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

Primary Purpose

Chronic Hepatitis B

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
RO7565020
Placebo
Nucleos(t)ide analogue (NUC) treatment
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Inland Empire Liver FoundationRecruiting
  • Quest Clinical ResearchRecruiting
  • New Zealand Clinical Research - AucklandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RO7565020

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Healthy Volunteers With Adverse Events
Percentage of Participants With Chronic Hepatitis B With Adverse Events

Secondary Outcome Measures

Serum Concentrations of RO7565020
Change from Baseline in Serum Quantitative Hepatitis B Surface Antigen (HBsAg)
Maximum Reduction from Baseline of Serum HBsAg Across All Timepoints
Percentage of Participants With HBsAg Loss
Percentage of Participants With HBsAg Seroconversion
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss Among HBeAg-positive Participants at Baseline
Percentage of Participants With HBeAg Seroconversion Among HBeAg-positive Participants at Baseline

Full Information

First Posted
February 28, 2023
Last Updated
October 5, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT05763576
Brief Title
A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2023 (Actual)
Primary Completion Date
February 1, 2027 (Anticipated)
Study Completion Date
February 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RO7565020
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
RO7565020
Intervention Description
RO7565020 will be administered by subcutaneous injection or intravenous infusion.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Matching placebo will be administered by subcutaneous injection or intravenous infusion.
Intervention Type
Drug
Intervention Name(s)
Nucleos(t)ide analogue (NUC) treatment
Intervention Description
NUC treatment, including tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), or entecavir (ETV), will be administered orally per local prescribing information.
Primary Outcome Measure Information:
Title
Percentage of Healthy Volunteers With Adverse Events
Time Frame
Up to 104 weeks
Title
Percentage of Participants With Chronic Hepatitis B With Adverse Events
Time Frame
Up to 104 weeks
Secondary Outcome Measure Information:
Title
Serum Concentrations of RO7565020
Time Frame
Up to 104 weeks
Title
Change from Baseline in Serum Quantitative Hepatitis B Surface Antigen (HBsAg)
Time Frame
Up to 104 weeks
Title
Maximum Reduction from Baseline of Serum HBsAg Across All Timepoints
Time Frame
Up to 104 weeks
Title
Percentage of Participants With HBsAg Loss
Time Frame
Up to 104 weeks
Title
Percentage of Participants With HBsAg Seroconversion
Time Frame
Up to 104 weeks
Title
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss Among HBeAg-positive Participants at Baseline
Time Frame
Up to 104 weeks
Title
Percentage of Participants With HBeAg Seroconversion Among HBeAg-positive Participants at Baseline
Time Frame
Up to 104 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: BP44118 https://forpatients.roche.com/
Phone
888-662-6728 (U.S. Only)
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Inland Empire Liver Foundation
City
Rialto
State/Province
California
ZIP/Postal Code
92377
Country
United States
Individual Site Status
Recruiting
Facility Name
Quest Clinical Research
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Individual Site Status
Recruiting
Facility Name
New Zealand Clinical Research - Auckland
City
Auckland
ZIP/Postal Code
1010
Country
New Zealand
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Learn more about this trial

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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