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
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Peking university first hospital
RECRUITING
Beijing
The First Affiliated Hospital,College of Medicine,Zhejiang University
RECRUITING
Hangzhou
Longhua Hospital Shanghai University of Traditional Chinese Medicine
RECRUITING
Shanghai
Longhua Hospital Shanghai University of Traditional Chinese Medicine
RECRUITING
Shanghai
Hebei General Hospital
RECRUITING
Shijiazhuang
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Contact Information
Primary
Minghui Zhao
mhzhao@bjmu.edu.cn
0086-13501243815
Time Frame
Start Date:2023-03-02
Estimated Completion Date:2027-12-30
Participants
Target number of participants:52
Treatments
Experimental: B007:350mg
B007:350mg Subcutaneous injection was administered on days 1 and 15~B007 matched Placebo Subcutaneous injection was administered on days 1 and 15
Experimental: B007:700mg
B007: 700mg Subcutaneous injection was administered on days 1 and 15~B007 matched Placebo Subcutaneous injection was administered on days 1 and 15
Experimental: B007:1000mg
B007: 1000mg Subcutaneous injection was administered on days 1 and 15~B007 matched Placebo Subcutaneous injection was administered on days 1 and 15