The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SCTC21C in subjects with plasma cell-driven autoimmune diseases
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥18 years at the time of signing the ICF;
2. The subject has been diagnosed with IgA nephropathy through kidney tissue biopsy;
3. The subject has been on a stable and maximally tolerated dose of ACEI or ARB (or the maximum allowable dose according to the prescribing information) for at least 12 weeks prior to the first dose. Subjects using both ACEI and ARB simultaneously will not be accepted;
4. The estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI formula must be ≥30 mL/min/1.73 m²;
5. During the screening period, the subject must have 24-hour proteinuria ≥1.0 g or a urine protein-to-creatinine ratio (UPCR) ≥0.75 g/g based on 24-hour urine protein;
6. All male subjects or women of childbearing potential (with a negative blood pregnancy test within 7 days prior to the first dose of investigational drug) must agree to use reliable contraception together with their partner from the time of signing the ICF until 5 months after the last dose of the study drug;
7. Understand the study procedures and voluntarily sign the informed consent form in writing.
Exclusion Criteria:
1. IgA nephropathy secondary to other diseases;
2. Any kidney disease with special pathological or clinical types, such as nephrotic syndrome, crescentic glomerulonephritis, etc.;
3. Use of systemic corticosteroids within the 3 months prior to baseline or expected use during the study period;
4. Use of systemic immunosuppressive drugs within the 3 months prior to baseline or expected use during the study period;
5. Use of other B-cell-targeting biologics or unapproved investigational biologics within the 6 months prior to baseline;
6. Patients who have experienced any of the following cardiovascular events within 24 weeks prior to baseline: myocardial infarction, unstable angina, ventricular arrhythmias, heart failure with NYHA class II or higher, stroke, etc.;
7. A history of solid organ or hematopoietic stem cell or bone marrow transplantation, or expected to undergo a transplant procedure during the treatment period with the investigational drug;
8. Currently undergoing hemodialysis or peritoneal dialysis, or expected to require hemodialysis or peritoneal dialysis during the treatment period with the investigational drug;
9. Any symptoms or signs within 30 days prior to baseline indicating an active infection (excluding the common cold), or requiring systemic anti-infective treatment, or being at high risk for infection;
10. Positive viral serology, including HIV, HCV, and HBV, etc.; Hepatitis B patients: active hepatitis or severe liver disease;
11. Currently or within the past 5 years has had malignant tumors, except for fully treated skin basal cell carcinoma, squamous cell carcinoma, cervical carcinoma in situ, or cervical intraepithelial neoplasia;
12. Known allergy to the active ingredient or excipients of the investigational drug.
Primary outcome measure(s)
Phase 1: Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs). — 36 Weeks 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.
A serious adverse event (SAE) is any untoward medical occurrence that at any dose:
Results in death Is life-threatening Requires in patient hospitalisation or prolongation of existing hospitalisation Is a congenital anomaly or birth defect Is an infection that requires treatment parenteral antibiotics Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above.
Phase 2: Percentage change in urine protein-to-creatinine ratio (UPCR) at Week 24 compared to baseline — 24 Weeks UPCR is calculated by dividing the concentration of protein in urine by the urine creatinine concentration.
Trial sites (20)
Facility
City
Region
Status
The First Affiliated Hospital of Baotou Medical College
Baotou
China
Beijing Tsinghua Changgung Hospital
Beijing
China
Peking University First Hospital
Beijing
China
Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital
Chengdu
China
Guangdong Provincial People's Hospital
Guangzhou
China
The First Affliated Hospital, Zhejiang University School of Medicine
Hangzhou
China
Zhejiang Provincial People's Hospital
Hangzhou
China
Shandong Provincial Hospital
Jinan
China
The First Affiliated Hospital of Nanchang University
Nanchang
China
The Second Affiliated Hospital of Nanchang University
Nanchang
China
Guangxi Zhuang Autonomous Region People's Hospital
Nanning
China
Ningbo NO.2 Hospital
Ningbo
China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai
China
Shanghai General Hospital
Shanghai
China
Wuxi People's Hospital
Wuxi
China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an
China
The First Affiliated Hospital of Xiamen University
Xiamen
China
The Second Affiliated Hospital of Xingtai Medical College
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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