Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 Compared With EU-Phesgo®

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.

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.

Inclusion Criteria:

1. Male subjects aged ≥18 and ≤45 years;
2. The skin at the injection site is intact, without damage, tattoos, or other markings;
3. Subjects have no history of disease or past medical history abnormalities that, in the judgment of the study physician, would affect the trial;
4. Physical examination, vital signs, chest x-ray, electrocardiogram, and laboratory investigations are normal or show abnormalities without clinical significance.
5. Body weight (BW) ≥50 and ≤75 kg;
6. Body mass index (BMI) ≥19 and ≤24 kg/m² [BMI = weight (kg) / height² (m²)];
7. Within 14 days prior to random allocation, left ventricular ejection fraction (LVEF) assessed by echocardiography is within the normal range (≥55%);

Exclusion Criteria:

1. 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;
2. History of allergy or hypersensitivity reactions.
3. Intake of prescription drugs, over-the-counter drugs, or traditional Chinese medicine within 28 days prior to randomization;
4. History of blood donation or blood loss (>450mL) within 3 months prior to randomization;
5. 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;
6. History of upper respiratory tract infection or other acute infections within 2 weeks prior to r randomization;
7. History of drug abuse, substance use;
8. History of alcoholism or positive alcohol test results;

11. History of long-term heavy smoking .