Chronic Hepatitis BPhase 1NCT03038113

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of RO7062931in Healthy Volunteers and Subjects With Chronic Hepatitis B

A Phase 1 study testing RO7062931 and Immune Modulator in people with Chronic Hepatitis B, run by Hoffmann-La Roche at 19 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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?: RO7062931 and Immune Modulator
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 119 participants
Where: 19 sitesin 7 countries
Study dates: 6 Feb 2017to 18 Oct 2019
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

FOR HEALTHY VOLUNTEERS ONLY - PART 1 -
A Body Mass Index (BMI) between 18 to 30 kg/m2 inclusive and a body weight of at least 50 kg.
Women should be of non-childbearing potential. A woman is considered to be of childbearing potential if she is post-menarcheal but has not reached a post-menopausal state and has not undergone surgical sterilization (removal of ovaries and/or uterus).
Men must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures during treatment and up to 105 days after the last dose, and agree to refrain from donating sperm.
Non-smoker (nor tobacco containing products) for at least 90 days prior to dosing on Day 1 and agree to remain as non-smoker during the study.
FOR CHB PARTICIPANTS ONLY - PARTS 2a and 2b:

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A BMI between 18 to 32 kg/m2 inclusive.
Chronic hepatitis B (HBV) infection.
Positive test for HBsAg for more than 6 months prior to randomization and HBsAg titer ≥ 10^3 IU/mL at screening.
On entecavir, tenofovir, adefovir or telbivudine treatment for at least 6 months prior to randomization and will remain on stable treatment during the study.
HBV deoxyribonucleic acid (DNA) ≤ 90 IU/mL for at least the preceding 6 months.
Screening laboratory values (hematology, chemistry, urinalysis) obtained up to 56 days prior to first study treatment within normal ranges.
Liver biopsy, fibroscan® or equivalent test obtained within the past 6 months demonstrating liver disease consistent with chronic HBV infection without evidence of bridging fibrosis or cirrhosis
Women should be of non-childbearing potential. A woman is considered to be of childbearing potential if she is post-menarcheal but has not reached a post-menopausal state and has not undergone surgical sterilization (removal of ovaries and/or uterus).
Men must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures during treatment and up to 105 days after the last dose, and agree to refrain from donating sperm.
FOR CHB PARTICIPANTS ONLY - PART 2c
BMI between 18 to 32 kg/m2 inclusive
CHB infection (HBsAg-positive for at least 6 months)
For NUC-suppressed CHB participants: Must have been treated with a single NUC for at least 12 months, and have been on the same NUC therapy for at least 3 months prior to screening; HBV DNA <lower limit of quantification (LLOQ) at screening and in the 6 months prior to screening (at least one measurement must be >30 days prior to screening); alanine aminotransferase (ALT) </=2x upper limit of normal (ULN) for >6 months prior to screening and confirmed at screening; total bilirubin within normal range at screening, except for patients with Gilbert's syndrome
For treatment-naive and immune-active participants: HBV DNA at screening >/=2x10^4 IU/mL for HBeAg positive participants, or >/=2x10^3 IU/mL for HBeAg negative participants; elevated serum ALT>2 ULN to </=5, 2 values within 6 months, at least one of which is at screening and that are at least 14 days apart; total bilirubin within normal range except for participants with Gilbert's syndrome
Screening laboratory values (hematology, chemistry, urinalysis) obtained up to 28 days prior to first study treatment within normal ranges
Liver biopsy, fibroscan, or equivalent test obtained within the last 6 months demonstrating liver disease consistent with chronic HBV infection without evidence of bridging fibrosis or cirrhosis
Women should be of non-childbearing potential
Men must agree to remain abstinent or use contraception, and agree to refrain from donating sperm

Who cannot join

FOR HEALTHY VOLUNTEERS ONLY - PART 1:
History of drug or alcohol abuse or dependence in previous 6 months.
Positive urine drug and alcohol screen or positive cotinine test at screening or Day -1.
Positive result on hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV) 1 and 2.
Confirmed blood pressure or resting pulse rate outside of accepted ranges.
Participation in an investigational drug or device study within 90 days prior to screening.

