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Hepatitis B, ChronicPhase 1NCT02604355

A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7020322 Following Oral Administration in Healthy Participants and Chronic Hepatitis B Patients

A Phase 1 study testing RO7020322 in people with Hepatitis B, Chronic, run by Hoffmann-La Roche at 4 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a multiple-center, randomized, double-blind, placebo-controlled, single-ascending dose and multiple-ascending dose, adaptive parallel study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO7020322 following oral administration in healthy participants and chronic hepatitis B… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Hepatitis B, Chronic
What is being tested?
RO7020322
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
49 participants
Where
4 sitesin 3 countries
Study dates
28 Nov 2015to 9 May 2016
Phase
Phase 1
Are there results?
None posted in the registry

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 Participants' Inclusion Criteria:
  • A Body Mass Index (BMI) between 18 to 30 kg/m^2, inclusive, and a body weight of at least 50 kg
  • Males must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agree to refrain from donating sperm during the study
  • Women should be of non-childbearing potential
  • Able to comply with study restrictions
  • Non-smoker (nor tobacco-containing products) for at least 90 days prior to dosing on Day 1 and agreeing not to smoke during the study
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  • Chronic Hepatitis B-Infected Participants' Inclusion Criteria:
  • Chronic hepatitis B infection
  • A BMI between 18 to 32 kg/m^2, inclusive
  • Positive test for HBsAg for more than 6 months prior to randomization
  • On entecavir or tenofovir treatment for at least 6 months prior to randomization and remaining on stable treatment during the study
  • Liver biopsy, fibroscan® or equivalent test obtained within the past 6 months demonstrating liver disease consistent with chronic hepatitis B (HBV) infection without evidence of bridging fibrosis or cirrhosis
  • Males must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agree to refrain from donating sperm during the study
  • Women of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use non-hormonal contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least until the end of the follow-up period

Who cannot join

  • Healthy Participants' Exclusion Criteria:
  • Women who are lactating
  • Any suspicion or history of alcohol and/or other substance abuse or dependence in the past 6 months
  • Positive urine drug and alcohol screen (barbiturates, benzodiazepines, methadone, amphetamines, methamphetamines, opiates, cocaine, cannabinoids, and alcohol), or positive cotinine test at Day -1
  • Positive result on HBV, hepatitis C (HCV), or human immunodeficiency virus (HIV) 1 and 2
  • A personal history of unexplained blackouts or faints, or known risk factors for Torsade de Pointes
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  • Clinically significant abnormalities (as judged by the Investigator) in the physical examination and in the laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis) at screening and on Day -1
  • Participation in an investigational drug or device study within 90 days prior to screening or 5 times the half-life of the investigational drug (whichever is longer)
  • Donation of blood over 500 mL within three months prior to screening
  • Concomitant disease or condition (including allergic reactions against any drug, or multiple allergies) that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the healthy participant in this study
  • Chronic Hepatitis B-Infected Participants' Exclusion Criteria:
  • Women who are pregnant (positive pregnancy test) or lactating
  • History or other evidence of bleeding from esophageal varices
  • Decompensated liver disease
  • 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
  • Positive test for hepatitis A (IgM anti-HAV), hepatitis C, or HIV
  • Documented history of infection with hepatitis D virus
  • Expected to need systemic antiviral therapy other than that provided by the study at any time during their participation in the study, with the exception of oral therapy for herpes simplex virus (HSV) I or HSV II
  • History of immunologically-mediated disease

Trial locations and contacts

4 sites in 3 countries.

4 sites in 3 countries

New Zealand2 sites

  • Auckland Clinical Studies Limited

    Grafton, 1010

  • Tauranga Hospital

    Tauranga, 3143

Other trials in New Zealand

Hong Kong1 site

  • Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

Taiwan1 site

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

Other trials in Taiwan

About this study

Official title: A Multiple-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose and Multiple-Ascending Dose, Adaptive Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7020322 Following Oral Administration in Healthy Subjects and Chronic Hepatitis B Patients

This is a multiple-center, randomized, double-blind, placebo-controlled, single-ascending dose and multiple-ascending dose, adaptive parallel study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO7020322 following oral administration in healthy participants and chronic hepatitis B patients.

