Hepatitis B VirusPhase 1NCT03570658
A Double-Blind Single-Ascending Dose (SAD) and Multiple-Ascending Dose (MAD) Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7049389 in Healthy Chinese Participants
A Phase 1 study testing RO7049389 in people with Hepatitis B Virus, run by Hoffmann-La Roche at 1 site in China.
Trial summary
This study will assess the safety and tolerability of RO7049389 compared to placebo in single- and multiple-ascending doses in healthy Chinese participants. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B Virus
- What is being tested?
- RO7049389
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 24 Aug 2018to 28 Jan 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chinese healthy male and female subjects, 18 to 60 years of age, inclusive.
- A Body Mass Index (BMI) of between 19 to 27 kg/m2 inclusive, and a body weight of at least 45 kg.
- Women should be of non-childbearing potential. Female subjects must be either surgically sterile (by means of hysterectomy and/or bilateral oophorectomy) or post-menopausal for at least one year (defined as amenorrhea >/=12 consecutive months without another cause, and confirmed by follicle stimulating hormone level >35 mIU/mL).
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm
Who cannot join
- Pregnant (positive pregnancy test) or lactating women, and male subjects with partners who are pregnant or lactating.
- History or symptoms of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer or cirrhosis.
- Personal history of congenital long QT syndrome or family history of sudden death.
- History of Gilbert's syndrome.
- History of having received or currently receiving any systemic anti-neoplastic (including radiation) or immune-modulatory treatment (including systemic oral or inhaled corticosteroids) </=6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study.
- Subjects who have had significant acute infection, e.g., influenza, local infection, acute gastrointestinal symptoms or any other clinically significant illness within two weeks of dose administration.
Show all 17Show fewer
- Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, or multiple drug allergies (non-active hay fever is acceptable).
- Electrocardiogram (ECG) with QRS and/or T-wave judged to be unfavorable for a consistently accurate QT measurement (e.g., neuromuscular artifact that cannot be readily eliminated, arrhythmias, indistinct QTS onset, low amplitude T-wave, merged T- and U waves, prominent U-waves)
- Creatinine clearance (CrCl) </=70 mL/min (using the Cockcroft-Gault formula)
- Positive test at screening of any of the following: hepatitis A (HAV IgM Ab), hepatitis B (HBsAg), hepatitis C (HCV RNA or HCV Ab) or human immunodeficiency virus 1 and 2 (HIV Ab).
- Participation in an investigational drug or device study within 90 days prior to screening or more than 4 times per year.
- Donation or loss of blood over 500 mL within 3 months prior to screening.
- Any suspicion or history of drug and/or alcohol abuse within the last year.
- History (within 3 months of screening) of alcohol consumption exceeding two standard drinks per day on average (1 standard drink = 10 grams of alcohol). Alcohol consumption will be prohibited at least 48 hours before screening, 48 hours before and 48 hours after each dose, and 48 hours before each scheduled visit.
- Use of >5 cigarettes or equivalent nicotine-containing product per day.
- Taking any prescribed or over-the-counter medications (including vitamins or herbal remedies) within 2 weeks of first dosing or within 5 times the elimination half-life of the medication prior to first dosing (whichever is longer). Occasional acetaminophen/paracetamol is allowed.
- Subjects under judicial supervision, guardianship or curatorship.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Sponsor-Open, Investigator-Blinded, Subject-Blinded, Placebo-Controlled, Single-Ascending Dose (SAD) and Multiple-Ascending Dose (MAD) Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7049389 in Healthy Chinese Subjects
This study will assess the safety and tolerability of RO7049389 compared to placebo in single- and multiple-ascending doses in healthy Chinese participants.
- Conditions
- Hepatitis B Virus
- Being tested
- RO7049389, Placebo
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7049389Drug
RO7049389 will be administered orally either as a single dose (SAD) or as multiple doses defined by the SAD portion of the study (MAD).
PlaceboDrug
Placebo will be administered orally at a dose and frequency matched to RO7049389.
| Study group | Role | What they receive |
|---|---|---|
| Single-Ascending Dose (SAD) | Experimental | Participants will receive a single dose of RO7049389. Receives: Drug: RO7049389 |
| Multiple-Ascending Dose (MAD) | Experimental | Participants will receive multiple doses of RO7049389. Receives: Drug: RO7049389 |
| Placebo | Placebo comparator | Participants will receive either a single dose (SAD cohorts) or multiple doses (MAD cohorts) of placebo matched to RO7049389. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events
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.
Measured: From the date of first administered dose through 28 days after the last administered dose.
Secondary outcomes (9)
Maximum Observed Plasma Concentration (Cmax) of RO7049389
Measured: At pre-defined intervals on Day 1 (SAD) and Day 14 (MAD)
Time to Maximum Observed Plasma Concentration (Tmax) of RO7049389
Measured: At pre-defined intervals on Day 1 (SAD) and Day 14 (MAD)
Area Under the Plasma Concentration vs Time Curve to Last Measurable Concentration (AUClast) of RO7049389
Measured: At pre-defined intervals on Day 1 (SAD) and Day 14 (MAD)
Area Under the Plasma Concentration vs Time Curve Extrapolated to Infinity (AUC0-inf)
Measured: At pre-defined intervals on Day 1 (SAD) and Day 14 (MAD)
Apparent Half-Life (T1/2) of RO7049389
Measured: At pre-defined intervals on Day 1 (SAD) and Day 14 (MAD)
Clearance (CL/F) of RO7049389
Measured: At pre-defined intervals on Day 1 (SAD)
Trough Plasma Concentration (Ctrough) of RO7049389
Measured: At pre-defined intervals on Day 14 (MAD)
Accumulation Index of RO7049389
Measured: At pre-defined intervals on Day 14 (MAD)
Area Under the Concentration vs Time Curve for a Dosing Interval (AUCtau)
Measured: At pre-defined intervals on Day 14 (MAD)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start24 Aug 2018
- Primary completion28 Jan 2019
- Study completion28 Jan 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 Hepatitis B VirusStudies 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
- 31 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
- NCT03570658
- Sponsor's protocol ID
- YP39406
- Status last verified
- Feb 2020
- First submitted
- 18 Jun 2018
- Last updated
- 28 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wu X, Feng S, Zhang J, Zhang W, Zhang Y, Zhu M, Triyatni M, Zhao N, Bo Q, Jin Y. Evaluation of the safety, tolerability, and pharmacokinetics of RO7049389 in healthy Chinese volunteers. Clin Transl Sci. 2022 Jan;15(1):195-203. doi: 10.1111/cts.13134. Epub 2021 Sep 25.
