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

NCT04411550 | Completed Phase 1

• 1 other identifier: HLX11-001
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Male Volunteers

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• safety and tolerability of 4 groups

  from day1 to day 99

• safety and tolerability of 4 groups

  from day1 to day 99

• safety and tolerability of two groups

  from day1 to day 99

Study Arms (4)

HLX11 group

EXPERIMENTAL

HLX11 are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min).

Drug: HLX11

CN-Perjeta group

ACTIVE COMPARATOR

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)

EU-Perjeta group

ACTIVE COMPARATOR

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)

US-Perjeta group

ACTIVE COMPARATOR

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)

Interventions

HLX11 DRUG

healthy volunteers receive HLX11 (420mg) once

HLX11 group

CN-Perjeta(Pertuzumab) DRUG

healthy volunteers receive CN-Perjeta (420mg) once

CN-Perjeta group

EU-Perjeta(Pertuzumab) DRUG

healthy volunteers receive EU-Perjeta (420mg) once

EU-Perjeta group

US-Perjeta(Pertuzumab) DRUG

healthy volunteers receive US-Perjeta (420mg) once

US-Perjeta group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Study Sites (1)

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Location

Related Publications (2)

• 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.

  PMID: 35132630 RESULT

• 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.

  PMID: 35594017 DERIVED

Study Officials

• Wei Hu

  The Second Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

• Hui Zhao

  The Second Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: June 2, 2020
• Study Start: July 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 30, 2021
• Last Updated: May 11, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)