Study of Intravenous ZMA001 in Healthy Subjects

Study Description: ZMA001 is a fully human, monoclonal antibody (IgG1) that inhibits migration of activated monocytes and macrophages and reduces pulmonary vascular remodeling and pulmonary artery pressure in pre-clinical rodent models of pulmonary arterial hypertension (PAH). The current first-in-human, single ascending-dose study will determine the safety, tolerability, and pharmacokinetics of intravenous ZMA001 in healthy subjects. Objectives: Primary Objective: Safety and tolerability of ZMA001 in healthy subjects Secondary Objectives: Determine the pharmacokinetics of ZMA001 in healthy subjects following a single, intravenous dose Endpoints: Primary Endpoint: The number of all-cause, treatment-emergent adverse events, grade 1 and above (following CTCAE v5.0 criteria) through day 113 Secondary Endpoints: For each ZMA001 dose level (1.5, 0.25, 0.50, and 1.0 mg/kg), the following will be determined \[Timeframe: Pre-infusion, end of infusion, 2, 4, 8, 12, 24, and 48h; Days 8, 15, 22, 29, 57, 85 and 113\]: 1. Time to peak drug concentration (Tmax) 2. Peak drug concentration (Cmax) 3. Area under the drug concentration-time curve (AUC) 4. Elimination half-life