Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00333515
Status:
COMPLETED
Last Update Posted:
2021-05-05
First Post:
2006-06-01
Brief Title:
Pharmacokinetic PK and Safety Study of Plasma-derived Human Butyrylcholinesterase Administered Intravenously
Sponsor:
Baxalta now part of Shire
Organization:
Takeda
Study Overview
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
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 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 31 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
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