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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-45
SponsorShanghai Henlius Biotech

About this trial

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.

Eligibility criteria

Qualifiers

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.

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

  • HLX319
  • EU-Phesgo

Treatment groups

24 Participants
are divided into 2 treatment groups

Sponsors and collaborators