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NCT00333515 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic (PK) and Safety Study of Plasma-derived Human Butyrylcholinesterase Administered Intravenously
A Phase 1 study, sponsored by Baxalta now part of Shire.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT00333515: Completed Phase 1 study, sponsored by Baxalta now part of Shire.
NCT00333515 is a Phase 1 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00333515, a Phase 1 study, has completed, sponsored by Baxalta now part of Shire.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
The purpose of this placebo-controlled study is to evaluate the safety, tolerability and pharmacokinetics of a single dose regimen of human butyrylcholinesterase (HuBChE) in healthy adults at 3 ascending dosage levels administered IV. 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 in each dosage cohort will be randomized to treatment with HuBChE active drug or normal saline placebo in a 3:1 ratio. 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 inpatients and will be closely monitored for patient safety. Afterwards, they will return to the trial site (at pre-determined intervals) as outpatients for 8 further visits, where patient safety will be assessed.
Interventions
- DRUG Placebo: Normal saline
- DRUG Human Butyrylcholinesterase (HuBChE) derived from human plasma
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2007-01-01 |
| Est. Completion | 2008-08-01 |
| Phase | Phase 1 |
What the finished NCT00333515 record still lists
NCT00333515 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo: Normal saline is the first listed.
NCT00333515 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00333515 about?
NCT00333515 is a clinical study titled "Pharmacokinetic (PK) and Safety Study of Plasma-derived Human Butyrylcholinesterase Administered Intravenously". The purpose of this placebo-controlled study is to evaluate the safety, tolerability and pharmacokinetics of a single dose regimen of human butyrylcholinesterase (HuBChE) in healthy adults at 3 ascending dosage levels administered IV. HuBChE, which occurs naturally in human plasma, is being evaluate...
What is the current status of trial NCT00333515?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2007-01-01. Estimated completion is 2008-08-01.
What interventions are being tested in trial NCT00333515?
The interventions under investigation include: Placebo: Normal saline (DRUG), Human Butyrylcholinesterase (HuBChE) derived from human plasma (DRUG).
Who is sponsoring clinical trial NCT00333515?
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 NCT00333515's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 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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