Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00333528 · ClinicalTrials.gov registry record · Phase 1
A Study of Plasma-Derived Human Butyrylcholinesterase Administered Intramuscularly
A Phase 1 study, sponsored by Baxalta now part of Shire.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT00333528 is a Phase 1 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 8 participants.
The verdict
NCT00333528, a Phase 1 study, has completed, sponsored by Baxalta now part of Shire.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
The purpose of this placebo-controlled study is to evaluate the safety, tolerability and pharmacokinetics of a single dosage of human butyrylcholinesterase (HuBChE) in healthy adults. HuBChE, which occurs naturally in human plasma, is being evaluated for prophylaxis and treatment in the event of exposure to chemical nerve agents (as employed during chemical warfare or as an act of terrorism). Volunteers will receive a single intramuscular infusion of either HuBChE or normal saline placebo. The volunteers will remain in the study for 90 (+/- 7) days. For the first 3 days following dose administration, they will remain at the clinical trial site as an inpatient and will be closely monitored for patient safety. Afterwards, they will return to the trial site (at pre-determined intervals) as an outpatient for a further 8 visits, where patient safety will be assessed.
Interventions
- DRUG Human butyrylcholinesterase (HuBChE) derived from human plasma
- DRUG Placebo: Normal saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2007-12-01 |
| Est. Completion | 2008-08-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00333528
The ClinicalTrials.gov registry entry for NCT00333528 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 Baxalta now part of Shire, which has 74 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Human butyrylcholinesterase (HuBChE) derived from human plasma is the first listed.
NCT00333528 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00333528 about?
NCT00333528 is a clinical study titled "A Study of Plasma-Derived Human Butyrylcholinesterase Administered Intramuscularly". The purpose of this placebo-controlled study is to evaluate the safety, tolerability and pharmacokinetics of a single dosage of human butyrylcholinesterase (HuBChE) in healthy adults. HuBChE, which occurs naturally in human plasma, is being evaluated for prophylaxis and treatment in the event of exp...
What is the current status of trial NCT00333528?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2007-12-01. Estimated completion is 2008-08-01.
What interventions are being tested in trial NCT00333528?
The interventions under investigation include: Human butyrylcholinesterase (HuBChE) derived from human plasma (DRUG), Placebo: Normal saline (DRUG).
Who is sponsoring clinical trial NCT00333528?
This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
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.