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

Henlius Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Male Volunteers

Treatments: Drug: EU-Perjeta(Pertuzumab); Drug: CN-Perjeta(Pertuzumab); Drug: US-Perjeta(Pertuzumab); Drug: HLX11

Study type: Interventional

Funder types: Industry

Identifiers

NCT04411550

HLX11-001

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 4 patient groups

HLX11 group

Experimental group

Description:

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

Treatment:

Drug: HLX11

CN-Perjeta group

Active Comparator group

Description:

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

Treatment:

Drug: CN-Perjeta(Pertuzumab)

EU-Perjeta group

Active Comparator group

Description:

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

Treatment:

Drug: EU-Perjeta(Pertuzumab)

US-Perjeta group

Active Comparator group

Description:

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

Treatment:

Drug: US-Perjeta(Pertuzumab)