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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Adult Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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99mTc-rhAnnexin V-128

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Interventions

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

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes