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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05763576




Registration number
NCT05763576
Ethics application status
Date submitted
28/02/2023
Date registered
10/03/2023
Date last updated
8/11/2024

Titles & IDs
Public title
A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection
Scientific 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
Secondary ID [1] 0 0
EU Trial Number
Secondary ID [2] 0 0
BP44118
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - RO7565020
Other interventions - Placebo
Treatment: Drugs - Nucleos(t)ide analogue (NUC) treatment

Experimental: RO7565020 -

Placebo comparator: Placebo -


Treatment: Drugs: RO7565020
RO7565020 will be administered by subcutaneous injection or intravenous infusion.

Other interventions: Placebo
Matching placebo will be administered by subcutaneous injection or intravenous infusion.

Treatment: Drugs: Nucleos(t)ide analogue (NUC) treatment
NUC treatment, including tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), or entecavir (ETV), will be administered orally per local prescribing information.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Healthy Volunteers With Adverse Events
Timepoint [1] 0 0
Up to 104 weeks
Primary outcome [2] 0 0
Percentage of Participants With Chronic Hepatitis B With Adverse Events
Timepoint [2] 0 0
Up to 104 weeks
Secondary outcome [1] 0 0
Serum Concentrations of RO7565020
Timepoint [1] 0 0
Up to 104 weeks
Secondary outcome [2] 0 0
Change from Baseline in Serum Quantitative Hepatitis B Surface Antigen (HBsAg)
Timepoint [2] 0 0
Up to 104 weeks
Secondary outcome [3] 0 0
Maximum Reduction from Baseline of Serum HBsAg Across All Timepoints
Timepoint [3] 0 0
Up to 104 weeks
Secondary outcome [4] 0 0
Percentage of Participants With HBsAg Loss
Timepoint [4] 0 0
Up to 104 weeks
Secondary outcome [5] 0 0
Percentage of Participants With HBsAg Seroconversion
Timepoint [5] 0 0
Up to 104 weeks
Secondary outcome [6] 0 0
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss Among HBeAg-positive Participants at Baseline
Timepoint [6] 0 0
Up to 104 weeks
Secondary outcome [7] 0 0
Percentage of Participants With HBeAg Seroconversion Among HBeAg-positive Participants at Baseline
Timepoint [7] 0 0
Up to 104 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
13/05/2026
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
Bulgaria
State/province [2] 0 0
Sofia
Country [3] 0 0
France
State/province [3] 0 0
Clichy cedex
Country [4] 0 0
France
State/province [4] 0 0
Paris
Country [5] 0 0
Hong Kong
State/province [5] 0 0
Hong Kong
Country [6] 0 0
Hong Kong
State/province [6] 0 0
Shatin, New Territories
Country [7] 0 0
Korea, Republic of
State/province [7] 0 0
Chuncheon
Country [8] 0 0
Korea, Republic of
State/province [8] 0 0
Seoul
Country [9] 0 0
New Zealand
State/province [9] 0 0
Auckland
Country [10] 0 0
Spain
State/province [10] 0 0
Pontevedra
Country [11] 0 0
Taiwan
State/province [11] 0 0
Taoyuan City
Country [12] 0 0
Taiwan
State/province [12] 0 0
Xitun Dist.
Country [13] 0 0
Thailand
State/province [13] 0 0
Bangkok
Country [14] 0 0
Thailand
State/province [14] 0 0
Chiang Mai

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT05763576
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: BP44118 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. Only)
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05763576