4 results
Primary Objective- To demonstrate dose proportionality between 1 mg and 5 mg of PedPRM (Neurim Pharmaceuticals Ltd.) following a single oral dose in healthy male and female volunteers (treatment A and C), under fed conditions.Secondary Objectives-…
The primary objective is:• To evaluate the safety and tolerability of a single local i.c. dose of SI-053 to establish the MTD and/or the RP2D (dose escalation) and to further evaluate safety at the RP2D (dose expansion).The secondary objective is:•…
Part APrimary Objective:• The primary objective of Part A is to determine whether BIVV009 administration results in a >= 2 g/dL increase in hemoglobin (Hgb) levels or increases Hgb to >= 12 g/dL and obviates the need for blood…
Primary Objective:The purpose of Part A is to determine whether sutimlimab administration results in a greater than or equal to (>=)1.5 gram per deciliter (g/dL) increase in hemoglobin (Hgb) level and avoidance of transfusion in participants…