COVID-19 Clinical Trial
Official title:
A Phase Ib, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BDB-001 Injection in Patients With Novel Coronavirus (2019-nCoV) Infection
Verified date | August 2021 |
Source | Staidson (Beijing) Biopharmaceuticals Co., Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 18 |
Est. completion date | April 14, 2020 |
Est. primary completion date | April 14, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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: 1. Calcineurin inhibitors (such as cyclosporin and tacrolimus); 2. Proliferation inhibitors (such as everolimus, sirolimus, etc); 3. anti-metabolic agents (such as mycophenolate mofetil, mycophenolic acid, purine sulfate, etc); - Pregnant or lactating women. |
Country | Name | City | State |
---|---|---|---|
China | Shu Lan (Hangzhou) Hospital | Hangzhou | Zhejiang |
China | Sanya Central Hospital (Hainan Third People'S Hospital) | Sanya | Hainan |
China | General Hospital of Gentral Rheater Command | Wuhan | Hubei |
China | Renmin Hospital Of Wuhan University Bubei General Hospital | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Staidson (Beijing) Biopharmaceuticals Co., Ltd | Beijing Defengrui Biotechnology Co. Ltd |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with serious adverse events (SAEs) and non-serious adverse events | 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. | Up to Day 40 | |
Primary | Number of participants with abnormal laboratory tests | Blood samples were collected for the assessment of laboratory tests. Number of participants with abnormal laboratory tests parameters are presented. | Up to Day 40 | |
Primary | Number of participants with physical examination | Blood samples were collected for the assessment of physical examination. Number of participants with abnormal physical examination parameters are presented. | Up to Day 40 | |
Primary | Number of participants with abnormal vital signs | 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. | Up to Day 40 | |
Primary | Number of participants with abnormal electrocardiogram (ECG) findings | Number of participants with abnormality Abnormal Electrocardiogram (ECG) are presented. | Up to Day 40 | |
Primary | Plasma concentration of BDB-001 following intravenous administration | 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. | 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. | |
Primary | Plasma concentration of ADA | Within 60 minutes (prior to start of the first and second BDB-001 IV infusion), Day 7 24 hours after infusion, day 14. |
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