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NCT00517855 · ClinicalTrials.gov registry record · Phase 1

Phase 1 Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of PRTX-100 in Healthy Adult Volunteers

A Phase 1 study, sponsored by Protalex.

Completed
Registry status
Phase 1
Development phase
20
Enrollment target

NCT00517855: Completed Phase 1 study, sponsored by Protalex.

NCT00517855 is a Phase 1 study that has completed, run by Protalex. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00517855, a Phase 1 study, has completed, sponsored by Protalex.

COMPLETED
Registry status
Phase 1
Development phase
20 participants
Enrollment target

Study Summary

This study is the second human clinical study with PRTX-100. It is designed to assess the safety of a single intravenous (IV) dose of PRTX-100, as well as, how the drug is eliminated from the blood after dosing. Additionally, this study provides an opportunity to monitor immune system response to PRTX-100.

Interventions

  • BIOLOGICAL PRTX-100 (Staphylococcal protein A)

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2007-06
Est. Completion 2007-09
Phase Phase 1
Protalex

4 total trials

What the finished NCT00517855 record still lists

NCT00517855 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).

The record links to 0 conditions, and to 1 intervention - of which PRTX-100 (Staphylococcal protein A) is the first listed.

NCT00517855 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00517855 about?

NCT00517855 is a clinical study titled "Phase 1 Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of PRTX-100 in Healthy Adult Volunteers". This study is the second human clinical study with PRTX-100. It is designed to assess the safety of a single intravenous (IV) dose of PRTX-100, as well as, how the drug is eliminated from the blood after dosing. Additionally, this study provides an opportunity to monitor immune system response to PR...

What is the current status of trial NCT00517855?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2007-06. Estimated completion is 2007-09.

What interventions are being tested in trial NCT00517855?

The interventions under investigation include: PRTX-100 (Staphylococcal protein A) (BIOLOGICAL).

Who is sponsoring clinical trial NCT00517855?

This trial is sponsored by Protalex, which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00517855's enrollment target sits among peer trials

20 1629th of 2000 higher than 285 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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Source: ClinicalTrials.gov NCT00517855, the US trial registry maintained by the National Library of Medicine. NCT00517855 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.