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

Advanced Accelerator Applications

Status and phase: Completed; Phase 1

Conditions: Healthy Adult Volunteers

Treatments: Drug: Kit for the Preparation of 99mTc-rhAnnexin V-128

Study type: Interventional

Funder types: Industry

Identifiers

NCT02182609

CAAA113A12101 (Other Identifier)

1001

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

99mTc-rhAnnexin V-128

Experimental group

Treatment:

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