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Donation of blood over 500 mL within three months prior to screening.
Any major illness within the one month, or any febrile illness within two weeks preceding the screening visit.
Alcohol consumption of more than 2 standard drinks per day on average.
FOR CHB PARTICIPANTS ONLY - PARTS 2a and 2b:
History or other evidence of bleeding from esophageal varices.
Decompensated liver disease.
History of or suspicion of hepatocellular carcinoma or alpha fetoprotein (AFP) ≥ 13 ng/mL at Screening
History or other evidence of a medical condition associated with chronic liver disease other than HBV infection.
Documented history or other evidence of metabolic liver disease within one year of randomization or documented history of infection with hepatitis D virus.
Positive test for hepatitis A (IgM anti-HAV), hepatitis C, or HIV.
Organ transplantation.
Significant acute infection or any other clinically significant illness within 2 weeks of randomization.
Abnormal renal function.
Participation in an investigational drug or device study within 30 days prior to randomization.
Donation or loss of blood over 500 mL within 3 months prior to starting study medication.
Administration of any blood product within 3 months of randomization.
History or evidence of alcohol abuse (consumption of more than 2 standard drinks per day on average).
FOR CHB PARTICIPANTS ONLY - PART 2c
History or other evidence of bleeding from esophageal varices
Evidence of liver cirrhosis or decompensated liver disease
One or more of the following laboratory abnormalities at screening: Total serum bilirubin > ULN (except for participants with Gilbert's disease); international normalized ratio (INR) > 1.1 ULN; serum albumin < 3.5 g/dL; AFP >13 ng/mL; positive results for anti-mitochondrial antibodies (AMA > 1:80), anti-nuclear antibody (ANA > 1:80), anti-smooth muscle antibody (ASMA > 1:40), anti-thyroperoxidase antibodies (a-TPO), anti-thyroglobulin, or anti-platelet antibodies; thyroid stimulating hormone (TSH) outside of normal range; platelet count <100,000 cells/mm^3; hemoglobin <12 g/dL (females) or <13 g/dL (males); white blood cell count <2500 cells/mm^3; and neutrophil count <1500 cells/mm^3
History or other evidence of a medical condition associated with chronic liver disease other than HBV infection
History of thyroid disease poorly controlled on prescribed medications or clinically relevant abnormal thyroid function tests
Documented history or other evidence of metabolic liver disease within one year of randomization
Positive test for hepatitis A, hepatitis C, or HIV
History of organ transplantation
Participation in an investigational drug or device study within 30 days prior to screening or previous treatment with an investigational agent for HBV within 6 months prior to screening
Significant acute infection or any other clinically significant illness within 2 weeks of randomization
Abnormal renal function, including serum creatinine > ULN or calculated creatinine clearance < 70 mL/min
Donation or loss of blood over 500 mL within 3 months prior to randomization
Administration of any blood product within 3 months prior to randomization
History of alcohol abuse and/or drug abuse

Trial locations and contacts

19 sites in 7 countries.

Country

City, postcode or hospital

19 sites in 7 countries

South Korea5 sites

Chuncheon Sacred Heart Hospital
Gangwon-Do, 200-704
Gangnam Severance Hospital
Seoul, 06273
ChungAng University Hospital
Seoul, 06973
University of Ulsan College of Medicine, Asan Medical Center, Digestive Disease Center
Seoul, 138736
SMG-SNU Boramae Medical Center
Seoul, 156-707

Other trials in South Korea

Taiwan4 sites

Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
Chang Gung Medical Foundation - Kaohsiung Branch
Kaohsiung City
Taipei Veterans General Hospital
Taipei, 112
Chang Gung Medical Foundation Linkou Branch
Taoyuan City, 333

Other trials in Taiwan

Australia2 sites

Linear Clinical Research Limited
Nedlands, Western Australia, 6009
Royal Melbourne Hospital
Parkville, Victoria, 3050

Other trials in Australia

Hong Kong2 sites

Queen Mary Hospital
Hong Kong
Prince of Wales Hospital
Shatin, New Territories

Other trials in Hong Kong

New Zealand2 sites

Auckland Clinical Studies
Auckland, 1142
Middlemore Hospital
Auckland, 1640

Other trials in New Zealand

Singapore2 sites

National University Hospital; Dept of Gastroenterology & Hepatology
Singapore, 119228
Singapore General Hospital; Gastroenterology & Hepatology
Singapore, 169608

Other trials in Singapore

Thailand2 sites

Siriraj Hospital; Dept. of Medicine
Bangkok, 10700
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, 50200

Other trials in Thailand

About this study

Official title: A Randomized, Sponsor-Open, Placebo-Controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of Subcutaneous Administration of RO7062931 With Single Ascending Doses in Healthy Volunteers and Multiple Doses and Modified Regimens in Virologically Suppressed Patients With Chronic Hepatitis B Virus Infection

This randomized study will be conducted in two parts to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of subcutaneous administration of RO7062931. Part 1 will include only healthy participants and Part 2 will include only participants with chronic hepatitis B (CHB). Part 1 is an adaptive, single-ascending dose study with an adaptive dose-escalating schedule to determine the best dose to be evaluated in participants with CHB. Part 2 is an adaptive, parallel multiple-dose study comprised of three sub-parts which will be used to further refine the dose and dosing regimen, and to evaluate the safety and efficacy of RO7062931 when administered with standard-of-care (SoC) therapy.

