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

NCT02182609 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2019-11-21

No results posted yet for this study

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

DRUG

Kit for the Preparation of 99mTc-rhAnnexin V-128

Kit for the Preparation of Tc-99m Recombinant Human Annexin V-128 for Injection

Sponsors & Collaborators

  • Atreus Pharmaceuticals Corporation

    collaborator INDUSTRY

  • Advanced Accelerator Applications

    lead INDUSTRY

Principal Investigators

  • Terrence D. Rudy, MD, FRCPC · The University of Ottawa Heart Institute, The Ottawa Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-10-31
Completion
2015-08-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02182609 on ClinicalTrials.gov