About this trial
This is a randomized, double-blind, parallel-controlled study to compare the PK profile of HLX29 and HLX11 and evaluate their safety, tolerability, and immunogenicity after a single intravenous dose in healthy male adult participants.
Eligibility criteria
Qualifiers
Male subjects aged ≥18 and ≤45 years;
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 mass index (BMI) ≥19 and ≤26 kg/m²;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- HLX29
- HLX11