Pharmacokinetic (PK) and Safety Study of Plasma-Derived Human Butyrylcholinesterase Administered Intravenously

2014-08-27 03:44:19 | BioPortfolio


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.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Chemical Terrorism


Human Butyrylcholinesterase (HuBChE) derived from human plasma, Placebo: Normal saline


Quintiles Phase 1 Services
United States




Baxter Healthcare Corporation

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:44:19-0400

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Medical and Biotech [MESH] Definitions

A sulfur-containing analog of butyrylcholine which is hydrolyzed by butyrylcholinesterase to butyrate and thiocholine. It is used as a reagent in the determination of butyrylcholinesterase activity.

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The complete genetic complement contained in the DNA of a set of CHROMOSOMES in a HUMAN. The length of the human genome is about 3 billion base pairs.

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A specific pair of human chromosomes in group A (CHROMOSOMES, HUMAN, 1-3) of the human chromosome classification.

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