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NCT07776132
Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX29 Compared With HLX11
Conditions: Health Adult Subjects
Sex: Male
Ages: 18 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 60
Sponsor: Shanghai Henlius Biotech
Location: Nucleus Network Pty Ltd Melbourne Victoria
Summary
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
Inclusion Criteria:
1. Male subjects aged ≥18 and ≤55 years;
2. Subjects have no history of disease or past medical history abnormalities that, in the judgment of the study physician, would affect the trial;
3. Physical examination, vital signs, chest x-ray, electrocardiogram, and laboratory investigations are normal or show abnormalities without clinical significance.
4. Body mass index (BMI) ≥18 and ≤30 kg/m²;
5. 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 drug abuse, substance use;
7. History of alcoholism or positive alcohol test results;
8. History of long-term heavy smoking .
Source: ClinicalTrials.gov (NCT07776132). StuddyBuddy aggregates publicly available trial information.