[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648780":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":36,"locations":42,"responsibleParty":56,"collaborators":30,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":30,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":30,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":45,"whyStopped":30,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Immunomic Therapeutics, Inc.","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Drug: ITI-9001",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm 2, Part B ITI-9001 Dose Expansion","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).",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"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",[23],"Other: Placebo",[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"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.",[9,15],null,{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":30},"OTHER","Placebo","Saline placebo injection",[19],[37],{"name":38,"role":39,"phone":40,"phoneExt":30,"email":41},"Scott Wehage, M.S.","CONTACT","301-968-3501","clinicaloperations@immunomix.com",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":30,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":30},"Medical Corporation Shinanokai SHINANOZAKA Clinic","RECRUITING","Tokyo","Shinjuku-ku","Japan","JP",{"type":51,"coordinates":52},"Point",[53,54],139.69171,35.6895,{"lat":54,"lon":53},{"type":57,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100648780","phase-1-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-100648780",false,"NCT07726147","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","Phase 1, First in Human (FIH), Ascending Dose Study to Assess the Safety, Tolerability and Preliminary Immunogenicity of ITI-9001 in Japanese Patients With Japanese Red Cedar (JRC) Pollinosis: A Two-part Design Consisting of an Open-Label, Single-Arm Part A and a Randomized, Double-Blind, Part B","Inclusion Criteria:\n\n1. Signed and dated informed consent form (ICF)\n2. 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 \\\u003C55 years)\n3. Confirmed JCP sensitivity by positive skin prick test (wheal diameter ≥3 mm)\n4. Confirmed JCP sensitivity by ImmunoCAP (serum JCP-specific IgE ≥ class 2)\n5. ≥2 year history of seasonal rhinoconjunctivitis symptoms requiring medication upon JCP exposure\n6. Contraception requirements: \\\u003Cbr\\> a. Women of non-childbearing potential: negative serum pregnancy test ≤3 days before first dose \\\u003Cbr\\> 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)\n7. 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\n8. Willing and able to participate and comply with all study procedures\n\nExclusion Criteria:\n\n1. Women of childbearing potential (do not meet inclusion criterion #2)\n2. Respiratory function: \\\u003Cbr\\> a. Fever ≥38°C (100.4°F) on day of study drug administration \\\u003Cbr\\> b. FEV1 \\\u003C80% as predicted on spirometry \\\u003Cbr\\> c. Current smoker\u002Ftobacco user \\\u003Cbr\\> d. History of asthma requiring daily medication (except exercise-induced or mild intermittent asthma)\n3. Contraindications: \\\u003Cbr\\> a. Known allergy to ITI-9001 components \\\u003Cbr\\> b. Contraindication to intramuscular injections or blood draws \\\u003Cbr\\> c. History of intolerance or severe allergic reaction to previous immunotherapy \\\u003Cbr\\> d. History of anaphylaxis requiring medical intervention (including severe reactions to mRNA vaccines)\n4. Prior\u002Fconcurrent treatments: \\\u003Cbr\\> a. Participation in another therapeutic clinical trial within 30 days before screening \\\u003Cbr\\> b. Prior or current immunotherapy for JCP \\\u003Cbr\\> c. Specific or nonspecific immunotherapy within 1 year prior to screening \\\u003Cbr\\> d. Biologics (e.g., anti-IgE, anti-IL-5, anti-TNFα) \\\u003Cbr\\> e. mRNA vaccine within 28 days before first study drug administration \\\u003Cbr\\> f. Live vaccine within 28 days or inactivated\u002Ftoxoid vaccine within 7 days before first study drug administration \\\u003Cbr\\> g. Chronic (more than 30 days) systemic corticosteroids (inhaled, oral, IM, IV, potent topical) \\\u003Cbr\\> h. Inability\u002Funwillingness to discontinue beta-blockers up to 48 hours before first study drug administration and during the study \\\u003Cbr\\> i. Inability\u002Funwillingness to comply with washout periods for antihistamines and other allergy medications (per Table 3)\n5. Medical history\u002Fcomorbidities: \\\u003Cbr\\> 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) \\\u003Cbr\\> 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) \\\u003Cbr\\> c. Congenital or acquired immune deficiency or suppression (e.g., malignancy, infection, chemotherapy, radiation, corticosteroids) \\\u003Cbr\\> d. History of organ transplant, hematologic malignancy, or autoimmune disease \\\u003Cbr\\> e. History of stroke, transient ischemic attack, unstable angina, myocardial infarction within 3 months prior to first study drug administration \\\u003Cbr\\> f. Symptomatic congestive heart failure (NYHA Class III-IV), unstable angina, significant arrhythmia, or LVEF \\\u003C45% \\\u003Cbr\\> g. History of myocarditis or pericarditis \\\u003Cbr\\> h. Risk factors for torsades de pointes or use of medications known to prolong QT\u002FQTc (except low-risk premedications) \\\u003Cbr\\> i. Clinically significant gastrointestinal, renal, hepatic, neurologic, or hematologic disease \\\u003Cbr\\> j. HIV\u002FAIDS, hepatitis B, or hepatitis C infection \\\u003Cbr\\> k. Recurrent sinusitis, urticaria, or angioedema within past 12 months prior to first study drug administration \\\u003Cbr\\> l. Symptomatic overlap with JRC pollinosis requiring regular medications \\\u003Cbr\\> m. Alcohol or drug abuse within 1 year before screening or current dependence","ALL","18 Months","65 Years",{"count":69,"type":70},45,"ESTIMATED","INTERVENTIONAL",[73],"PHASE1","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.",[76],"Allergen Immunotherapy",[78,79,80,81],"Japanese Red Cedar (JRC) pollinosis","Japanese Cedar Pollen (JCP) allergy","seasonal allergic rhinitis","self-amplifying RNA (saRNA)","2026-07-20",{"date":84,"type":85},"2026-07-24","ACTUAL",{"date":87,"type":85},"2026-06-20",{"date":89,"type":70},"2028-02",{"name":5,"class":6},1]