臨床研究等提出・公開システム

Date of registration	Mar. 02, 2022
Last modified on	Sept. 29, 2023
Trial ID	jRCT2051210183

Scientific Title	A Single Dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-6194 in Healthy Japanese Participants
Public Title	Single Dose Study of MK-6194 in Healthy Japanese Participants

Contact for Scientific Queries	Name	Tanaka Yoshiyuki
	Affiliation	MSD K.K.
	Address	KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan
	Telephone	+81-3-6272-1957
	E-mail	msdjrct@msd.com
Contact for Public Queries	Name	MSDJRCT inquiry mailbox
	Affiliation	MSD K.K.
	Address	KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan
	Telephone	+81-3-6272-1957
	E-mail	msdjrct@msd.com

Recruitment status	Complete

Anticipated date of first enrollment		Mar. 08, 2022
Actual date of first enrollment		Mar. 09, 2022
Target sample size		48
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	Healthy Japanese male between the ages of 20 and 55 years with BMI within 18 to 25 kg/m2 inclusive and weight >=50 kg
	Exclusion Criteria	History of clinically significant abnormalities or diseases
	Age Minimum	20age old over
	Age Maximum	55age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		Ulcerative colitis
Intervention(s)		- Drug: MK-6194 MK-6194 1-7.5 mg subcutaneously administered in sterile solution form once - Drug: Placebo 5% glucose subcutaneously administered in sterile solution form once
Primary Outcome(s)		Adverse events
Secondary Outcome(s)		- AUC0-last, AUC0-inf, Cmax, Tmax, apparent t1/2, CL/F and Vz/F - Immunophenotyping of regulatory T cells

Primary Sponsor	MSD K.K.

Secondary Sponsor

Name of Certified Review Board	Medical Corporation Heishinkai OPHAC Hospital IRB
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	Feb. 25, 2022

Plan to share IPD	Yes
Plan description	http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Sept. 29, 2023	(this page)	Changes
3	Mar. 17, 2022	Detail	Changes
2	Mar. 08, 2022	Detail	Changes
1	Mar. 02, 2022	Detail

List of change history