Systemic Lupus Erythematosus Clinical Trial
Official title:
An Open-label, Multicenter, Dose Escalation, First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered RO7507062 in Participants With Systemic Lupus Erythematosus
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of RO7507062 in participants with systemic lupus erythematosus (SLE). The study will have 2 parts: Part 1 is a single ascending dose-finding (SAD) part and Part 2 is a dose escalation with fractionated dosing part.
Tocilizumab is an additional investigational medicinal product (IMP), which will be used when required in case of clinical presentation of cytokine release syndrome (CRS). Data on the efficacy of tocilizumab in ameliorating the symptoms of CRS related to RO7507062 will be collected in this study. ;
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