Conditions: Chronic Hepatitis B
Being tested: RO7062931, Placebo, Immune Modulator
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.

RO7062931Drug
Administered subcutaneously in Parts 1 and 2. Part 1 will be administered in single-ascending doses after 0.1 mg/kg starting dose. Subsequent doses of 0.3, 1, 2 and 4 mg/kg may be administered based upon tolerability. In Part 2a, participants will receive two monthly doses of either 0.4, 0.8, 1.2 times the saturation dose or placebo. In Part 2b, a dose selected from Part 2a will be administered to participants randomized into 4 cohorts QW or Q2W. In Part 2c, participants will receive RO7062831 QW on top of another therapy for up to 24 or 48 weeks.
PlaceboDrug
Part 1 cohorts: active drug vs placebo 4:1. Part 2a 4 parallel cohorts of 3 active drug doses and placebo in 1:1:1:1. Part 2b active drug vs placebo in 3:1 in 2 parallel cohorts.
Immune ModulatorDrug
Participants in Part 2c will receive an immune modulator subcutaneously QW for up to 48 weeks.

Study groups in NCT03038113
Study group	Role	What they receive
Part 1: Single-Ascending Dose (SAD)	Experimental	Healthy volunteers will be enrolled in up to 8 cohorts with doses starting from 0.1 mg/kg and escalating sequentially after review of safety and pharmacokinetic (PK) data. Receives: Drug: RO7062931; Drug: Placebo
Part 2: Multiple Ascending Dose	Experimental	Participants with Chronic Hepatitis B will enrolled in Part 2. In Part 2a, participants will receive two monthly injections of either 3 doses equivalent to a multiple of the saturation dose or placebo in a 1:1:1:1 ratio. In Part 2b, a dose selected from Part 2a will be administered to participants randomized into 4 cohorts where they will be dosed weekly (QW) or bi-weekly (Q2W). Each of the cohorts in Part 2b will include participants receiving active drug or placebo in a 3:1 ratio. In Part 2c, NUC-suppressed CHB participants will receive either RO7062931+NUC for up to 24 weeks, or RO7062931+NUC+an immune modulator for up to 48 weeks, at a dose determined from Part 2a and 2b. Part 2c may also enroll treatment-naive immune-active CHB participants. Receives: Drug: RO7062931; Drug: Placebo; Drug: Immune Modulator

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest
An adverse event is 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 adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
AEs of Special Interest were defined as: i.) elevated ALT/AST in combination with elevated bilirubin/clinical jaundice, ii.) suspected transmission of infectious agent by the study drug, iii.) severe injection site reactions, iv.) ALT elevation ≥10x ULN, v.) creatinine elevation ≥1.5x ULN or ≥50% from baseline.
Measured: Up to day 113
Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 1
Marked reference range has been predefined for each laboratory parameter. The marked reference range is broader than the standard reference range. Values falling outside the marked reference range that also represent a defined change from baseline will be considered marked laboratory abnormalities (i.e., potentially clinically relevant). If a baseline value is not available for a study subject, the midpoint of the standard reference range will be used as the study participant baseline value for the purposes of determining marked laboratory abnormalities.
Measured: Screening, Days -1, 2, 8, 15, 29, 85
Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2
Marked reference range has been predefined for each laboratory parameter. The marked reference range is broader than the standard reference range. Values falling outside the marked reference range that also represent a defined change from baseline will be considered marked laboratory abnormalities (i.e., potentially clinically relevant). If a baseline value is not available for a study subject, the midpoint of the standard reference range will be used as the study participant baseline value for the purposes of determining marked laboratory abnormalities.
Measured: Screening, Days -1, 2, 8, 15, 29, at discontinuation, Days 36, 43, 57, 85, 113
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1
Participants were monitored for clinically-significant RO7062931-related ECG changes, defined as QTcF > 500 msec, or > 60 msec longer than the pre-dose baseline, within the first 48 hours post-dose.
Measured: Day 1 (1,4,8,12h), Days 2 and 8, Follow Up Days 15, 29, 85
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2
Participants were monitored for clinically-significant RO7062931-related ECG changes, defined as QTcF > 500 msec, or > 60 msec longer than the pre-dose baseline, within the first 48 hours post-dose.
Measured: Day 1 (1,4,8h), Days 2,8,15,22 (1h and 8h), Day 23, Day 29 (1,4,8h), Day 30, Follow Up Days 36, 43, 50, 57, 78, 85, 106, 113
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1
Table entries provide the percentage of participants with abnormalities during treatment assessment. Abnormalities reported in participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
Measured: Day 1 (1,4,8,12h), Days 2 and 8, Follow Up Days 15, 29, 85
Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1
Table entries provide the percentage of participants with abnormalities during treatment assessment. Abnormalities reported in participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
Measured: Day 1 (1,4,8,12h), Days 2 and 8, Follow Up Days 15, 29, 85
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2
Table entries provide the percentage of participants with abnormalities during treatment assessment. Abnormalities reported in participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
Measured: Day 1 (1,4,8h), Days 2,8,15,22 (1h and 8h), Day 23, Day 29 (1,4,8h), Day 30, Follow Up Days 36, 43, 50, 57, 78, 85, 106, 113
Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2
Table entries provide the percentage of participants with abnormalities during treatment assessment. Abnormalities reported in participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
Measured: Day 1 (1,4,8h), Days 2,8,15,22 (1h and 8h), Day 23, Day 29 (1,4,8h), Day 30, Follow Up Days 36, 43, 50, 57, 78, 85, 106, 113
Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2
Table entries provide the percentage of participants with abnormalities during treatment assessment. Abnormalities reported in participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
Measured: Day 1 (1,4,8h), Days 2,8,15,22 (1h and 8h), Day 23, Day 29 (1,4,8h), Day 30, Follow Up Days 36, 43, 50, 57, 78, 85, 106, 113

