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

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Allergen Immunotherapy

In brief

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.

Key facts

Study ID: NCT07726147
Run by: Immunomic Therapeutics, Inc.
People needed: 45
Starts: 2026-06-20
Expected to finish: 2028-02-01
Last updated by the study team: 2026-07-24

Who can join

Age: 2 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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: a. Women of non-childbearing potential: negative serum pregnancy test ≤3 days before first dose 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…

Women of childbearing potential (do not meet inclusion criterion #2)
Respiratory function: a. Fever ≥38°C (100.4°F) on day of study drug administration b. FEV1 <80% as predicted on spirometry c. Current smoker/tobacco user d. History of asthma requiring daily medication (except exercise-induced or mild intermittent asthma)
Contraindications: a. Known allergy to ITI-9001 components b. Contraindication to intramuscular injections or blood draws c. History of intolerance or severe allergic reaction to previous immunotherapy d. History of anaphylaxis requiring medical intervention (including severe reactions to mRNA vaccines)
Prior/concurrent treatments: a. Participation in another therapeutic clinical trial within 30 days before screening b. Prior or current immunotherapy for JCP c. Specific or nonspecific immunotherapy within 1 year prior to screening d. Biologics (e.g., anti-IgE, anti-IL-5, anti-TNFα) e. mRNA vaccine within 28 days before first study drug administration f. Live vaccine within 28 days or inactivated/toxoid vaccine within 7 days before first study drug administration g. Chronic (more than 30 days) systemic corticosteroids (inhaled, oral, IM, IV, potent topical) h. Inability/unwillingness to discontinue beta-blockers up to 48 hours before first study drug administration and during the study i. Inability/unwillingness to comply with washout periods for antihistamines and other allergy medications (per Table 3)
Medical history/comorbidities: 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) 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) c. Congenital or acquired immune deficiency or suppression (e.g., malignancy, infection, chemotherapy, radiation, corticosteroids) d. History of organ transplant, hematologic malignancy, or autoimmune disease e. History of stroke, transient ischemic attack, unstable angina, myocardial infarction within 3 months prior to first study drug administration f. Symptomatic congestive heart failure (NYHA Class III-IV), unstable angina, significant arrhythmia, or LVEF <45% g. History of myocarditis or pericarditis h. Risk factors for torsades de pointes or use of medications known to prolong QT/QTc (except low-risk premedications) i. Clinically significant gastrointestinal, renal, hepatic, neurologic, or hematologic disease j. HIV/AIDS, hepatitis B, or hepatitis C infection k. Recurrent sinusitis, urticaria, or angioedema within past 12 months prior to first study drug administration l. Symptomatic overlap with JRC pollinosis requiring regular medications m. Alcohol or drug abuse within 1 year before screening or current dependence

Where it is running

Medical Corporation Shinanokai SHINANOZAKA Clinic — Tokyo, Shinjuku-ku, Japan (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.