NCT04850339

First in Human Study of ANXV (Recombinant Human Annexin A5) in Healthy Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Annexin Pharmaceuticals AB · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	ANXV	Intravenous infusion
OTHER	Placebo	Intravenous infusion

Timeline

• Start date: 2020-12-21
• Primary completion: 2021-10-27
• Completion: 2021-10-27
• First posted: 2021-04-20
• Last updated: 2022-05-16

Locations

1 site across 1 country: Netherlands