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

NCT04744363 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 294

Last updated 2022-05-23

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Stelara PFS

Pre filled syringes filled with AVT04 and Stelara

Sponsors & Collaborators

  • Iqvia Pty Ltd

    collaborator INDUSTRY

  • Alvotech Swiss AG

    lead INDUSTRY

Principal Investigators

  • Paul Duijzings, MSc · Program Lead

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-25
Primary Completion
2022-03-19
Completion
2022-03-19
FDA Drug
Yes

Countries

  • Australia
  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04744363 on ClinicalTrials.gov