Pharmacokinetics, Safety and Tolerability Study of AVT02 to EU-approved and US-licensed Humira (Adalimumab)

Sponsor
Alvotech Swiss AG
Study ID
NCT03849313
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Adalimumab — DRUG
    AVT02, a proposed similar biological product (biosimilar) of Humira which contains adalimumab . Adalimumab is a recombinant, fully human monoclonal immunoglobulin G1 (IgG1) antibody that binds specifically and with high affinity to the soluble and transmembrane forms of tumor necrosis factor (TNF)-α thereby inhibiting the binding of TNF-α with its receptor, and inhibiting TNF -α's biological function. Tumor necrosis factor-α is a naturally occurring cytokine that is key to normal inflammatory and immune responses. Elevated levels of TNF-α are found in the synovial fluid of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis patients and psoriasis plaques and play an important role in both the pathologic inflammation and joint destruction that are hallmarks of these inflammatory diseases

Study Details

This study has been designed as a multicentre, randomised, double-blind study of AVT02 in healthy adult subjects. The study will assess the PK, safety and tolerability of AVT02 compared to EU-Humira and US licenced Humira (US-Humira), when administered as a single 40 mg SC dose.

Key Dates

Start date
Mar 20, 2019
Status verified
May 2022
Primary completion
Feb 17, 2020
Completion
Feb 17, 2020

Study Design

Enrollment
390 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: AVT02 100mg/mL
    Biosimilar Adalimumab AVT02
  • Active Comparator: EU-Humira 100mg/mL
    EU Approved Adalimumab originator Humira
  • Active Comparator: US-Humira 100mg/mL
    US licensed Adalimumab originator Humira

Primary Outcome Measure

Area under the plasma concentration-time curve AUC0-t [ Time Frame: From baseline to day 64 ]

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