臨床研究等提出・公開システム

Date of registration	July. 05, 2024
Last modified on	Jan. 20, 2025
Trial ID	jRCT2071240029

Scientific Title	A placebo-controlled, within-group randomised, and double-blind trial investigating safety, tolerability, and pharmacokinetics of FE 999301 after single ascending doses in healthy Japanese men
Public Title	A Study Investigating the Safety, Tolerability and Pharmacokinetics of Olamkicept in Healthy Japanese Persons.

Contact for Scientific Queries	Name	Imura Futoshi
	Affiliation	Ferring Pharmaceuticals Co., Ltd.
	Address	2-10-4 Toranomon, Minato-ku, Tokyo
	Telephone	+81-3-5544-9274
	E-mail	JP0-chiken.info@ferring.com
Contact for Public Queries	Name	Saga China
	Affiliation	Ferring Pharmaceuticals Co., Ltd.
	Address	2-10-4 Toranomon, Minato-ku, Tokyo
	Telephone	+81-3-5544-9274
	E-mail	JP0-chiken.info@ferring.com

Recruitment status	Not Recruiting

Anticipated date of first enrollment		July. 04, 2024
Target sample size		24
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	- Japanese men with 18 to 45 years of age at screening - In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs measurements, and clinical laboratory evaluations, as assessed by the investigator (or delegated person) at screening and on Day -1
	Exclusion Criteria	- History of clinically significant medical conditions including, but not limited to, diseases of the renal, hepatic, respiratory, gastrointestinal, cardiovascular, neurological, musculoskeletal, immunological, haematological, endocrine, and metabolic systems, as well as oncological, psychiatric, dermatological, and allergic diseases (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
	Age Minimum	18age old over
	Age Maximum	45age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		Healthy Adult Male Volunteers
Intervention(s)		Single intravenous infusion of the investigational drug
Primary Outcome(s)		- Number of treatment-emergent adverse events, including type, intensity, and causality. - Change from baseline in vital signs, 12-lead electrocardiogram (ECG), haematology, clinical chemistry, haemostasis, and urinalysis parameters after a single IV dose infusion.

Primary Sponsor	Ferring Pharmaceuticals Co., Ltd.

Name of Certified Review Board	Souseikai Hakata Clinic IRB
Address	6-18 Tenyamachi, Hakata-ku, Fukuoka-shi, Fukuoka, Fukuoka
Date of approval	June. 20, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Jan. 20, 2025	(this page)	Changes
1	July. 05, 2024	Detail

List of change history