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

NCT05668403 | Recruiting Phase 1

• 1 other identifier: B007-102
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 6

Brief 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

Conditions

Primary Membranous Nephropathy

Outcome Measures

Primary Outcomes (2)

• Dose limiting toxicity（DLT）

  Adverse reactions that are certainly or possibly related to the drug being tested during the dose escalation phase.

  Approximately 1 years

• Security: Incidence of Treatment-Emergent Adverse Events

  Adverse event type, incidence, duration, correlation with study drug

  Approximately 2 years

Secondary Outcomes (7)

• PK (Pharmacokinetics)

  Approximately 1 years

• PK (Pharmacokinetics)

  Approximately 1 years

• PK (Pharmacokinetics)

  Approximately 1 years

• Biomarkers

  Approximately 1 years

• Immunogenicity

  Approximately 1 years

Study Arms (3)

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

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

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

Drug: B007

Interventions

B007 DRUG

Drug: B007 injection Drug: Placebo injection

B007:350mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Shanghai Jiaolian Drug Research and Development Co., Ltd: lead
• Shanghai Pharmaceuticals Holding Co., Ltd: collaborator

Study Sites (6)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, He'nan, 410100, China

RECRUITING

Hebei General Hospital

Shijiazhuang, Hebei, 050057, China

RECRUITING

The First Affiliated Hospital,College of Medicine,Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

Peking university first hospital

Beijing, 100010, China

RECRUITING

Longhua Hospital Shanghai University of Traditional Chinese Medicine

Shanghai, 200032, China

RECRUITING

Longhua Hospital Shanghai University of Traditional Chinese Medicine

Shanghai, 200032, China

RECRUITING

Central Study Contacts

Minghui Zhao

CONTACT

0086-13501243815; mhzhao@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: December 29, 2022
• Study Start: March 2, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

CN (6)