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

Phase 1

Terminated

• Conditions: COVID-19
• Interventions: Drug: BDB-001 injection

• Registration Number: NCT05075304
• Lead Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-21
• Primary Completion: 2020-04-14
• Study Completion: 2020-04-14
• Status Verified: 2021-08
• Study First Submitted: 2021-08-22
• Study First Submitted QC: 2021-10-08
• Study First Posted: 2021-10-12
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
A intermediate dose of BDB-001	BDB-001 injection	6 patients administered intermediate dose of BDB-001 injection
A low dose of BDB-001	BDB-001 injection	6 patients administered low dose of BDB-001 injection
A high dose of BDB-001	BDB-001 injection	3-6 patients administered high dose of BDB-001 injection

Primary Outcome Measures

Name	Time	Method
Number of participants with abnormal electrocardiogram (ECG) findings	Up to Day 40	Number of participants with abnormality Abnormal Electrocardiogram (ECG) are presented.
Plasma concentration of BDB-001 following intravenous administration	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	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	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	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	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	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.

Trial Locations

Locations (4)

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