Last updated on April 2018

Study to Assess Safety Efficacy Pharmacokinetics and Pharmacodynamics of RO7112689 in Healthy Volunteers and Participants With Paroxysmal Nocturnal Hemoglobinuria


Brief description of study

This is a Phase I/II, first-in-human study consisting of 3 sequential parts and an open-label extension (OLE) in which the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single-doses of RO7112689 will be evaluated in healthy volunteers (HV) during Part I, and safety, tolerability, PK, and PD of RO7112689 will be evaluated in participants with PNH during Parts 2, 3, and OLE of the study. Efficacy of RO7112689 will be evaluated in Parts 2 and 3.

Clinical Study Identifier: NCT03157635

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Universit tsklinikum Essen; Klinik f r H matologie
Essen, Germany
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Semmelweis Egyetem, 1. Szamu Belgyogyaszati Klinika, Diabetologia
Budapest, Hungary
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Kaposi Mor Teaching Hospital, Dept of Internal Medicine/Hematology
Kaposvar, Hungary
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Osaka University Hospital; Hematology and Oncology
Osaka, Japan
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NTT Medical Center Tokyo
Tokyo, Japan
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University of Tsukuba Hospital; Hematology
Tsukuba, Japan
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Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of
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Asan Medical Center
Seoul, Korea, Republic of
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Seoul National University Hosp; Dept Internal Med Hem Onc
Seoul, Korea, Republic of
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Pra International Group B.V
Groningen, Netherlands
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Institut hematologie Centre Hayem CHU paris Saint-Louis Lariboisiere F Widal Hopital St Louis
Paris, France
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Uniklinik RWTH Aachen; Med. Klinik IV; Klinik f r H matologie, Onkologie, H mostaseologie und Stammz
Aachen, Germany
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Elblandklinikum Riesa; Klinik fuer Haematologie Onkologie und Gastroenterologie
Riesa, Germany
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Universit tsklinikum Ulm; Institut f r Klinische Transfusionsmedizin
Ulm, Germany
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Policlinico Universitario Agostino Gemelli
Roma, Italy
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Ospedale Di Vicenza; Nefrologia, Ematologia
Vicenza, Italy
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Tohoku University Hospital
Miyagi, Japan
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Tokyo Medical University Hospital
Tokyo, Japan
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Keio University Hospital
Tokyo, Japan
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Centre Hospitalier Lyon Sud
Pierre Benite, France
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A.O. UNIVERSITARIA FEDERICO II DI NAPOLI;Dipartimento di Medicina Clinica e Chirurgia
Napoli, Italy
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