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
This is a randomized, double-blind, placebo-controlled Phase I/II study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of multiple doses of SCTC21C in subjects with plasma cell-driven autoimmune diseases. In phase 1 study, participants will be assigned to receive sequentially higher doses of SCTC21C to determine the recommended dose of SCTC21C for the randomized dose optimization- stage. In phase 2 study, 2 dose levels will be used. A total of 72 participants will be randomized in a 1:1:1 ration to dose 1, dose 2 or placebo groups to better understand the exposure/efficacy/toxicity relationship.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
99
Drug: SCTC21C Administered SC
The First Affiliated Hospital of Baotou Medical College
Baotou, China
Beijing Tsinghua Changgung Hospital
Beijing, China
Phase 1: Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs).
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.
Time frame: 36 Weeks
Phase 2: Percentage change in urine protein-to-creatinine ratio (UPCR) at Week 24 compared to baseline
UPCR is calculated by dividing the concentration of protein in urine by the urine creatinine concentration.
Time frame: 24 Weeks
Phase 1: Percentage change in urine protein-to-creatinine ratio (UPCR) compared to baseline
UPCR is calculated by dividing the concentration of protein in urine by the urine creatinine concentration.
Time frame: 36 Weeks
Phase 1: Percentage change in 24-hour urinary protein excretion compared to baseline
Time frame: 36 Weeks
Phase 1: Percentage change in urine albumin-to-creatinine ratio (UACR) compared to baseline
UACR is calculated by dividing the concentration of albumin in urine by the urine creatinine concentration.
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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
...and 10 more locations
Time frame: 36 Weeks
Phase 1: Percentage change in eGFR compared to baseline
eGFR is calculated using the CKD-EPI formula.
Time frame: 36 Weeks
Phase 1: Change from baseline in Immunoglobulin A (IgA), Immunoglobulin M (IgM), Immunoglobulin G (IgG), etc.
Time frame: 36 Weeks
Phase 1: C-max
Maximum observed plasma concentration
Time frame: 24 Weeks
Phase 1: T1/2
apparent terminal half-life
Time frame: 24 Weeks
Phase 1: AUC0-t
area under the plasma concentration time curve from time 0 to the time of last observed quantifiable concentration
Time frame: 24 Weeks
Phase 1: Percentage of Participants With Positive Antidrug Antibody (ADA) and Neutralizing Antibody (Nab)
Results for ADA analysis were reported.
Time frame: 36 Weeks
Phase 2: Percentage change in urine protein-to-creatinine ratio (UPCR) compared to baseline
UPCR is calculated by dividing the concentration of protein in urine by the urine creatinine concentration.
Time frame: 104 Weeks
Phase 2: Percentage change in 24-hour urinary protein excretion compared to baseline
Time frame: 104 Weeks
Phase 2: Percentage change in urine albumin-to-creatinine ratio (UACR) excretion compared to baseline
UPCR is calculated by dividing the concentration of albumin in urine by the urine creatinine concentration.
Time frame: 104 Weeks
Phase 2: Percentage change in eGFR compared to baseline
eGFR is calculated using the CKD-EPI formula.
Time frame: 104 Weeks
Phase 2: Change from baseline in Immunoglobulin A (IgA), Immunoglobulin M (IgM), Immunoglobulin G (IgG), etc.
Time frame: 104 Weeks
Phase 2: C-max
Maximum observed plasma concentration
Time frame: 32 Weeks
Phase 2: T1/2
apparent terminal half-life
Time frame: 32 Weeks
Phase 2: AUC0-t
area under the plasma concentration time curve from time 0 to the time of last observed quantifiable concentration
Time frame: 32 Weeks
Phase 2: Percentage of Participants With Positive Antidrug Antibody (ADA) and Neutralizing Antibody (Nab)
Results for ADA analysis were reported.
Time frame: 104 Weeks