For Healthcare Professionals

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

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About the study

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).
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

Healthy volunteers:

  1. Healthy participants
  2. Body mass index (BMI) between 18 and 32 kg/m^2

CHB participants:

  1. CHB infection (HBsAg-positive for >/= 6 months)
  2. On NUC (ETV, TAF, or TDF) monotherapy for >/= 12 months
  3. 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
  4. BMI between 18 and 32 kg/m^2

EXCLUSION CRITERIA

Exclusion Criteria:

Healthy volunteers:

  1. History of any clinically significant disease
  2. Concomitant disease that could interfere with treatment or conduct of study
  3. Use of any treatment within the 2 weeks or within 5 half-lives prior to first dosing (whichever is longer)

CHB participants:

  1. Evidence of liver cirrhosis or decompensated liver disease
  2. History or suspicion of hepatocellular carcinoma (HCC)
  3. 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
  4. 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.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Chronic Hepatitis B

Age (in years)

18 - 65

Phase

Phase 1

Participants needed

110

Est. Completion Date

Feb 1, 2027

Treatment type

Interventional


Sponsor

Hoffmann-La Roche

ClinicalTrials.gov identifier

NCT05763576

Study number

BP44118

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