Primary Membranous NephropathyPhase 1NCT05668403
A Phase I Clinical Study of Recombinant Humanized Anti-CD20(B-lymphocyte Antigen CD20) Monoclonal Antibody Subcutaneous Injection in the Treatment of Primary Membranous Nephropathy
A Phase 1 study testing B007 in people with Primary Membranous Nephropathy, run by Shanghai Jiaolian Drug Research and Development Co., Ltd at 6 sites in China.
Trial summary
This Phase I Clinical Study assessed the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles and Preliminary Efficacy of Subcutaneous Injection of Recombinant Humanized Anti-CD20 Monoclonal Antibody in the Treatment of Primary Membranous Nephropathy Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Membranous Nephropathy
- What is being tested?
- B007
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 6 sitesChina
- Study dates
- 2 Mar 2023to 30 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who have fully understood this study and voluntarily signed the informed consent form;
- Male or female subjects, aged between 18 and 75 years;
- Subjects with primary membranous nephropathy pathologically confirmed by renal biopsy;
- Subjects with systolic blood pressure ≤ 140 mmHg and diastolic blood pressure ≤ 90 mmHg at screening;
- If taking ACEI(Angiotensin converting enzyme inhibitors), ARB(Angiotensin receptor blocker), a stable dose within 4 weeks before screening is required;
- Subjects who are able to follow the study protocol as judged by the investigator.
Who cannot join
- Subjects with secondary membranous nephropathy;
- Subjects with uncontrolled blood pressure as judged by the investigator within 3 months before screening;
- Subjects with decreases in urine protein ≥ 50% within 6 months before screening;
- Subjects who have received or are receiving renal replacement therapy;
- Subjects with type 1 diabetes mellitus, or those with type 2 diabetes mellitus who are diagnosed as diabetic nephropathy by percutaneous renal biopsy;
- Subjects who have a clear history of tuberculosis or have received anti-tuberculosis treatment;
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- Subjects with active bacterial, viral, fungal, mycobacterial, parasitic or other infections requiring systemic antibiotics or antiviral therapy;
- Subjects with known history of severe allergic reactions to humanized monoclonal antibodies；
- Subjects who received live vaccination, major surgery, or participated in other clinical trials within 28 days before receiving the study drug;
- Pregnant or lactating women; women of childbearing potential who have not been sterilized do not agree to use appropriate contraceptive measures during treatment and for at least 12 months after the last dose of the study drug;
- Subjects with serious, progressive, or uncontrolled disease that may increase risks during the participation in the study as assessed by the investigator;
- Subjects with a history of alcoholism or drug abuse within 12 months;
- Subjects with positive hepatitis B surface antigen; those with positive hepatitis C virus antibody; those with a history of immunodeficiency;
- Subjects with CD4+ T lymphocyte count < 300 cells/μL;
- Other conditions unsuitable for participation in this study determined by the Investigator.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Peking university first hospital
Beijing, 100010
Minghui Zhao, 0086-13501243815, mhzhao@bjmu.edu.cn
- Recruiting
The First Affiliated Hospital,College of Medicine,Zhejiang University
Hangzhou, Zhejiang, 310003
Heng Li, 0086-0571-87236114, zdyy6616@126.com
- Recruiting
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, 200032
Ming Yang, 0086-021-64385700, lhgcpoffice@126.com
- Recruiting
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, 200032
Yueyi Deng, 0086-021-64385700, lhgcpoffice@126.com
- Recruiting
Hebei General Hospital
Shijiazhuang, Hebei, 050057
Kai Niu, 0086-0311-85989696, hbpphosp@126.com
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, He'nan, 410100
Zhangsuo Liu, 0086-0371-66913114, 66862001@163.com
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles and Preliminary Efficacy of Subcutaneous Injection of Recombinant Humanized Anti-CD20 Monoclonal Antibody in the Treatment of Primary Membranous Nephropathy
This Phase I Clinical Study assessed the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles and Preliminary Efficacy of Subcutaneous Injection of Recombinant Humanized Anti-CD20 Monoclonal Antibody in the Treatment of Primary Membranous Nephropathy
- Conditions
- Primary Membranous Nephropathy
- Being tested
- B007
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B007Drug
Drug: B007 injection Drug: Placebo injection
B007Drug
Drug: B007 injection Drug: Placebo injection
B007Drug
Drug: B007 injection Drug: Placebo injection
| Study group | Role | What they receive |
|---|---|---|
| B007:350mg | Experimental | B007:350mg Subcutaneous injection was administered on days 1 and 15
B007 matched Placebo Subcutaneous injection was administered on days 1 and 15 Receives: Drug: B007 |
| B007:700mg | Experimental | B007: 700mg Subcutaneous injection was administered on days 1 and 15
B007 matched Placebo Subcutaneous injection was administered on days 1 and 15 Receives: Drug: B007 |
| B007:1000mg | Experimental | B007: 1000mg Subcutaneous injection was administered on days 1 and 15
B007 matched Placebo Subcutaneous injection was administered on days 1 and 15 Receives: Drug: B007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity（DLT）
Adverse reactions that are certainly or possibly related to the drug being tested during the dose escalation phase.
