Clinical Study of CM338 in the Treatment of Immunoglobulin A Nephropathy

Study Overview
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Brief Summary
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This study is a multicenter, randomized phase II clinical study to evaluate Efficacy and safety, while observing pharmacokinetic profiles, pharmacodynamic effects, and immunogenicity of CM338 in subjects with Immunoglobulin A(IgA) nephropathy.

Detailed Description
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In 1968, immunoglobulin A nephropathy (IgAN) was developed by French pathologist Dr. Jean Berger and his colleague Dr. Nicole Hinglais that what is described as glomerular immunoglobulin A (IgA)-immune globule - immune globule Protein G (IgG) intercapillary deposition of kidney disease, the main pathological feature of which is on the glomerulus IgA deposition, usually accompanied by local cell proliferation and stromal dilation. Since there is not enough specificity and spirit Biomarkers of sensitivity, the only way to confirm the diagnosis is renal biopsy.

Official Title
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A Phase II Clinical Study Evaluating the Efficacy and Safety of CM338 Injection in Subjects With Immunoglobulin A Nephropathy

Conditions
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IgA Nephropathy

Intervention / Treatment
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* Biological: CM338


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged 18-75. Understand the nature of the study and sign the Informed Consent Form voluntarily. Take effective contraception measures throughout the study period. Exclusion Criteria: Used other investigational drugs within 30 days before the first study administration. With previous history of Human immunodeficiency virus(HIV) infection. Treponema pallidum antibody positive in screening period. May have active Mycobacterium tuberculosis infection. Major surgery is planned during the study. Other reasons the investigator believes that the subject is not suitable to participate in this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>CM338 will be injected subcutaneously. | Biological: CM338<br>* CM338 injection<br>|
| Experimental: Group B<br>CM338 will be injected subcutaneously. | Biological: CM338<br>* CM338 injection<br>|
| Experimental: Group C<br>CM338 will be injected subcutaneously. | Biological: CM338<br>* CM338 injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of adverse events of CM338 in subjects with immunoglobulin A nephropathy | To evaluate the incidence of adverse events, including abnormalities of laboratory examination, physical examination, vital signs, 12-lead electrocardiogram (12-ECG) and others. | up to week 112 |