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Safety and Immunogenicity of High-dose IN-B001 in Healthy Subjects

NCT04637919 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-11-20

No results posted yet for this study

Summary

This study aims to evaluate the safety and immunogenicity of high-dose IN-B001 after administration in healthy subjects

Conditions

  • Hand, Foot and Mouth Disease

Interventions

BIOLOGICAL

IN-B001 EV71 A dose

Inactivated vaccine against EV71, three doses, 28 days interval

BIOLOGICAL

IN-B001 CVA16 B dose

Inactivated vaccine against CVA16, three doses, 28 days interval

BIOLOGICAL

IN-B001 Bivalent C dose

Inactivated vaccine against EV71/CVA16, three doses, 28 days interval

BIOLOGICAL

Placebo

Placebo, three doses, 28 days interval

Sponsors & Collaborators

  • HK inno.N Corporation

    lead INDUSTRY

Principal Investigators

  • In-Jin Jang, MD, Ph.D · Seoul National University Hospital, Dept. of Clinical Pharmacology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
19 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-31
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04637919 on ClinicalTrials.gov