Measured: Approximately 1 years
Security: Incidence of Treatment-Emergent Adverse Events
Adverse event type, incidence, duration, correlation with study drug
Measured: Approximately 2 years
Secondary outcomes (7)
PK (Pharmacokinetics)
Cmax
Measured: Approximately 1 years
PK (Pharmacokinetics)
Tmax
Measured: Approximately 1 years
PK (Pharmacokinetics)
AUC0-last（Area Under Curve of 0-last）
Measured: Approximately 1 years
Biomarkers
Changes in serum anti-PLA2R(Antiphospholipase A2 receptor) antibody levels relative to baseline
Measured: Approximately 1 years
Immunogenicity
Incidence of ADA(Adenosine deaminase)
Measured: Approximately 1 years
Dynamics of pharmacodynamics
Changes of peripheral blood CD19+B cells(B-lymphocyte antigen CD19) relative to baseline
Measured: Approximately 1 years
Proportion of subjects achieving clinical remission
Proportion of subjects achieving clinical remission
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2022
- Study start2 Mar 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Membranous NephropathyStudies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiaolian Drug Research and Development Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Pharmaceuticals Holding Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05668403
- Sponsor's protocol ID
- B007-102
- Status last verified
- Apr 2026
- First submitted
- 12 Dec 2022
- Last updated
- 30 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles and Preliminary Efficacy of Subcutaneous Injection of Recombinant Humanized Anti-CD20 Monoclonal Antibody in the Treatment of Primary Membranous Nephropathy
- ClinicalTrials.gov ID
- NCT05668403
- Acronym / sponsor ID
- B007-102
- Conditions
- Primary Membranous Nephropathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Shanghai Jiaolian Drug Research and Development Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Pharmaceuticals Holding Co., Ltd
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 29 Dec 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.
This Phase I Clinical Study assessed the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles and Preliminary Efficacy of Subcutaneous Injection of Recombinant Humanized Anti-CD20 Monoclonal Antibody in the Treatment of Primary Membranous Nephropathy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| B007:350mg | Experimental | Drug: B007B007:350mg Subcutaneous injection was administered on days 1 and 15 B007 matched Placebo Subcutaneous injection was administered on days 1 and 15 |
| B007:700mg | Experimental | Drug: B007B007: 700mg Subcutaneous injection was administered on days 1 and 15 B007 matched Placebo Subcutaneous injection was administered on days 1 and 15 |
| B007:1000mg | Experimental | Drug: B007B007: 1000mg Subcutaneous injection was administered on days 1 and 15 B007 matched Placebo Subcutaneous injection was administered on days 1 and 15 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects who have fully understood this study and voluntarily signed the informed consent form;
- Male or female subjects, aged between 18 and 75 years;
- Subjects with primary membranous nephropathy pathologically confirmed by renal biopsy;
- Subjects with systolic blood pressure ≤ 140 mmHg and diastolic blood pressure ≤ 90 mmHg at screening;
- If taking ACEI(Angiotensin converting enzyme inhibitors), ARB(Angiotensin receptor blocker), a stable dose within 4 weeks before screening is required;
Key exclusion criteria (15 listed)
- Subjects with secondary membranous nephropathy;
- Subjects with uncontrolled blood pressure as judged by the investigator within 3 months before screening;
- Subjects with decreases in urine protein ≥ 50% within 6 months before screening;
- Subjects who have received or are receiving renal replacement therapy;
- Subjects with type 1 diabetes mellitus, or those with type 2 diabetes mellitus who are diagnosed as diabetic nephropathy by percutaneous renal biopsy;
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 |
|---|---|---|
| B007Drug: B007 injection Drug: Placebo injection | Drug | B007:350mg |
| B007Drug: B007 injection Drug: Placebo injection | Drug | B007:700mg |
| B007Drug: B007 injection Drug: Placebo injection | Drug | B007:1000mg |
Primary outcome
Dose limiting toxicity（DLT）
Time frame: Approximately 1 years
Adverse reactions that are certainly or possibly related to the drug being tested during the dose escalation phase.
Security: Incidence of Treatment-Emergent Adverse Events
Time frame: Approximately 2 years
Adverse event type, incidence, duration, correlation with study drug
7 secondary outcomes
PK (Pharmacokinetics)
Time frame: Approximately 1 years
PK (Pharmacokinetics)
Time frame: Approximately 1 years
PK (Pharmacokinetics)
Time frame: Approximately 1 years
Biomarkers
Time frame: Approximately 1 years
Immunogenicity
Time frame: Approximately 1 years
Dynamics of pharmacodynamics
Time frame: Approximately 1 years
Proportion of subjects achieving clinical remission
Time frame: Approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
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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.
6 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 B007 in people with Primary Membranous Nephropathy, run by Shanghai Jiaolian Drug Research and Development Co., Ltd at 6 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 6 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Minghui Zhao (0086-13501243815, mhzhao@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity（DLT） (time frame: Approximately 1 years). The study lists 2 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 30 Apr 2026.