Distribution of Secukinumab (AIN457) Into Dermal Interstitial Fluid After a Single Subcutaneous Administration of 300 mg
Status:
Completed
Trial end date:
2013-01-01
Target enrollment:
Participant gender:
Summary
The proposed exploratory study aims to understand the in vivo skin distribution properties of
subcutaneously (s.c.) administered AIN457 in psoriatic and healthy skin using open flow
microperfusion (OFM). The data of this study will help to understand the mode of action of
AIN457 in its target tissue.
It aims to establish a technique assessing in vivo distribution of AIN457 and its metabolites
in human dermal interstitial fluid (ISF) and exploring a potential pharmacodynamic effect in
situ. In addition, the study will further evaluate safety and local tolerability of
subcutaneously administered AIN457 and explore dermal interstitial fluid skin levels of
potential disease relevant biomarkers.
The study is divided into two parts - Part I with 8 healthy volunteers (HV) to validate the
method is completed and Part II with 8 psoriasis patients will start based on the outcome of
Part I.