HealthyPhase 1NCT05360927
Safety and Tolerability of BDB-001 Injection in Healthy Subjects
A Phase 1 study testing BDB-001 injection in people with Healthy, run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 1 site in China.
Trial summary
A clinical study to evaluate the safety,tolerability,PK and PD characteristics of BDB-001 Injection in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BDB-001 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 25 Sep 2019to 25 Dec 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 but ≤ 65, male and female;
- Medical histories, physical examinations, laboratory examinations and study-related examinations and tests of the subjects，the Investigator judges that they are healthy;
- Body weight: 50- 80 kg, inclusive; Body mass index: 18.0 -26.0 kg/m2, inclusive;
- Vital signs: Blood pressure (90 mmHg≤ systolic ≤140 mmHg, 50 mmHg≤ diastolic ≤90 mmHg), heart rate (50≤ heart rate ≤100 beats/min), body temperature < 37°C;
- Subjects (including their partners) agree to take highly effective contraceptive measures during the study, and they have no birth plan or sperm donation plan within 6 months after the end of the study;
- Subjects are aware of the risks of the study, and voluntarily participate in the clinical study and sign an informed consent form (ICF).
Who cannot join
- History of cardiovascular, respiratory, kidney, liver, metabolism, endocrine, gastrointestinal, blood, nerve, skin and mental illness, cancer or other major disease that in the judgment of the Investigator might put the subject as risk on this study;
- Past history of tuberculosis, history of contact with active tuberculosis, TB-SPOT test results exceeding the upper limit of 2 times or more, and recent infectious diseases;
- During the screening and baseline period, the white blood cell count and C-reactive protein test results are abnormal and have clinical significance, hemoglobin: male <120g/L or female <110g/L;
- Electrocardiogram (ECG) abnormalities and have clinical significance;
- Subjects who have an autoimmune disease or an immune deficiency disease, or a family history of an autoimmune disease or an immune deficiency disease;
- Subjects with clinically obvious allergic diseases;
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- Positive screening test results for human immunodeficiency virus (HIV-1/HIV-2) antibodies, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab), treponema pallidum antibody;
- Participate in any drug or vaccine clinical trial as a subject within 3 months before screening or prepare to be vaccinated during the study period to 2 months after the end of the study;
- Have received any monoclonal antibody or biological agent treatment within the previous 3 months;
- Have taken drugs that may affect immune function within 6 months before screening or have taken prescription/over-the-counter drugs within the previous 14 days;
- Subjects who have donated either more than approximately 500 mL of blood within 3 months prior to screening or any plasma within 4 weeks prior to screening; Subjects who donated blood (>400 ml) within 3 months prior to screening, or plasma exchange within 4 weeks prior to screening;
- Drink more than 5 cups of coffee, tea or cola per day (150ml and above per cup);
- Subjects who test positive for alcohol or drugs during the screening;
- Subjects who smoke or smoke test results are positive;
- Subjects with poor compliance;
- Pregnant or lactating women;
- The investigator believes that there are any subjects who are not suitable to participate in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032
About this study
Official title: A Randomized, Double-blind,Placebo-controlled,Single-Ascending Dose Phase Ⅰ Study to Evaluate the Safety,Tolerability,and Pharmacokinetics of BDB-001 Injection in Healthy Subjects
A clinical study to evaluate the safety,tolerability,PK and PD characteristics of BDB-001 Injection in healthy subjects.
- Conditions
- Healthy
- Being tested
- BDB-001 injection, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BDB-001 injectionDrug
Intravenous injection
PlaceboDrug
Intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 0.3mg/kg | Experimental | All participants (fasted) received either 0.3 mg/kg of BDB-001 as a single dose or dose-matched placebo. Receives: Drug: BDB-001 injection; Drug: Placebo |
| Cohort 1mg/kg | Experimental | All participants (fasted) received either 1 mg/kg of BDB-001 as a single dose or dose-matched placebo. Receives: Drug: BDB-001 injection; Drug: Placebo |
| Cohort 3mg/kg | Experimental | All participants (fasted) received either 3 mg/kg of BDB-001 as a single dose or dose-matched placebo. Receives: Drug: BDB-001 injection; Drug: Placebo |
| Cohort 8mg/kg | Experimental | All participants (fasted) received either 8 mg/kg of BDB-001 as a single dose or dose-matched placebo. Receives: Drug: BDB-001 injection; Drug: Placebo |
| Cohort 16mg/kg | Experimental | All participants (fasted) received either 16 mg/kg of BDB-001 as a single dose or dose-matched placebo. Receives: Drug: BDB-001 injection; Drug: Placebo |
| Cohort 20mg/kg | Experimental | All participants (fasted) received either 20 mg/kg of BDB-001 as a single dose or dose-matched placebo. Receives: Drug: BDB-001 injection; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events, Clinically Significant Laboratory Abnormalities, Clinically Significant Electrocardiogram Abnormalities, Clinically Significant Vital Signs Abnormalities And Clinically Significant Physical Examination Abnormalities
Measured: Up to 50 days
Maximum plasma concentration (Cmax)
Measured: Up to 1200 hours postdose
Area under the plasma concentration-time curve from time 0 to infinity (AUC0inf)
Measured: Up to 1200 hours postdose
Area under the plasma concentration-time curve from time 0 to 1200hr(AUC00-1200hr)
Measured: Up to 1200 hours postdose
Time of maximum concentration (Tmax)
Measured: Up to 1200 hours postdose
Elimination half-life (t1/2)
Measured: Up to 1200 hours postdose
Clearance (CL)
Measured: Up to 1200 hours postdose
Apparent volume of distribution (Vz)
Measured: Up to 1200 hours postdose
Mean residence time (MRT)
Measured: Up to 1200 hours postdose
Secondary outcomes (1)
Number of participants developing anti-BDB-001 antibodies
Measured: Up to 50 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start25 Sep 2019
- Primary completion25 Dec 2020
- Study completion25 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Defengrei Biotechnology Co.,Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360927
- Sponsor's protocol ID
- STS-BDB001-01
- Status last verified
- Apr 2022
- First submitted
- 29 Apr 2022
- Last updated
- 4 May 2022
- 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 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind,Placebo-controlled,Single-Ascending Dose Phase Ⅰ Study to Evaluate the Safety,Tolerability,and Pharmacokinetics of BDB-001 Injection in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05360927
- Acronym / sponsor ID
- STS-BDB001-01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Staidson (Beijing) Biopharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Beijing Defengrei Biotechnology Co.,Ltd
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 25 Dec 2020 (actual)
- Study completion
- 25 Dec 2020 (actual)
- First posted
- 4 May 2022 (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.
