Healthy Adult Volunteers
Conditions
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.
Interventions
DRUGKit for the Preparation of 99mTc-rhAnnexin V-128
Kit for the Preparation of Tc-99m Recombinant Human Annexin V-128 for Injection
Sponsors
Atreus Pharmaceuticals Corporation
Advanced Accelerator Applications
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 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 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Amount of 99mTc excreted in faeces | Baseline and within 24h post injection | — |
| rhAnnexin V-128 serum concentration | 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 |
| Anti-rhAnnexin V-128 IgG and IgM antibodies | Baseline and 14 and 30 days post-injection | — |
| Whole-body SPECT imaging | 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 | 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 | One sample at baseline and urine collection within 24 hours post-injection | — |
Countries
Canada
Outcome results
None listed