NCT00333515

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

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (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 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.

Conditions

• Healthy Volunteers
• Chemical Terrorism
• Chemical Warfare

Interventions

Type	Name	Description
DRUG	Human Butyrylcholinesterase (HuBChE) derived from human plasma	Administration via IV infusion at a rate of 50 mg/min (2 mL/min)
DRUG	Placebo: Normal saline	Administration via IV infusion at a rate of 50 mg/min (2 mL/min)

Timeline

• Start date: 2007-01-01
• 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