Clinical Research Directory
Browse clinical research sites, groups, and studies.
A First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7507062 in Participants With Systemic Lupus Erythematosus
Sponsor: Hoffmann-La Roche
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.
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
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2023-12-18
Completion Date
2027-11-30
Last Updated
2026-03-12
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (24)
Clinica De La Costa
Barranquilla, Colombia
Hospital Pablo Tobon Uribe
Medellín, Colombia
Oncomedica S.A.
Montería, Colombia
Hôpital Saint Eloi
Montpellier, France
Groupe Hospitalier Pitie-Salpetriere
Paris, France
Charité Research Organisation GmbH
Berlin, Germany
Universitätsklinikum Duesseldorf
Düsseldorf, Germany
Hospital Umum Sarawak
Kuching, Malaysia
CREA Hospital Mexico Americano
Guadalajara, Jalisco, Mexico
Hospital Angeles De Lindavista
Mexico City, Mexico CITY (federal District), Mexico
Hospital General De Mexico
Mexico City, Mexico CITY (federal District), Mexico
Centre For Human Drug Research
Leiden, Netherlands
Clínica San Juan Bautista CSJB
Lima, Peru
Uniwersytecki Szpital Kliniczny w Poznaniu
Późna, Poland
MICS Centrum Medyczne Damiana, Walbrzyska
Warsaw, Poland
Wojskowy Instytut Medyczny- Panstwowy Instytut Badawczy
Warsaw, Poland
FARMOVS (Pty) Ltd
Bloemfontein, South Africa
Hospital Universitario Reina Sofia
Córdoba, Spain
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 District, Taiwan
Ramathibodi Hospital, Mahidol Uni
Bangkok, Thailand
UCL Hospital NHS Trust
London, United Kingdom