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Clinical Trial Summary

The primary objective of the study is to assess whether human subjects can be made tolerant to intravenously administered Crotoxin and achieve higher and more therapeutically effective doses levels without the previously reported adverse effects associated with bolus i.m. administration.


Clinical Trial Description

Crotoxin has been shown to induce neurotoxic tolerance in animals allowing them to receive high doses associated with effective anti-tumor activity in the absence of adverse side effects. The study plans to demonstrate this effect in human subjects using two dose escalation protocols; slow and fast. It is believed that this approach will prevent toxic side effects to subjects. The route of administration has not been employed clinically and is designed to avoid the myonecrotic effects of intramuscular injections. The target maximum dose is almost five times that of the previously reported MTD. The revised protocol incorporates continuous infusion with a mobile pump and includes active suppression of the allergic reaction by pre-treatment administration of antihistamines. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01481532
Study type Interventional
Source Celtic Biotech Ltd
Contact Dorothy Bray, Ph.D.
Phone +447884005367
Email dorothy.bray@celticbiotech.com
Status Not yet recruiting
Phase Phase 1
Start date August 2024
Completion date December 2025

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