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Human butyrylcholinesterase derived from human plasma

Phase 1

Healthy Volunteers | Small molecule | Other |Takeda Pharmaceutical Company Limited|Last Updated: May 5, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

Human butyrylcholinesterase derived from human plasma · 2 trials · 3 indications

Phase 1 2
NCT00333528A Study of Plasma-Derived Human Butyrylcholinesterase Administered IntramuscularlyHealthy Volunteers
COMPLETED8 Analytics
NCT00333515Pharmacokinetic (PK) and Safety Study of Plasma-derived Human Butyrylcholinesterase Administered IntravenouslyHealthy Volunteers
COMPLETED28 Analytics
PHASE1COMPLETED
A Study of Plasma-Derived Human Butyrylcholinesterase Administered Intramuscularly
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PHASE1COMPLETED
Pharmacokinetic (PK) and Safety Study of Plasma-derived Human Butyrylcholinesterase Administered Intravenously
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Study Endpoints

Primary Endpoints

Frequency and severity of local and systemic adverse events (AEs)
until post-infusion Day 90 (+/- 7 days)
Frequence and severity of local and systemic AEs
until post-infusion Day 90 (+/- 7 days)
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALAdministration of one dose of the active drug (6 volunteers)
2PLACEBO_COMPARATORAdministration of placebo (2 volunteers)

Interventions

NameTypeDescription
Human butyrylcholinesterase (HuBChE) derived from human plasmaDRUGIntramuscular administration
Placebo: Normal salineDRUGIntramuscular administration
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * The volunteer is between 18 and 55 years of age (inclusive) at the time of administration of HuBChE. * The volunteer is in good health as determined by the Investigator (Study Doctor) from a medical history and physical examination. * The volunteer has clinical chemistry, hema...

Countries:United States
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