A Randomized, Double-blinded, Placebo-controlled, Single Ascending Dose, Phase I Study to Evaluate the Tolerability, Safety, Pharmacokinetics of SCTA01 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity(DLT)
研究概览
简要总结
The purpose of this study is to evaluate the tolerability, safety, pharmacokinetics of SCTA01(anti-SARS-CoV-2 monoclonal antibody) in Healthy Chinese Subjects.
详细描述
This is a Phase 1, First-in-Human, Randomized, Double-blinded, Placebo-Controlled, Single Ascending Dose Study of SCTA01(Anti-SARS-CoV-2 monoclonal antibody) in Healthy Chinese Subjects.
Dose escalation will be guided by a safety review of clinical signs and symptoms, adverse events (AEs), and laboratory results of the prior dose cohort.
An Interim analysis will be performed after Day 28 post-dose for the last dose cohort for review.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to provide written informed consent
- •Males or females. Aged ≥ 18 years old
- •Body mass index (BMI) between 18.0 and 26.0 kg/m2
- •Normal or abnormal but non-clinical significant physical examination, vital signs, 12-ECG and chest CT, etc
- •No plan of pregnancy and being willing to use effective contraceptive measures (including partner) from informed consent to 6 months after administration of SCTA01/placebo (abstinence，sterilization operation，contraceptive barrier，acyeterion , etc.)
排除标准
- •Having a history of severe allergy, such as severe allergic reactions, urticaria, angioedema;
- •Having one of the following evidence on SARS-CoV-2 infection(previous tests were accepted)：
- •SARS-CoV-2 positive: reverse transcription-polymerase chain reaction (RT-PCR) and/or next generation sequencing (NGS)
- •Previous viral gene sequencing showed high homology with the known SARS-CoV-2
- •Positive specific antibody IgM or IgG against serum SARS-CoV-2
- •Having a history of severe allergies, such as severe allergic reactions, urticaria, angioedema;
- •Having active infection or fever before to enrollment(≥ 37.3℃)
- •Having primary disease in main organs, such as heart, lung, kidney, liver, nervous system, gastrointestinal system dysfunction, history of thrombocytopenia or abnormal bleeding
- •Suffering from autoimmune diseases or a history of autoimmune diseases (such as systemic lupus erythematosus, thyroid Inflammation, vasculitis, etc.)
- •Within 7 days prior to the first dose of SCTA01/placebo, subject has received any prescription drugs, non-prescription drugs, Chinese herbal medicines and health products
- •Within 3 months prior to the first dose of SCTA01/placebo, subjects who participated in other clinical study, or remaining in the elimination period of the drug (within 5 half-lives) before treatment
- •Within 30 days prior to the first dose of SCTA01/placebo, subjects who have received vaccine
- •Within 3 months prior to the first dose of SCTA01/placebo, subjects who have received blood product treatment or blood donation and hemorrhage ≥400mL, or subjects who has a blood donation plan within 3 months after treatment
- •Within 6 months prior to the first dose of SCTA01/placebo, subjects who have received major surgery, or has surgery plan during clinical trail
- •Pregnant or lactating women or positive β-HCG, has plan of pregnancy from informed consent signed to 6 months after administration of SCTA01/placebo
- •Positive of anti-HIV, TP-Ab, anti-HCV, anti-HBV
- •Having a history of epilepsy
- •Having a history of malignancies
- •Within 3 months prior to screening, sujects who have drunk more than 14 standard units (1 standard unit contains 14g alcohol, such as 360mL beer, 45mL spirits with 40% alcohol or 150mL wine), or positive of alcohol breath test
- •Within 3 months prior to screening, subjects who smoked more than 5 cigarettes per day, do not accept smoking cessation during the study
- •Having a history of drug addiction and drug abuse; or who have a positive urine test result for drug abuse; or cannot guarantee that they will not abuse drugs during the study
- •Subjects who are not able to follow the plan to complete the study
- •Subjects who are not considered suitable for the study by investigators
研究组 & 干预措施
Placebo
Placebo: single dose on Day0
干预措施: Placebo (Other)
anti-SARS-CoV-2 monoclonal antibody(SCTA01)
SCTA01: single dose on Day0
干预措施: SCTA01 (Biological)
结局指标
主要结局
Dose-limiting toxicity(DLT)
时间窗: 7 days
DLT will be assessed by DAIDS v2.1. The measurements include clinical symptoms and abnormal vital signs, abnormal laboratory tests (complete blood cell count, serum chemistry, routine urinalysis, coagulation function, etc.) and 12-lead ECGs
Maximal Tolerable Dose(MTD)
时间窗: 12 weeks
MTD will be assessed by DAIDS v2.1. The measurements include clinical symptoms and abnormal vital signs, abnormal laboratory tests (complete blood cell count, serum chemistry, routine urinalysis, coagulation function, etc.) and 12-lead ECGs.
次要结局
- t1/2(12 weeks)
- Tmax(12 weeks)
- Anti-drug antibody(ADA)(12 weeks)
- AUC0-t(12 weeks)
- AUC0-∞(12 weeks)
- Adverse events(12 weeks)