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An Exploratory Study to Investigate the Distribution of Secukinumab (AIN457) Into Dermal Interstitial Fluid Using Open Flow Microperfusion After a Single Subcutaneous Administration of 300 mg in Healthy Subjects and Psoriatic Patients
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
Yes
Novartis Investigative Site
Graz, Austria
Start Date
February 1, 2012
Primary Completion Date
January 1, 2013
Completion Date
January 1, 2013
Last Updated
December 8, 2020
16
ACTUAL participants
secukinumab (AIN457)
DRUG
Lead Sponsor
Novartis Pharmaceuticals
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07310264