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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

NCT07726147 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-07-24

No results posted yet for this study

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.

Conditions

  • Allergen Immunotherapy

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

Sponsors & Collaborators

  • Immunomic Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Months
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-20
Primary Completion
2028-02-29
Completion
2028-02-29

Countries

  • Japan

Study Locations

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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 NCT07726147 on ClinicalTrials.gov