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

Phase 1

Completed

• Conditions: Psoriasis; Healthy
• Interventions: Drug: secukinumab (AIN457)

• Registration Number: NCT01539213
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-23
• Study Start: 2012-02
• Study First Submitted QC: 2012-02-21
• Study First Posted: 2012-02-27
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2015-02
• Last Update Submitted: 2020-12-06
• Last Update Posted: 2020-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AIN457	secukinumab (AIN457)	secukinumab (AIN457)

Primary Outcome Measures

Name	Time	Method
Amount (ng/ml) of AIN457 in dermal interstitial fluid.	Day 15	Distribution of AIN457 into dermal interstitial fluid after single subcutaneous administration of AIN457 in healthy subjects and in psoriatic patients

Secondary Outcome Measures

Name	Time	Method
Number of adverse events to measure Safety of subcutaneously administered AIN457 in healthy volunteers and psoriatic patients	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.	Day 8	Concentration of sinistrin in serum compared to dermal interstitial fluid.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇦🇹 Graz, Austria