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NCT05763576TerminatedPhase 1

A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection

A Phase I Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection

Source: ClinicalTrials.gov · Last updated 22 Jan 2026

Brief summary (registry, in English)

This is a first in human (FIH), multi-center, dose-finding, and dose-escalation Phase I clinical study of RO7565020 to investigate the safety and tolerability and to characterize the pharmacokinetics and pharmacodynamics following single and/or multiple doses of RO7565020 in healthy participants and/or virologically suppressed participants with chronic hepatitis B (CHB).

Status (registry)
Terminated
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
60 (actual)
First submitted
28 Feb 2023
Start date
28 Apr 2023
Primary completion date
23 Dec 2024
Lead sponsor
Hoffmann-La Roche
Diseases
Hepatitis B
NCT number
NCT05763576

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concomitant disease that could interfere with treatment or conduct of study
  • Use of any treatment within the 2 weeks or within 5 half-lives prior to first dosing (whichever is longer)
    • CHB participants:
  • History of or currently receiving any systemic anti-neoplastic or immune-modulatory treatment within the 8 weeks prior to the first dosing or the expectation that such treatment will be needed at any time during the study.

Other illness

  • History of any clinically significant disease
  • Evidence of liver cirrhosis or decompensated liver disease
  • History or evidence of a medical condition associated with chronic liver disease other than HBV infection, or clinically significant and not adequately controlled non-hepatic disease

Other

  • Healthy volunteers:
  • History or suspicion of hepatocellular carcinoma (HCC)

Who the study is looking for

  • Healthy volunteers:
  • Healthy participants
  • Body mass index (BMI) between 18 and 32 kg/m\^2
    • CHB participants:
  • CHB infection (HBsAg-positive for >/= 6 months)
  • On NUC (ETV, TAF, or TDF) monotherapy for >/= 12 months
  • Liver biopsy, FibroScan, or equivalent test within the past 6 months demonstrating liver disease consistent with chronic HBV infection without evidence of bridging fibrosis or cirrhosis
  • BMI between 18 and 32 kg/m\^2

Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Hospital Alvaro Cunqueiro
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VigoSpainUnknown status
Queen Mary Hospital
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Hong KongHong KongUnknown status
Prince of Wales Hospital
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Shatin, New TerritoriesHong KongUnknown status
Hallym University Chuncheon Sacred Heart Hospital
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ChuncheonSouth KoreaUnknown status
New Zealand Clinical Research - Auckland
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AucklandNew ZealandUnknown status
Faculty of Medicine Siriraj Hospital
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BangkokThailandUnknown status
Maharaj Nakorn Chiang Mai Hospital
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Chiang MaiThailandUnknown status
Chang Gung Medical Foundation Linkou Branch
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Taoyuan CityTaiwanUnknown status
Quest Clinical Research
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San FranciscoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.