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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
IV infusions of Injection diluted in sodium chloride
IV infusions of Injection diluted in sodium chloride
IV infusions of Injection diluted in sodium chloride
Sanya Central Hospital (Hainan Third People'S Hospital)
Sanya, Hainan, China
Renmin Hospital Of Wuhan University Bubei General Hospital
Wuhan, Hubei, China
General Hospital of Gentral Rheater Command
Wuhan, Hubei, China
Shu Lan (Hangzhou) Hospital
Hangzhou, Zhejiang, China
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.
Time frame: Up to Day 40
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.
Time frame: Up to Day 40
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.
Time frame: Up to Day 40
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.
Time frame: Up to Day 40
Number of participants with abnormal electrocardiogram (ECG) findings
Number of participants with abnormality Abnormal Electrocardiogram (ECG) are presented.
Time frame: Up to Day 40
Plasma concentration of BDB-001 following intravenous administration
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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.
Time frame: 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.
Plasma concentration of ADA
Time frame: Within 60 minutes (prior to start of the first and second BDB-001 IV infusion), Day 7 24 hours after infusion, day 14.