Clinical trial NCT03607903: Adalimumab Microneedles in Healthy Volunteers
Official title: A Randomized, Double Blind, Placebo-controlled, Double-dummy Study to Assess Microneedle Delivery in Comparison to Subcutaneous Injection of Adalimumab in Healthy Volunteers
Conditions: Pain
Injection Site
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.
Interventions:
description: Adalimumab intradermal using MicronJet600 microneedle from NanoPass
name: Adalimumab ID
type: Biological
description: Adalimumab subcutaneous using regular needle
name: Adalimumab SC
type: Biological
description: Saline intradermal using MicronJet600 microneedle from NanoPass
name: Saline ID
type: Other
description: Saline subcutaneous using regular needle
name: Saline SC
type: Other
Study arms:
design_group_description: adalimumab SC (40 mg in 0.4 mL) and saline ID (0.9%, 0.4 mL)
design_group_title: Subcutaneous adalimumab and placebo
design_group_type: Active Comparator
design_group_description: saline ID (0.9%, 0.4 mL) and adalimumab SC (40 mg in 0.4 mL)
design_group_title: PLacebo and subcutaneous adalimumab
design_group_type: Active Comparator
design_group_description: saline SC (0.9%, 0.4 mL) and adalimumab ID (40 mg in 0.4 mL)
design_group_title: Placebo and intradermal adalimumab
design_group_type: Experimental
design_group_description: adalimumab ID (40 mg in 0.4 mL) and saline SC (0.9%, 0.4 mL)
design_group_title: Intradermal adalimumab and placebo
design_group_type: Experimental
Sponsor: Centre for Human Drug Research
Collaborators: Leiden Amsterdam Center for Drug Research
Leids Universitair Medisch Centrum
Drug name mappings:
name: 阿达木单抗
lang: CN
name: Adalimumab
lang: EN
name: アダリムマブ（遺伝子組換え）
lang: JP