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NCT00636285 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacokinetics Study in Adults for the Prevention of S. Epidermidis Infection in Low Birth Weight Infants
A Phase 1 study, sponsored by Biosynexus Incorporated.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT00636285 is a Phase 1 study that has completed, run by Biosynexus Incorporated. The registered enrollment target is 8 participants.
The verdict
NCT00636285, a Phase 1 study, has completed, sponsored by Biosynexus Incorporated.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
The purpose of this Phase 1 study is to evaluate the safety and pharmacokinetics of BSYX-A110 in a small number of healthy adult volunteers. Following the demonstration of safety in adults, this anti-Staphylococcal monoclonal antibody will then be evaluated in the target population of hospitalized low birth weight neonates.
Interventions
- DRUG Placebo
- DRUG BSYX-A110
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2001-04 |
| Est. Completion | 2001-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00636285
The ClinicalTrials.gov registry entry for NCT00636285 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 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 2 interventions - of which Placebo is the first listed.
NCT00636285 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00636285 about?
NCT00636285 is a clinical study titled "Safety and Pharmacokinetics Study in Adults for the Prevention of S. Epidermidis Infection in Low Birth Weight Infants". The purpose of this Phase 1 study is to evaluate the safety and pharmacokinetics of BSYX-A110 in a small number of healthy adult volunteers. Following the demonstration of safety in adults, this anti-Staphylococcal monoclonal antibody will then be evaluated in the target population of hospitalized l...
What is the current status of trial NCT00636285?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2001-04. Estimated completion is 2001-11.
What interventions are being tested in trial NCT00636285?
The interventions under investigation include: Placebo (DRUG), BSYX-A110 (DRUG).
Who is sponsoring clinical trial NCT00636285?
This trial is sponsored by Biosynexus Incorporated, which has 4 total clinical trials registered on ClinicalTrials.gov.
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