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RECRUITING
NCT05835986
PHASE1

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

View on ClinicalTrials.gov

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

Interventions

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.

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