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A Study to Investigate the Safety, Tolerability, and Processing by the Body of Intravenous and Subcutaneous RO7121932 Administration in Participants With Multiple Sclerosis
Sponsor: Hoffmann-La Roche
Summary
The primary purpose of the study is to evaluate the safety and tolerability of a single-ascending intravenous (IV) dose (Part 1), a single-ascending subcutaneous (SC) dose (Part 2), and multiple ascending SC doses (Part 3) of RO7121932 in participants with multiple sclerosis (MS).
Official title: A Multiple-center, Non-randomized, Open-label, Adaptive, Single-ascending Dose (Part 1 and Part 2) and Multiple-ascending Dose (Part 3) Parallel, Phase IB Study to Investigate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of RO7121932 Following Intravenous (Parts 1) and Subcutaneous Administration (Parts 2 and 3) in Participants With Multiple Sclerosis
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
129
Start Date
2021-08-11
Completion Date
2027-07-08
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
RO7121932 IV
Participants will receive RO7121932, as an IV infusion, per the schedule specified in the treatment arms.
RO7121932 SC
Participants will receive RO7121932, as SC injection, per the schedule specified in the treatment arms.
Locations (32)
Stanford University Medical Center
Stanford, California, United States
Yale University Multiple Sclerosis Center
New Haven, Connecticut, United States
University of South Florida
Tampa, Florida, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
UC Health, LLC.
Cincinnati, Ohio, United States
Cliniques Universitaires St-Luc
Brussels, Belgium
UZ Gent
Ghent, Belgium
Montreal Neurological Institute and Hospital
Montreal, Quebec, Canada
Universitätsklinikum "Carl Gustav Carus"
Dresden, Germany
Universitätsmedizin Göttingen Georg-August-Universität
Göttingen, Germany
Klinikum rechts der Isar der TU Muenchen
München, Germany
Universitätsklinikum Münster Klinik u. Poliklinik f. Neurologie
Münster, Germany
Universitätsklinikum Tübingen, Zentrum für Neurologie
Tübingen, Germany
Universitätsklinikum Ulm
Ulm, Germany
Hadassah University Hospital - Ein Kerem
Jerusalem, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
IRCCS Ospedale San Raffaele
Milan, Lombardy, Italy
Fond. Istituto Neurologico C.Besta
Milan, Lombardy, Italy
ARENSIA Exploratory Medicine Phase I, PMSI Republican Clinical Hospital
Chisinau, Moldova
Uniwersyteckie Centrum Kliniczne
Gda?sk, Poland
Regionalny Szpital Specjalistyczny im. W. Bieganskiego
Grudzi?dz, Poland
MedPolonia
Poznan, Poland
Osrodek Badan Klinicznych Euromedis
Szczecin, Poland
Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
Warsaw, Poland
SPSK nr 1
Zabrze, Poland
Hospital de Braga
Braga, Portugal
Hospital Santo Antonio dos Capuchos
Lisbon, Portugal
Centro Hospitalar Entre o Douro e Vouga E.P.E. - Hospital de São Sebastião
Santa Maria da Feira, Portugal
ARENSIA Exploratory Medicine SRL - Bucharest (Monza Medical Center)
Bucharest, Romania
ARENSIA Exploratory Medicine, County Emergency Hospital
Cluj-Napoca, Romania
University Clinical Center of Serbia
Belgrade, Serbia
Hospital Universitari Vall dHebron (CEMCAT)
Barcelona, Spain