Secondary outcomes (19)

Maximum Plasma Concentration (Cmax) After Single Ascending Doses - Part 1
Cmax values are the the peak plasma concentration reached after administration of RO7062931.
Measured: Days 1-8
Cmax After Multiple Ascending Doses - Part 2
Cmax values are the the peak plasma concentration reached after administration of RO7062931.
Measured: Days 1-113
Time to Reach Maximum Plasma Concentration (Tmax) After Single-Ascending Doses - Part 1
Tmax values are the amount of time to maximum concentration in plasma after administration of RO7062931.
Measured: Days 1-8
Tmax After Multiple Ascending Doses - Part 2
Tmax values are the amount of time to maximum concentration in plasma after administration of RO7062931.
Measured: Days 1-113
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) After Single-Ascending Doses - Part 1
AUC0-inf was calculated based on non-compartmental analysis.
Measured: Days 1-8
AUC0-inf After Multiple Ascending Doses - Part 2
AUC0-inf was calculated based on non-compartmental analysis.
Measured: Days 1,22,29
Area Under the Plasma Concentration-Time Curve From Time Zero Until the Last Quantifiable Time-Point (AUC0-last) After Single Ascending Doses - Part 1
AUC0-last was calculated based on non-compartmental analysis.
Measured: Days 1-8
AUC0-last After Multiple Ascending Doses - Part 2
AUC0-last was calculated based on non-compartmental analysis.
Measured: Days 1,22,29
Terminal Elimination Half-Life (t1/2) After Single Ascending Doses - Part 1
T1/2 was calculated based on non-compartmental analysis.
Measured: Days 1-8
Terminal Elimination Half-Life (t1/2) After Multiple Ascending Doses - Part 2
T1/2 was calculated based on non-compartmental analysis.
Measured: Days 1-113
Total Clearance (CL) After Single Ascending Doses - Part 1
Apparent oral clearance was calculated from Dose/AUCinf.
Measured: Days 1-8
Total Clearance (CL) After Multiple Ascending Doses - Part 2
Apparent oral clearance was calculated from Dose/AUCinf.
Measured: Days 1-113
Volume of Distribution (Vss) After Single Ascending Doses - Part 1
Vss was calculated from dose/AUCinf
Measured: Days 1-8
Volume of Distribution (Vss) After Multiple Ascending Doses - Part 2
Vss was calculated from dose/AUCinf
Measured: Days 1-113
Cumulative Amount Excreted Unchanged in Urine (Ae) After Single Ascending Doses - Part 1
Ae: cumulative amount of drug excreted in urine over a 24 hour period or over defined time periods linked to the pools of urine collected.
Measured: Hours 0-4, 0-8, 0-12, and 0-24
Cumulative Amount Excreted Unchanged in Urine (Ae) After Multiple Ascending Doses - Part 2
Ae: cumulative amount of drug excreted in urine over a 24 hour period or over defined time periods linked to the pools of urine collected.
Measured: Days 1-113
Change From Baseline of Quantitative HBsAg (qHBsAg) (log10) After Multiple Ascending Doses - Part 2
HBsAg is a viral parameter that can be affected by the action of RO7062931. A change from baseline in qHBsAg can indicate the drug's effect.
Measured: Days 1-113
Summary of Maximum qHBsAg Decrease on Days 1-113 - Part 2
HBsAg is a viral parameter that can be affected by the action of RO7062931. A change from baseline in qHBsAg can indicate the drug's effect.
Measured: Day 1 - Day 113
Summary of Time to Maximum qHBsAg Decrease on Day 1-113 - Part 2
HBsAg is a viral parameter that can be affected by the action of RO7062931. A change from baseline in qHBsAg can indicate the drug's effect.
Measured: Day 1 - Day 113

