A Safety and Tolerability Study of BDB-001 in Mild, Moderate COVID-19 Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: A low dose of BDB-001 6 patients administered low dose of BDB-001 injection |
Drug: BDB-001 injection
IV infusions of Injection diluted in sodium chloride
|
| Experimental: A intermediate dose of BDB-001 6 patients administered intermediate dose of BDB-001 injection |
Drug: BDB-001 injection
IV infusions of Injection diluted in sodium chloride
|
| Experimental: A high dose of BDB-001 3-6 patients administered high dose of BDB-001 injection |
Drug: BDB-001 injection
IV infusions of Injection diluted in sodium chloride
|
Outcome Measures
Primary Outcome Measures
- 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.]
Eligibility Criteria
Criteria
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:
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sanya Central Hospital (Hainan Third People'S Hospital) | Sanya | Hainan | China | 572000 |
| 2 | Renmin Hospital Of Wuhan University Bubei General Hospital | Wuhan | Hubei | China | 430060 |
| 3 | General Hospital of Gentral Rheater Command | Wuhan | Hubei | China | 430070 |
| 4 | Shu Lan (Hangzhou) Hospital | Hangzhou | Zhejiang | China | 310022 |
Sponsors and Collaborators
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
- Beijing Defengrui Biotechnology Co. Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STS-BDB001-02