COVID-19
Conditions
Brief summary
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.
Interventions
IV infusions of Injection diluted in sodium chloride
Sponsors
Beijing Defengrui Biotechnology Co. Ltd
Staidson (Beijing) Biopharmaceuticals Co., Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with serious adverse events (SAEs) and non-serious adverse events | 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 | 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 | 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 | 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. |
| Number of participants with abnormal electrocardiogram (ECG) findings | Up to Day 40 | Number of participants with abnormality Abnormal Electrocardiogram (ECG) are presented. |
| Plasma concentration of BDB-001 following intravenous administration | 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 | Within 60 minutes (prior to start of the first and second BDB-001 IV infusion), Day 7 24 hours after infusion, day 14. | — |
Countries
China
Outcome results
None listed