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Feb 201718 Oct 2019

First posted31 Jan 2017 (estimated)
Study start6 Feb 2017
Primary completion18 Oct 2019
Study completion18 Oct 2019

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.
Publications (1)Papers the sponsor has linked to this study.
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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 119 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03038113
Sponsor's protocol ID: BP39405
Status last verified: Nov 2020
First submitted: 30 Jan 2017
Last updated: 24 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Gane E, Yuen MF, Kim DJ, Chan HL, Surujbally B, Pavlovic V, Das S, Triyatni M, Kazma R, Grippo JF, Buatois S, Lemenuel-Diot A, Krippendorff BF, Mueller H, Zhang Y, Kim HJ, Leerapun A, Lim TH, Lim YS, Tanwandee T, Kim W, Cheng W, Hu TH, Wat C. Clinical Study of Single-Stranded Oligonucleotide RO7062931 in Healthy Volunteers and Patients With Chronic Hepatitis B. Hepatology. 2021 Oct;74(4):1795-1808. doi: 10.1002/hep.31920. Epub 2021 Aug 25.
PubMed 34037271

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Sponsor-Open, Placebo-Controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of Subcutaneous Administration of RO7062931 With Single Ascending Doses in Healthy Volunteers and Multiple Doses and Modified Regimens in Virologically Suppressed Patients With Chronic Hepatitis B Virus Infection
ClinicalTrials.gov ID: NCT03038113
Acronym / sponsor ID: BP39405
Conditions: Chronic Hepatitis B
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 119 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: 6 Feb 2017 (actual)
Primary completion: 18 Oct 2019 (actual)
Study completion: 18 Oct 2019 (actual)
First posted: 31 Jan 2017 (estimated)
Results: Posted 24 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Part 1: Single-Ascending Dose (SAD)	Experimental	Drug: RO7062931, Drug: PlaceboHealthy volunteers will be enrolled in up to 8 cohorts with doses starting from 0.1 mg/kg and escalating sequentially after review of safety and pharmacokinetic (PK) data.
Part 2: Multiple Ascending Dose	Experimental	Drug: RO7062931, Drug: Placebo, Drug: Immune ModulatorParticipants with Chronic Hepatitis B will enrolled in Part 2. In Part 2a, participants will receive two monthly injections of either 3 doses equivalent to a multiple of the saturation dose or placebo in a 1:1:1:1 ratio. In Part 2b, a dose selected from Part 2a will be administered to participants randomized into 4 cohorts where they will be dosed weekly (QW) or bi-weekly (Q2W). Each of the cohorts in Part 2b will include participants receiving active drug or placebo in a 3:1 ratio. In Part 2c, NUC-suppressed CHB participants will receive either RO7062931+NUC for up to 24 weeks, or RO7062931+NUC+an immune modulator for up to 48 weeks, at a dose determined from Part 2a and 2b. Part 2c may also enroll treatment-naive immune-active CHB participants.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (24 listed)

FOR HEALTHY VOLUNTEERS ONLY - PART 1 -
A Body Mass Index (BMI) between 18 to 30 kg/m2 inclusive and a body weight of at least 50 kg.
Women should be of non-childbearing potential. A woman is considered to be of childbearing potential if she is post-menarcheal but has not reached a post-menopausal state and has not undergone surgical sterilization (removal of ovaries and/or uterus).
Men must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures during treatment and up to 105 days after the last dose, and agree to refrain from donating sperm.
Non-smoker (nor tobacco containing products) for at least 90 days prior to dosing on Day 1 and agree to remain as non-smoker during the study.

Key exclusion criteria (38 listed)

History of drug or alcohol abuse or dependence in previous 6 months.
Positive urine drug and alcohol screen or positive cotinine test at screening or Day -1.
Positive result on hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV) 1 and 2.
Confirmed blood pressure or resting pulse rate outside of accepted ranges.
Participation in an investigational drug or device study within 90 days prior to screening.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RO7062931Administered subcutaneously in Parts 1 and 2. Part 1 will be administered in single-ascending doses after 0.1 mg/kg starting dose. Subsequent doses of 0.3, 1, 2 and 4 mg/kg may be administered based upon tolerability. In Part 2a, participants will receive two monthly doses of either 0.4, 0.8, 1.2 times the saturation dose or placebo. In Part 2b, a dose selected from Part 2a will be administered to participants randomized into 4 cohorts QW or Q2W. In Part 2c, participants will receive RO7062831 QW on top of another therapy for up to 24 or 48 weeks.	Drug	Part 1: Single-Ascending Dose (SAD), Part 2: Multiple Ascending Dose
PlaceboPart 1 cohorts: active drug vs placebo 4:1. Part 2a 4 parallel cohorts of 3 active drug doses and placebo in 1:1:1:1. Part 2b active drug vs placebo in 3:1 in 2 parallel cohorts.	Drug	Part 1: Single-Ascending Dose (SAD), Part 2: Multiple Ascending Dose
Immune ModulatorParticipants in Part 2c will receive an immune modulator subcutaneously QW for up to 48 weeks.	Drug	Part 2: Multiple Ascending Dose

