臨床研究等提出・公開システム

Japanese

Date of registration	April. 28, 2025
Last modified on	April. 30, 2025
Trial ID	jRCT2031250033

Scientific Title	A Phase I study evaluating safety, tolerability, and immunogenicity of FPP004X intramuscularly administered (FPP004X-JP-SAR-01)
Public Title	A Phase I study evaluating safety, tolerability, and immunogenicity of FPP004X (FPP004X-JP-SAR-01)

Contact for Scientific Queries	Name	Tomioka Hideki
	Affiliation	FunPep Co., Ltd.
	Address	Office for University-Industry Collaboration Bldg. A, 5F No.509, Osaka University 2-1 Yamadaoka, Suita, Osaka
	Telephone	+81-6-6369-7957
	E-mail	htomioka@funpep.co.jp
Contact for Public Queries	Name	Kasahara Satoru
	Affiliation	FunPep Co., Ltd.
	Address	Office for University-Industry Collaboration Bldg. A, 5F No.509, Osaka University 2-1 Yamadaoka, Suita, Osaka
	Telephone	+81-6-6369-7957
	E-mail	skasahara@funpep.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		April. 17, 2025
Actual date of first enrollment		April. 17, 2025
Target sample size		93
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 adults(Part 1): 1. Males aged >= 18 to < 45 years at the time of consent 2. Body mass index (BMI) >= 18.5 kg/m2 to < 25.0 kg/m2 Patients with seasonal allergic rhinitis(Part 2): 1. Males aged >= 18 to < 50 years at the time of consent 2. Body mass index (BMI) >= 17.6 kg/m2 to < 26.5 kg/m2
	Exclusion Criteria	1. Subjects who who have participated (been vaccinated) in a clinical trial of an unapproved vaccine within 1 year prior to the start of the clinical trial (starting from the date of administration of the investigational drug) 2. Subjects who have been diagnosed with immunodeficiency or autoimmune disease 3. Subjects who have or have a history of allergic diseases (atopic dermatitis, bronchial asthma, etc.) 4. Subjects who have a history of hypersensitivity to any component of the investigational product 5. Subjects who are judged by the investigator (subinvestigator) to be ineligible for this clinical trial
	Age Minimum	18age old over
	Age Maximum	50age old not
	Gender	Male
Health Condition(s) or Problem(s) Studied		Healthy adults and patients with seasonal allergic rhinitis
Intervention(s)		1. Healthy adults (Part 1): FPP004X or placebo will be administered twice or three times at 4-week intervals. 2. Patients with seasonal allergic rhinitis (Part 2): FPP004X or placebo will be administered three times at 4-week intervals. Subjects in Part 2 will be exposed to cedar pollen.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Safety, tolerability and immunogenicity
Secondary Outcome(s)		Pharmacokinetics

Primary Sponsor	FunPep Co., Ltd.

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 Bldg. 3F, 20, Samon-cho, Shinjuku-ku, Tokyo, 160-0017, Japan, Tokyo
Telephone	+81-3-5366-3006
E-Mail	scl-irb@shinanokai.com
Approval Status	Approval
Date of approval	Mar. 25, 2025

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	April. 30, 2025	(this page)	Changes
1	April. 28, 2025	Detail

List of change history