Healthy Male Volunteers
Conditions
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.
Interventions
DRUGCN-Perjeta(Pertuzumab)
healthy volunteers receive CN-Perjeta (420mg) once
DRUGEU-Perjeta(Pertuzumab)
healthy volunteers receive EU-Perjeta (420mg) once
DRUGUS-Perjeta(Pertuzumab)
healthy volunteers receive US-Perjeta (420mg) once
DRUGHLX11
healthy volunteers receive HLX11 (420mg) once
Sponsors
Shanghai Henlius Biotech
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | from predose to 2352 hours (Day 99),13 timepoints | Peak concentration |
| 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 |
| AUC0~inf | from predose to 2352 hours (Day 99),13 timepoints | Area under the plasma concentration-time curve from time 0 to infinity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| safety and tolerability of 4 groups | from day1 to day 99 | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 |
| safety and tolerability of two groups | from day1 to day 99 | AE listing as assessed by CTCAE v5.0 |
Countries
China
Outcome results
None listed