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Clinical Trials in China / NCT07776132
Starting soon Phase 1

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

NCT07776132 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Henlius Biotech
Phase
Phase 1
Started
2026-09-05
Last updated
2026-08-20

Condition(s) studied

Health Adult Subjects

Investigational drug(s) / intervention(s)

HLX29HLX11

HLX29: Pertuzumab injection after process change

HLX11: Pertuzumab injection before process change

Study 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

Sex
MALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. Male subjects aged ≥18 and ≤45 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) ≥19 and ≤26 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 .

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Anhui Medical University Second Affiliated Hospital Hefei Anhui

More Shanghai Henlius Biotech trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07776132 on ClinicalTrials.gov ↗ ← All trials in China