Clinical trial NCT04411550: Compare Pharmacokinetics, Safety, and Immunogenicity of HLX11 vs. Perjeta in Healthy Chinese Male Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Volunteers
Lead sponsor: Shanghai Henlius Biotech
Sponsor class: INDUSTRY
First posted: 2020-06-02
Enrollment: 160
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cmax
timeFrame: from predose to 2352 hours (Day 99),13 timepoints
measure: AUC0~t
timeFrame: from predose to 2352 hours (Day 99),13 timepoints
measure: AUC0~inf
timeFrame: from predose to 2352 hours (Day 99),13 timepoints
Secondary outcomes:
measure: safety and tolerability of 4 groups
timeFrame: from day1 to day 99
measure: safety and tolerability of 4 groups
timeFrame: from day1 to day 99
measure: safety and tolerability of two groups
timeFrame: from day1 to day 99
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Second Hospital of Anhui Medical University
state: Anhui
Study officials:
affiliation: The Second Hospital of Anhui Medical University
name: Wei Hu
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Hospital of Anhui Medical University
name: Hui Zhao
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.