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A Phase 1B/2 Study To Evaluate The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, And Clinical Activity Of Eq001 In Subjects With Newly Diagnosed Acute Graft Versus Host Disease
Part A is an open label study and will enroll approximately 24 evaluable subjects with aGVHD across 4 cohorts. The total number of patients will depend on the number of dose escalations necessary to enable a decision to be made on the recommended dose to take forward into Part B of the study. The planned dose escalation will start with cohort 1, where subjects will receive EQ001 administered intravenously every two weeks for a total of 5 doses. Part B is a randomized, double-blind, placebo-controlled study and will enroll approximately 60 additional subjects, randomized in a 2:1 ratio to either active treatment EQ001 (40) or placebo (20). Subjects will receive either EQ001 or placebo administered intravenously every two weeks for a total of 5 doses.
The objectives of Part A of the study are to: Primary: *Determine the safety and tolerability of intravenous (IV) dosing of EQ001 in subjects with newly diagnosed acute graft versus host disease (aGVHD) *Determine optimal IV dose level(s) of EQ001 in subjects with newly diagnosed aGVHD Secondary: *To characterize the pharmacokinetics (PK) of EQ001 in subjects with newly diagnosed aGVHD *To characterize the pharmacodynamics (PD) of EQ001 in subjects with newly diagnosed aGVHD *To assess the PK/PD relationships of EQ001 in subjects with newly diagnosed aGVHD *To assess the clinical activity of EQ001 in subjects with newly diagnosed aGVHD The objectives of Part B of the study are to: Primary : *To define the clinical activity of EQ001 in subjects with newly diagnosed aGVHD Secondary : *To further characterize the safety, tolerability, and PD of EQ001 in subjects with newly diagnosed aGVHD
EQ001 (); Placebo ()
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