Last updated on September 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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Reference Study ID Number: BP39144 ...

Universit tsklinikum Essen; Klinik f r H matologie
Essen, Germany

Reference Study ID Number: BP39144 ...

Semmelweis Egyetem, 1. Szamu Belgyogyaszati Klinika, Diabetologia
Budapest, Hungary

Reference Study ID Number: BP39144 ...

Kaposi Mor Teaching Hospital, Dept of Internal Medicine/Hematology
Kaposvar, Hungary

Reference Study ID Number: BP39144 ...

Osaka University Hospital; Hematology and Oncology
Osaka, Japan

Reference Study ID Number: BP39144 ...

NTT Medical Center Tokyo
Tokyo, Japan

Reference Study ID Number: BP39144 ...

University of Tsukuba Hospital; Hematology
Tsukuba, Japan

Reference Study ID Number: BP39144 ...

Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of

Reference Study ID Number: BP39144 ...

Asan Medical Center
Seoul, Korea, Republic of

Reference Study ID Number: BP39144 ...

Seoul National University Hosp; Dept Internal Med Hem Onc
Seoul, Korea, Republic of

Reference Study ID Number: BP39144 ...

Pra International Group B.V
Groningen, Netherlands

Reference Study ID Number: BP39144 ...

Institut hematologie Centre Hayem CHU paris Saint-Louis Lariboisiere F Widal Hopital St Louis
Paris, France

Reference Study ID Number: BP39144 ...

Uniklinik RWTH Aachen; Med. Klinik IV; Klinik f r H matologie, Onkologie, H mostaseologie und Stammz
Aachen, Germany

Reference Study ID Number: BP39144 ...

Elblandklinikum Riesa; Klinik fuer Haematologie Onkologie und Gastroenterologie
Riesa, Germany

Reference Study ID Number: BP39144 ...

Universit tsklinikum Ulm; Institut f r Klinische Transfusionsmedizin
Ulm, Germany

Reference Study ID Number: BP39144 ...

Policlinico Universitario Agostino Gemelli
Roma, Italy

Reference Study ID Number: BP39144 ...

Ospedale Di Vicenza; Nefrologia, Ematologia
Vicenza, Italy

Reference Study ID Number: BP39144 ...

Tohoku University Hospital
Miyagi, Japan

Reference Study ID Number: BP39144 ...

Tokyo Medical University Hospital
Tokyo, Japan

Reference Study ID Number: BP39144 ...

Keio University Hospital
Tokyo, Japan

Reference Study ID Number: BP39144 ...

Centre Hospitalier Lyon Sud
Pierre Benite, France

Reference Study ID Number: BP39144 ...

A.O. UNIVERSITARIA FEDERICO II DI NAPOLI;Dipartimento di Medicina Clinica e Chirurgia
Napoli, Italy