Adalimumab Microneedles in Healthy Volunteers

Summary

Adalimumab (Humira, AbbVie) is a highly effective treatment for a variety of auto-immune/auto-inflammatory diseases including juvenile idiopathic arthritis (JIA). Adalimumab works by binding to tumor necrosis factor alpha (TNF), hereby preventing its interaction with the TNF receptor. In the presence of complement, adalimumab can also lyse TNF-expressing cells.

Adalimumab is administered via subcutaneous injection, which has the major drawback of being perceived as unpleasant and painful, especially during long term use for both adults and children. As subcutaneous administration may therefore eventually jeopardize treatment adherence, there is a clear need for less invasive alternatives to administer highly effective biological drugs such as adalimumab.

Microneedles may be a potential alternative for invasive drug administration. Microneedles are currently widely investigated for the administration of various vaccines. The experience with administration of biological drugs is rather limited. The sparse available data suggests similar pharmacokinetics of adalimumab when administered either subcutaneous or intradermal in healthy volunteers. Moreover, the first studies report good tolerability of microneedles. However, no systematic studies have been performed yet i) to investigate pain, acceptability, and local tolerability for intradermal versus subcutaneous adalimumab administration ii) to evaluate safety, PK and immunogenicity for intradermal versus subcutaneous adalimumab and iii) to explore the usability of optical coherence tomography, clinical photography, thermal imaging and laser speckle contrast imaging in the evaluation of intradermal injections.

This study will directly compare the pain perception and hence acceptability of a single dose (40 mg) of adalimumab administered subcutaneously (SC) versus intradermally (ID) via microneedles in healthy adult volunteers. Furthermore, the pharmacokinetic profile, pharmacodynamics, the immunogenicity and the tolerability will be assessed. This study will enable bridging to a future study in children and adolescents with JIA, in which the suitability of microneedles for the administration of adalimumab in pediatric patients will be examined. The overarching aim of these studies is to make administration of biologicals in children as pain free as possible.

Conditions

• Pain
• Injection Site

Interventions

BIOLOGICAL

Adalimumab ID

Adalimumab intradermal using MicronJet600 microneedle from NanoPass

BIOLOGICAL

Adalimumab SC

Adalimumab subcutaneous using regular needle

OTHER

Saline ID

Saline intradermal using MicronJet600 microneedle from NanoPass

OTHER

Saline SC

Saline subcutaneous using regular needle

Sponsors & Collaborators

• Leiden University Medical Center

  collaborator OTHER

• Leiden Academic Center for Drug Research, the Netherlands

  collaborator UNKNOWN

• Centre for Human Drug Research, Netherlands

  lead OTHER

Principal Investigators

• Robert Rissmann, RPh PhD · Centre for Human Drug Research

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-07-11

Primary Completion

2018-10-30

Completion

2018-10-30

Countries

• Netherlands

Study Locations