Distribution of Secukinumab (AIN457) Into Dermal Interstitial Fluid After a Single Subcutaneous Administration of 300 mg

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01539213
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Feb 29, 2012
Status verified
Feb 2015
Primary completion
Jan 31, 2013
Completion
Jan 31, 2013

Study Design

Enrollment
16 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: AIN457
    secukinumab (AIN457)

Primary Outcome Measure

Amount (ng/ml) of AIN457 in dermal interstitial fluid. [ Time Frame: Day 8 ]

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