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 | Recruiting Phase 1

• 1 other identifier: 9001-01-JRC-P1
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Japanese Red Cedar (JRC) pollinosis; Japanese Cedar Pollen (JCP) allergy; seasonal allergic rhinitis; self-amplifying RNA (saRNA)

Outcome Measures

Primary Outcomes (1)

• Frequency and severity of dose-limiting toxicities (DLTs)

  DLTs will be summarized by frequency and severity from first study drug administration through End of Study (see timeframe below)

  From enrollment to Day 382

Other Outcomes (1)

• Measurements of blood antibody titers from immune biomarkers, and skin prick tests

  From screening through Day 382

Study Arms (3)

Arm 1 - Part A, ITI-9001 Dose Escalation

EXPERIMENTAL

Part A Eligible participants receive two intramuscular doses of ITI-9001 (either 1 µg or 10 µg) 21 days apart to find maximum tolerated dose.

Drug: ITI-9001

Arm 2, Part B ITI-9001 Dose Expansion

EXPERIMENTAL

Arm 2 of Part B is a double-blind, placebo-controlled group in which eligible Japanese adults with Japanese Red Cedar (JRC) pollinosis receive intramuscular injections of ITI-9001 at the maximum tolerated dose (determined in Arm 1, Part A).

Drug: ITI-9001

Arm 3, Part B Placebo Control

PLACEBO COMPARATOR

Arm 3 of Part B is a double-blind, placebo-controlled group in which eligible Japanese adults with Japanese Red Cedar (JRC) pollinosis receive intramuscular injections of placebo (normal saline) on the same schedule as the ITI-9001, Part B arm

Other: Placebo

Interventions

ITI-9001 DRUG

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.

Arm 1 - Part A, ITI-9001 Dose Escalation; Arm 2, Part B ITI-9001 Dose Expansion

Placebo OTHER

Saline placebo injection

Arm 3, Part B Placebo Control

Eligibility Criteria

• Age: 18 Months - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated informed consent form (ICF)
• Female of non-childbearing potential or male aged 18-65 years (inclusive). Women are not considered to be of childbearing potential if they have had a hysterectomy or tubal ligation, or are postmenopausal (≥12 months without menstruation, or FSH in postmenopausal range for women \<55 years)
• Confirmed JCP sensitivity by positive skin prick test (wheal diameter ≥3 mm)
• Confirmed JCP sensitivity by ImmunoCAP (serum JCP-specific IgE ≥ class 2)
• ≥2 year history of seasonal rhinoconjunctivitis symptoms requiring medication upon JCP exposure
• Contraception requirements: \<br\> a. Women of non-childbearing potential: negative serum pregnancy test ≤3 days before first dose \<br\> b. Men: surgically sterile, or agree to abstinence or use 2 highly effective methods of contraception during study and for 3 months after last dose if partner is of childbearing potential (male condom + oral hormonal contraceptives, intrauterine device, or intrauterine hormone-releasing system)
• No significant ischemic heart disease or myocardial infarction within 6 months before first study drug administration; adequate cardiac function at screening (QTcF ≤470 msec for females or ≤450 msec for males; average of triplicate ECGs). Participants with ventricular arrhythmia assessed case-by-case
• Willing and able to participate and comply with all study procedures

You may not qualify if:

• Respiratory function: \<br\> a. Fever ≥38°C (100.4°F) on day of study drug administration \<br\> b. FEV1 \<80% as predicted on spirometry \<br\> c. Current smoker/tobacco user \<br\> d. History of asthma requiring daily medication (except exercise-induced or mild intermittent asthma)
• Contraindications: \<br\> a. Known allergy to ITI-9001 components \<br\> b. Contraindication to intramuscular injections or blood draws \<br\> c. History of intolerance or severe allergic reaction to previous immunotherapy \<br\> d. History of anaphylaxis requiring medical intervention (including severe reactions to mRNA vaccines)
• Prior/concurrent treatments: \<br\> a. Participation in another therapeutic clinical trial within 30 days before screening \<br\> b. Prior or current immunotherapy for JCP \<br\> c. Specific or nonspecific immunotherapy within 1 year prior to screening \<br\> d. Biologics (e.g., anti-IgE, anti-IL-5, anti-TNFα) \<br\> e. mRNA vaccine within 28 days before first study drug administration \<br\> f. Live vaccine within 28 days or inactivated/toxoid vaccine within 7 days before first study drug administration \<br\> g. Chronic (more than 30 days) systemic corticosteroids (inhaled, oral, IM, IV, potent topical) \<br\> h. Inability/unwillingness to discontinue beta-blockers up to 48 hours before first study drug administration and during the study \<br\> i. Inability/unwillingness to comply with washout periods for antihistamines and other allergy medications (per Table 3)
• Medical history/comorbidities: \<br\> a. Clinically significant abnormalities on physical exam, labs, or medical history that jeopardize safety or validity of results (except HEENT findings consistent with allergic rhinitis) \<br\> b. Malignant tumor diagnosed or treated within 5 years prior to first study drug administration (except adequately treated non-melanoma skin cancer or carcinoma in situ) \<br\> c. Congenital or acquired immune deficiency or suppression (e.g., malignancy, infection, chemotherapy, radiation, corticosteroids) \<br\> d. History of organ transplant, hematologic malignancy, or autoimmune disease \<br\> e. History of stroke, transient ischemic attack, unstable angina, myocardial infarction within 3 months prior to first study drug administration \<br\> f. Symptomatic congestive heart failure (NYHA Class III-IV), unstable angina, significant arrhythmia, or LVEF \<45% \<br\> g. History of myocarditis or pericarditis \<br\> h. Risk factors for torsades de pointes or use of medications known to prolong QT/QTc (except low-risk premedications) \<br\> i. Clinically significant gastrointestinal, renal, hepatic, neurologic, or hematologic disease \<br\> j. HIV/AIDS, hepatitis B, or hepatitis C infection \<br\> k. Recurrent sinusitis, urticaria, or angioedema within past 12 months prior to first study drug administration \<br\> l. Symptomatic overlap with JRC pollinosis requiring regular medications \<br\> m. Alcohol or drug abuse within 1 year before screening or current dependence

Sponsors & Collaborators

• Immunomic Therapeutics, Inc.: lead

Study Sites (1)

Medical Corporation Shinanokai SHINANOZAKA Clinic

Tokyo, Shinjuku-ku, Japan

RECRUITING

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal; Hypersensitivity

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Immune System Diseases

Central Study Contacts

Scott Wehage, M.S.

CONTACT

301-968-3501; clinicaloperations@immunomix.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Part A is open-label, so no masking is used and both participants and investigators know that ITI-9001 is being administered. Part B is randomized and double-blind, meaning participants, investigators, and blinded site staff do not know whether a subject receives ITI-9001 or placebo; only the unblinded pharmacist and designated dispensing staff prepare and mask the injections. Blinding is maintained by restricting treatment information and certain biomarker data that could reveal assignment, emergency unblinding is allowed only when necessary for subject safety and must be documented.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This protocol uses an early-phase, interventional, ascending-dose design with a single-arm, open-label safety lead-in (Part A), followed by a randomized, double-blind, placebo-controlled expansion (Part B) to robustly assess safety, tolerability, and preliminary immunogenicity of ITI-9001 in the target population

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 24, 2026
• Study Start: June 20, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)