Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 Compared With EU-Phesgo®
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HLX319, EU-Phesgo.
- Who it may be relevant to
- Registry conditions: Health Adult Subjects. Basic parameters: 18 years — 45 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Double-blind, Single Subcutaneous Administration, Parallel Control Phase I Clinical Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 and EU-Phesgo® in Chinese Healthy Male Subjects.
Overview
The study is being conducted to compare the pharmacokinetic (PK) parameters of HLX319 and EU-Phesgo® after a single subcutaneous administration in healthy male subjects in China, providing a basis for the design of subsequent clinical study protocols.
Interventions
- Drug HLX319
HLX319 is a biosimilar of pertuzumab-trastuzumab monoclonal antibody injection (subcutaneous injection). - Drug EU-Phesgo
EU-Phesgo is an original marketed drug product, with the generic name pertuzumab-trastuzumab monoclonal antibody injection (subcutaneous injection).
Primary outcome measures
- AUC0-inf [Time frame: up to 85 days]
- Cmax [Time frame: up to 85 days]
Secondary outcome measures (1)
- AUC0-t [Time frame: up to 85 days]
Eligibility criteria
Inclusion criteria
- Male subjects aged ≥18 and ≤45 years;
- The skin at the injection site is intact, without damage, tattoos, or other markings;
- Subjects have no history of disease or past medical history abnormalities that, in the judgment of the study physician, would affect the trial;
- Physical examination, vital signs, chest x-ray, electrocardiogram, and laboratory investigations are normal or show abnormalities without clinical significance.
- Body weight (BW) ≥50 and ≤75 kg;
- Body mass index (BMI) ≥19 and ≤24 kg/m² \[BMI = weight (kg) / height² (m²)\];
- Within 14 days prior to random allocation, left ventricular ejection fraction (LVEF) assessed by echocardiography is within the normal range (≥55%);
Exclusion criteria
- Clinically significant diseases including but not limited to the gastrointestinal tract, kidneys, liver, nerves, blood, endocrine system, tumors, respiratory system, immune system, mental health, and cardiovascular and cerebrovascular diseases;
- History of allergy or hypersensitivity reactions.
- Intake of prescription drugs, over-the-counter drugs, or traditional Chinese medicine within 28 days prior to randomization;
- History of blood donation or blood loss (>450mL) within 3 months prior to randomization;
- Positive test results for Hepatitis B Surface Antigen (HbsAg), Hepatitis C Virus (HCV) antibodies, and Human Immunodeficiency Virus (HIV) antibodies, or abnormal and clinically significant quantitative test results for syphilis spirochetes as determined by the sub investigator;
- History of upper respiratory tract infection or other acute infections within 2 weeks prior to r randomization;
- History of drug abuse, substance use;
- History of alcoholism or positive alcohol test results;
11\. History of long-term heavy smoking .
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Anhui Medical University Second Affiliated Hospital — Hefei
Identifiers
NCT: NCT07495930 · HLX319-001