臨床研究等提出・公開システム

Date of registration	May. 25, 2022
Last modified on	Jan. 22, 2024
Trial ID	jRCT2031220092

Scientific Title	A single-dose study of HP-6050
Public Title	A single-dose study of HP-6050

Contact for Scientific Queries	Name	Inakura Hiroshi
	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	Complete

Anticipated date of first enrollment		May. 27, 2022
Actual date of first enrollment		May. 31, 2022
Target sample size		16
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	- Healthy Japanese adult males and females aged >=18 and <40 years - Body mass index (BMI) is >=18.5 and <25.0
	Exclusion Criteria	- Subjects with vagal tone - Subjects with current or history of serious cardiac, vascular, renal, hepatic, psychiatric/neurological, or metabolic diseases - Subjects who received any drug within a week prior to application of the study drug
	Age Minimum	18age old over
	Age Maximum	40age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Healthy adult
Intervention(s)		Single dose of HP-6050
Primary Outcome(s)		Pharmacokinetic parameters, adverse events
Secondary Outcome(s)		Pharmacodynamics

Primary Sponsor	Hisamitsu Pharmaceutical Co., Inc.

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Review Board of Human Rights and Ethics for Clinical Studies
Address	2-2-1, Kyobashi, Chuo-ku, Tokyo
Telephone	+81-3-5213-0028
E-Mail	crb@hurecs.org
Approval Status	Approval
Date of approval	May. 27, 2022

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
5	Jan. 22, 2024	(this page)	Changes
4	Mar. 14, 2023	Detail	Changes
3	Aug. 18, 2022	Detail	Changes
2	June. 10, 2022	Detail	Changes
1	May. 25, 2022	Detail

List of change history