A Phase Ib, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BDB-001 Injection in Patients With Novel Coronavirus (2019-nCoV) Infection
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Number of participants with abnormal electrocardiogram (ECG) findings
研究概览
简要总结
This open, multi-center, multiple ascending dose study was designed to evaluate the safety, tolerability, preliminary efficacy and PK/PD of BDB-001 injection in patients with mild, or general COVID-19.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18≤ age ≤60, 18 kg/m2 ≤BMI ≤28 kg/m2, male or female;
- •Diagnosed with 2019-nCoV infection and classified clinically as mild or general;
- •Agreed not to participate in other clinical studies before completing this study;
- •With the subject's consent and signed informed consent form by the subject or his/her legal representative.
排除标准
- •Diagnosed with 2019-nCoV infection and classified clinically as severe or critical severe; severe pneumonia or acute respiratory distress syndrome, sepsis and septic shock;
- •The disease would deteriorate significantly within 48 hours judged by the investigators;
- •Immunodeficiency or immune related diseases not suitable for participation judged by the investigators (such as autoimmune diseases, IgG4 related diseases, allergic alveolitis, vasculitis, etc);
- •Lymphocyte count <0.5×109/L;
- •Neutropenia history (neutrophil absolute count was less than 2×109/L in adults), except for infection;
- •D- dimer >2000 µg/L;
- •Severe history of lung diseases, such as chronic obstructive pulmonary disease, lung cancer, tuberculosis, etc., history of heart disease: unstable angina pectoris, myocardial infarction, cardiac surgery, cardiac function≥ grade 3 (NYHA classification), serious history of liver disease (such as Child Pugh score ≥grade C), serious renal disease history, such as renal insufficiency (GFR ≤ 15ml/min/1.73m2), etc;
- •The subjects used the following drugs within 2 weeks (including 2 weeks) before screening:
- •Calcineurin inhibitors (such as cyclosporin and tacrolimus);
- •Proliferation inhibitors (such as everolimus, sirolimus, etc);
- •anti-metabolic agents (such as mycophenolate mofetil, mycophenolic acid, purine sulfate, etc);
- •Pregnant or lactating women.
研究组 & 干预措施
A low dose of BDB-001
6 patients administered low dose of BDB-001 injection
干预措施: BDB-001 injection (Drug)
A intermediate dose of BDB-001
6 patients administered intermediate dose of BDB-001 injection
干预措施: BDB-001 injection (Drug)
A high dose of BDB-001
3-6 patients administered high dose of BDB-001 injection
干预措施: BDB-001 injection (Drug)
结局指标
主要结局
Number of participants with abnormal electrocardiogram (ECG) findings
时间窗: Up to Day 40
Number of participants with abnormality Abnormal Electrocardiogram (ECG) are presented.
Plasma concentration of BDB-001 following intravenous administration
时间窗: Within 60 minutes (prior to start of BDB-001 IV infusion), 10 minutes (end of infusion); at 6, 12,24, 48 hours after end of infusion.
Blood samples were collected at indicated time points for measurement of Plasma concentrations of BDB-001 following intravenous administration. Pharmacokinetic Population comprised of all participants for whom at least one evaluable pharmacokinetic sample was obtained and analyzed.
Plasma concentration of ADA
时间窗: Within 60 minutes (prior to start of the first and second BDB-001 IV infusion), Day 7 24 hours after infusion, day 14.
Number of participants with serious adverse events (SAEs) and non-serious adverse events
时间窗: Up to Day 40
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations as judged by physician. Number of participants who had SAEs and non-SAEs are presented.
Number of participants with abnormal laboratory tests
时间窗: Up to Day 40
Blood samples were collected for the assessment of laboratory tests. Number of participants with abnormal laboratory tests parameters are presented.
Number of participants with physical examination
时间窗: Up to Day 40
Blood samples were collected for the assessment of physical examination. Number of participants with abnormal physical examination parameters are presented.
Number of participants with abnormal vital signs
时间窗: Up to Day 40
Vital signs were measured in a semi-supine position after five minutes of rest and included temperature, systolic blood pressure (SBP), diastolic blood pressure (DBP) , heart rate, respiratory rate. Number of participants with abnormality in any vital signs are presented.
次要结局
未报告次要终点