A Phase Ib, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BDB-001 Injection in Patients With Novel Coronavirus (2019-nCoV) Infection
Overview
- Phase
- Phase 1
- Intervention
- BDB-001 injection
- Conditions
- COVID-19
- Sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
- Enrollment
- 18
- Locations
- 4
- Primary Endpoint
- Number of participants with abnormal electrocardiogram (ECG) findings
- Status
- Terminated
- Last Updated
- last year
Overview
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.
Investigators
Eligibility 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);
Arms & Interventions
A low dose of BDB-001
6 patients administered low dose of BDB-001 injection
Intervention: BDB-001 injection
A intermediate dose of BDB-001
6 patients administered intermediate dose of BDB-001 injection
Intervention: BDB-001 injection
A high dose of BDB-001
3-6 patients administered high dose of BDB-001 injection
Intervention: BDB-001 injection
Outcomes
Primary Outcomes
Number of participants with abnormal electrocardiogram (ECG) findings
Time Frame: Up to Day 40
Number of participants with abnormality Abnormal Electrocardiogram (ECG) are presented.
Plasma concentration of BDB-001 following intravenous administration
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.
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
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.
Number of participants with serious adverse events (SAEs) and non-serious adverse events
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.