A clinical study to evaluate the safety,tolerability,PK and PD characteristics of BDB-001 Injection in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 0.3mg/kg | Experimental | Drug: BDB-001 injection, Drug: PlaceboAll participants (fasted) received either 0.3 mg/kg of BDB-001 as a single dose or dose-matched placebo. |
| Cohort 1mg/kg | Experimental | Drug: BDB-001 injection, Drug: PlaceboAll participants (fasted) received either 1 mg/kg of BDB-001 as a single dose or dose-matched placebo. |
| Cohort 3mg/kg | Experimental | Drug: BDB-001 injection, Drug: PlaceboAll participants (fasted) received either 3 mg/kg of BDB-001 as a single dose or dose-matched placebo. |
| Cohort 8mg/kg | Experimental | Drug: BDB-001 injection, Drug: PlaceboAll participants (fasted) received either 8 mg/kg of BDB-001 as a single dose or dose-matched placebo. |
| Cohort 16mg/kg | Experimental | Drug: BDB-001 injection, Drug: PlaceboAll participants (fasted) received either 16 mg/kg of BDB-001 as a single dose or dose-matched placebo. |
| Cohort 20mg/kg | Experimental | Drug: BDB-001 injection, Drug: PlaceboAll participants (fasted) received either 20 mg/kg of BDB-001 as a single dose or dose-matched placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged ≥ 18 but ≤ 65, male and female;
- Medical histories, physical examinations, laboratory examinations and study-related examinations and tests of the subjects，the Investigator judges that they are healthy;
- Body weight: 50- 80 kg, inclusive; Body mass index: 18.0 -26.0 kg/m2, inclusive;
- Vital signs: Blood pressure (90 mmHg≤ systolic ≤140 mmHg, 50 mmHg≤ diastolic ≤90 mmHg), heart rate (50≤ heart rate ≤100 beats/min), body temperature < 37°C;
- Subjects (including their partners) agree to take highly effective contraceptive measures during the study, and they have no birth plan or sperm donation plan within 6 months after the end of the study;
Key exclusion criteria (17 listed)
- History of cardiovascular, respiratory, kidney, liver, metabolism, endocrine, gastrointestinal, blood, nerve, skin and mental illness, cancer or other major disease that in the judgment of the Investigator might put the subject as risk on this study;
- Past history of tuberculosis, history of contact with active tuberculosis, TB-SPOT test results exceeding the upper limit of 2 times or more, and recent infectious diseases;
- During the screening and baseline period, the white blood cell count and C-reactive protein test results are abnormal and have clinical significance, hemoglobin: male <120g/L or female <110g/L;
- Electrocardiogram (ECG) abnormalities and have clinical significance;
- Subjects who have an autoimmune disease or an immune deficiency disease, or a family history of an autoimmune disease or an immune deficiency disease;
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 injectionIntravenous injection | Drug | Cohort 0.3mg/kg, Cohort 16mg/kg, Cohort 1mg/kg, Cohort 20mg/kg, Cohort 3mg/kg, Cohort 8mg/kg |
| PlaceboIntravenous injection | Drug | Cohort 0.3mg/kg, Cohort 16mg/kg, Cohort 1mg/kg, Cohort 20mg/kg, Cohort 3mg/kg, Cohort 8mg/kg |
Primary outcome
Incidence of Adverse Events, Clinically Significant Laboratory Abnormalities, Clinically Significant Electrocardiogram Abnormalities, Clinically Significant Vital Signs Abnormalities And Clinically Significant Physical Examination Abnormalities
Time frame: Up to 50 days
Maximum plasma concentration (Cmax)
Time frame: Up to 1200 hours postdose
Area under the plasma concentration-time curve from time 0 to infinity (AUC0inf)
Time frame: Up to 1200 hours postdose
Area under the plasma concentration-time curve from time 0 to 1200hr(AUC00-1200hr)
Time frame: Up to 1200 hours postdose
Time of maximum concentration (Tmax)
Time frame: Up to 1200 hours postdose
Elimination half-life (t1/2)
Time frame: Up to 1200 hours postdose
Clearance (CL)
Time frame: Up to 1200 hours postdose
Apparent volume of distribution (Vz)
Time frame: Up to 1200 hours postdose
Mean residence time (MRT)
Time frame: Up to 1200 hours postdose
1 secondary outcome
Number of participants developing anti-BDB-001 antibodies
Time frame: Up to 50 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- 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.
1 site 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 Healthy, run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 1 site 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 6 inclusion and 17 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: finished, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of Adverse Events, Clinically Significant Laboratory Abnormalities, Clinically Significant Electrocardiogram Abnormalities, Clinically Significant Vital Signs Abnormalities And Clinically Significant Physical Examination Abnormalities (time frame: Up to 50 days). The study lists 9 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 4 May 2022.