A Safety and Tolerability Study of BDB-001 in Mild, Moderate COVID-19 Patients

Study Overview
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Brief Summary
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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.

Official Title
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A Phase Ib, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BDB-001 Injection in Patients With Novel Coronavirus (2019-nCoV) Infection

Conditions
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COVID-19

Intervention / Treatment
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* Drug: BDB-001 injection
* Drug: BDB-001 injection
* Drug: BDB-001 injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A low dose of BDB-001<br>6 patients administered low dose of BDB-001 injection | Drug: BDB-001 injection<br>* IV infusions of Injection diluted in sodium chloride<br>|
| Experimental: A intermediate dose of BDB-001<br>6 patients administered intermediate dose of BDB-001 injection | Drug: BDB-001 injection<br>* IV infusions of Injection diluted in sodium chloride<br>|
| Experimental: A high dose of BDB-001<br>3-6 patients administered high dose of BDB-001 injection | Drug: BDB-001 injection<br>* IV infusions of Injection diluted in sodium chloride<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Number of participants with abnormal electrocardiogram (ECG) findings | Number of participants with abnormality Abnormal Electrocardiogram (ECG) are presented. | Up to Day 40 | 
| 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. | 
| 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. |