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Also known as [12C] RO7049389
RO7049389 · 2 trials · 2 indications
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.
Functional cure is defined as HBV DNA \< lower limit of quantification (LLOQ, 20 IU/mL) with HBsAg loss (\< 0.05 IU/mL) at 24 weeks post-treatment.
| Arm | Type | Description |
|---|---|---|
| Single-Ascending Dose (SAD) | EXPERIMENTAL | Participants will receive a single dose of RO7049389. |
| Multiple-Ascending Dose (MAD) | EXPERIMENTAL | Participants will receive multiple doses of RO7049389. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive either a single dose (SAD cohorts) or multiple doses (MAD cohorts) of placebo matched to RO7049389. |
| Parts 1a and 1b: SAD in Healthy Volunteers (Placebo) | PLACEBO_COMPARATOR | In Part 1a, participants will receive a single oral dose of placebo matching to RO7049389 film coated tablet on Day 1. In Part 1b, minimum 8 participants from Part 1a will be selected and 2 of whom will receive another single dose of placebo matching to RO7049389 on Day 16 after eating the standard United States - Food and Drug Administration (US FDA)-recommended high-fat and high-calorie breakfast. |
| Parts 1a and 1b: SAD in Healthy Volunteers (RO7049389) | EXPERIMENTAL | In Part 1a, participants will receive a single oral dose of RO7049389 film coated tablet on Day 1 in dose-escalation cohorts with a starting dose of 150 milligrams (mg). The doses for subsequent cohorts will be defined by an adaptive approach based on the safety and PK data in previously-dosed healthy volunteers. In Part 1b, minimum 8 participants from Part 1a will be selected and 6 of whom will receive another single dose of RO7049389 on Day 16 after eating the standard US FDA-recommended high-fat and high-calorie breakfast. |
| Part 1c: MAD in Healthy Volunteers (Placebo) | PLACEBO_COMPARATOR | Participants will receive placebo matching to RO7049389 film coated tablet from Days 1 to 13 (either once a day \[QD\] or twice a day \[BID\]) and a single dose of placebo matching to RO7049389 film coated tablet in the morning of Day 14. Participants will also receive a single dose of midazolam solution (100 micrograms \[mcg\]) on Day -1 and Day 14. |
| Part 1c: MAD in Healthy Volunteers (RO7049389) | EXPERIMENTAL | Participants will receive RO7049389 film coated tablet from Days 1 to 13 (either QD or BID; dose and regimen will be decided based on the available PK and safety data) and a single dose of RO7049389 film coated tablet in the morning of Day 14. Participants will also receive a single dose of midazolam solution (100 mcg) on Day -1 and Day 14. |
| Part 2: POM in Chronic HBV Participants (Placebo) | PLACEBO_COMPARATOR | Participants will receive placebo matching to RO7049389 film coated tablet from Days 1 to 27 (either QD or BID) and a single dose of placebo matching to RO7049389 film coated tablet in the morning of Day 28. |
| Part 2: POM in Chronic HBV Participants (RO7049389) | EXPERIMENTAL | Participants will receive RO7049389 film coated tablet from Days 1 to 27 (either QD or BID; dose and regimen will be decided based on the available PK and safety data) and a single dose of RO7049389 film coated tablet in the morning of Day 28. |
| Part 3: POM in NUC-Suppressed CHB Participants (Cohort A) | EXPERIMENTAL | Participants will receive RO7049389 on top of a NUC for 48 weeks at a dose determined from Part 2. NUC therapy will be administered per local label or guidelines. |
| Part 3: POM in Treatment-Naive CHB Participants (Cohort B) | EXPERIMENTAL | Participants will receive RO7049389 for 4 weeks, followed by RO7049389 with an added NUC for 44 weeks. RO7049389 will be administered at a dose determined from Part 2. NUC therapy will be administered per local label or guidelines. |
| Part 3: POM in Treatment-Naive CHB Participants (Cohort C) | EXPERIMENTAL | Participants will receive RO7049389 + NUC + Pegylated-Interferon (Peg-IFN) for 48 weeks. RO7049389 will be administered at a dose determined from Part 2. NUC and Peg-IFN therapy will be administered per local label or guidelines. |
| Name | Type | Description |
|---|---|---|
| RO7049389 | DRUG | RO7049389 will be administered orally either as a single dose (SAD) or as multiple doses defined by the SAD portion of the study (MAD). |
| Placebo | DRUG | Placebo will be administered orally at a dose and frequency matched to RO7049389. |
| Midazolam | DRUG | Single dose of 100 mcg midazolam solution will be administered orally, before (Day -1) and after (Day 14) the treatment with RO7049389 or matching placebo |
Inclusion Criteria * 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...
RO7049389 is an investigational small molecule developed by Roche Holding AG for chronic hepatitis B virus infection. It has been studied in Phase 1 clinical trials in healthy volunteers and in participants with chronic hepatitis B. It is not an approved medicine and remains in clinical development.
RO7049389 is being developed for the treatment of hepatitis B virus infection, including chronic hepatitis B. Its clinical program has evaluated safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers and in people with chronic HBV infection. No approved use has been established.
RO7049389 is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche sponsored the Phase 1 studies of the compound in healthy volunteers and in participants with chronic hepatitis B virus infection.
RO7049389 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one in healthy Chinese participants and one in healthy volunteers and participants with chronic hepatitis B. It is an investigational agent and has not been approved for any indication.
RO7049389 has been evaluated in two completed Phase 1 trials. NCT02952924 studied single and multiple doses in healthy volunteers and chronic hepatitis B participants across Australia, Bulgaria, China, Hong Kong, New Zealand, Singapore, Taiwan, and Thailand. NCT03570658 studied single and multiple ascending doses in healthy Chinese participants in China.
Yes. [12C] RO7049389 is an alternative name for RO7049389, the Roche small molecule studied in Phase 1 trials for chronic hepatitis B virus infection. Both names refer to the same investigational compound.