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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02182609
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : November 21, 2019
Sponsor:
Collaborator:
Atreus Pharmaceuticals Corporation
Information provided by (Responsible Party):
Advanced Accelerator Applications

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Adult Volunteers Drug: Kit for the Preparation of 99mTc-rhAnnexin V-128 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Phase I Study of Safety, Tolerance, Pharmacokinetics and Nuclear Medicine Imaging of 99mTc-rhAnnexin V-128 Administered Intravenously in Healthy Adult Volunteers
Study Start Date : April 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : August 2015

Arm Intervention/treatment
Experimental: 99mTc-rhAnnexin V-128 Drug: Kit for the Preparation of 99mTc-rhAnnexin V-128
Kit for the Preparation of Tc-99m Recombinant Human Annexin V-128 for Injection




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age between 18 and 65 years
  2. No significant medical history
  3. Normal physical examination
  4. No clinically significant abnormalities in baseline laboratory values
  5. No clinically significant abnormalities on 12 lead electrocardiogram
  6. 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
  7. Written informed consent signed

Exclusion Criteria:

  1. Pregnancy or lactation
  2. Know hypersensitivity to the investigational drug or any of its components
  3. Current enrolment in another investigational study
  4. Unwillingness to provide or continue informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02182609


Locations
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Canada, Ontario
The University of Ottawa Heart Institute
Ottawa, Ontario, Canada, ON K1Y 4W7
Sponsors and Collaborators
Advanced Accelerator Applications
Atreus Pharmaceuticals Corporation
Investigators
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Principal Investigator: Terrence D. Rudy, MD, FRCPC The University of Ottawa Heart Institute, The Ottawa Hospital

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Responsible Party: Advanced Accelerator Applications
ClinicalTrials.gov Identifier: NCT02182609    
Other Study ID Numbers: 1001
CAAA113A12101 ( Other Identifier: Novartis )
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: November 21, 2019
Last Verified: November 2019