Chronic Hepatitis BPhase 1NCT05763576
A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection
A Phase 1 study testing RO7565020 and Nucleos(t)ide analogue (NUC) treatment in people with Chronic Hepatitis B, run by Hoffmann-La Roche at 9 sites in 7 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- RO7565020 and Nucleos(t)ide analogue (NUC) treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 9 sitesin 7 countries
- Study dates
- 28 Apr 2023to 23 Dec 2024
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
9 sites in 7 countries.
9 sites in 7 countries
Hong Kong2 sites
Queen Mary Hospital
Hong Kong
Prince of Wales Hospital
Shatin, New Territories
Thailand2 sites
Faculty of Medicine Siriraj Hospital
Bangkok, 10700
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, 50200
United States1 site
Quest Clinical Research
San Francisco, California, 94115
South Korea1 site
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, 24253
About this study
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
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).
- Conditions
- Chronic Hepatitis B
- Being tested
- RO7565020, Placebo, Nucleos(t)ide analogue (NUC) treatment
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7565020Drug
RO7565020 will be administered by subcutaneous injection or intravenous infusion.
PlaceboOther
Matching placebo will be administered by subcutaneous injection or intravenous infusion.
Nucleos(t)ide analogue (NUC) treatmentDrug
NUC treatment, including tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), or entecavir (ETV), will be administered orally per local prescribing information.
| Study group | Role | What they receive |
|---|---|---|
| RO7565020 | Experimental | Not described Receives: Drug: RO7565020; Drug: Nucleos(t)ide analogue (NUC) treatment |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1a: Number of Healthy Volunteers With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory finding), symptoms, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any significant hazard, contraindication, or side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention.
Measured: Up to approximately 40 weeks
Part 2a: Number of CHB Participants With AEs and SAEs
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory finding), symptoms, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any significant hazard, contraindication, or side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention.
Measured: Up to approximately 32 weeks
Part 1a: Number of Healthy Volunteers With Adverse Events of Special Interest (AESI)
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory finding), symptoms, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AESI includes elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value in combination with either an elevated bilirubin value or clinical jaundice and suspected transmission of an infectious agent by the study treatment.
Measured: Up to approximately 40 weeks
Part 2a: Number of CHB Participants With AESI
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory finding), symptoms, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AESI includes elevated ALT or AST value in combination with either an elevated bilirubin value or clinical jaundice and suspected transmission of an infectious agent by the study treatment.
Measured: Up to approximately 32 weeks
Secondary outcomes (17)
Part 1a (SC Cohorts) and Part 2a: Time to Maximum Concentration (Tmax) of RO7565020
Measured: Part 1a: Predose, 1, 4, and 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 21, 29, 57, 85, 141, 197, and 253. Part 2a: Predose, 1, 4, and 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, and 169
Part 1a (IV Cohorts): Tmax of RO7565020
Measured: Predose, 0.08, 1, 4, and 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 21, 29, 57, 85, 141, 197, and 253
Parts 1a and 2a: Maximum Serum Concentration (Cmax) of RO7565020
Measured: Both Part 1a & 2a Cohorts: Predose, 1, 4, 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 29, 57, 85, & 141. Additionally, Part 1a: Days 21, 197, & 253; Part 2a: Days 22, 113, & 169; IV Cohorts: 0.08 hours after start of infusion, Days 21, 197, & 253
Parts 1a and 2a: Area Under the Time-concentration Curve From Time 0 to Time of Last Sampling Point or Last Quantifiable Sample, Whichever Comes First (AUC0-last) of RO7565020
