A Study of RO7239958 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Volunteers and Participants With Chronic Hepatitis B Virus Infection

  • Infectious Diseases
  • Hepatitis B Virus
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Terminated

This study runs in
Countries
  • Bulgaria
  • Hong Kong
  • New Zealand
  • Poland
  • South Korea
  • Taiwan
  • United Kingdom
Study Identifier:

NCT03762681 NP40520

  • Acibadem City Clinic Tokuda Hospital Ead

    51Б bul. "Nikola Y. Vaptsarov"1407SofiaBulgaria
  • Asan Medical Center.

    05505SeoulSouth Korea
  • Auckland Clinical Studies Limited

    12 Queen St1010AucklandNew Zealand
  • Chelsea & Westminster Hospital

    369 Fulham Rd.SW10 9NHLondonUnited Kingdom
  • COMAC Medical; Clinical Research Unit for Phase I

    SofiaBulgaria
  • ID Clinic

    19 Janowska41-400MysłowicePoland
  • Kaohsiung Medical University

    100號 Shihcyuan 1st Rd807Kaohsiung CityTaiwan
  • King College Hospital NHS Foundation Trust

    SE5 9RSLondonUnited Kingdom
  • National Cheng Kung University Hospital

    138號 Shengli Rd704Tainan CityTaiwan
  • Pusan National University Hospital

    BusanSouth Korea
  • Queen Mary Hospital

    Hong Kong IslandHong Kong
  • Royal Liverpool University Hospital

    L7 8YELiverpoolUnited Kingdom
  • St George's Hospital

    SW17 0QTLondonUnited Kingdom
  • Western General Hospital

    EH4 2XUEdinburghUnited Kingdom
    Show study locations

    The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

    The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

    Results Disclaimer

    Study Summary

    This study is designed to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending doses in healthy volunteers (HV) and participants diagnosed with chronic hepatitis B (CHB).

    Hoffmann-La Roche Sponsor
    Phase 1 Phase
    NCT03762681, NP40520, 2018-003530-32 Study Identifier
    RO7239958, Placebo Treatments
    Hepatitis B Virus Infection Condition
    Official Title

    A Randomized, Placebo-controlled,Observer-blinded Study, to Evaluate Safety,Tolerability, Pharmacokinetics and Pharmacodynamics of RO7239958 in Healthy Volunteers and Patients With Chronic Hepatitis B Virus Infection

    Eligibility Criteria

    All Gender
    ≥18 Years & ≤ 65 Years Age
    Accepts Healthy Volunteers Healthy Volunteers
    Inclusion Criteria

    All Parts

    • Female participants should be of non-childbearing potential and male participants who are with pregnant partners or partners of childbearing potential must agree to remain abstinent or use contraceptive measures

    Part 1 (SAD HV only)

    • Healthy, as judged by the Investigator
    • Non-smoker (nor tobacco containing products) for at least 90 days prior to dosing on Day 1, and agrees to remain non-smoker during the study

    Part 2 (CHB only)

    • Positive serum HBsAg status for > 6 months prior to screening
    • Serum HBsAg level ≥ 250 IU/mL at screening
    • On stable entecavir or tenofovir (alone or in combination) treatment and having received the same drug in the 3 months prior to randomisation
    • HBV DNA below the lower limit of quantification (LLQ) for ≥ 6 months prior to screening by local testing, and confirmed at screening
    • Screening laboratory values (including hematology, chemistry, urinalysis) within normal ranges
    • No past or current diagnosis of cirrhosis
    Exclusion Criteria

    All Parts

    • History or presence of significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological disorders, or diagnosed central or peripheral neurological disease, capable of altering the absorption, metabolism, or elimination of drugs, or constituting a risk when taking the study treatment, or of interfering with the interpretation of the data
    • History of lymphoma, leukemia, or malignancy within the past five years
    • Positive for human immunodeficiency virus (HIV) infection
    • Participant under judicial supervision, guardianship or curatorship

    Part 1 (SAD HV only)

    • Screening ECG showing clinically relevant abnormalities
    • Abnormal blood pressure
    • History or presence of liver disease, or known hepatic or biliary abnormalities
    • Alanine aminotransferase (ALT) ≥1.5 × upper limit of normal (ULN)
    • Any clinically significant out of range findings in other laboratory test results or any other clinically significant (as judged by the Investigator) abnormalities in the physical examination at screening and on Day -1
    • Positive for hepatitis B surface antigen (HBsAg), or hepatitis B core total antibody [anti-HBc]), or hepatitis C virus (HCV) antibody test result

    Part 2 (CHB only)

    • History or presence of bridging fibrosis or cirrhosis or decompensated liver disease
    • History or presence of a medical condition associated with liver disease other than HBV infection. Other known hepatic or biliary abnormalities
    • History of or suspicion of hepatocellular carcinoma or alpha fetoprotein (AFP) ≥13 ng/mL
    • History of having received (in the last six months) or currently receiving any systemic antineoplastic (including radiation) or immune-modulatory treatment (including systemic corticosteroids)
    • History of organ transplantation
    • Estimated glomerular filtration rate (eGFR) <70 mL/min/1.73m^2
    • Confirmed QT interval corrected using Fridericia's formula (QTcF) >450 ms
    • Expected to need any other systemic antiviral therapy at any time during participation in the study
    • Positive hepatitis C antibody test

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