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Clinical Trial Summary

The novel humanized monoclonal antibody CaCP29 was developed to control the inflammatory response to various stimuli in humans and espacially during sepsis. Purpose of this phase I clinical trial in healthy human males is to investigate various parameters concerning safety and tolerability of CaCP29 and assess pharmacokinetic and pharmacodynamic parameters.


Clinical Trial Description

The acute inflammatory innate host response, as being present during the development of sepsis and various other acute inflammatory diseases, represents a powerful mechanisms which can lead to destruction of host tissue and severe organ dysfunction. CaCP29 was developed to lower the complement mediated acute inflammatory response and thereby control the extend of a strongly activated often times self-destructive inflammatory response by controlling activation of a key inflammatory mechanism. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01319903
Study type Interventional
Source InflaRx GmbH
Contact
Status Completed
Phase Phase 1
Start date March 2011
Completion date October 2011

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