Pharmacokinetic (PK) and Safety Study of Plasma-derived Human Butyrylcholinesterase Administered Intravenously
Public ClinicalTrials.gov record NCT00333515. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1, Randomized, Observer-blinded, Single Dose, Placebo Controlled Dosage-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Plasma-Derived Human Butyrylcholinesterase (HuBChE) Administered Intravenously (IV)
Study identification
- NCT ID
- NCT00333515
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Lead sponsor
- Baxalta now part of Shire
- Industry
- Enrollment
- 28 participants
Conditions and interventions
Conditions
Interventions
- Human Butyrylcholinesterase (HuBChE) derived from human plasma Drug
- Placebo: Normal saline Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2006
- Primary completion
- Mar 31, 2008
- Completion
- Jul 31, 2008
- Last update posted
- May 4, 2021
2007 – 2008
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Quintiles Phase 1 Services | Lenexa | Kansas | 66219 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00333515, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 4, 2021 · Synced Jul 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00333515 live on ClinicalTrials.gov.