99mTc-rhAnnexin V-128: a First In Man Study in Healthy Volunteers
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|ClinicalTrials.gov Identifier: NCT02182609|
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : November 21, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|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
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- Amount of 99mTc excreted in urine [ Time Frame: One sample at baseline and urine collection within 24 hours post-injection ]
- Amount of 99mTc excreted in faeces [ Time Frame: Baseline and within 24h post injection ]
- Anti-rhAnnexin V-128 IgG and IgM antibodies [ Time Frame: Baseline and 14 and 30 days post-injection ]
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
|The University of Ottawa Heart Institute|
|Ottawa, Ontario, Canada, ON K1Y 4W7|
|Principal Investigator:||Terrence D. Rudy, MD, FRCPC||The University of Ottawa Heart Institute, The Ottawa Hospital|