Last updated on August 2018

A Study to Evaluate the Safety Tolerability and Pharmacokinetics and Pharmacodynamics of RO7062931in Healthy Volunteers and Subjects With Chronic Hepatitis B


Brief description of study

This randomized study will be conducted in two parts to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of subcutaneous administration of RO7062931. Part 1 will include only healthy participants and Part 2 will include only participants with chronic hepatitis B (CHB). Part 1 is an adaptive, single-ascending dose study with an adaptive dose-escalating schedule to determine the best dose to be evaluated in participants with CHB. Part 2 is an adaptive, parallel multiple-dose study comprised of two sub-parts which will be used to further refine the dose and dosing regimen.

Clinical Study Identifier: NCT03038113

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Auckland Clinical Studies
Auckland, New Zealand
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Linear Clinical Research Limited
Nedlands, Australia
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Queen Mary Hospital
Hong Kong, Hong Kong
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Gangnam Severance Hospital
Seoul, Korea, Republic of
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SMG-SNU Boramae Medical Center
Seoul, Korea, Republic of
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Middlemore Hospital
Auckland, New Zealand
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Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
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Chang Gung Medical Foundation - Kaohsiung Branch
Kaohsiung, Taiwan
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Prince of Wales Hospital
Shatin, New Territories, Hong Kong
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Chuncheon Sacred Heart Hospital
Gangwon-Do, Korea, Republic of
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ChungAng University Hospital
Seoul, Korea, Republic of
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University of Ulsan College of Medicine, Asan Medical Center, Digestive Disease Center
Seoul, Korea, Republic of
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National University Hospital; Dept of Gastroenterology & Hepatology
Singapore, Singapore
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Siriraj Hospital; Dept. of Medicine
Bangkok, Thailand
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Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, Thailand
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Royal Melbourne Hospital
Parkville, Australia
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Singapore General Hospital; Gastroenterology & Hepatology
Singapore, Singapore
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Taipei Veterans General Hospital
Taipei City, Taiwan
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Chang Gung Medical Foundation Linkou Branch
Taoyuan City, Taiwan
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