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NCT00631878 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacokinetics Study in VLBW Neonates With BSYX-A110
A Phase 1 study, sponsored by Biosynexus Incorporated.
- Completed
- Registry status
- Phase 1
- Development phase
- 53
- Enrollment target
NCT00631878 is a Phase 1 study that has completed, run by Biosynexus Incorporated. The registered enrollment target is 53 participants.
The verdict
NCT00631878, a Phase 1 study, has completed, sponsored by Biosynexus Incorporated.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 53 participants
- Enrollment target
Study Summary
"Phase I/II, Randomized, Double Blind, Placebo Controlled, Dose Escalating, Safety and Pharmacokinetics Study in Very Low Birth Weight Neonates of Four Doses of BSYX-A110 for the Prevention of S. epidermidis Infection." The purpose of this study is to evaluate the safety and pharmacokinetics of escalating doses of BSYX-A110 administered on Study Days 0 and 14.
Interventions
- DRUG Pagibaximab (formerly BSYX-A110)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2001-11 |
| Est. Completion | 2003-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00631878
The ClinicalTrials.gov registry entry for NCT00631878 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biosynexus Incorporated, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Pagibaximab (formerly BSYX-A110) is the first listed.
NCT00631878 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00631878 about?
NCT00631878 is a clinical study titled "Safety and Pharmacokinetics Study in VLBW Neonates With BSYX-A110". "Phase I/II, Randomized, Double Blind, Placebo Controlled, Dose Escalating, Safety and Pharmacokinetics Study in Very Low Birth Weight Neonates of Four Doses of BSYX-A110 for the Prevention of S. epidermidis Infection." The purpose of this study is to evaluate the safety and pharmacokinetics of esca...
What is the current status of trial NCT00631878?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 53 participants. The study started on 2001-11. Estimated completion is 2003-08.
What interventions are being tested in trial NCT00631878?
The interventions under investigation include: Pagibaximab (formerly BSYX-A110) (DRUG).
Who is sponsoring clinical trial NCT00631878?
This trial is sponsored by Biosynexus Incorporated, which has 4 total clinical trials registered on ClinicalTrials.gov.
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