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| ID | Type | Description | Link |
|---|---|---|---|
| CAAA113A12101 | Other Identifier | Novartis |
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| Name | Class |
|---|---|
| Atreus Pharmaceuticals Corporation | INDUSTRY |
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The objectives of this study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 99mTc-rhAnnexin V-128 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kit for the Preparation of 99mTc-rhAnnexin V-128 | Drug | Kit for the Preparation of Tc-99m Recombinant Human Annexin V-128 for Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | 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. | Whole study period |
| Laboratory assessments | 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. | baseline and 24 hrs, 72 hrs and 30 days after injection |
| Electrocardiography | 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. | screening and immediatly, 24hrs, 72 hrs, 7 days and 30 days after injection |
| Vital signs | 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. | At each study visit |
| Measure | Description | Time Frame |
|---|---|---|
| rhAnnexin V-128 serum concentration | In addition to dosimetry, pharmacokinetic will be assessed based on rhAnnexin V-128 serum concentration | 0, 5, 10, 15, 30, 60, 90, minutes and 3 h, 6h and 24 h post-injection |
| Whole-body SPECT imaging |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Terrence D. Rudy, MD, FRCPC | The University of Ottawa Heart Institute, The Ottawa Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Ottawa Heart Institute | Ottawa | Ontario | ON K1Y 4W7 | Canada |
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| ID | Term |
|---|---|
| D020794 | Receptor Protein-Tyrosine Kinases |
| ID | Term |
|---|---|
| D011505 | Protein-Tyrosine Kinases |
| D011494 | Protein Kinases |
| D017853 | Phosphotransferases (Alcohol Group Acceptor) |
| D010770 | Phosphotransferases |
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The quantitative in vivo biodistribution (whole body dosimetry) of the 99mTc-rhAnnexin V-128 will be determined through whole-body SPECT imaging.
| 30min, 90min, 3hrs, 6hrs and 24 hours post-injection |
| Blood sample counting | Radioactivity of the whole blood and serum samples will be counted in a gamma counter to assess blood dosimetry and pharmacokinetic. | baseline and 0, 5,10, 15, 30, 60, 90 min, 3 h, 6 h and 24 hours post-injection |
| Amount of 99mTc excreted in urine | One sample at baseline and urine collection within 24 hours post-injection |
| Amount of 99mTc excreted in faeces | Baseline and within 24h post injection |
| Anti-rhAnnexin V-128 IgG and IgM antibodies | Baseline and 14 and 30 days post-injection |
| D014166 | Transferases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D047908 | Intracellular Signaling Peptides and Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |