臨床研究等提出・公開システム

Date of registration	Nov. 21, 2023
Last modified on	Dec. 13, 2024
Trial ID	jRCT1050230133

Scientific Title	Measurement of biomarkers using existing samples from Phase 1 study of EA3571 in healthy adult subjects (EA3571-CP1)
Public Title	Measurement of biomarkers using existing samples from Phase 1 study of EA3571 in healthy adult subjects

Completion date	Jan. 05, 2024
Result actual enrolment	21
Baseline Characteristics	The participants in this study were healthy adult male participants who took part in the Phase 1 study of EA3571, receiving either a multiple dose of placebo or EA3571. The Japanese participants who received the placebo (n=6) were aged between 22 and 34 years, and the Japanese participants who received EA3571 (n=6) were aged between 20 and 36 years. The Caucasian participants who received the placebo (n=3) were aged between 20 and 26 years, and the Caucasian participants who received EA3571 (n=6) were aged between 21 and 39 years.
Participant flow	Plasma biomarker concentrations were measured using existing samples from all 21 participants who had provided informed consent.
Adverse events	Not applicable.
Outcome measures	The concentrations of the plasma biomarker were found to be lower at the time of multiple dose completion than at the time of baseline in both the placebo and EA3571 groups. The rate of change from baseline in plasma biomarker concentrations at the time of multiple dose completion was -14.8% in the Japanese placebo group, -11.7% in the Japanese EA3571 group, -26.3% in the Caucasian placebo group, and -12.4% in the Caucasian EA3571 group. The rate of change in plasma biomarker concentrations from baseline was smaller in the EA3571 group than in the placebo group, both Japanese and Caucasian participants.
Brief summary	The rate of decrease in plasma biomarker concentrations was observed to be less pronounced in the EA3571 group than in the placebo group, in both Japanese and Caucasian healthy adult males.
Date of posting of results summaries	Dec. 27, 2024

Plan to share IPD	No
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCT1050230133

Contact for Scientific Queries	Name	Takeuchi Yutaka
	Affiliation	EA Pharma Co., Ltd
	Address	2-1-1, Irifune, Chuo-ku, Tokyo
	Telephone	+81-3-6280-9600
	E-mail	contact_ea@eapharma.co.jp
Contact for Public Queries	Name	Takeuchi Yutaka
	Affiliation	EA Pharma Co., Ltd
	Address	2-1-1, Irifune, Chuo-ku, Tokyo
	Telephone	+81-3-6280-9600
	E-mail	contact_ea@eapharma.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Dec. 01, 2023
Actual date of first enrollment		Dec. 03, 2023
Target sample size		21
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	Subjects who received multiple doses of placebo-or EA3571 in a Phase 1 study of EA3571 in healthy adult subjects
	Exclusion Criteria	Subjects who refused to participate in this study
	Age Minimum	20age old over
	Age Maximum	45age old not
	Gender	Male
Health Condition(s) or Problem(s) Studied		nonalcoholic steatohepatitis
Primary Outcome(s)		Plasma hormone concentration

Primary Sponsor	EA Pharma Co., Ltd

Source of Monetary Support	EA Pharma Co., Ltd
Secondary Sponsor	Applicable

Name of Certified Review Board	Medical Corporation Heishinkai OPHAC Hospital ERC
Address	4-1-29 Miyahara,Yodogawa-ku,Osaka-shi , Osaka
Telephone	+81-6-6395-9000
E-Mail	ophach_irb@heishinkai.com
Approval Status	Approval
Date of approval	Nov. 30, 2023

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Dec. 27, 2024	(this page)	Changes
3	Mar. 06, 2024	Detail	Changes
2	Jan. 10, 2024	Detail	Changes
1	Nov. 21, 2023	Detail

List of change history