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RECRUITING
NCT07818629
PHASE1

A Study to Evaluate INT101 in Healthy Adults for the Prevention of Norovirus Gastroenteritis

Sponsor: InThera Inc. Korea

View on ClinicalTrials.gov

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

BIOLOGICAL

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.

BIOLOGICAL

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.

BIOLOGICAL

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.

BIOLOGICAL

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