NCT02182609

99mTc-rhAnnexin V-128: a First In Man Study in Healthy Volunteers

A Phase I Study of Safety, Tolerance, Pharmacokinetics and Nuclear Medicine Imaging of 99mTc-rhAnnexin V-128 Administered Intravenously in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Advanced Accelerator Applications · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The objectives of this study are: * To determine the safety and tolerability of a single dose of 99mTc-rhAnnexin V-128 administered as an intravenous bolus over 10-20 seconds. * To determine the biodistribution, pharmacokinetics and radiation dosimetry of 99mTc-rhAnnexin V-128 in normal healthy adult volunteers.

Conditions

• Healthy Adult Volunteers

Interventions

Type	Name	Description
DRUG	Kit for the Preparation of 99mTc-rhAnnexin V-128	Kit for the Preparation of Tc-99m Recombinant Human Annexin V-128 for Injection

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-10-01
• Completion: 2015-08-01
• First posted: 2014-07-08
• Last updated: 2019-11-21

Locations

1 site across 1 country: Canada