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Human butyrylcholinesterase derived from human plasma · 1 trial · 3 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Administration of one of 3 doses (dose escalation) of the active drug (HuBChE). (Dose-escalation proceeds only after safety evaluation and after the previous dosage has been found to be acceptable by an independent Data Safety Monitoring Board.) |
| 2 | PLACEBO_COMPARATOR | Administration of placebo |
| Name | Type | Description |
|---|---|---|
| Human Butyrylcholinesterase (HuBChE) derived from human plasma | DRUG | Administration via IV infusion at a rate of 50 mg/min (2 mL/min) |
| Placebo: Normal saline | DRUG | Administration via IV infusion at a rate of 50 mg/min (2 mL/min) |
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...
Human butyrylcholinesterase derived from human plasma is an investigational plasma-derived enzyme therapy being developed for chemical terrorism and chemical warfare exposure. It is a small molecule given intravenously and is intended for use in healthy adult volunteers as well as emergency settings involving nerve agent exposure. It remains in clinical development.
It is being studied for chemical terrorism and chemical warfare, specifically as a countermeasure against nerve agent exposure. The single completed Phase 1 trial enrolled healthy adult volunteers to assess pharmacokinetics and safety. It has not been approved for any indication and remains investigational.
Its molecular target is INSR, the insulin receptor, and it acts as an agonist at that target. This target class distinguishes it from the endogenous human enzyme butyrylcholinesterase, which hydrolyzes choline esters. The INSR agonist activity is the mechanism described for this plasma-derived product candidate.
Takeda Pharmaceutical Company Limited, which trades under the ticker TAK, is the developer of human butyrylcholinesterase derived from human plasma. The company sponsored the Phase 1 pharmacokinetic and safety study conducted in the United States.
Human butyrylcholinesterase derived from human plasma is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. It is an investigational product and has not been approved by the FDA for any use.
The candidate has been evaluated in one completed Phase 1 trial, NCT00333515, titled a pharmacokinetic and safety study of plasma-derived human butyrylcholinesterase administered intravenously. It enrolled 28 participants in the United States, was randomized, double-blind, and placebo-controlled, and included healthy volunteers aged 18 years and older.
Yes. Human butyrylcholinesterase derived from human plasma is also known as HuBChE, short for human butyrylcholinesterase. The full name and the abbreviation refer to the same plasma-derived product candidate developed by Takeda for chemical terrorism and chemical warfare indications.