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A Phase I/II Clinical Trial of BK6501 in Healthy Japanese participants aged 60 or over

A Phase I/II Clinical Trial of BK6501 in Healthy Japanese participants aged 60 or over

Mika Oshio

The Research Foundation for Microbial Diseases of Osaka University

3-1, Yamada oka, Suita, Osaka, Japan

clinicaldevelopment@mail.biken.or.jp

Mika Oshio

The Research Foundation for Microbial Diseases of Osaka University

3-1, Yamada oka, Suita, Osaka, Japan

+81-6-6877-4812

clinicaldevelopment@mail.biken.or.jp

Complete

Feb. 08, 2026

Interventional

randomized controlled trial

double blind

active control

parallel assignment

prevention purpose

1.Individuals who are healthy and who have provided written informed consent.
Healthy refers to individuals who do not have any active disease requiring treatment and/or clinical follow-up (including acute diseases, chronic diseases, or exacerbations of chronic progressive diseases). However, individuals whose active diseases are well controlled through pharmacotherapy or other medical management shall also be regarded as healthy

2. Individuals who are able to comply with the study requirements, incliding attending all protocol-specified visits and examinations, and who can accurately report symptoms and other relevant information during the study

3.Individuals who are Japanese and aged 60 years or older at the time of investigational product administration.

1. Individuals who have got flu within 1 year from IP administration.
2. Individuals who have received Influenza vaccine within 1 year from IP administration.
3. Individuals who have received a blood transfusion or gamma globulin preparation within 3 months prior to IP administration, or who habe received high-dose gamma globulin therapy (>= 200 mg/kg/day) within 6 months prior to IP administration.
4.Individuals who are receiving treatments that cause immunosuppression, those with a prior diagnosis of immunodeficiency, and those who have a close relative with a congenital immunodeficiency disorder..
5. Individuals with a known history of anaphylaxis caused by any component of the IP.
6. Individuals with a history of seizures, excluding febrile seizures in childhood.
7. Individuals with respiratory diseases such as interstitial pneumonia or bronchial asthma.
8. Individuals with a history of allergy to any component of the investigational product, or to eggs, chicken, or other chicken-derived substances.
9. Individuals who experienced fever >= 37.5 degree celcius within 2 days after a previous influenza vaccination, or who developed generalized rash or other symptoms suggestive of an allergic reaction.
10. Individuals with serious underlying cardiovascular, renal, hepatic, or hematologic diseases requiring long-term treatment.
11. Individuals with a history of acute disseminated encephalomyelitis, encephalitis/encephalopathy, myelitis, optic neuritis,Guillain-Barre symdorome, hepatic dysfunction, jaundice, idiopathic thrombocytopenic purpura, thromobocytopenia, vasculitis (including allergic purpura, eosinophilic granulomatosis with polyangitis, leukocytoclastic vasculitus), Stevens-Johnson syndrome, or nephrotic syndrome.
12. Individuals with a history or current diagnosis of malignant tumors, except those who have had no recurrence for at least 5 years.
13. Individuals receiving anticoagulant therapy, or those with thrombocytopenia or bleeding disorders for which the investigator or subinvestigator judges intramuscular injection to be contraindicated.
14. Individuals who test positive for HBs antigen, HCV antibody, syphilis serology, or HIV antigen/antibody.
15. Individuals with a BMI < 17.6 or >= 30 at the time of screening.
16. Individuals who have received any other unapproved investigational drug within 4 months prior to IP administration.
17. Individuals judged by the investigator or subinvestigator to be unsuitable for participation in this study.

Both

Prevention of Flu

Arm BK6501 : Administer a single intramuscular dose of investigational product L, M, or H into the deltoid muscle of the upper arm
Arm Control : Administer the seasonal influenza vaccine subcutaneously into the extensor surface of the upper arm.

Safety : Solicited Injection Site and Systemic Reactions, AE, Immediate Unsolicited AE
Immunogenesity : GMT, GMTR, seroconversion rate, and seroprotection rate of influenza virus HI antibodies on Day 29

Feb. 05, 2026

No

none