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Recruiting
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
Conditions: Allergen Immunotherapy
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 45
Sponsor: Immunomic Therapeutics, Inc.
Location: Medical Corporation Shinanokai SHINANOZAKA Clinic Tokyo Shinjuku-ku
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.
Eligibility Criteria
Inclusion Criteria:
1. Signed and dated informed consent form (ICF)
2. 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 \
Source: ClinicalTrials.gov (NCT07726147). StuddyBuddy aggregates publicly available trial information.
