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

Healthy Adult Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02182609
• Other study ID #: 1001
• Secondary ID: CAAA113A12101
• Status: Completed
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Healthy Adult Volunteers

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