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This study is divided into two parts (Part A and Part B). This study aims to evaluate the safety and efficacy of CM313 in subjects with primary Immunoglobulin A nephropathy(IgAN), while also observing its Pharmacokinetics(PK) characteristics, Pharmacokinetics(PD) effects, and immunogenicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: CM313 low dose | Experimental |
| |
| Part A: CM313 high dose | Experimental |
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| Part B: CM313 low dose with low frequency | Experimental |
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| Part B: CM313 low dose with high frequency | Experimental |
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| Part B: Placebo matching the volume of low dose CM313 | Placebo Comparator |
| |
| Part B: CM313 high dose with low frequency | Experimental |
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| Part B: CM313 high dose with high frequency | Experimental |
| |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM313 | Biological | CM313(SC) injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | Up to 108 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qian Jia | Contact | 028-88610620 | qianjia@keymedbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Jicheng Lv | Peking University Frist Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| Part B: Placebo matching the volume of high dose CM313 |
| Placebo Comparator |
|
| Placebo | Drug | Matched placebo |
|
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |