NCT05835986

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Tocilizumab is an additional investigational medicinal product (IMP), which may be used at the investigator's discretion when required in case of clinical presentation of cytokine release syndrome (CRS).

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	RO7507062	RO7507062 solution for injection will be administered SC as specified in each treatment part (arm).
DRUG	Tocilizumab	When applicable, tocilizumab solution for infusion will be administered intravenously at 8 milligram per kilogram (mg/kg) for participants \>/= 30 kg or at 12 mg/kg for participants \< 30 kg.

Timeline

• Start date: 2023-12-18
• Primary completion: 2027-11-30
• Completion: 2027-11-30
• First posted: 2023-04-28
• Last updated: 2026-04-13

Locations

24 sites across 13 countries: Colombia, France, Germany, Malaysia, Mexico, Netherlands, Peru, Poland, South Africa, Spain, Taiwan, Thailand, United Kingdom