Primary outcome

Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest
Time frame: Up to day 113
An adverse event is 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 adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs of Special Interest were defined as: i.) elevated ALT/AST in combination with elevated bilirubin/clinical jaundice, ii.) suspected transmission of infectious agent by the study drug, iii.) severe injection site reactions, iv.) ALT elevation ≥10x ULN, v.) creatinine elevation ≥1.5x ULN or ≥50% from baseline.
Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 1
Time frame: Screening, Days -1, 2, 8, 15, 29, 85
Marked reference range has been predefined for each laboratory parameter. The marked reference range is broader than the standard reference range. Values falling outside the marked reference range that also represent a defined change from baseline will be considered marked laboratory abnormalities (i.e., potentially clinically relevant). If a baseline value is not available for a study subject, the midpoint of the standard reference range will be used as the study participant baseline value for the purposes of determining marked laboratory abnormalities.
Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2
Time frame: Screening, Days -1, 2, 8, 15, 29, at discontinuation, Days 36, 43, 57, 85, 113
Marked reference range has been predefined for each laboratory parameter. The marked reference range is broader than the standard reference range. Values falling outside the marked reference range that also represent a defined change from baseline will be considered marked laboratory abnormalities (i.e., potentially clinically relevant). If a baseline value is not available for a study subject, the midpoint of the standard reference range will be used as the study participant baseline value for the purposes of determining marked laboratory abnormalities.
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1
Time frame: Day 1 (1,4,8,12h), Days 2 and 8, Follow Up Days 15, 29, 85
Participants were monitored for clinically-significant RO7062931-related ECG changes, defined as QTcF > 500 msec, or > 60 msec longer than the pre-dose baseline, within the first 48 hours post-dose.
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2
Time frame: Day 1 (1,4,8h), Days 2,8,15,22 (1h and 8h), Day 23, Day 29 (1,4,8h), Day 30, Follow Up Days 36, 43, 50, 57, 78, 85, 106, 113
Participants were monitored for clinically-significant RO7062931-related ECG changes, defined as QTcF > 500 msec, or > 60 msec longer than the pre-dose baseline, within the first 48 hours post-dose.
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1
Time frame: Day 1 (1,4,8,12h), Days 2 and 8, Follow Up Days 15, 29, 85
Table entries provide the percentage of participants with abnormalities during treatment assessment. Abnormalities reported in participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1
Time frame: Day 1 (1,4,8,12h), Days 2 and 8, Follow Up Days 15, 29, 85
Table entries provide the percentage of participants with abnormalities during treatment assessment. Abnormalities reported in participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2
Time frame: Day 1 (1,4,8h), Days 2,8,15,22 (1h and 8h), Day 23, Day 29 (1,4,8h), Day 30, Follow Up Days 36, 43, 50, 57, 78, 85, 106, 113
Table entries provide the percentage of participants with abnormalities during treatment assessment. Abnormalities reported in participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2
Time frame: Day 1 (1,4,8h), Days 2,8,15,22 (1h and 8h), Day 23, Day 29 (1,4,8h), Day 30, Follow Up Days 36, 43, 50, 57, 78, 85, 106, 113
Table entries provide the percentage of participants with abnormalities during treatment assessment. Abnormalities reported in participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2
Time frame: Day 1 (1,4,8h), Days 2,8,15,22 (1h and 8h), Day 23, Day 29 (1,4,8h), Day 30, Follow Up Days 36, 43, 50, 57, 78, 85, 106, 113
Table entries provide the percentage of participants with abnormalities during treatment assessment. Abnormalities reported in participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.

