NCT07776132尚未招募1 期
A RANDOMIZED, DOUBLE-BLIND, INTRAVENOUS SINGLE-DOSE, PARALLEL-CONTROLLED PHASE I CLINICAL STUDY TO COMPARE THE PHARMACOKINETICS, SAFETY, AND IMMUNOGENICITY OF PERTUZUMAB INJECTION BEFORE AND AFTER PROCESS CHANGE IN HEALTHY CHINESE MALE PARTICIPANTS
Shanghai Henlius Biotech1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年9月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- AUC0-inf
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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;
- •Within 14 days prior to random allocation, left ventricular ejection fraction (LVEF) assessed by echocardiography is within the normal range (≥55%);
排除标准
- •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;
- •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;
- •History of drug abuse, substance use;
- •History of alcoholism or positive alcohol test results;
- •History of long-term heavy smoking .
结局指标
主要结局
AUC0-inf
时间窗: up to 71 days
Area-under-curve of blood drug concentration-time from time 0 to infinity after a single drug administration
次要结局
- Cmax(up to 71 days)
- AUC0-t(up to 71 days)
研究者
研究点 (1)
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