drugset / Trial / NCT01627002

A Phase 1, First in Human Study to Investigate the Safety and Tolerability of PA401

NCT01627002 ↗

Phase 1 Terminated 49 enrolled ProtAffin Biotechnologie AG
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to examine the safety, tolerability, immunogenicity and the way the body absorbs, distributes, breaks down and excretes various increasing single and multiple subcutaneous doses of PA401 in healthy subjects. This study will also look at the effect of PA401 on inflammation in the lungs following an inhaled lipopolysaccharide (LPS) challenge (LPS is a bacterial cell wall fragment) and sputum induction (a procedure performed to help to cough up sputum (phlegm)) after a single subcutaneous dose of two dose levels.

Timeline

Start
2012-05
Primary completion
2013-04
Completion
2013-04

Drugs

EvaluationDrugModalityDoseRoute
Subject CANOCTAKIN Protein / enzyme biologic — Subcutaneous

Indications

No indication recorded.