NCT04784312已完成1 期
A Phase Ia Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Immunogenicity of a Single Dose of MW14 Injection in Healthy Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Serious Adverse Event
研究概览
简要总结
This is a Phase 1, first time in human study enrolling approximately 42 healthy adult subjects (18-45 yrs) from one study site. The purpose of this study is to evaluate the safety, tolerability and PK of MW14 in healthy adult volunteers administered as a single IV dose compared with placebo, across 5 cohorts. The 5 dose cohorts will enroll sequentially. Subjects will be followed for safety from the time of Informed Consent through 85 days post dose.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects aged 18 to 45 years (including 18 and 45 years).
- •Weight≥50.0 kg for males, or weight≥45.0 kg for females, and body mass index (BMI) in the range of 19.0 ~ 26.0 kg/m2 (including cut-off value).
- •The medical history, physical examination, clinical laboratory tests and other tests related study show no abnormalities, or abnormalities without clinical significance.
- •Subjects do not have a pregnancy plan, have no sperm and egg donation plans during the screening period and the next 6 months, and take effective contraceptive measures voluntarily.
- •Are willing to follow study procedures, signed informed consent voluntarily, and ensure that he/she will complete the study according to the program requirements.
排除标准
- •Prior or current medical conditions:
- •Health status: clinically significant histories of heart, liver, kidney, digestive tract, nervous system, respiratory system, blood and lymphatic system, immune system, mental, metabolic, and bone abnormalities.
- •Subjects who have a history of allergies to biological agents or any drug components; those who have a history of allergies and judged by the investigator to be ineligible for enrollment.
- •Those who undergone acute infection within 2 weeks prior to screening.
- •Those with abnormalities in pulmonary imaging examination prior to screening and judged to be clinically significant by the investigator.
- •Those who have undergone surgery within 3 months prior to screening, or who plan to undergo surgery during the study.
- •Those who cannot tolerate venipuncture or have a history of needle-sickness and blood-sickness.
- •Those who have a history of drug abuse within 6 months prior to screening.
- •Use of illicit drugs within 3 months prior to screening.
- •Those who donated blood within 3 months prior to screening (including component blood), or massive blood loss (≥ 200 mL), or blood transfusions or use of blood products.
- •Subject (female) who is pregnant or lactating at screening or during the trial.
- •Subjects have a fertility plan or sperm or egg donation plan at screening and within the next 6 months.
- •Use of any prescription, over-the-counter, or Chinese herbal medicines within 2 weeks prior to screening.
- •Those who have been vaccinated within 4 weeks prior to screening or who are scheduled to be vaccinated during the study.
- •Those who have smoked more than 5 cigarettes per day within 3 months prior to screening.
- •Those who have consumed more than 14 units of alcohol per week (1 unit of alcohol ≈ 360 mL of beer or 45 mL of spirits containing 40% alcohol or 150 mL of wine) within 3 months prior to screening, or who cannot abstain from alcohol during the trial.
- •Those who have special dietary requirements and cannot accept a standard diet.
- •Those who have participated in drug or medical devices clinical trials within 3 months prior to screening.
- •Those who have previously used immunosuppressants or monoclonal antibodies for any reason.
- •Those with abnormal vital signs with clinical significance: diastolic blood pressure≤50 mmHg or ≥90 mmHg, pulse≤50 beats/min or ≥100 beats/min, body temperature (ear temperature) <35.5°C or >37.5°C, respiration>20 breaths/min. The specific situation will be comprehensively determined by the investigator.
- •Those with abnormalities in laboratory tests and auxiliary examinations that are judged by the investigator to be clinically significant.
- •Those who have one or more clinically significant tests of hepatitis B virological markers, hepatitis C virus antibodies, anti-human immunodeficiency virus antibodies, or anti-Treponema pallidum-specific antibodies.
- •Female subjects with a positive blood pregnancy test at screening.
- •Alcohol breath test results greater than 0.0 mg/100 ml or positive drug screening (morphine, icenarcotics [methamphetamine], ketamine, ecstasy [methylenedioxyamphetamine], cannabis [tetrahydrocannabinolate], erythroxylin).
- •Subjects who is inappropriate to participate in the trial due to any reasons as determined by the investigator.
结局指标
主要结局
Serious Adverse Event
时间窗: 12 weeks
safety evaluation
Adverse Event
时间窗: 12 weeks
safety evaluation
次要结局
未报告次要终点
研究者
研究点 (1)
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