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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: Completed Phase 1 study, sponsored by Biosynexus Incorporated.
NCT00636285 is a Phase 1 study that has completed, run by Biosynexus Incorporated. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00636285 record still lists
NCT00636285 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00636285 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00636285's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 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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