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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: Completed Phase 1 study, sponsored by PharmAthene.
NCT01265745 is a Phase 1 study that has completed, run by PharmAthene. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
* Determination of changes from baseline for clinical laboratory tests and urinalysis, body temperature, heart rate, blood pressure, respiratory rate, physical examination and electrocardiogram (ECG). * Occurrence and evaluation of adverse events and serious adverse events.
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 |
What the finished NCT01265745 record still lists
NCT01265745 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which Normal Saline for Injection is the first listed.
NCT01265745 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01265745's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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