Calendario›ALVO›Adalimumab 100 MG · ALVOPAD

Adalimumab 100 MG · ALVOPAD

Comparative Safety, Tolerability, Pharmacokinetic Study of AVT02 (100MG/ML) and Humira (100MG/ML) in Healthy Volunteers

Ensayo de Alvotech en Voluntarios sanos.

Fase

Fase 1

Estado

Completado

Participantes

24

previstos

Centros

1

Fin del objetivo primario

ago 2018

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, simple ciego. Comenzó en may 2018.

Qué mide

Cambio desde el inicio en la presion arterial a los 1, 2, 3, 4, 5, 6, 7, 8, 9, 64 dias posteriores a la dosificacion (Predose and 1, 2, 3, 4, 5, 6, 7, 8, 9, 64 days post dosing) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroAdalimumab is an immunosuppressive drug that belongs to the family of anti-TNF agents. It contains a monoclonal antibody produced by biotechnology. It is designed to bind to tumor necrosis factor (TNF), a substance that is involved in several auto-immune processes. By binding to TNF, adalimumab blocks its activity, reducing the severity of various chronic inflammatory diseases including Rheumatoid Arthritis, Plaque Psoriasis and others. Often, the high cost of biologic products may preclude access to the treatment to a big portion of the population worldwide. A biosimilar product that provides comparable safety and efficacy at more affordable cost would fulfill a broader medical need. Humira has been available on the market for several years. Recently, a higher concentration (100 mg/mL) formulation has been introduced in major markets. Alvotech is developing AVT02, that is a proposed biosimilar of adalimumab containing high concentration (100 mg/mL) of active ingredient. The objective of this clinical trial is to assess the similarity of AVT02 (100 mg/mL) with Humira (100 mg/mL), in terms of tolerability, safety (including immunogenicity) and compare the pharmacokinetics in healthy volunteers.

Más ensayos de ALVO

Todos los de ALVO, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03579823), actualizada en ene 2019.