A Randomized, Intravenous Single-Dose, Parallel, Phase I Clinical Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX13 and YERVOY® (US-, EU-, and CN-Sourced) in Healthy Chinese Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 304
- 试验地点
- 1
- 主要终点
- Maximum (peak) serum drug concentration (Cmax)
研究概览
简要总结
Phase I Study to Compare the Pharmacokinetic Characteristics, Safety, Tolerability, and Immunogenicity (Randomized, Double-blind, Parallel Controlled) of HLX13 with YERVOY® Injection in Healthy Chinese Male Subjects
详细描述
This is a randomized, intravenous single-dose, parallel study to compare the PK characteristics of HLX13 and YERVOY® (US-, EU-, and CN-sourced) and evaluate their safety, tolerability, and immunogenicity in healthy Chinese male subjects.
This study is divided into two parts. Part I is an open-label, randomized, single-dose, parallel study to compare the PK parameters of HLX13 with those of EU-sourced YERVOY® in healthy Chinese male subjects after a single intravenous infusion and provide supporting data for the design of Part II. This part of the study consists of two groups.
Part II is a double-blind, randomized, single-dose, parallel study to evaluate the PK similarity of HLX 13 and YERVOY® (US-, EU-, and CN-sourced) in healthy Chinese male subjects. This part of the study consists of four groups.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Willing to sign the informed consent form.
- •Healthy Chinese males (no significant clinical abnormalities in medical history, physical examination, vital signs, chest X-ray, 12-lead ECG, and laboratory examinations).
- •Age ≥ 18 and ≤ 60 years old.
- •Body mass index (BMI) ≥ 18.5 and ≤ 28 kg/m
- •Left ventricular ejection fraction (LVEF) > 50%, as measured by echocardiography within 14 days before randomization.
- •Subjects either agree that they and their spouse/partner will take reliable contraceptive measures within 3 months after the end of drug infusion or be infertile.
排除标准
- •History of any severe hematological or renal, endocrinic, respiratory, gastrointestinal, cardiovascular, hepatic, neuropsychiatric, or neurological diseases or tumors.
- •Use of a monoclonal antibody or any biological product within 6 months prior to the study treatment.
- •History of allergy or anaphylaxis, including that due to any drug or drug excipients in clinical studies.
- •Use of prescription/over-the-counter drugs or traditional Chinese medicines (except vitamins, mineral supplements, and health products) within 28 days prior to the study treatment.
- •History of blood donation within 3 months prior to the study treatment.
- •Participation in another clinical study and use of a clinical investigational drug or reference product within 3 months prior to the study treatment, or planning to participate in another drug clinical trial during the study period.
- •Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or Treponema pallidum antibody.
- •History of drug abuse, or positive urine drug screen during the screening period.
- •Have undergone surgery within 3 months before screening or plan to undergo surgery during the study period; have undergone surgery that will affect drug absorption, distribution, metabolism, and excretion.
- •Have been vaccinated within 28 days prior to screening or plan to be vaccinated during the study.
- •Intolerant to venipuncture or with a history of needle or blood phobia.
- •People on special diets who reject the arranged meals.
- •Smoking more than 5 cigarettes per day within 3 months before screening or cannot stop using any tobacco products during the study.
- •An average daily alcohol intake of more than 15 g (equivalent to 450 mL beer or 150 mL wine or 50 mL low-alcohol liquor) within 1 month prior to screening; or a positive blood alcohol test at screening; or unwilling or unable to abstain from alcohol during the study.
- •Failure to comply with protocol requirements and instructions, protocol restrictions, etc., as judged by the investigator; uncooperative or unable to return to the study site for follow-up visits or complete the entire clinical study process, etc.
研究组 & 干预措施
HLX13 group
Recombinant anti-CTLA-4 fully human monoclonal antibody injection developed by Shanghai Henlius Biotech, Inc.
干预措施: HLX13 (Drug)
CN-sourced ipilimumab group
CN-sourced ipilimumab
干预措施: CN-sourced ipilimumab (Drug)
EU-sourced ipilimumab group
EU-sourced ipilimumab
干预措施: EU-sourced ipilimumab group (Drug)
US-sourced ipilimumab group
US-sourced ipilimumab
干预措施: US-sourced ipilimumab group (Drug)
结局指标
主要结局
Maximum (peak) serum drug concentration (Cmax)
时间窗: Up to Day 90
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Area under the serum concentration-time curve from time 0 to infinity (AUC0-inf)
时间窗: Up to Day 90
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
次要结局
- Percentage of area under the serum concentration-time curve extrapolated to infinity (%AUCex)(Up to Day 90)
- Time to reach maximum (peak) serum drug concentration (Tmax)(Up to Day 90)
- Area under the serum concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-t)(Up to Day 90)
- Elimination half life (t1/2)(Up to Day 90)
- Total clearance (CL)(Up to Day 90)
- Apparent volume of distribution during terminal phase (Vz)(Up to Day 90)
- Mean residence time (MRT)(Up to Day 90)