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drugset / Trial / NCT05835986

A First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7507062 in Participants With Systemic Lupus Erythematosus

NCT05835986 ↗

Phase 1 Active not recruiting 70 enrolled Hoffmann-La Roche
Non-randomizedSequentialOpen-labelTreatment

Summary

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.

Timeline

Start
2023-12-18
Primary completion
2027-11-30
Completion
2027-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject RO7507062 Unknown — Subcutaneous
Background Tocilizumab Monoclonal antibody 8 mg/kg Intravenous
Background Tocilizumab Monoclonal antibody 12 mg/kg Intravenous

Indications

systemic lupus erythematosus