Safety and Immunogenicity of High-dose IN-B001 in Healthy Subjects
NCT ID: NCT04637919
Last Updated: 2020-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
30 participants
INTERVENTIONAL
2020-12-31
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
QUADRUPLE
Study Groups
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IN-B001 EV71 A dose
Inactivated EV71 vaccine(A dose) or placebo in 10 healthy adults (three doses, 28 days interval)
IN-B001 EV71 A dose
Inactivated vaccine against EV71, three doses, 28 days interval
Placebo
Placebo, three doses, 28 days interval
IN-B001 CVA16 B dose
Inactivated CVA16 vaccine(B dose) or placebo in 10 healthy adults (three doses, 28 days interval)
IN-B001 CVA16 B dose
Inactivated vaccine against CVA16, three doses, 28 days interval
Placebo
Placebo, three doses, 28 days interval
IN-B001 Bivalent C dose
Inactivated EV71/CVA16 vaccine(C dose) or placebo in 10 healthy adults (three doses, 28 days interval)
IN-B001 Bivalent C dose
Inactivated vaccine against EV71/CVA16, three doses, 28 days interval
Placebo
Placebo, three doses, 28 days interval
Interventions
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IN-B001 EV71 A dose
Inactivated vaccine against EV71, three doses, 28 days interval
IN-B001 CVA16 B dose
Inactivated vaccine against CVA16, three doses, 28 days interval
IN-B001 Bivalent C dose
Inactivated vaccine against EV71/CVA16, three doses, 28 days interval
Placebo
Placebo, three doses, 28 days interval
Eligibility Criteria
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Inclusion Criteria
* Body mass index(BMI) of ≥18.0 kg/m2 to ≤27.0 kg/m2, with body weight of ≥55.0 kg to ≤90.0 kg for men and ≥50.0 kg to ≤90.0 kg for women at the time of screening tests
* Determined by the investigator to be eligible for study participation based on the results of screening tests
* Intact deltoid muscle that allows administration of the investigational product
* Consent to use medically acceptable contraception throughout the study
* Negative finding from a pregnancy test (urine hCG) at the time of the screening for women of childbearing potential
* Voluntary decision and provision of written consent on participation in this study
Exclusion Criteria
* Medical history of an anaphylactic or similar acute reaction to IN-B001 or similar vaccine
* Febrile disease or infectious disease within 2 weeks prior to the 1st IP administration
* Whole blood donation within 2 months or apheresis within 1 month prior to the 1st IP administration
* Vaccination with other prevention vaccine within 2 months prior to the 1st IP administration
* Use of an immunomodulator or immunosuppressant within 3 months prior to the 1st IP administration
* History of a Guillain Barre syndrome
* Excessive caffeine intake or continuous alcohol consumption or incapable of abstention from alcohol during the study
* Participation in other clinical trial within 6 months prior to the 1st IP administration
* Pregnant or breastfeeding women
* Clinically significant hepatic, renal, neurological, respiratory, endocrine, hematology and oncology, cardiovascular, urological or psychiatric disease or such history
* Positive serological finding (type B hepatitis test, type C hepatitis test, human immunodeficiency virus(HIV) test)
* History of drug abuse or positive finding from a urine screening test for an abusive drug
* Use or of any prescription medication or oriental medicine within 2 weeks or any over-the-counter(OTC) medication, health functional food or vitamin within 1 week prior to the 1st IP administration or expected use of such products
* Administration of a blood product or blood-derived agent within 3 months prior to the 1st IP administration
* Determined by the investigator to be ineligible for study participation due to other reason including clinical laboratory findings
19 Years
49 Years
ALL
Yes
Sponsors
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HK inno.N Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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In-Jin Jang, MD, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital, Dept. of Clinical Pharmacology
Locations
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Seoul National University Hospital, Clinical Trial Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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In-Jin Jang, MD, PhD
Role: primary
Other Identifiers
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IN_HFM_102
Identifier Type: -
Identifier Source: org_study_id