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?

A (Randomised, Double-Blind, Intravenous Single-Dose, Parallel, Four-Arm) Phase I Clinical Study to Compare Pharmacokinetics, Safety, and Immunogenicity of HLX11 vs. Perjeta® (US, EU, and CN-Sourced) in Healthy Chinese Male Subjects

Next Previous
Search
Trial Profile

A (Randomised, Double-Blind, Intravenous Single-Dose, Parallel, Four-Arm) Phase I Clinical Study to Compare Pharmacokinetics, Safety, and Immunogenicity of HLX11 vs. Perjeta® (US, EU, and CN-Sourced) in Healthy Chinese Male Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 07 Feb 2025

Price :
$35 *
Note:
  • 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 Pertuzumab (Primary)
  • Indications Breast cancer
  • Focus Pharmacokinetics
  • Sponsors Shanghai Henlius Biotech

    • Most Recent Events

    • 02 Feb 2025 According to a Shanghai Henlius Biotech media release, the Biologic license application for HLX11 has been accepted by the USFDA. This BLA filing is based on data from a series of studies for HLX11 versus Perjeta, including this study, along with other analytical similarity studies and comparative clinical studies.
    • 13 Jun 2022 According to an Organon media release, HLX11 has met the primary endpoint in this clinical trial, showing similar pharmacokinetic and safety profiles to the reference drugs from different sources.
    • 20 May 2022 Primary endpoint (AUC0~inf) has been met according to the results published in the BioDrugs

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