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

Sponsor
Staidson (Beijing) Biopharmaceuticals Co., Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT05075304
Collaborator
Beijing Defengrui Biotechnology Co. Ltd (Other)
18
Enrollment
4
Locations
3
Arms
1.7
Actual Duration (Months)
4.5
Patients Per Site
2.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: BDB-001 injection
  • Drug: BDB-001 injection
  • Drug: BDB-001 injection
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase Ib, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BDB-001 Injection in Patients With Novel Coronavirus (2019-nCoV) Infection
Actual Study Start Date :
Feb 21, 2020
Actual Primary Completion Date :
Apr 14, 2020
Actual Study Completion Date :
Apr 14, 2020

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Number of participants with abnormal electrocardiogram (ECG) findings [Up to Day 40]

    Number of participants with abnormality Abnormal Electrocardiogram (ECG) are presented.

  6. 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.

  7. 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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Sanya Central Hospital (Hainan Third People'S Hospital)SanyaHainanChina572000
2Renmin Hospital Of Wuhan University Bubei General HospitalWuhanHubeiChina430060
3General Hospital of Gentral Rheater CommandWuhanHubeiChina430070
4Shu Lan (Hangzhou) HospitalHangzhouZhejiangChina310022

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Staidson (Beijing) Biopharmaceuticals Co., Ltd
ClinicalTrials.gov Identifier:
NCT05075304
Other Study ID Numbers:
  • STS-BDB001-02
First Posted:
Oct 12, 2021
Last Update Posted:
Oct 12, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 12, 2021