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)
Parallel
ITI-9001
DrugITI-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.
Placebo
Other interventionSaline placebo injection
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)
Measurements of blood antibody titers from immune biomarkers, and skin prick tests
Immune biomarkers of pharmacodynamic activity, including blood antibody titer assessments from screening through end of study (see timeframe below)
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