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

Staidson Biopharmaceuticals

Status and phase: Terminated; Phase 1

Conditions: COVID-19

Treatments: Drug: BDB-001 injection

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05075304

STS-BDB001-02

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

A low dose of BDB-001

Experimental group

Description:

6 patients administered low dose of BDB-001 injection

Treatment:

Drug: BDB-001 injection

Drug: BDB-001 injection

Drug: BDB-001 injection

A intermediate dose of BDB-001

Experimental group

Description:

6 patients administered intermediate dose of BDB-001 injection

Treatment:

Drug: BDB-001 injection

Drug: BDB-001 injection

Drug: BDB-001 injection

A high dose of BDB-001

Experimental group

Description:

3-6 patients administered high dose of BDB-001 injection

Treatment:

Drug: BDB-001 injection

Drug: BDB-001 injection

Drug: BDB-001 injection