3 results
Primary:To determine the safety, tolerability, and pharmacokinetic (PK) profile of single ascending intravenous (iv) doses and of multiple ascending iv doses of FMX-8 in healthy subjectsSecondary:To evaluate the pharmacodynamics (PD) of FMX-8 in…
Primary ObjectiveTo assess the efficacy of Kamada-AAT for Inhalation administered at a dose of 80 mg daily versus (vs) placebo, with efficacy measured by FEV1 post bronchodilator change from baseline at 104 weeks.Secondary ObjectiveTo assess the…
Primary Objectives:• To characterize the safety and tolerability and to identify the recommended Phase 2 dose (RP2D) of ALKS 4230 administered subcutaneously (SC) as lead-in monotherapy and in combination with pembrolizumab in subjects with advanced…