臨床研究等提出・公開システム

Japanese

Date of registration	Sept. 11, 2024
Last modified on	Sept. 11, 2024
Trial ID	jRCT2031240331

Scientific Title	Pharmacokinetic study of HP-5120
Public Title	Pharmacokinetic study of HP-5120

Contact for Scientific Queries	Name	Tanaka Yusuke
	Affiliation	Hisamitsu Pharmaceutical Co., Inc.
	Address	2-4-1 Marunouchi, Chiyoda-ku, Tokyo
	Telephone	+81-3-5293-1734
	E-mail	shikenjoho@hisamitsu.co.jp
Contact for Public Queries	Name	Clinical Development Department Contact for Clinical Trial Information
	Affiliation	Hisamitsu Pharmaceutical Co., Inc.
	Address	2-4-1 Marunouchi, Chiyoda-ku, Tokyo
	Telephone	+81-3-5293-1734
	E-mail	shikenjoho@hisamitsu.co.jp

Recruitment status	Pending

Anticipated date of first enrollment		Oct. 15, 2024
Actual date of first enrollment
Target sample size		112
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	- Healthy adult Japanese males and females aged 18 or older and younger than 45 years - Subjects weighing 40 kg or more
	Exclusion Criteria	- Subjects with or with a history of serious cardiovascular, renal, hepatic, gastrointestinal, endocrine, neuropsychiatric, dermatological, metabolic, or immunological disease - Subjects who received any drug within 1 week prior to administration of the investigational product - Subjects who took any drug considered to affect drug metabolism within 4 weeks prior to administration of the investigational product
	Age Minimum	18age old over
	Age Maximum	45age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		healthy adult males and females
Intervention(s)		[Single ascending dose in healthy adult Japanese males and females] In Cohort 1, a single dose of HP-5120 Dose 1 or placebo will be administered. In Cohort 2, a single dose of HP-5120 Dose 2 or placebo will be administered. In Cohort 3-1, a single dose of HP-5120 Dose 4 or placebo will be administered. In Cohort 3-2, a single dose of HP-5120 Dose 3 or placebo will be administered. In Cohort 4, a single dose of HP-5120 Dose 5 or placebo will be administered. [Single-dose administration by sex in healthy adult Japanese males and females] In the male group, the maximum tolerated dose of HP-5120 in Dose 1 or 2 will be administered at a single dose. In the female group, the maximum tolerated dose of HP-5120 in Dose 1 or 2 will be administered at a single dose. [Multiple doses in healthy Japanese adult males and females] HP-5120 among Doses 1 to 5 that have been found to be tolerated will be administered for 14 days in repeated dose study.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Pharmacokinetics, Safety
Secondary Outcome(s)

Primary Sponsor	Hisamitsu Pharmaceutical Co., Inc.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Medical Corporation Shinanokai Shinanozaka Clinic Institutional Review Board
Address	Yotsuya Medical Building, 20 Samoncho, Shinjuku-ku, Tokyo
Telephone	+81-3-5366-3006
E-Mail	scl-irb@shinanokai.com
Approval Status	Not approval
Date of approval

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none