Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 Compared With EU-Phesgo® (NCT07495930) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 Compared With EU-Phesgo®
China24 participantsStarted 2026-04-30
Plain-language summary
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.
Who can participate
Age range18 Years – 45 Years
SexMALE
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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;