Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX29 Compared With HLX11

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

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

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators