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A Study to Evaluate INT101 in Healthy Adults for the Prevention of Norovirus Gastroenteritis
Sponsor: InThera Inc. Korea
Summary
This study is being conducted to evaluate the safety and immunogenicity of INT101, an investigational vaccine intended to prevent norovirus gastroenteritis, in healthy adults. INT101 contains multivalent norovirus antigens (GII.3, GII.4, and GII.17) and is administered as an intramuscular injection. Participants will receive either INT101 or a placebo, given three times at 4-week intervals. This is a single-center, single-blind, randomized, dose-escalation, placebo-controlled, multiple-dose, Phase 1 clinical trial. Approximately 30 healthy adult participants will be enrolled and randomly assigned to receive either a low dose or high dose of INT101, or a matching placebo, in a 2:1 ratio within each dose group. The primary objective is to evaluate the safety of multiple intramuscular doses of INT101 compared to placebo. The secondary objective is to evaluate the immunogenicity (antibody response) of INT101 compared to placebo. Participants will be followed for approximately 6 months after their last dose to monitor safety and immune response.
Official title: A Single Center, Single-Blind, Randomized, Dose-Escalation, Placebo-Controlled, Multiple Dose, Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of INT101 Intramuscular Injection in Healthy Adults
Key Details
Gender
All
Age Range
19 Years - 48 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-08-10
Completion Date
2028-01
Last Updated
2026-09-14
Healthy Volunteers
Yes
Interventions
INT101 Low Dose
Norovirus multivalent antigen vaccine (GII.3, GII.4, GII.17), total 30 μg per 0.25 mL, administered via intramuscular injection into the deltoid muscle, 3 doses at 4-week intervals.
INT101 High Dose
Norovirus multivalent antigen vaccine (GII.3, GII.4, GII.17), total 60 μg per 0.5 mL, administered via intramuscular injection into the deltoid muscle, 3 doses at 4-week intervals.
INT101 Placebo (0.25 mL)
Matching placebo identical in formulation and appearance to INT101, excluding the active norovirus antigens; 0.25 mL, administered via intramuscular injection into the deltoid muscle, 3 doses at 4-week intervals.
INT101 Placebo (0.5 mL)
Matching placebo identical in formulation and appearance to INT101, excluding the active norovirus antigens; 0.5 mL, administered via intramuscular injection into the deltoid muscle, 3 doses at 4-week intervals.
Locations (1)
Severance Hospital, Yonsei University Health System
Seoul, South Korea