NCT01319903

Clinical Assessment of Safety and Tolerability of the New Monoclonal Humanized Antibody CaCP29

A Single Ascending, Placebo-controlled, Double-blind Study in Healthy Male Subjects to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the New Humanized Monoclonal Antibody CaCP29

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: InflaRx GmbH · Industry
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Drug Safety

Interventions

Type	Name	Description
BIOLOGICAL	CaCP29, a humanized monoclonal antibody	CaCP29 or placebo single i.v. infusion in ascending doses in healthy human males

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2011-03-22
• Last updated: 2012-01-13

Locations

1 site across 1 country: Germany