Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

Phase 1, FIH, Randomized, Double-blind, Single-dose, Parallel-group, 3-arm Study Comparing the PK, Safety, Tolerability, and Immunogenicity Profiles of AVT04, EU-approved Stelara®, and US-licensed Stelara in Healthy Adult Subjects

Next Previous
X
Search
Trial Profile

Phase 1, FIH, Randomized, Double-blind, Single-dose, Parallel-group, 3-arm Study Comparing the PK, Safety, Tolerability, and Immunogenicity Profiles of AVT04, EU-approved Stelara®, and US-licensed Stelara in Healthy Adult Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 16 Jan 2024

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Ustekinumab (Primary) ; Ustekinumab (Primary)
  • Indications Psoriasis
  • Focus First in man; Pharmacokinetics
  • Sponsors Alvotech

    • Most Recent Events

    • 10 Jan 2024 According to a Alvotech media release, In Feb 2023, company announced that the EMA had accepted their MAA for AVT04, based on data from AVT04-GL-301 confirmatory comparative efficacy and safety clinical trial and Stelara in patients with moderate to severe chronic plaque-type psoriasis. Pharmacokinetic similarity was demonstrated in the AVT04-GL-101 study.
    • 01 May 2023 Results assessing pharmacokinetics safety, and immunogenicity of AVT04 in healthy adults, published in the Expert Opinion on Investigational Drugs.
    • 21 Mar 2023 Results assessing Bioequivalence Between Candidate Biosimilar AVT04 and Reference Ustekinumab presented at the American Academy of Dermatology annual Meeting 2023

You need to be a logged in or subscribed to view this content Request demo

If your organization or you do not have a subscription, try one of the following:
  • Contacting your organization’s admin about adding this content to your AdisInsight subscription
  • Buying a PDF version of any individual profile
  • Request a free trial
If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top