drugset / Trial / NCT02182609
99mTc-rhAnnexin V-128: a First In Man Study in Healthy Volunteers
Phase 1
Completed
14 enrolled
Advanced Accelerator Applications
Atreus Pharmaceuticals Corporation · collab
NaSingle-groupOpen-labelDiagnostic
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.
Timeline
- Start
- 2013-04
- Primary completion
- 2014-10
- Completion
- 2015-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 99mTc-rhAnnexin V-128 | Diagnostic / imaging agent | — | Intravenous |
Indications
No indication recorded.