NCT05518695已完成1 期
A Randomized, Double-Blind, Phase I Clinical Study to Evaluate the Pharmacokinetics of BAT2022 in Healthy Chinese Subjects
Bio-Thera Solutions1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2022年6月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Dose limiting toxicity (DLT)
研究概览
简要总结
To evaluate the safety and tolerability of BAT2022 in healthy subjects.
详细描述
This is a single-center, randomized, double-blind, placebo-controlled, dose-escalation clinical study to evaluate the pharmacokinetics, safety, tolerability, immunogenicity and pharmacodynamics of BAT2022 for Injection in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-Blind
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have signed the informed consent form prior to the study and have a full understanding of the content, process and possible adverse reactions;
- •Subjects who are willing and able to follow the visit and treatment specified in this study;
- •Subject (including partner) who is willing to have no pregnancy plan or sperm donation plan within the following 6 months (i.e., within 6 months after administration of the investigational product) and voluntarily take effective contraceptive measures;
- •Healthy male or female subjects aged 18 ~ 55 years (inclusive);
- •Subjects with body weight of 50 kg ~ 100 kg (inclusive);
- •Subjects with normal or abnormal physical examination without clinical significance;
排除标准
- •Subjects who have smoked more than 5 cigarettes per day three months prior to Screening;
- •Any subject with a current or past serious allergic reaction to food or drug, or serious allergic or allergic reaction to human, humanized or mouse monoclonal antibody;
- •Subjects with a history of alcoholism (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of liquor, or 125 mL of wine);
- •Subjects who have donated blood or had massive blood loss (>450 mL) within three months prior to screening, or intend to donate blood or undergo surgery during the study;
- •Subjects who have taken any prescription drug, over-the-counter drug, any vitamin products or herbal medicines 28 days prior to Screening;
- •Subjects who have significant changes in diet or exercise habits 2 weeks prior to screening or from screening to administration;
- •Subjects who have used any biological products within 3 months prior to screening;
- •Subjects with clinical significance of abnormal heart assessed using Color Doppler echocardiography
- •Subjects with clinical significance of abnormal laboratory findings (hematology, urinalysis, serum chemistry, coagulation function, virology of infectious diseases and pregnancy test for women of childbearing age), or other clinical findings suggestive of the following disorders with clinical relevance (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, pulmonary, immune, psychiatric or cardiovascular and cerebrovascular diseases);
- •Subjects with clinical significance of abnormal (as judged by the investigator) ECG, or QTcF > 450 ms (allowed to be repeated for once);
- •Subjects with acute illness or concomitant medication from screening to prior to administration of the investigational product;
- •Subjects with positive urine drug screen, or subjects with a history of drug abuse or drug use in the past 5 years;
- •Subjects who have taken any alcohol-containing products within 48 hours prior to administration of the investigational product, or who are unable to limit alcohol consumption as required during the course of the study;
- •Subjects with current or previous malignant tumours;
- •Subjects with a history of hypertension or systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg at screening/baseline;
- •Subjects with liver disorder who are judged by the investigator as inappropriate for enrollment;
- •Subjects with abnormal focal shadows on chest radiograph, including but not limited to active pulmonary tuberculosis;
- •Subjects who have participated in drug clinical study within three months prior to the first dose of the investigational product, or planned to participate in other drug clinical study during the study;
- •Subjects who are considered by the investigator as inappropriate for enrollment.
研究组 & 干预措施
A1/100mg
Experimental
Drug:BAT2022 for Intravenous fluids 100mg
干预措施: BAT2022 (Drug)
A2/300mg
Experimental
Drug:BAT2022 for Intravenous fluids 300mg
干预措施: BAT2022 (Drug)
A3/1000mg
Experimental
Drug:BAT2022 for Intravenous fluids 1000mg
干预措施: BAT2022 (Drug)
A4/1500mg
Experimental
Drug:BAT2022 for Intravenous fluids 1500mg
干预措施: BAT2022 (Drug)
结局指标
主要结局
Dose limiting toxicity (DLT)
时间窗: DLT observation period is 7 days postdose.
Grade ≥3 AEs in this criteria are defined as dose-limiting toxicity (DLT).
次要结局
- Maximum tolerated dose (MTD)(DLT observation period is 7 days postdose.)
研究者
研究点 (1)
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