HealthyPhase 1NCT05361005
Tolerability and Safety 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 tolerability, PK and PD characteristics of BDB-001 Injection in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 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
- 33 participants
- Where
- 1 siteChina
- Study dates
- 12 Mar 2020to 8 May 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female subjects between 18~55 years old (including 18 and 55 years old);
- A healthy subject evaluated by medical history etc;
- Physical examination and vital signs normal, or abnormal without clinical significance;
- Weight: 80 kg ≥ male ≥50 kg, and 80 kg ≥ female ≥45 kg. Body Mass Index (BMI) between 18~28kg/m2 (including 18 and 28). Body mass index (BMI) = body weight (kg) / height 2 (m2);
- Be able to complete the study in compliance with protocol;
- The subjects (including sex partners) willing to take effective contraception measures within 6 months after the last dose. Refer to the appendix for the detailed contraceptive methods;
- Informed consent form signed prior to the study and the content, process and possible adverse reactions of the study fully understood.
Who cannot join
- More than 5 cigarettes were smoked daily within 3 months prior to screening period of the study;
- Allergic history (drugs and food);
- A history of drug abuse and / or drinking (drinking 14 units per week of alcohol: 1 unit = 285 mL beer, or liquor 25 mL, or wine 100ml);
- Subjects who had donated blood or massive blood loss (> 450 mL) within 3 months prior to screening period, or those who had plasma exchange within 4 weeks prior to screening period;
- Any prescription drugs, OTC drugs, any vitamin products or herbs were used within the 14 days prior to screening period, and immunomodulators were used within 28 days prior to screening period;
- Subjects who had taken other investigational product(s) or vaccine within 3 months prior to screening period, or those who were expected to be vaccinated within 2 months after completion of the study;
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- Vigorous exercise or other factors affecting drug absorption, distribution, metabolism, excretion within 2 weeks prior to screening;
- Significant change in eating or exercise habits recently;
- Subjects who have taken BDB-001 injection or participated in clinical trials of investigational drugs within three months prior to taking study drugs;
- Subjects with a history of previous tuberculosis and exposure to active tuberculosis, TB-spot test results is greater than 2 UL(upper limit) of normal range, and those with infectious diseases recently;
- Subjects with autoimmune or immunodeficiency diseases, or with a family history of autoimmune diseases or immunodeficiency diseases;
- Abnormal ECG with clinical significance;
- Female subjects are in the lactation period or have positive serum pregnancy results during the period of trial (from screening to completion);
- Clinical laboratory examination result with clinical significance, or other clinical findings within 12 months prior to screening period with clinical significance ( including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular diseases);
- Subjects whose white blood cell count, high-sensitivity C-reactive protein test results were abnormal with clinical significance during screening and baseline period (-1 day), hemoglobin: male <120g/L or female <110g/L;
- Subjects with positive result of viral hepatitis (including hepatitis B and C), AIDS antibody, or treponema pallidum antibody;
- Subjects with acute disease or with concomitant medication from the screening stage to the start time of drug administration;
- Subjects with more than 5 cups (150mL cups) of coffee, tea or cola each day;
- Subjects with any alcohol-containing products within 48 hours before taking study medication;
- Subjects with a positive urine drug screening or with a history of drug abuse or drug use within the past five years;
- The investigators suggested the subject was not suitable to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ic Single Center, Randomized, Double-Blind, Placebo-controlled, Single Dose Escalation and Multiple Dose Study to Evaluate the Tolerability and Pharmacokinetics of BDB-001 Injection in Healthy Subjects
A clinical study to evaluate the 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 2mg/kg | Experimental | All participants (fasted) received either 2 mg/kg of BDB-001 as a single dose or dose-matched placebo. Receives: Drug: BDB-001 injection; Drug: Placebo |
| Cohort 4mg/kg | Experimental | All participants (fasted) received either 4 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 8mg/kg of BDB-001 as a single dose or dose-matched placebo. Receives: Drug: BDB-001 injection; Drug: Placebo |
| Cohort 4mg/kg multiple doses | Experimental | All participants (fasted) received either 4 mg/kg of BDB-001 as a multiple doses or doses-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 28 Days
