A Randomized, Double-blind, Placebo-controlled, Phase Ib/II Clinical Study to Evaluate the Preliminary Efficacy, Safety, Pharmacokinetic Profiles and Immunogenicity of JS016 in Participants With Mild and Moderate COVID-19 or of SARS-CoV-2 Asymptomatic Infection
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Efficacy Measurs(Time to negative conversion in viral nucleic acid test(by RT-PCR) for diagnostic samples)
研究概览
简要总结
JS016-002-Ib/II is a randomized, double-blinded, placebo-controlled study, to investigate the safety, PK profiles, preliminary efficacy and immunogenicity of intravenous Recombinant Human Anti-SARS-CoV-2 Monoclonal Antibody (JS016) in participants with mild and moderate COVID-19 or of SARS-CoV-2 Asymptomatic Infection.
Three doses of JS016 are to be investigated, including 25mg/kg, 50mg/kg and 100mg/kg, given as single dose of intravenous infusion. In total, 90 participants will be enrolled with 30 participants each for 25, 50 and 100mg/kg dose cohort at a ratio of 2:1 to receive investigational product or placebo treatment, respectively.
详细描述
"Each participant will receive JS016 or matched placebo intravenous infusion on D1 (randomizing day). Non-pharmaceutical supportive background therapy (e.g. oxygen inhalation) for COVID-19 is allowed per clinical needs.
Investigators will be kept blinded to review the preliminary efficacy and safety data on a regular basis. Meanwhile, a study evaluation team (SET) composed of medical monitors, safety assessors and statisticians will be set up to review the study status, safety and preliminary efficacy of the participants at the pre-specified time points or as necessary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18-65 years (inclusive) ,women or man
- •SARS-CoV-2 detected in the diagnostic specimen (nasopharyngeal swab)
- •High homology of viral gene sequencing with the known SARS-CoV-2."
- •Mild/moderateillness COVID-19 or SARS-CoV-2 asymptomatic infection
- •Within 7 days from the onset time of symptoms to randomization or within 5 days from the first time of SARS-CoV-2 positive test to randomization with required viral load
- •No plan of pregnancy and being willing to use effective contraceptive measures
- •Signed the informed consent form, sufficiently understanding of the content
排除标准
- •positive IgM/IgG against SARS-CoV-2 prior to randomization.
- •Severeor critical illness
- •Uncontrolled hypertension, cardiovascular/cerebrovascular diseases,lung diseases
- •Type 1 diabetes, or newly diagnosed or poorly controlled type 2 diabetes
- •Liver and kidney dysfunction, immune or inflammatory diseases, infections, surgery, tumors, and other major diseases
- •History of SARS-CoV-2 vaccination or participation in clinical trial with neutralizing antibody against SARS-CoV-
- •Use of therapeutic biologics within 3 months prior to screening, or within the elimination period (5 half-lives) of such drugs as the day of dosing
- •Has participated in any other interventional clinical study involving anstudy drug within 3 months prior to screening, or within the elimination period (5 half-lives) of the study drug as the day of dosing
- •Platelets and hemoglobin test results during screening period are abnormal and have clinical significanc.
- •Anaphylaxis, urine drug screening, alcohol dependence, lactation during pregnancy, blood loss, and others
研究组 & 干预措施
Anti-SARS-CoV-2 Monoclonal Antibody dose 1/2/3
use Anti-SARS-CoV-2 Monoclonal Antibody,dose 1/2/3 to treat COVID-19
干预措施: Recombinant Human Anti-SARS-CoV-2 Monoclonal Antibody(25mg/kg;50mg/kg;100mg/kg) (Biological)
Placebo
use placebo to treat COVID-19
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacy Measurs(Time to negative conversion in viral nucleic acid test(by RT-PCR) for diagnostic samples)
时间窗: 0-85days
Time to negative conversion in viral nucleic acid test (by RT-PCR) for diagnostic samples, negative conversion is defined as two consecutive negative nucleic acid test for diagnostic samples after randomization
Safety Measurements : 90 of participants with treatment-related adverse events as assessed byCTCAE v5.0
时间窗: 0-85days
Any adverse event, serious adverse events (SAEs) occurring during the clinical study, including clinical symptoms and abnormal vital signs, abnormal laboratory tests (complete blood cell count, serum chemistry, routine urinalysis, coagulation function, myocardial enzymogram, etc.) and abnormality of 12-lead ECGs will be observed for all the participants
次要结局
- PK Measures：CL(Day 0 to Day 85)
- PK Measures：Tmax(Day 0 to Day 85)
- PK Measures：Vd(Day 0 to Day 85)
- Pulmonary CT（observe by imaging reports to degree of pulmonary inflammation, degree of vitreous fibrosis)(Day 0 to Day 85)
- PK Measures:AUC0-tau(Day 0 to Day 85)
- PK Measures：Cmax(Day 0 to Day 85)
- Proportions of participants with negative conversion in viral nucleic acid test(Day 0 to Day 85)
- PK Measures：t1/2(Day 0 to Day 85)
- Viral load change from baseline(Day 0 to Day 85)