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

Phase 1

Completed

• Conditions: Healthy Male Volunteers
• Interventions: Drug: EU-Perjeta(Pertuzumab); Drug: HLX11; Drug: CN-Perjeta(Pertuzumab); Drug: US-Perjeta(Pertuzumab)

• Registration Number: NCT04411550
• Lead Sponsor: Shanghai Henlius Biotech

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-19
• Study First Submitted QC: 2020-05-31
• Study First Posted: 2020-06-02
• Study Start: 2020-07-01
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-30
• Status Verified: 2022-04
• Last Update Submitted: 2022-05-06
• Last Update Posted: 2022-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EU-Perjeta group	EU-Perjeta(Pertuzumab)	EU-Perjeta are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min).
HLX11 group	HLX11	HLX11 are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min).
CN-Perjeta group	CN-Perjeta(Pertuzumab)	CN-Perjeta are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min).
US-Perjeta group	US-Perjeta(Pertuzumab)	US-Perjeta are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
safety and tolerability of two groups	from day1 to day 99	AE listing as assessed by CTCAE v5.0
safety and tolerability of 4 groups	from day1 to day 99	Number of AE as assessed by CTCAE v5.0

Trial Locations

Locations (1)

The Second Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China