Compare Pharmacokinetics, Safety, and Immunogenicity of HLX11 vs. Perjeta in Healthy Chinese Male Subjects

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

This is a randomised, double-blind, intravenous single-dose, four-arm parallel study designed to compare the PK of HLX11 and US, EU, and CN-sourced Perjeta® in healthy Chinese adult male subjects, and to assess the safety, tolerability, and immunogenicity of these 4 drugs.

Study Overview

• Status: Completed
• Conditions: Healthy Male Volunteers
• Intervention / Treatment: Drug: HLX11; Drug: CN-Perjeta(Pertuzumab); Drug: EU-Perjeta(Pertuzumab); Drug: US-Perjeta(Pertuzumab)

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • The Second Hospital of Anhui Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy Chinese males
• aged ≥ 18 and ≤ 45
• body mass index (BMI) ≥ 19 and ≤ 26 kg/m2
• LVEF≥ 55%

Exclusion Criteria:

• A history of any serious clinical disease such as haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, mental, neurological diseases, and tumour, or allergic diseases
• Use of a monoclonal antibody or any biological product within 6 months before study drug administration
• A history of allergic reactions or anaphylaxis, including such reactions to any drug or excipient in the clinical study
• Use of prescription drugs, over-the-counter drugs (OTC), or traditional Chinese medicine (TCM) (excluding vitamins, mineral supplements, and dietary supplements) within 28 days before study drug administration
• A history of blood donation within 3 months before study drug administration
• Participation in other clinical study and use of the investigational product/comparator within 3 months before study drug administration
• Positive for hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or treponema pallidum antibody
• A history of drug abuse
• Failure to comply with protocol requirements, instructions, and study limitations, such as uncooperative attitude, failure to return to the study site for follow-up visits, or failure to complete the entire clinical study, as judged by investigators

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HLX11 group; HLX11 are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min).	Drug: HLX11; healthy volunteers receive HLX11 (420mg) once
Active Comparator: CN-Perjeta group; CN-Perjeta are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min).	Drug: CN-Perjeta(Pertuzumab); healthy volunteers receive CN-Perjeta (420mg) once
Active Comparator: EU-Perjeta group; EU-Perjeta are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min).	Drug: EU-Perjeta(Pertuzumab); healthy volunteers receive EU-Perjeta (420mg) once
Active Comparator: US-Perjeta group; US-Perjeta are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min).	Drug: US-Perjeta(Pertuzumab); healthy volunteers receive US-Perjeta (420mg) once

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Peak concentration	from predose to 2352 hours (Day 99),13 timepoints
AUC0~t	Area under the plasma concentration-time curve from time 0 to the last concentration-measurable time point	from predose to 2352 hours (Day 99),13 timepoints
AUC0~inf	Area under the plasma concentration-time curve from time 0 to infinity	from predose to 2352 hours (Day 99),13 timepoints

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety and tolerability of 4 groups	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	from day1 to day 99
safety and tolerability of 4 groups	Number of AE as assessed by CTCAE v5.0	from day1 to day 99
safety and tolerability of two groups	AE listing as assessed by CTCAE v5.0	from day1 to day 99

Collaborators and Investigators

• Sponsor: Shanghai Henlius Biotech
• Investigators: Principal Investigator: Wei Hu, The Second Hospital of Anhui Medical University; Principal Investigator: Hui Zhao, The Second Hospital of Anhui Medical University

Publications and helpful links

General Publications

• American Society for Clinical Pharmacology and Therapeutics. Clin Pharmacol Ther. 2022 Mar;111 Suppl 1:S5-S80. doi: 10.1002/cpt.2521. No abstract available. Erratum In: Clin Pharmacol Ther. 2022 Apr 17;:1344.
• Yang J, Lin L, Long Q, Zhang Q, Sun G, Zhou L, Wang Q, Zhu J, Li F, Hu W. HLX11, a Proposed Pertuzumab Biosimilar: Pharmacokinetics, Immunogenicity, and Safety Profiles Compared to Three Reference Biologic Products (US-, EU-, and CN-Approved Pertuzumab) Administered to Healthy Male Subjects. BioDrugs. 2022 May;36(3):393-409. doi: 10.1007/s40259-022-00534-w. Epub 2022 May 20.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): July 30, 2021

Study Registration Dates

• First Submitted: May 19, 2020
• First Submitted That Met QC Criteria: May 31, 2020
• First Posted (Actual): June 2, 2020

Study Record Updates

• Last Update Posted (Actual): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 6, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antineoplastic Agents; Antineoplastic Agents, Immunological; Pertuzumab
• Other Study ID Numbers: HLX11-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes