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Completed

NCT Number: NCT02182609

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

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.

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Key information

Conditions

Healthy Adult Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The University of Ottawa Heart Institute

Ottawa, Ontario, ON K1Y 4W7, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 65 years
  • No significant medical history
  • Normal physical examination
  • No clinically significant abnormalities in baseline laboratory values
  • No clinically significant abnormalities on 12 lead electrocardiogram
  • Female subjects must be post-menopausal, surgically sterilized or have negative urine beta human chorionic gonadotropin pregnancy test at initial screening and pre-injection on dosing day
  • Written informed consent signed

Exclusion criteria

  • Pregnancy or lactation
  • Know hypersensitivity to the investigational drug or any of its components
  • Current enrolment in another investigational study
  • Unwillingness to provide or continue informed consent

Treatment and study plan

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

Drug

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

Primary outcomes

  1. Adverse events

    Time frame: Whole study period

    Type and incidence of AEs, as well as severity and relatedness to the study medication will be tabulated. Special attention will be given to those subjects who prematurely discontinue the study or the study medication due to an AE, or who experience a severe AE or an SAE.

  2. Laboratory assessments

    Time frame: baseline and 24 hrs, 72 hrs and 30 days after injection

    Laboratory data (Hematology, coagulation, biochemistry, and urinalysis) will be analysed with respect to the normal ranges of values provided by the local laboratory and with respect to pre-defined levels of change in these values.

    Abnormal laboratory test results will be tabulated.

  3. Electrocardiography

    Time frame: screening and immediatly, 24hrs, 72 hrs, 7 days and 30 days after injection

    ECG parameters will include heart rate (HR), RR interval, PR interval, QRS width and QT interval.

    ECG results will be evaluated by means of descriptive statistics and frequency tabulations.

  4. Vital signs

    Time frame: At each study visit

    Descriptive statistics of the vital signs (pulse rate and blood pressure) observed values as well as for the changes from baseline value will be created. Frequency tabulations with values within, below or above the normal ranges will be made.

Secondary outcomes

  1. rhAnnexin V-128 serum concentration

    Time frame: 0, 5, 10, 15, 30, 60, 90, minutes and 3 h, 6h and 24 h post-injection

    In addition to dosimetry, pharmacokinetic will be assessed based on rhAnnexin V-128 serum concentration

  2. Whole-body SPECT imaging

    Time frame: 30min, 90min, 3hrs, 6hrs and 24 hours post-injection

    The quantitative in vivo biodistribution (whole body dosimetry) of the 99mTc-rhAnnexin V-128 will be determined through whole-body SPECT imaging.

  3. Blood sample counting

    Time frame: baseline and 0, 5,10, 15, 30, 60, 90 min, 3 h, 6 h and 24 hours post-injection

    Radioactivity of the whole blood and serum samples will be counted in a gamma counter to assess blood dosimetry and pharmacokinetic.

  4. Amount of 99mTc excreted in urine

    Time frame: One sample at baseline and urine collection within 24 hours post-injection

  5. Amount of 99mTc excreted in faeces

    Time frame: Baseline and within 24h post injection

  6. Anti-rhAnnexin V-128 IgG and IgM antibodies

    Time frame: Baseline and 14 and 30 days post-injection

Sponsors and collaborators

Lead sponsor

Advanced Accelerator Applications

Industry

Collaborators

  • Atreus Pharmaceuticals Corporation

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jul 8, 2014
Registry last updated
Nov 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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