Last updated on September 2017

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 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, PD, and efficacy of multiple-doses of RO7112689 will be evaluated in participants with paroxysmal nocturnal hemoglobinuria (PNH) during Parts 2 and 3 of the study.

Clinical Study Identifier: NCT03157635

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Reference Study ID Number: BP39144 ...

Universit tsklinikum Essen; Klinik f r H matologie
Essen, Germany
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Reference Study ID Number: BP39144 ...

Semmelweis Egyetem, 1. Szamu Belgyogyaszati Klinika, Diabetologia
Budapest, Hungary
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Reference Study ID Number: BP39144 ...

Kaposi Mor Teaching Hospital, Dept of Internal Medicine/Hematology
Kaposvar, Hungary
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Reference Study ID Number: BP39144 ...

Osaka University Hospital; Hematology and Oncology
Osaka, Japan
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Reference Study ID Number: BP39144 ...

NTT Medical Center Tokyo
Tokyo, Japan
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Reference Study ID Number: BP39144 ...

University of Tsukuba Hospital; Hematology
Tsukuba, Japan
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Reference Study ID Number: BP39144 ...

Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of
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Reference Study ID Number: BP39144 ...

Asan Medical Center
Seoul, Korea, Republic of
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Reference Study ID Number: BP39144 ...

Seoul National University Hosp; Dept Internal Med Hem Onc
Seoul, Korea, Republic of
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Reference Study ID Number: BP39144 ...

Pra International Group B.V
Groningen, Netherlands
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