Finding studies
Finding studies
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lei liu
CONTACT
Lead
Nanjing Leads Biolabs Co.,Ltd
With
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).
Age
18–60
Sex
ALL
Healthy volunteers
Accepted
