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.
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)
Women of childbearing potential (do not meet inclusion criterion #2)
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)