A Pilot Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel Group, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Virology of CT-P59 in Patient With Mild Symptoms of SARS-CoV-2 Infection
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Celltrion
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Number of Patients With TEAEs
研究概览
简要总结
This is a Phase I study that randomized, double-blind, Placebo-controlled, Parallel Group, Single Ascending Dose Study to evaluate Safety, Tolerability and Virology of CT-P59 in Patient with Mild Symptoms of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Infection.
详细描述
'CT-P59 is a monoclonal antibody targeted against SARS-CoV-2 spike receptor binding protein as a treatment for SARS CoV 2 infection. CT-P59 is currently being developed by the Sponsor as a potential treatment for SARS-CoV-2 infection. In this study, safety, tolerability and virology of CT-P59 will be evaluated in patient with mild symptoms of SARS-CoV-2 Infection.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Each patient must meet all of the following criteria to be randomized in this study:
- •Adult male or female patient, aged between 18 to 60 years (both inclusive).
- •Patient with laboratory confirmed SARS-CoV-2 infection by Reverse Transcription Polymerase Chain Reaction (RT-PCR) at Screening.
- •Patient has mild conditions meeting all of the following criteria:
- •Oxygen saturation ≥ 94% on room air.
- •Not requiring supplemental oxygen.
- •Onset of symptom is no more than 7 days prior to the study drug administration.
排除标准
- •Patient with severe condition meeting one of the following:
- •Respiratory distress with respiratory rate ≥ 30 breaths/min.
- •Requires supplemental oxygen.
- •Experience shock.
- •Complicated with other organs failure, and intensive care unit monitoring treatment is needed by investigator's discretion.
- •Any other conditions suspected of being severe symptoms of SARS-CoV-2 infection, in the opinion of the investigator, including but not limited to radiographic findings in lung.
结局指标
主要结局
Number of Patients With TEAEs
时间窗: Up to Day 14
Number of Patients With Treatment-Emergent Serious Adverse Events (TESAEs)
时间窗: Up to Day 14
Number of Patients With Treatment-Emergent Adverse Events of Special Interest (TEAESI; Infusion Related Reactions Including Hypersensitivity/Anaphylactic Reaction)
时间窗: Up to Day 14
Number of Patients With Potential Effects on the Incidence of Antibody-Dependent Enhancement (ADE)
时间窗: Up to Day 14
次要结局
- Number of Patients Requiring Supplemental Oxygen(Up to Day 28)
- Terminal Half-life (t1/2) of CT-P59(Up to Day 90)
- Number of Patients With All-cause Mortality(Up to Day 28)
- Number of Patients With Clinical Recovery(Up to Day 28)
- Number of Mechanical Ventilation(Up to Day 28)
- The Percentage of Patients With Positive/Negative for Quantitative Polymerase Chain Reaction (qPCR)(At Day 28)
- Area Under the Concentration-time Curve of Viral Titers for qPCR(Up to Day 28)
- Actual Results and Change From Baseline for Viral Shedding in Nasopharyngeal Swab Specimens for qPCR(Up to Day 28)
- Number of Patients With Intensive Care Unit Transfer(Up to Day 28)
- Duration of Viral Shedding in Nasopharyngeal Swab Specimens for qPCR(Up to Day 28)
- Number of Patients With Hospital Admission(Up to Day 28)
- Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of CT-P59(Up to Day 90)
- Percentage of AUC0-inf Obtained by Extrapolation (%AUCext) of CT-P59(Up to Day 90)
- Time to Cmax (Tmax) of CT-P59(Up to Day 90)
- Dose Normalized AUC0-inf (AUC0-inf/Dose) of CT-P59 (Normalized to Total Body Dose)(Up to Day 90)
- Total Body Clearance (CL) of CT-P59(Up to Day 90)
- Terminal Elimination Rate Constant (λz) of CT-P59(Up to Day 90)
- Volume of Distribution During the Elimination Phase (Vz) of CT-P59(Up to Day 90)