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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.

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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

FieldValue
Enrollment Target 8 participants
Start Date 2001-04
Est. Completion 2001-11
Phase Phase 1

Sponsor

Biosynexus Incorporated

4 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.