COVID-19Phase 1NCT05075304
A Safety and Tolerability Study of BDB-001 in Mild, Moderate COVID-19 Patients
A Phase 1 study testing BDB-001 injection in people with COVID-19, run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- COVID-19
- What is being tested?
- BDB-001 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 4 sitesChina
- Study dates
- 21 Feb 2020to 14 Apr 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Shu Lan (Hangzhou) Hospital
Hangzhou, Zhejiang, 310022
Sanya Central Hospital (Hainan Third People'S Hospital)
Sanya, Hainan, 572000
Renmin Hospital Of Wuhan University Bubei General Hospital
Wuhan, Hubei, 430060
General Hospital of Gentral Rheater Command
Wuhan, Hubei, 430070
About this study
Official title: 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.
- Conditions
- COVID-19
- Being tested
- BDB-001 injection
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BDB-001 injectionDrug
IV infusions of Injection diluted in sodium chloride
BDB-001 injectionDrug
IV infusions of Injection diluted in sodium chloride
BDB-001 injectionDrug
IV infusions of Injection diluted in sodium chloride
| Study group | Role | What they receive |
|---|---|---|
| A low dose of BDB-001 | Experimental | 6 patients administered low dose of BDB-001 injection Receives: Drug: BDB-001 injection |
| A intermediate dose of BDB-001 | Experimental | 6 patients administered intermediate dose of BDB-001 injection Receives: Drug: BDB-001 injection |
| A high dose of BDB-001 | Experimental | 3-6 patients administered high dose of BDB-001 injection Receives: Drug: BDB-001 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Day 40
Number of participants with abnormal electrocardiogram (ECG) findings
Number of participants with abnormality Abnormal Electrocardiogram (ECG) are presented.
Measured: 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.
Measured: 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
Measured: Within 60 minutes (prior to start of the first and second BDB-001 IV infusion), Day 7 24 hours after infusion, day 14.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start21 Feb 2020
- Primary completion14 Apr 2020
- Study completion14 Apr 2020
Why it stopped: Due to the COVID-19 epidemic situation, the sponsor has decided to terminate the project.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Defengrui Biotechnology Co. Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05075304
- Sponsor's protocol ID
- STS-BDB001-02
- Status last verified
- Aug 2021
- First submitted
- 22 Aug 2021
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BDB-001 Injection in Patients With Novel Coronavirus (2019-nCoV) Infection
- ClinicalTrials.gov ID
- NCT05075304
- Acronym / sponsor ID
- STS-BDB001-02
- Conditions
- COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the COVID-19 epidemic situation, the sponsor has decided to terminate the project.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Staidson (Beijing) Biopharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Beijing Defengrui Biotechnology Co. Ltd
- Study start
- 21 Feb 2020 (actual)
- Primary completion
- 14 Apr 2020 (actual)
- Study completion
- 14 Apr 2020 (actual)
- First posted
- 12 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A low dose of BDB-001 | Experimental | Drug: BDB-001 injection6 patients administered low dose of BDB-001 injection |
| A intermediate dose of BDB-001 | Experimental | Drug: BDB-001 injection6 patients administered intermediate dose of BDB-001 injection |
| A high dose of BDB-001 | Experimental | Drug: BDB-001 injection3-6 patients administered high dose of BDB-001 injection |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BDB-001 injectionIV infusions of Injection diluted in sodium chloride | Drug | A low dose of BDB-001 |
| BDB-001 injectionIV infusions of Injection diluted in sodium chloride | Drug | A intermediate dose of BDB-001 |
| BDB-001 injectionIV infusions of Injection diluted in sodium chloride | Drug | A high dose of BDB-001 |
Primary outcome
Number of participants with serious adverse events (SAEs) and non-serious adverse events
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Number of participants with abnormal electrocardiogram (ECG) findings
Time frame: Up to Day 40
Number of participants with abnormality Abnormal Electrocardiogram (ECG) are presented.
Plasma concentration of BDB-001 following intravenous administration
Time frame: 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
Time frame: Within 60 minutes (prior to start of the first and second BDB-001 IV infusion), Day 7 24 hours after infusion, day 14.
Results and safety
The study was stopped early (reason given: Due to the COVID-19 epidemic situation, the sponsor has decided to terminate the project.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BDB-001 injection in people with COVID-19, run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to the COVID-19 epidemic situation, the sponsor has decided to terminate the project.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with serious adverse events (SAEs) and non-serious adverse events (time frame: Up to Day 40). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.