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

  • Chronic Hepatitis B
Trial Status:

Not yet recruiting

This trial runs in
Cities
Trial Identifier:

NCT05763576 EU Trial Number BP44118

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      Trial Summary

      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).

      Hoffmann-La Roche Sponsor
      Phase 1 Phase
      NCT05763576 , BP44118 , EU Trial Number Trial Identifier
      RO7565020, Placebo, Nucleos(t)ide analogue (NUC) treatment Treatments
      Chronic Hepatitis B Condition
      Official Title

      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

      Eligibility Criteria

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

      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
      Exclusion Criteria

      Healthy volunteers:

      • History of any clinically significant disease
      • 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:

      • Evidence of liver cirrhosis or decompensated liver disease
      • History or suspicion of hepatocellular carcinoma (HCC)
      • 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
      • 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.

      For the latest version of this information please go to www.forpatients.roche.com

       

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