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Stelara PFS

Pharmacokinetics, Safety and Tolerability Study of AVT04 to EU Approved and US Licensed Stelara (Ustekinumab)

Ensayo de Alvotech en Psoriasis.

Más ensayos de: Psoriasis.

Fase

Fase 1

Estado

Completado

Participantes

294

previstos

Centros

4

Fin del objetivo primario

mar 2022

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, simple ciego. Comenzó en may 2021.

Qué mide

Area bajo la curva de concentracion plasmatica-tiempo AUC0-inf (From Baseline to day 92) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroProtocol Title: A Phase 1, first-in-human, randomized, double-blind, single-dose, parallel-group, 3-arm study comparing the pharmacokinetic, safety, tolerability, and immunogenicity profiles of AVT04, EU approved Stelara®, and US-licensed Stelara® in healthy adult subjects Short Title: A first-in-human randomized, double-blind study to compare AVT04 with EU-approved Stelara and US-licensed Stelara as a single-dose subcutaneous injection in healthy adult subjects Rationale: Alvotech (hereafter, the Sponsor) is developing AVT04 globally as a proposed biosimilar to the reference product Stelara (ustekinumab) for subcutaneous (SC) use. This is a first-in-human (FIH) clinical study with AVT04. The study aims to demonstrate pharmacokinetic (PK) similarity of the proposed biosimilar test product AVT04 and the reference products EU approved Stelara and US-licensed Stelara, in addition to evaluating the safety and tolerability of AVT04, when administered as a single 45 mg/0.5 mL SC dose.

Más ensayos de ALVO

Todos los de ALVO, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT04744363), actualizada en may 2022.