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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02182609
Other study ID # 1001
Secondary ID CAAA113A12101
Status Completed
Phase Phase 1
First received
Last updated
Start date April 2013
Est. completion date August 2015

Study information

Verified date November 2019
Source Advanced Accelerator Applications
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date August 2015
Est. primary completion date October 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Kit for the Preparation of 99mTc-rhAnnexin V-128
Kit for the Preparation of Tc-99m Recombinant Human Annexin V-128 for Injection

Locations

Country Name City State
Canada The University of Ottawa Heart Institute Ottawa Ontario

Sponsors (2)

Lead Sponsor Collaborator
Advanced Accelerator Applications Atreus Pharmaceuticals Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Secondary 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
Secondary Whole-body SPECT imaging 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
Secondary 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
Secondary Amount of 99mTc excreted in urine One sample at baseline and urine collection within 24 hours post-injection
Secondary Amount of 99mTc excreted in faeces Baseline and within 24h post injection
Secondary Anti-rhAnnexin V-128 IgG and IgM antibodies Baseline and 14 and 30 days post-injection
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