19 secondary outcomes

Maximum Plasma Concentration (Cmax) After Single Ascending Doses - Part 1
Time frame: Days 1-8
Cmax After Multiple Ascending Doses - Part 2
Time frame: Days 1-113
Time to Reach Maximum Plasma Concentration (Tmax) After Single-Ascending Doses - Part 1
Time frame: Days 1-8
Tmax After Multiple Ascending Doses - Part 2
Time frame: Days 1-113
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) After Single-Ascending Doses - Part 1
Time frame: Days 1-8
AUC0-inf After Multiple Ascending Doses - Part 2
Time frame: Days 1,22,29
Area Under the Plasma Concentration-Time Curve From Time Zero Until the Last Quantifiable Time-Point (AUC0-last) After Single Ascending Doses - Part 1
Time frame: Days 1-8
AUC0-last After Multiple Ascending Doses - Part 2
Time frame: Days 1,22,29
Terminal Elimination Half-Life (t1/2) After Single Ascending Doses - Part 1
Time frame: Days 1-8
Terminal Elimination Half-Life (t1/2) After Multiple Ascending Doses - Part 2
Time frame: Days 1-113
Total Clearance (CL) After Single Ascending Doses - Part 1
Time frame: Days 1-8
Total Clearance (CL) After Multiple Ascending Doses - Part 2
Time frame: Days 1-113
Volume of Distribution (Vss) After Single Ascending Doses - Part 1
Time frame: Days 1-8
Volume of Distribution (Vss) After Multiple Ascending Doses - Part 2
Time frame: Days 1-113
Cumulative Amount Excreted Unchanged in Urine (Ae) After Single Ascending Doses - Part 1
Time frame: Hours 0-4, 0-8, 0-12, and 0-24
Cumulative Amount Excreted Unchanged in Urine (Ae) After Multiple Ascending Doses - Part 2
Time frame: Days 1-113
Change From Baseline of Quantitative HBsAg (qHBsAg) (log10) After Multiple Ascending Doses - Part 2
Time frame: Days 1-113
Summary of Maximum qHBsAg Decrease on Days 1-113 - Part 2
Time frame: Day 1 - Day 113
Summary of Time to Maximum qHBsAg Decrease on Day 1-113 - Part 2
Time frame: Day 1 - Day 113

Results and safety

Results posted to the registry on 24 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1 - RO7062931 0.1 mg/kg	8	8
Part 1 - RO7062931 0.3 mg/kg	8	8
Part 1 - RO7062931 1.0 mg/kg	8	7
Part 1 - RO7062931 2.0 mg/kg	8	8
Part 1 - RO7062931 3.0 mg/kg	8	8
Part 1 - RO7062931 4.0 mg/kg	8	8
Part 1 - Placebo	12	11
Part 2a - RO7062931 0.5 mg/kg Q1M	6	6
Part 2a - RO7062931 1.5 mg/kg Q1M	7	7
Part 2a - RO7062931 3.0 mg/kg Q1M	6	6
Part 2b - RO7062931 3.0 mg/kg QW	14	14
Part 2b - RO7062931 3.0 mg/kg Q2W	7	7
Part 2b - RO7062931 4.0 mg/kg QW	4	4
Part 2 - Placebo	15	14

Primary outcome: Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest

Time frame: Up to day 113. Number. Unit: Percentage of Participants

Measure	Part 1 - RO7062931 0.1 mg/kg n = 8	Part 1 - RO7062931 0.3 mg/kg n = 8	Part 1 - RO7062931 1.0 mg/kg n = 8	Part 1 - RO7062931 2.0 mg/kg n = 8	Part 1 - RO7062931 3.0 mg/kg n = 8	Part 1 - RO7062931 4.0 mg/kg n = 8	Part 1 - Placebo n = 12	Part 2a - RO7062931 0.5 mg/kg Q1M n = 6	Part 2a - RO7062931 1.5 mg/kg Q1M n = 7	Part 2a - RO7062931 3.0 mg/kg Q1M n = 6	Part 2b - RO7062931 3.0 mg/kg QW n = 14	Part 2b - RO7062931 3.0 mg/kg Q2W n = 7	Part 2b - RO7062931 4.0 mg/kg QW n = 4	Part 2 - Placebo n = 15
AEs	75.0	87.5	37.5	75.0	87.5	50.0	58.3	33.3	85.7	66.7	71.4	57.1	75.0	53.3
AEs of Special Interest	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Population analysed: Safety population: All study subjects that received at least one dose of study medication, whether prematurely withdrawn from the study or not.

Primary outcome: Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 1

Time frame: Screening, Days -1, 2, 8, 15, 29, 85. Number. Unit: Percentage of Participants

Measure	Part 1 - RO7062931 0.1 mg/kg n = 8	Part 1 - RO7062931 0.3 mg/kg n = 8	Part 1 - RO7062931 1.0 mg/kg n = 8	Part 1 - Placebo n = 12
SGOT/AST - High	0	0	12.5	0
Chloride - Low	0	0	0	8.3
HDL Cholesterol - Low	0	12.5	0	0
Triglycerides - High	12.5	0	0	0

Population analysed: Safety population: All study subjects that received at least one dose of study medication, whether prematurely withdrawn from the study or not.

