NCT00333528

A Study of Plasma-Derived Human Butyrylcholinesterase Administered Intramuscularly

A Phase 1, Randomized, Observer-Blinded, Single Dose, Placebo Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Plasma-Derived Human Butyrylcholinesterase (HuBChE) Administered Intramuscularly (IM)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Baxalta now part of Shire · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Human butyrylcholinesterase (HuBChE) derived from human plasma	Intramuscular administration
DRUG	Placebo: Normal saline	Intramuscular administration

Timeline

• Start date: 2007-12-01
• Primary completion: 2008-04-01
• Completion: 2008-08-01
• First posted: 2006-06-05
• Last updated: 2021-05-05

Locations

1 site across 1 country: United States