FPP003-JP-SPA-02

JRCT ID: jRCT2051220007

Registered date:22/04/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Axial spondyloarthritis that does not meet X-ray criteria
• Date of first enrollment: 22/04/2022
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Two doses (15 mg/body or 24 mg/body) of FPP003 and placebo are given to healthy subjects three times at 4-week intervals to evaluate safety, tolerability and immunogenicity.

Outcome(s)

Primary Outcome

(1)Safety end point
The type, frequency, and severity of adverse events, serious adverse events, etc. occurring from the time of the first dose (Day 1) to 20 weeks (Day 141) after the first dose of the investigational product (vaccination period, observation period) will be collected to assess safety.
(2)Immunogenicity endpoint
The geometric mean increase factor (GMFR) based on the IL-17A-specific antibody titer before the first inoculation of the investigational drug (Day 1) is analyzed to evaluate immunogenicity.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 65age old
• Gender: Both

Include criteria

1)Individuals who gave written informed consent at their own discretion to participate in the clinical trial.
2)Individuals aged 20 to less than 65 years at the time of informed consent
3)Women who have been menopausal for at least 12 months after their last menstrual period at the time of obtaining informed consent
4)A person who falls under any of the following a)-(c)
a) PCR-negative persons with SARS-CoV-2
b) Individuals who are negative for both SARS-CoV-2 IgM and SARS-CoV-2 IgG antibodies by antibody test.
c) Individuals who have received two or more doses of COVID-19 vaccine

Exclude criteria

(1)Individuals with a history of participation (vaccination history) in an unapproved vaccine clinical trial within 1 year before the start of the clinical trial (the first date of administration of the investigational product)
(2)Individuals with a history of anaphylaxis due to foods, drugs, etc. in the past.
(3)Individuals with uncontrolled and clinically problematic neurological, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological or endocrine disorders, or other abnormalities that may affect study participation or study results.
(4)Individuals with a history of convulsion or epilepsy who are judged ineligible by the investigator or subinvestigator.
(5)Individuals with a history of diagnosis of immunodeficiency
(6)Individuals with a relative (within the third degree) with congenital immunodeficiency
(7)Individuals with clinically significant abnormal ECG results during the screening period or prior to Day 1 vaccination.
(8)Subjects who have collected at least 200 mL of whole blood within 4 weeks before the start of the clinical trial (the first date of vaccination with the investigational product)
(9)Individuals who collect at least 400 mL of whole blood within 12 weeks before the start of the clinical trial (the first date of vaccination with the investigational product) for males and within 16 weeks before the start of the clinical trial (the first date of vaccination with the investigational product) for females.
(10)Individuals who donate ingredients within 2 weeks before the start of the clinical trial (the first date of vaccination with the investigational product)
(11)Persons with a history of inflammatory bowel disease
(12)Individuals with or without active tuberculosis or LTBI or a history of it.
(13)Individuals who have ever abused drugs or alcohol prior to the first dose of the investigational product.
(14)Individuals who participated in clinical trials of other unapproved drugs, etc., and received study drugs, etc., within 4 weeks before the start of the clinical trial (the first date of vaccination with the investigational product).
(15)Individuals who have received COVID19, live, inactivated, or toxoid vaccination or who are scheduled to receive the vaccine for up to Day 85 after the start of the clinical trial within 4 weeks prior to the start of the clinical trial (the first date of administration of the investigational product)
(16)Subjects who have received immunomodulators (e.g., DMARDs), immunosuppressants, biological agents, etc. that may affect the immune system (excluding topical preparations) within 4 weeks prior to the start of the clinical trial (the first date of administration of the investigational product)
(17)Individuals who have received blood transfusions or gamma globulin preparations within 12 weeks before the start of the clinical trial (the first date of vaccination with the investigational product) or who have received high-dose gamma globulin therapy (200 mg/kg or more) within 24 weeks (the first date of vaccination with the investigational product).
(18)Individuals who are positive for either human immunodeficiency virus (HIV) antigen/antibody, hepatitis B virus surface antigen (HBsAg), HBc antibody, HBs antibody (excluding persons with a history of obvious vaccination), or hepatitis C virus (HCV) antibody during the screening phase.
(19)Individuals who are unable to comply with the protocol and follow-up (due to mental, family, social, geographic, etc.).
(20)Other persons who are judged by the investigator or subinvestigator to be ineligible for the study.

Related Information

• Primary Sponsor: Mikami Hiroshi
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development,FunPep Co., Ltd