Trial Profile
A Phase I Study to Evaluate the Safety and Tolerability of Different Dosages of HLX02 (Open-label Part) and to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity Between HLX02 and Herceptin® (US and Germany Sourced; Double-blind, Randomized, Parallel-group Part) in Healthy Chinese Male Subjects
Status:
Completed
Phase of Trial:
Phase I
Latest Information Update: 20 Feb 2023
Price :
$35
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At a glance
- Drugs Trastuzumab (Primary)
- Indications Breast cancer; Gastric cancer
- Focus First in man; Pharmacokinetics
- Sponsors Shanghai Henlius Biotech
- 15 Feb 2023 According to a Shanghai Henlius Biotech media release, company announced, acceptance of Biologics License Application from US FDA for proposed biosimilar trastuzumab HLX02, based on clinical data of this trial.
- 07 Sep 2019 According to an Henlius Biopharmaceuticals media release, data from this study will be presented at the 22nd Congress of Chinese Society of Clinical Oncology (CSCO), 2019.
- 07 Sep 2019 According to an Henlius Biopharmaceuticals media release, the results from this safety, tolerability and pharmacokinetic bioequivalence study were previously reported at CSCO-2018 oral presentation and ESMO-ASIA-2018 poster display.