Maximum plasma concentration (Cmax)
Measured: Up to 504 hours postdose
Area under the plasma concentration-time curve from time 0 to infinity (AUC0inf)
Measured: Up to 504 hours postdose
Area under the plasma concentration-time curve from time 0 to 480hr(AUC00-480hr)
Measured: Up to 504 hours postdose
Time of maximum concentration (Tmax)
Measured: Up to 504 hours postdose
Elimination half-life (t1/2)
Measured: Up to 504 hours postdose
Clearance (CL)
Measured: Up to 504 hours postdose
Apparent volume of distribution (Vz)
Measured: Up to 504 hours postdose
Mean residence time (MRT)
Measured: Up to 504 hours postdose
Secondary outcomes (1)
Change from baseline in concentration of free C5a and anti-drug antibody
Measured: Up to 504 hours postdose
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 start12 Mar 2020
- Primary completion8 May 2020
- Study completion8 May 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
- 33 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
- NCT05361005
- Sponsor's protocol ID
- STS-BDB001-05
- 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 Phase Ic Single Center, Randomized, Double-Blind, Placebo-controlled, Single Dose Escalation and Multiple Dose Study to Evaluate the Tolerability and Pharmacokinetics of BDB-001 Injection in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05361005
- Acronym / sponsor ID
- STS-BDB001-05
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Staidson (Beijing) Biopharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Beijing Defengrei Biotechnology Co.,Ltd
- Study start
- 12 Mar 2020 (actual)
- Primary completion
- 8 May 2020 (actual)
- Study completion
- 8 May 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 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
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 2mg/kg | Experimental | Drug: BDB-001 injection, Drug: PlaceboAll participants (fasted) received either 2 mg/kg of BDB-001 as a single dose or dose-matched placebo. |
| Cohort 4mg/kg | Experimental | Drug: BDB-001 injection, Drug: PlaceboAll participants (fasted) received either 4 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 8mg/kg of BDB-001 as a single dose or dose-matched placebo. |
| Cohort 4mg/kg multiple doses | Experimental | Drug: BDB-001 injection, Drug: PlaceboAll participants (fasted) received either 4 mg/kg of BDB-001 as a multiple doses or doses-matched placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female subjects between 18~55 years old (including 18 and 55 years old);
- A healthy subject evaluated by medical history etc;
- Physical examination and vital signs normal, or abnormal without clinical significance;
- Weight: 80 kg ≥ male ≥50 kg, and 80 kg ≥ female ≥45 kg. Body Mass Index (BMI) between 18~28kg/m2 (including 18 and 28). Body mass index (BMI) = body weight (kg) / height 2 (m2);
- Be able to complete the study in compliance with protocol;
Key exclusion criteria (21 listed)
- More than 5 cigarettes were smoked daily within 3 months prior to screening period of the study;
- Allergic history (drugs and food);
- A history of drug abuse and / or drinking (drinking 14 units per week of alcohol: 1 unit = 285 mL beer, or liquor 25 mL, or wine 100ml);
- Subjects who had donated blood or massive blood loss (> 450 mL) within 3 months prior to screening period, or those who had plasma exchange within 4 weeks prior to screening period;
- Any prescription drugs, OTC drugs, any vitamin products or herbs were used within the 14 days prior to screening period, and immunomodulators were used within 28 days prior to screening period;
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 2mg/kg, Cohort 4mg/kg, Cohort 4mg/kg multiple doses, Cohort 8mg/kg |
| PlaceboIntravenous injection | Drug | Cohort 2mg/kg, Cohort 4mg/kg, Cohort 4mg/kg multiple doses, 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 28 Days
Maximum plasma concentration (Cmax)
Time frame: Up to 504 hours postdose
Area under the plasma concentration-time curve from time 0 to infinity (AUC0inf)
Time frame: Up to 504 hours postdose
Area under the plasma concentration-time curve from time 0 to 480hr(AUC00-480hr)
Time frame: Up to 504 hours postdose
Time of maximum concentration (Tmax)
Time frame: Up to 504 hours postdose
Elimination half-life (t1/2)
Time frame: Up to 504 hours postdose
Clearance (CL)
Time frame: Up to 504 hours postdose
Apparent volume of distribution (Vz)
Time frame: Up to 504 hours postdose
Mean residence time (MRT)
Time frame: Up to 504 hours postdose
1 secondary outcome
Change from baseline in concentration of free C5a and anti-drug antibody
Time frame: Up to 504 hours postdose
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 7 inclusion and 21 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 28 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; AzTrials last refreshed its copy on 8 Nov 2026.