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

Advanced Accelerator Applications14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Healthy Adult Volunteers

Interventions

Kit for the Preparation of 99mTc-rhAnnexin V-128DRUG

Kit for the Preparation of Tc-99m Recombinant Human Annexin V-128 for Injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

The University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: At each study visit

Secondary Outcomes

rhAnnexin V-128 serum concentration

In addition to dosimetry, pharmacokinetic will be assessed based on rhAnnexin V-128 serum concentration

Time frame: 0, 5, 10, 15, 30, 60, 90, minutes and 3 h, 6h and 24 h post-injection

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.

Data from ClinicalTrials.gov

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