Measured: Both Part 1a & 2a Cohorts: Predose, 1, 4, 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 29, 57, 85, & 141. Additionally, Part 1a: Days 21, 197, & 253; Part 2a: Days 22, 113, & 169; IV Cohorts: 0.08 hours after start of infusion, Days 21, 197, & 253
Parts 1a and 2a: Area Under the Time-concentration Curve From Time 0 to Infinity (AUC0-inf) of RO7565020
Measured: Both Part 1a & 2a Cohorts: Predose, 1, 4, 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 29, 57, 85, & 141. Additionally, Part 1a: Days 21, 197, & 253; Part 2a: Days 22, 113, & 169; IV Cohorts: 0.08 hours after start of infusion, Days 21, 197, & 253
Parts 1a and 2a: Terminal Half-life (t1/2) of RO7565020
Measured: Both Part 1a & 2a Cohorts: Predose, 1, 4, 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 29, 57, 85, & 141. Additionally, Part 1a: Days 21, 197, & 253; Part 2a: Days 22, 113, & 169; IV Cohorts: 0.08 hours after start of infusion, Days 21, 197, & 253
Part 1a (IV Cohorts): Volume of Distribution (Vss) of RO7565020
Measured: Predose, 0.08, 1, 4, and 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 21, 29, 57, 85, 141, 197 and 253
Part 1a (IV Cohorts): Clearance (CL) of RO7565020
Measured: Predose, 0.08, 1, 4, and 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 21, 29, 57, 85, 141, 197 and 253
Part 1a (SC Cohorts) and Part 2a: Apparent Clearance (CL/F) of RO7565020
Measured: Part 1a: Predose, 1, 4, and 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 21, 29, 57, 85, 141, 197, and 253. Part 2a: Predose, 1, 4, and 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, and 169
Part 1a (SC Cohorts) and Part 2a: Apparent Volume of Distribution (Vz/F) at Terminal Phase of RO7565020
Measured: Part 1a: Predose, 1, 4, and 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 21, 29, 57, 85, 141, 197, and 253. Part 2a: Predose, 1, 4, and 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, and 169
Part 2a: Change From Baseline in Serum Quantitative Hepatitis B Surface Antigen (HBsAg)
IU/mL= international units per milliliter
Measured: Baseline, 4- and 8-hours post-dose on Day 1; subsequently on Days 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, and 169
Part 2a: Maximum Reduction From Baseline in Serum HBsAg
Measured: Up to Day 169
Part 2a: Percentage of Participants With HBsAg Loss
Measured: Up to Day 169
Part 2a: Percentage of Participants With HBsAg Seroconversion
HBsAg seroconversion was defined as sustained loss of HBsAg and detection of anti-HBs antibody.
Measured: Up to Day 169
Part 2a: Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss Among HBeAg-positive Participants at Baseline
Measured: At Days 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, and 169
Part 2a: Percentage of Participants With HBeAg Seroconversion Among HBeAg-positive Participants at Baseline
HBeAg seroconversion was defined as sustained loss of HBeAg and detection of anti-HBe antibody.
Measured: Up to Day 169
Number of Participants With Anti-Drug Antibodies (ADAs) to RO7565020
The number of ADA-positive participants at baseline (baseline prevalence) and after drug administration was determined in participants exposed to RO7565020 (post-baseline). Participants were considered ADA positive if they had ADA negative or have missing data at baseline but develop an ADA response following study treatment administration (treatment-induced ADA response), or if they are ADA positive at baseline and the titer of one or more post-baseline samples is at least 4-fold (e.g., ≥ 0.60-titer units) greater than the titer of the baseline sample (treatment enhanced ADA response).
Measured: Part 1a: Baseline and post-baseline (up to approximately 40 weeks); Part 2a: Baseline and post-baseline (up to approximately 32 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start28 Apr 2023
- Primary completion23 Dec 2024
- Study completion23 Dec 2024
Why it stopped: The Sponsor decided to discontinue the development of RO7565020 and as a result the BP44118 study was terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763576
- Sponsor's protocol ID
- BP44118
- Other IDs
- EU Trial Number
- Status last verified
- Jan 2026
- First submitted
- 28 Feb 2023
- Last updated
- 22 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No