Primary outcome: Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2

Time frame: Screening, Days -1, 2, 8, 15, 29, at discontinuation, Days 36, 43, 57, 85, 113. Number. Unit: Percentage of Participants

Measure	Part 2a - RO7062931 0.5 mg/kg Q1M n = 6	Part 2a - RO7062931 1.5 mg/kg Q1M n = 7	Part 2a - RO7062931 3.0 mg/kg Q1M n = 6	Part 2b - RO7062931 3.0 mg/kg QW n = 14	Part 2b - RO7062931 4.0 mg/kg QW n = 4	Part 2 - Placebo n = 15
SGPT/ALT - High	0	0	0	14.3	0	0
SGOT/AST - High	0	0	0	7.1	0	0
Bicorbonate HCO3 - Low	0	0	0	7.1	0	0
Glucose, Fasting - High	0	0	0	7.1	0	0
Activated Partial Thromboplastin Time - High	0	0	0	7.1	0	0
Triglycerides - High	100	–	–	–	–	–

Population analysed: Safety population: All study subjects that received at least one dose of study medication, whether prematurely withdrawn from the study or not.

Primary outcome: Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1

Time frame: Day 1 (1,4,8,12h), Days 2 and 8, Follow Up Days 15, 29, 85. Number. Unit: Percentage of Participants

Measure	Part 1 - RO7062931 0.1 mg/kg n = 8	Part 1 - RO7062931 0.3 mg/kg n = 8	Part 1 - RO7062931 1.0 mg/kg n = 8	Part 1 - RO7062931 2.0 mg/kg n = 8	Part 1 - RO7062931 3.0 mg/kg n = 8	Part 1 - RO7062931 4.0 mg/kg n = 8	Part 1 - Placebo n = 12
Baseline	12.5	50.0	0	0	37.5	25.0	16.7
Day 1 - 1h	37.5	50.0	12.5	25.0	37.5	25.0	41.7
Day 1 - 4h	25.0	25.0	12.5	25.0	25.0	12.5	50.0
Day 1 - 8h	37.5	50.0	25.0	12.5	25.0	25.0	58.3
Day 1 - 12h	25.0	50.0	25.0	25.0	37.5	12.5	58.3
Day 2 - 24h	37.5	50.0	12.5	12.5	25.0	25.0	50.0
Day 8 - 168h	12.5	50.0	25.0	37.5	25.0	25.0	41.7
Follow-up Day 15	12.5	12.5	12.5	25.0	12.5	12.5	16.7

Population analysed: Safety population: All study subjects that received at least one dose of study medication, whether prematurely withdrawn from the study or not.

19 secondary outcomes are reported in the full results.

Adverse events

Time frame: Approximately 32 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1 - RO7062931 0.1 mg/kg	0 of 8 (0%)	6 of 8 (75%)	0 of 8
Part 1 - RO7062931 0.3 mg/kg	0 of 8 (0%)	7 of 8 (87.5%)	0 of 8
Part 1 - RO7062931 1.0 mg/kg	0 of 8 (0%)	3 of 8 (37.5%)	0 of 8
Part 1 - RO7062931 2.0 mg/kg	0 of 8 (0%)	6 of 8 (75%)	0 of 8
Part 1 - RO7062931 3.0 mg/kg	0 of 8 (0%)	7 of 8 (87.5%)	0 of 8
Part 1 - RO7062931 4.0 mg/kg	0 of 8 (0%)	4 of 8 (50%)	0 of 8
Part 1 - Placebo	0 of 12 (0%)	7 of 12 (58.3%)	0 of 12
Part 2a - RO7062931 0.5 mg/kg Q1M	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Part 2a - RO7062931 1.5 mg/kg Q1M	0 of 7 (0%)	6 of 7 (85.7%)	0 of 7
Part 2a - RO7062931 3.0 mg/kg Q1M	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Part 2b - RO7062931 3.0 mg/kg QW	0 of 14 (0%)	10 of 14 (71.4%)	0 of 14
Part 2b - RO7062931 3.0 mg/kg Q2W	0 of 7 (0%)	4 of 7 (57.1%)	0 of 7
Part 2b - RO7062931 4.0 mg/kg QW	0 of 4 (0%)	3 of 4 (75%)	0 of 4
Part 2 - Placebo	0 of 15 (0%)	8 of 15 (53.3%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34037271Gane E, Yuen MF, Kim DJ, Chan HL, Surujbally B, Pavlovic V, Das S, Triyatni M, Kazma R, Grippo JF, Buatois S, Lemenuel-Diot A, Krippendorff BF, Mueller H, Zhang Y, Kim HJ, Leerapun A, Lim TH, Lim YS, Tanwandee T, Kim W, Cheng W, Hu TH, Wat C. Clinical Study of Single-Stranded Oligonucleotide RO7062931 in Healthy Volunteers and Patients With Chronic Hepatitis B. Hepatology. 2021 Oct;74(4):1795-1808. doi: 10.1002/hep.31920. Epub 2021 Aug 25.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

19 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RO7062931 and Immune Modulator in people with Chronic Hepatitis B, run by Hoffmann-La Roche at 19 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in South Korea, Taiwan, Australia, Hong Kong, New Zealand and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest (time frame: Up to day 113). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03038113, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2020.