Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00333528
Status:
COMPLETED
Last Update Posted:
2021-05-05
First Post:
2006-06-01
Brief Title:
A Study of Plasma-Derived Human Butyrylcholinesterase Administered Intramuscularly
Sponsor:
Baxalta now part of Shire
Organization:
Takeda
Study Overview
Official Title:
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
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None