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Not Yet Recruiting 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 .

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07776132). StuddyBuddy aggregates publicly available trial information.