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

NCT01319903 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2012-01-13

No results posted yet for this study

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.

Conditions

  • Drug Safety

Interventions

BIOLOGICAL

CaCP29, a humanized monoclonal antibody

CaCP29 or placebo single i.v. infusion in ascending doses in healthy human males

Sponsors & Collaborators

  • InflaRx GmbH

    lead INDUSTRY

Principal Investigators

  • Grit Andersen, MD · FOCUS Clinical Drug Development GmbH Stresemannallee 6 41460 Neuss Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01319903 on ClinicalTrials.gov