A First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7507062 in Participants With Systemic Lupus Erythematosus
Condition(s) studied
Investigational drug(s) / intervention(s)
RO7507062: RO7507062 solution for injection will be administered SC as specified in each treatment part (arm).
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.
Study 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.
Eligibility
Primary outcome measure(s)
- Part 1: Number of Participants with Dose Limiting Adverse Events (DLAEs) — Day 1 through Day 29
- Part 2: Fractionated Dose Cohort: Number of Participants with DLAEs — Day 1 through to the end of the 28-day safety evaluation period
- Number of Participants with Adverse Events (AEs) — Up to approximately 12 months
Adverse events will be reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), and CRS, will be graded based on the American Society for Transplantation and Cell Therapy (ASTCT) criteria.
Trial sites (18)
| Facility | City | Region | Status |
|---|---|---|---|
| Clinica De La Costa | Barranquilla | Colombia | |
| Hospital Pablo Tobon Uribe | Medellín | Colombia | |
| Groupe Hospitalier Pitie-Salpetriere | Paris | France | |
| Charité Research Organisation GmbH | Berlin | Germany | |
| Hospital Umum Sarawak | Kuching | Malaysia | |
| CREA Hospital Mexico Americano | Guadalajara | Jalisco | |
| Hospital Angeles De Lindavista | Mexico City | Mexico CITY (federal District) | |
| Hospital General De Mexico | Mexico City | Mexico CITY (federal District) | |
| Centre For Human Drug Research | Leiden | Netherlands | |
| Clínica San Juan Bautista CSJB | Lima | Peru | |
| Wojskowy Instytut Medyczny- Panstwowy Instytut Badawczy | Warsaw | Poland | |
| FARMOVS (Pty) Ltd | Bloemfontein | South Africa | |
| Hospital General Universitario Gregorio Marañon | Madrid | Spain | |
| Hospital Universitario 12 de Octubre | Madrid | Spain | |
| Chung Shan Medical University Hospital | Taichung | Taiwan | |
| Chang Gung Medical Foundation - Linkou | Taoyuan | Taiwan | |
| Ramathibodi Hospital, Mahidol Uni | Bangkok | Thailand | |
| UCL Hospital NHS Trust | London | United Kingdom |
On this site
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05835986 on ClinicalTrials.gov ↗ ← All trials in the UK