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

NCT ID: NCT05075304

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-21
• Study Completion Date: 2020-04-14

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.

Conditions

COVID-19

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A low dose of BDB-001

6 patients administered low dose of BDB-001 injection

Group Type: EXPERIMENTAL

BDB-001 injection

Intervention Type: DRUG

IV infusions of Injection diluted in sodium chloride

A intermediate dose of BDB-001

6 patients administered intermediate dose of BDB-001 injection

Group Type: EXPERIMENTAL

BDB-001 injection

Intervention Type: DRUG

IV infusions of Injection diluted in sodium chloride

A high dose of BDB-001

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

Group Type: EXPERIMENTAL

BDB-001 injection

Intervention Type: DRUG

IV infusions of Injection diluted in sodium chloride

Interventions

BDB-001 injection

IV infusions of Injection diluted in sodium chloride

Intervention Type: DRUG

BDB-001 injection

IV infusions of Injection diluted in sodium chloride

Intervention Type: DRUG

BDB-001 injection

IV infusions of Injection diluted in sodium chloride

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Defengrui Biotechnology Co. Ltd

UNKNOWN

Sponsor Role: collaborator

Staidson (Beijing) Biopharmaceuticals Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sanya Central Hospital (Hainan Third People'S Hospital)

Sanya, Hainan, China

Renmin Hospital Of Wuhan University Bubei General Hospital

Wuhan, Hubei, China

General Hospital of Gentral Rheater Command

Wuhan, Hubei, China

Shu Lan (Hangzhou) Hospital

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

STS-BDB001-02

Identifier Type: -

Identifier Source: org_study_id