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

NCT05075304 | Terminated Phase 1

• 1 other identifier: STS-BDB001-02
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (7)

• 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.

Study Arms (3)

A low dose of BDB-001

EXPERIMENTAL

6 patients administered low dose of BDB-001 injection

Drug: BDB-001 injection

A intermediate dose of BDB-001

EXPERIMENTAL

6 patients administered intermediate dose of BDB-001 injection

Drug: BDB-001 injection

A high dose of BDB-001

EXPERIMENTAL

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

Drug: BDB-001 injection

Interventions

BDB-001 injection DRUG

IV infusions of Injection diluted in sodium chloride

A low dose of BDB-001

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ≤ 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.

You may not qualify if:

• 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:
• Calcineurin inhibitors (such as cyclosporin and tacrolimus);
• Proliferation inhibitors (such as everolimus, sirolimus, etc);
• anti-metabolic agents (such as mycophenolate mofetil, mycophenolic acid, purine sulfate, etc);
• Pregnant or lactating women.

Sponsors & Collaborators

• Staidson (Beijing) Biopharmaceuticals Co., Ltd: lead
• Beijing Defengrui Biotechnology Co. Ltd: collaborator

Study Sites (4)

Sanya Central Hospital (Hainan Third People'S Hospital)

Sanya, Hainan, 572000, China

Location

Renmin Hospital Of Wuhan University Bubei General Hospital

Wuhan, Hubei, 430060, China

Location

General Hospital of Gentral Rheater Command

Wuhan, Hubei, 430070, China

Location

Shu Lan (Hangzhou) Hospital

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Conditions

COVID-19

Interventions

BDB001

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2021
• First Posted: October 12, 2021
• Study Start: February 21, 2020
• Primary Completion: April 14, 2020
• Study Completion: April 14, 2020
• Last Updated: May 21, 2024

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)