Distribution of Secukinumab (AIN457) Into Dermal Interstitial Fluid After a Single Subcutaneous Administration of 300 mg (OFM ISF)
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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
|Official Title:||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|
- Amount (ng/ml) of AIN457 in dermal interstitial fluid. [ Time Frame: Day 8 ]Distribution of AIN457 into dermal interstitial fluid after single subcutaneous administration of AIN457 in healthy subjects and in psoriatic patients
- Amount (ng/ml) of AIN457 in dermal interstitial fluid. [ Time Frame: Day 15 ]Distribution of AIN457 into dermal interstitial fluid after single subcutaneous administration of AIN457 in healthy subjects and in psoriatic patients
- Number of adverse events to measure Safety of subcutaneously administered AIN457 in healthy volunteers and psoriatic patients [ Time Frame: 3 weeks ]Safety of AIN457 s.c. injection will be documented as numbers of adverse event.
- Part I only: concentration of sinistrin in serum vs. dermal interstitial fluid to confirm the ability of sinistrin to serve as reference to quantify AIN457 in dermal interstitial fluid. [ Time Frame: Day 8 ]Concentration of sinistrin in serum compared to dermal interstitial fluid.
|Study Start Date:||February 2012|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Drug: secukinumab (AIN457)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01539213
|Novartis Investigative Site|
|Graz, Austria, A-8036|
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|