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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04850339
Study type Interventional
Source Annexin Pharmaceuticals AB
Contact
Status Completed
Phase Phase 1
Start date December 21, 2020
Completion date October 27, 2021

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