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.
Inclusion Criteria:
Exclusion Criteria:
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Part A is open-label, so no masking is used and both participants and investigators know that ITI-9001 is being administered. Part B is randomized and double-blind, meaning participants, investigators, and blinded site staff do not know whether a subject receives ITI-9001 or placebo; only the unblinded pharmacist and designated dispensing staff prepare and mask the injections. Blinding is maintained by restricting treatment information and certain biomarker data that could reveal assignment, emergency unblinding is allowed only when necessary for subject safety and must be documented.
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.
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).
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
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