Clinical trial NCT05075304: A Safety and Tolerability Study of BDB-001 in Mild, Moderate COVID-19 Patients
Official title: A Phase Ib, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BDB-001 Injection in Patients With Novel Coronavirus (2019-nCoV) Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: COVID-19
Lead sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Beijing Defengrui Biotechnology Co. Ltd
First posted: 2021-10-12
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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:

  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.

Primary outcomes:
measure: Number of participants with serious adverse events (SAEs) and non-serious adverse events
timeFrame: Up to Day 40
measure: Number of participants with abnormal laboratory tests
timeFrame: Up to Day 40
measure: Number of participants with physical examination
timeFrame: Up to Day 40
measure: Number of participants with abnormal vital signs
timeFrame: Up to Day 40
measure: Number of participants with abnormal electrocardiogram (ECG) findings
timeFrame: Up to Day 40
measure: Plasma concentration of BDB-001 following intravenous administration
timeFrame: 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.
measure: Plasma concentration of ADA
timeFrame: Within 60 minutes (prior to start of the first and second BDB-001 IV infusion), Day 7 24 hours after infusion, day 14.
Secondary outcomes:
Other outcomes:
Locations:
city: Sanya
country: China
facility: Sanya Central Hospital (Hainan Third People'S Hospital)
state: Hainan
city: Wuhan
country: China
facility: Renmin Hospital Of Wuhan University Bubei General Hospital
state: Hubei
city: Wuhan
country: China
facility: General Hospital of Gentral Rheater Command
state: Hubei
city: Hangzhou
country: China
facility: Shu Lan (Hangzhou) Hospital
state: Zhejiang
Study officials:
References: