Pharmacokinetics, Safety and Tolerability Study of AVT04 to EU Approved and US Licensed Stelara (Ustekinumab)
Status:
Recruiting
Trial end date:
2022-07-28
Target enrollment:
Participant gender:
Summary
Protocol 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.