Adalimumab Microneedles in Healthy Volunteers

Sponsor
Centre for Human Drug Research, Netherlands
Study ID
NCT03607903
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Injection Site
  • Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Adalimumab ID — BIOLOGICAL
    Adalimumab intradermal using MicronJet600 microneedle from NanoPass
  • Adalimumab SC — BIOLOGICAL
    Adalimumab subcutaneous using regular needle
  • Saline ID — OTHER
    Saline intradermal using MicronJet600 microneedle from NanoPass
  • Saline SC — OTHER
    Saline subcutaneous using regular needle

Study Details

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.

Key Dates

Start date
Jul 11, 2018
Status verified
Aug 2021
Primary completion
Oct 30, 2018
Completion
Oct 30, 2018

Study Design

Enrollment
24 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Subcutaneous adalimumab and placebo
    adalimumab SC (40 mg in 0.4 mL) and saline ID (0.9%, 0.4 mL)
  • Active Comparator: PLacebo and subcutaneous adalimumab
    saline ID (0.9%, 0.4 mL) and adalimumab SC (40 mg in 0.4 mL)
  • Experimental: Placebo and intradermal adalimumab
    saline SC (0.9%, 0.4 mL) and adalimumab ID (40 mg in 0.4 mL)
  • Experimental: Intradermal adalimumab and placebo
    adalimumab ID (40 mg in 0.4 mL) and saline SC (0.9%, 0.4 mL)

Primary Outcome Measure

Amount of pain [ Time Frame: 7 weeks ]

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