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

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

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.

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.