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RECRUITING
NCT07726147
PHASE1

Phase 1, First in Human (FIH), Open-Label, Single-Arm, Ascending Dose Study to Assess the Safety, Tolerability and Preliminary Immunogenicity of ITI-9001 in Japanese Patients With Japanese Red Cedar (JRC) Pollinosis

Sponsor: Immunomic Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

This is a Phase 1, first-in-human clinical trial to test a new treatment called ITI-9001 for people with allergies to Japanese Red Cedar (JRC) pollen-a common cause of seasonal allergies in Japan. The main goals are to find out if ITI-9001 is safe, how well people tolerate it, and whether it can trigger helpful immune responses.

Official title: Phase 1, First in Human (FIH), Ascending Dose Study to Assess the Safety, Tolerability and Preliminary Immunogenicity of ITI-9001 in Japanese Patients With Japanese Red Cedar (JRC) Pollinosis: A Two-part Design Consisting of an Open-Label, Single-Arm Part A and a Randomized, Double-Blind, Part B

Key Details

Gender

All

Age Range

18 Months - 65 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2026-06-20

Completion Date

2028-02

Last Updated

2026-09-21

Healthy Volunteers

No

Interventions

DRUG

ITI-9001

ITI-9001 is a self-amplifying RNA (saRNA) immunotherapy formulated with lipid nanoparticles for intramuscular injection. The saRNA encodes a CryJ2-LAMP-1 fusion protein, targeting Japanese Red Cedar (JRC) pollen allergy. ITI-9001 is designed to enhance antigen presentation and stimulate robust immune responses, aiming to reduce allergic symptoms in JCP-sensitive patients.

OTHER

Placebo

Saline placebo injection

Locations (1)

Medical Corporation Shinanokai SHINANOZAKA Clinic

Tokyo, Shinjuku-ku, Japan