Healthy Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple Dose First in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ANXV Administered as an Intravenous Infusion to Healthy Male Subjects
This is an adaptive, randomised, double-blind, single-centre, placebo-controlled phase I, First in Human study designed to evaluate the safety, tolerability and pharmacokinetics of single and multiple intravenous dosing of ANXV in healthy male subjects.
This First in Human study is divided in two parts. Part I, Single Ascending Dose (SAD), will explore safety, tolerability and PK of single intravenous doses of ANXV. Part II, Multiple Ascending Dose (MAD), will explore safety, tolerability and PK of multiple doses (five consecutive daily doses) of intravenous ANXV. The objectives of this study are: Primary objective: - To evaluate the safety and tolerability of single/multiple ascending doses of ANXV in healthy male subjects. Secondary objective: - To determine the PK profile of single/multiple ascending doses of ANXV in healthy male subjects. Exploratory objectives: - To evaluate ADA to ANXV and other relevant parameters. ;
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