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: Completed Phase 1 study, sponsored by Baxalta now part of Shire.
NCT00333528 is a Phase 1 study that has completed, run by Baxalta now part of Shire. 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
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 |
What the finished NCT00333528 record still lists
NCT00333528 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 Human butyrylcholinesterase (HuBChE) derived from human plasma is the first listed.
NCT00333528 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT00333528'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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI