PK, Safety and Tolerability Study of AVT02 (Adalimumab) Pre-filled Syringe (PFS) vs, AVT02 Autoinjector (AI)

PHASE1CompletedINTERVENTIONAL
Enrollment

207

Participants

Timeline

Start Date

July 1, 2019

Primary Completion Date

December 3, 2019

Study Completion Date

December 3, 2019

Conditions
Phase 1
Interventions
DRUG

Adalimumab

"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 disease"

Trial Locations (2)

8011

Christchurch Clinical Studies Trust Limited, Christchurch

Unknown

Auckland Clinical Studies, Auckland

All Listed Sponsors
lead

Alvotech Swiss AG

INDUSTRY

NCT03983876 - PK, Safety and Tolerability Study of AVT02 (Adalimumab) Pre-filled Syringe (PFS) vs, AVT02 Autoinjector (AI) | Biotech Hunter | Biotech Hunter