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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

ConditionPrimary Membranous Nephropathy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Jiaolian Drug Research and Development Co., Ltd

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Sequential

Treatments tested in this trial

  • B007

    Drug

    Drug: B007 injection Drug: Placebo injection

  • B007

    Drug

    Drug: B007 injection Drug: Placebo injection

  • B007

    Drug

    Drug: B007 injection Drug: Placebo injection

Treatment groups

52 Participants
are divided into 3 treatment groups
Group A: B007:350mgExperimental treatment 1 intervention
Group B: B007:700mgExperimental treatment 1 intervention
Group C: B007:1000mgExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose limiting toxicity（DLT）

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

Time frame
Approximately 1 years
2

Security: Incidence of Treatment-Emergent Adverse Events

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

Time frame
Approximately 2 years

Secondary outcomes

1

PK (Pharmacokinetics)

Cmax

Time frame
Approximately 1 years
2

PK (Pharmacokinetics)

Tmax

Time frame
Approximately 1 years
3

PK (Pharmacokinetics)

AUC0-last（Area Under Curve of 0-last）

Time frame
Approximately 1 years
4

Biomarkers

Changes in serum anti-PLA2R(Antiphospholipase A2 receptor) antibody levels relative to baseline

Time frame
Approximately 1 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Jiaolian Drug Research and Development Co., Ltd

Lead sponsor

Shanghai Pharmaceuticals Holding Co., Ltd

Collaborator

Source ClinicalTrials.gov
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