Being tested
Matching Placebo, RO7020322
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.

  • Matching PlaceboOther

    Oral dosing with placebo capsules to match RO7020322.

  • RO7020322Drug

    Adaptive oral dosing with RO7020322 capsules, starting at 1 mg daily, with ascending or adjusted dosing based on the results of previous dosing.

Study groups in NCT02604355
Study groupRoleWhat they receive
Healthy Participants (Multiple-Ascending Dosing)ExperimentalNot described
Receives: Other: Matching Placebo; Drug: RO7020322
Healthy Participants (Single-Ascending Dosing)ExperimentalNot described
Receives: Other: Matching Placebo; Drug: RO7020322
Healthy Participants (Study of Food Effect)ExperimentalNot described
Receives: Other: Matching Placebo; Drug: RO7020322
Participants with Chronic Hepatitis B (Proof of mechanism)ExperimentalNot described
Receives: Other: Matching Placebo; Drug: RO7020322

What is being measured

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

  1. Number of participants with adverse events

    Measured: Up to 8 weeks

  2. Intensity of adverse events

    Measured: Up to 8 weeks

  3. Number of participants with clinically significant laboratory abnormalities

    Measured: Up to 8 weeks

  4. Number of participants with clinically significant electrocardiogram (ECG) abnormalities

    Measured: Up to 8 weeks

  5. Number of participants with clinically significant vital signs abnormalities

    Measured: Up to 8 weeks

Secondary outcomes (11)

  1. Maximum observed plasma concentration (Cmax) of RO7020322

    Measured: Up to 18 days

  2. Time from dosing to Cmax (Tmax) of RO7020322

    Measured: Up to 18 days

  3. Trough plasma concentrations (Ctrough) of RO7020322

    Measured: Up to 18 days

  4. Area under the plasma concentration-time curve between time zero (pre-dose) and the time of the last quantifiable concentration (AUClast) of RO7020322

    Measured: Up to 18 days

  5. Area under the plasma concentration-time curve between time zero (pre-dose) extrapolated to infinity (AUC0-Inf) of RO7020322

    Measured: Up to 18 days

  6. Apparent clearance (CL/F) of RO7020322

    Measured: Up to 18 days

  7. Apparent volume (V/F) of RO7020322

    Measured: Up to 18 days

  8. Apparent terminal phase half-life (t1/2) of RO7020322

    Measured: Up to 18 days

  9. Area under the plasma concentration-time curve (AUC0-t,ss) of RO7020322 at steady state

    Measured: Up to 18 days

  10. Area under the plasma concentration-time curve (AUC0-t) of RO7020322 on Day 1

    Measured: Up to 18 days

  11. Plasma concentration of hepatitis B surface antigen (HBsAg)

    Measured: Up to 8 weeks

Timeline

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

  1. First posted13 Nov 2015 (estimated)
  2. Study start28 Nov 2015
  3. Primary completion9 May 2016
  4. Study completion9 May 2016

Why it stopped: Molecule Development was Terminated

Resources

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
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02604355
Sponsor's protocol ID
BP29948
Status last verified
May 2017
First submitted
10 Nov 2015
Last updated
25 May 2017
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Misumi I, Yue Z, Jiang Z, Karampoori A, Whitmire JK, Cullen JM, Block T, Lemon SM, Du Y, Li Y. Hepato-selective dihydroquinolizinones active against hepatitis A virus in vitro and in vivo. Antiviral Res. 2025 May;237:106145. doi: 10.1016/j.antiviral.2025.106145. Epub 2025 Mar 19.

    PubMed 40118118

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RO7020322 in people with Hepatitis B, Chronic, run by Hoffmann-La Roche at 4 sites in 3 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 14 inclusion and 20 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: stopped early, as of the sponsor's last update on 25 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in New Zealand, Hong Kong, Taiwan. 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?

The study was stopped early (reason given: Molecule Development was Terminated). Results are not available in the source record.

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?

Number of participants with adverse events (time frame: Up to 8 weeks). The study lists 5 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 NCT02604355, 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 25 May 2017.

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