concentration of compound(s) Number of participants with adverse events

Primary Sponsor	ASAHI KASEI THERAPEUTICS CORPORATION

Name of Certified Review Board	Hakata Clinic Institutional Review Board
Address	6-18, Tenyamachi, Hakata-ku, Fukuoka-shi, Fukuoka, Japan, Fukuoka
Telephone	+81-92-283-7701
E-Mail	miyako-koga@lta-med.com
Approval Status	Approval
Date of approval	Oct. 13, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
6	April. 13, 2026	(this page)	Changes
5	April. 01, 2026	Detail	Changes
4	Mar. 31, 2026	Detail	Changes
3	Sept. 19, 2024	Detail	Changes
2	Sept. 18, 2024	Detail	Changes
1	Nov. 07, 2023	Detail

List of change history