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NCT01265745 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation Study of Valortim® (MDX-1303) Administered Intravenously (IV) in Healthy, Normal Subjects
A Phase 1 study, sponsored by PharmAthene.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT01265745 is a Phase 1 study that has completed, run by PharmAthene. The registered enrollment target is 28 participants.
The verdict
NCT01265745, a Phase 1 study, has completed, sponsored by PharmAthene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
Valortim is the name of the experimental drug that volunteers will receive in this study. Valortim may also be called MDX-1303. Experimental means that the drug is not yet approved by the Food and Drug Administration (FDA). Valortim is a monoclonal antibody (laboratory-made immune system molecule) for the treatment of inhalation anthrax (when the infection starts in the lungs). Valortim works by attaching itself to part of the anthrax toxin preventing the toxin from doing damage to cells. This study is being conducted to see if Valortim given over 120 minutes is safe and tolerable. This study will take place in five parts: Screening Phase, Check-in Phase (the day you arrive at Quintiles to start the study), Treatment Phase (the time when you receive the study medication), Follow-up Phase (the time after you receive the study medication) and Final Visit.
Interventions
- DRUG Normal Saline for Injection
- BIOLOGICAL MDX1303
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2010-12 |
| Est. Completion | 2011-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01265745
The ClinicalTrials.gov registry entry for NCT01265745 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is PharmAthene, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Normal Saline for Injection is the first listed.
NCT01265745 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01265745 about?
NCT01265745 is a clinical study titled "Dose Escalation Study of Valortim® (MDX-1303) Administered Intravenously (IV) in Healthy, Normal Subjects". Valortim is the name of the experimental drug that volunteers will receive in this study. Valortim may also be called MDX-1303. Experimental means that the drug is not yet approved by the Food and Drug Administration (FDA). Valortim is a monoclonal antibody (laboratory-made immune system molecule) f...
What is the current status of trial NCT01265745?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2010-12. Estimated completion is 2011-12.
What interventions are being tested in trial NCT01265745?
The interventions under investigation include: Normal Saline for Injection (DRUG), MDX1303 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01265745?
This trial is sponsored by PharmAthene, which has 4 total clinical trials registered on ClinicalTrials.gov.
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