A Double-blind, Randomized, Placebo-controlled, Dose-escalation Phase I Study to Assess the Safety and PK/PD of LBL-047 Subcutaneous Injection in Healthy Adults and Patients with Systemic Lupus Erythematosus.
This study is a double-blind, randomized, placebo-controlled phase I clinical study to evaluate the safety, tolerability, PK, PD and immunogenicity of LBL-047 subcutaneously administered in healthy adults and subjects with systemic lupus erythematosus, while also preliminarily evaluating the clinical efficacy of LBL-047 in subjects with systemic lupus erythematosus. The study is divided into two parts. Part A: Study in healthy adults.A total of 7 dose-escalation cohorts were planned for Part A.Dose escalation will be determined by the Safety Monitoring Committee (SMC). Part B: Study in Adult Patients with Systemic Lupus Erythematosus.Part B will commence at a dose level that has been confirmed to be safe and tolerable in Part A. This study is projected to enroll 81 participants (potentially with an additional 36).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
117
subcutaneous injection
subcutaneous injection
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China
NOT_YET_RECRUITINGBeijing GoBroad Hospital
Beijing, Beijing Municipality, China
Occurrence of Treatment-Emergent adverse event (TEAE) and serious adverse event (SAE)
Adverse event (AE) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0.The safety profile of LBL-047 will be assessed by monitoring the adverse event (AE) and serious adverse event (SAE) During treatment.
Time frame: From first dose until last visit(within 89 days after drug injection)
Cmax
Maximum drug concentration in plasma after administration.
Time frame: From first dose until last visit(within 89 days after drug injection)
Tmax
After administration,Time to reach maximum drug concentration in plasma.
Time frame: From first dose until last visit(within 89 days after drug injection)
Immunogenicity
The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects.Immunogenicity refers to the performance that can elicit an immune response.
Time frame: From first dose until last visit(within 89 days after drug injection)
Assessment of Pharmacodynamics
Drug therapy effect and adverse reaction, such as B cell level.
Time frame: From first dose until last visit(within 89 days after drug injection)
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Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGXiangya School of Medicine of Central South University
Changsha, Hunan, China
NOT_YET_RECRUITINGNanjing Drum Tower Hospital
Nanjing, Jiangsu, China
NOT_YET_RECRUITINGPingxiang People's Hospital
Pingxiang, Jiangxi, China
RECRUITINGShanghai JiaoTong University School of Medicine,Renji Hospital
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGShanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China
RECRUITINGShanxi Bethune Hospital
Taiyuan, Shanxi, China
NOT_YET_RECRUITINGThe Second Affiliated Hospital of Xian Jiaotong University
Xian, Shanxi, China
RECRUITING...and 2 more locations