Phase I Study of LBL-047 Given by Single Subcutaneous Injection in Healthy Adults and Patients With Systemic Lupus Erythematosus

What this Trial Is About

Researchers are evaluating LBL-047, a study drug given as a single subcutaneous injection, to assess its safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary clinical effects in both healthy adults and patients with systemic lupus erythematosus SLE. This Phase I, double-blind, randomized, placebo-controlled trial aims to understand how the drug behaves in the body and its initial effects in people with mild to moderate SLE. The study is divided into two parts. Part A involves healthy adults receiving escalating doses of LBL-047 or placebo through a single subcutaneous injection, with dose increases guided by a Safety Monitoring Committee. Part B enrolls adult patients with mild to moderate SLE, confirmed safe doses from Part A are administered as a single injection. Participants are randomized to either the drug or placebo groups. Participants will be monitored from the first dose until 85 days after injection for treatment-emergent and serious adverse events, drug levels in the body, immune responses, and pharmacodynamic effects. Assessments include laboratory tests and clinical evaluations to track safety and biological activity. The study plans to enroll 76 participants, with possible additions, and involves scheduled visits, laboratory testing, and safety monitoring throughout the observation period.

A Phase I Study to Assess LBL-047 in Healthy Adults and Patients With Systemic Lupus Erythematosus