PubMed 34562067
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Sponsor-Open, Investigator-Blinded, Subject-Blinded, Placebo-Controlled, Single-Ascending Dose (SAD) and Multiple-Ascending Dose (MAD) Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7049389 in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT03570658
- Acronym / sponsor ID
- YP39406
- Conditions
- Hepatitis B Virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 24 Aug 2018 (actual)
- Primary completion
- 28 Jan 2019 (actual)
- Study completion
- 28 Jan 2019 (actual)
- First posted
- 27 Jun 2018 (actual)
- Results
- Posted 28 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the safety and tolerability of RO7049389 compared to placebo in single- and multiple-ascending doses in healthy Chinese participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single-Ascending Dose (SAD) | Experimental | Drug: RO7049389Participants will receive a single dose of RO7049389. |
| Multiple-Ascending Dose (MAD) | Experimental | Drug: RO7049389Participants will receive multiple doses of RO7049389. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive either a single dose (SAD cohorts) or multiple doses (MAD cohorts) of placebo matched to RO7049389. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Chinese healthy male and female subjects, 18 to 60 years of age, inclusive.
- A Body Mass Index (BMI) of between 19 to 27 kg/m2 inclusive, and a body weight of at least 45 kg.
- Women should be of non-childbearing potential. Female subjects must be either surgically sterile (by means of hysterectomy and/or bilateral oophorectomy) or post-menopausal for at least one year (defined as amenorrhea >/=12 consecutive months without another cause, and confirmed by follicle stimulating hormone level >35 mIU/mL).
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm
Key exclusion criteria (17 listed)
- Pregnant (positive pregnancy test) or lactating women, and male subjects with partners who are pregnant or lactating.
- History or symptoms of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer or cirrhosis.
- Personal history of congenital long QT syndrome or family history of sudden death.
- History of Gilbert's syndrome.
- History of having received or currently receiving any systemic anti-neoplastic (including radiation) or immune-modulatory treatment (including systemic oral or inhaled corticosteroids) </=6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study.
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 |
|---|---|---|
| RO7049389RO7049389 will be administered orally either as a single dose (SAD) or as multiple doses defined by the SAD portion of the study (MAD). | Drug | Multiple-Ascending Dose (MAD), Single-Ascending Dose (SAD) |
| PlaceboPlacebo will be administered orally at a dose and frequency matched to RO7049389. | Drug | Placebo |
Primary outcome
Percentage of Participants With Adverse Events
Time frame: From the date of first administered dose through 28 days after the last administered dose.
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.
9 secondary outcomes
Maximum Observed Plasma Concentration (Cmax) of RO7049389
Time frame: At pre-defined intervals on Day 1 (SAD) and Day 14 (MAD)
Time to Maximum Observed Plasma Concentration (Tmax) of RO7049389
Time frame: At pre-defined intervals on Day 1 (SAD) and Day 14 (MAD)
Area Under the Plasma Concentration vs Time Curve to Last Measurable Concentration (AUClast) of RO7049389
Time frame: At pre-defined intervals on Day 1 (SAD) and Day 14 (MAD)
Area Under the Plasma Concentration vs Time Curve Extrapolated to Infinity (AUC0-inf)
Time frame: At pre-defined intervals on Day 1 (SAD) and Day 14 (MAD)
Apparent Half-Life (T1/2) of RO7049389
Time frame: At pre-defined intervals on Day 1 (SAD) and Day 14 (MAD)
Clearance (CL/F) of RO7049389
Time frame: At pre-defined intervals on Day 1 (SAD)
Trough Plasma Concentration (Ctrough) of RO7049389
Time frame: At pre-defined intervals on Day 14 (MAD)
Accumulation Index of RO7049389
Time frame: At pre-defined intervals on Day 14 (MAD)
Area Under the Concentration vs Time Curve for a Dosing Interval (AUCtau)
Time frame: At pre-defined intervals on Day 14 (MAD)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34562067Wu X, Feng S, Zhang J, Zhang W, Zhang Y, Zhu M, Triyatni M, Zhao N, Bo Q, Jin Y. Evaluation of the safety, tolerability, and pharmacokinetics of RO7049389 in healthy Chinese volunteers. Clin Transl Sci. 2022 Jan;15(1):195-203. doi: 10.1111/cts.13134. Epub 2021 Sep 25.
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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.
Clinical Trials study director
Hoffmann-La Roche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO7049389 in people with Hepatitis B Virus, run by Hoffmann-La Roche at 1 site in China.
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 4 inclusion and 17 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 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. Some participants in this study may receive a placebo. 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 28 Feb 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 (time frame: From the date of first administered dose through 28 days after the last administered dose.). 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 NCT03570658, 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 28 Feb 2020.