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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
26
CaCP29 or placebo single i.v. infusion in ascending doses in healthy human males
FOCUS Clinical Drug Development GmbH
Neuss, North Rhine-Westphalia, Germany
Number and extent of changes in safety relevant parameters after injection of CaCP29
Safety relevant parameters include changes from baseline of: * cytokine levels over time (IL-6, IL-8, IFN-gamma, TNF-alpha, IL-10) * CH50 activity over time * standard hematology, clinical chemistry and coagulation laboratory parameters * 12-lead ECG * vital signs
Time frame: pre-dose, days 1,2,3,7,14,28 and 70
Assessment of pharmacokinetic parameters of CaCP29 over time
* Area under the plasma concentration versus time curve (AUC) of CaCP29 * Peak Plasma Concentration (Cmax) of CaCP29 and time to reach Cmax * terminal phase half-life * clearance * volume of distribution during the terminal phase
Time frame: pre-dose, day 1,2,3,7, 14, 28 and 70
Number of Participants developing anti-CaCP29 antibodies - Immunogenicity
Time frame: pre-dose, days 28 and 70
Bioactivity of CaCP29 in human whole blood over time after injection
Time frame: pre-dose, days 1,2,3,7,14,28 and 70
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