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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: BDB-001 injection

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hainan
    • Sanya, Hainan, China, 572000
      • Sanya Central Hospital (Hainan Third People's Hospital)
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Renmin Hospital Of Wuhan University Bubei General Hospital
    • Wuhan, Hubei, China, 430070
      • General Hospital of Gentral Rheater Command
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Shu Lan (Hangzhou) Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A low dose of BDB-001; 6 patients administered low dose of BDB-001 injection	Drug: BDB-001 injection; IV infusions of Injection diluted in sodium chloride
Experimental: A intermediate dose of BDB-001; 6 patients administered intermediate dose of BDB-001 injection	Drug: BDB-001 injection; IV infusions of Injection diluted in sodium chloride
Experimental: A high dose of BDB-001; 3-6 patients administered high dose of BDB-001 injection	Drug: BDB-001 injection; IV infusions of Injection diluted in sodium chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with serious adverse events (SAEs) and non-serious adverse events	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.	Up to Day 40
Number of participants with abnormal laboratory tests	Blood samples were collected for the assessment of laboratory tests. Number of participants with abnormal laboratory tests parameters are presented.	Up to Day 40
Number of participants with physical examination	Blood samples were collected for the assessment of physical examination. Number of participants with abnormal physical examination parameters are presented.	Up to Day 40
Number of participants with abnormal vital signs	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.	Up to Day 40
Number of participants with abnormal electrocardiogram (ECG) findings	Number of participants with abnormality Abnormal Electrocardiogram (ECG) are presented.	Up to Day 40
Plasma concentration of BDB-001 following intravenous administration	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.	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.
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.

Collaborators and Investigators

• Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd
• Collaborators: Beijing Defengrui Biotechnology Co. Ltd

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2020
• Primary Completion (Actual): April 14, 2020
• Study Completion (Actual): April 14, 2020

Study Registration Dates

• First Submitted: August 22, 2021
• First Submitted That Met QC Criteria: October 8, 2021
• First Posted (Actual): October 12, 2021

Study Record Updates

• Last Update Posted (Actual): October 12, 2021
• Last Update Submitted That Met QC Criteria: October 8, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: STS-BDB001-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No