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RO7049389 · 4 trials · 3 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 |
|---|---|---|
| Mass Balance (MB) Cohort | EXPERIMENTAL | Participants will receive oral \[14C\] RO7049389 under fasted conditions, followed by intravenous IV \[13C\] after a two-hour period. |
| Absolute Bioavailability (BA) Cohort | EXPERIMENTAL | In Periods 1 and 2, participants will receive oral \[12C\] RO7049389 under fasted conditions, followed by IV \[13C\] RO7049389. There is a minimum 7-day washout between periods. |
| Pitavastatin | EXPERIMENTAL | Period 1: Participants will receive a single dose of pitavastatin on Day 1, followed by a wash-out period of at least 7 and up to 21 days. Period 2: Participants will receive RO7049389 on Days 1-6. Participants will also receive a single dose of pitavastatin on Day 4. |
| 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 |
|---|---|---|
| [12C] RO7049389 | DRUG | Participants will receive oral \[12C\] RO7049389. |
| [13C] RO7049389 | DRUG | Participants will receive IV \[13C\] RO7049389. |
| [14C] RO7049389 | DRUG | Participants will receive an oral suspension of \[14C\] RO7049389. |
| RO7049389 | DRUG | RO7049389 will be taken orally, in tablet form, BID on Days 1-6 of Period 2. |
| Pitavastatin | DRUG | Pitavastatin will be taken orally, in tablet form, once on Day 1 of Period 1, and once on Day 4 of Period 2. |
| 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: * Caucasian (must have Caucasian parents and grandparents) or East Asian (must have Chinese, Korean, or Japanese parents and grandparents) * Body mass index between 18 to 30 kg/m\^2 (inclusive) and a weight range of 50 kg to 100 kg (inclusive) at screening * For women of childbe...
RO7049389 is an investigational small molecule being studied for the treatment of chronic Hepatitis B Virus (HBV) infection. It has been evaluated in Phase 1 clinical trials involving healthy volunteers and participants with chronic hepatitis B to assess its safety, tolerability, pharmacokinetics, and pharmacodynamics.
RO7049389 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company has sponsored multiple Phase 1 clinical trials to investigate the drug's safety and pharmacokinetic profile in healthy volunteers and chronic hepatitis B patients.
RO7049389 is in Phase 1 clinical development. All completed trials for this drug are Phase 1 studies, including single and multiple ascending dose trials, a drug interaction study, and a mass balance study. It remains investigational and has not been approved by regulatory authorities.
RO7049389 has completed four Phase 1 trials: NCT02952924 in healthy volunteers and chronic HBV patients across multiple countries, NCT03570658 in healthy Chinese participants, NCT03717064 studying its effect on pitavastatin pharmacokinetics, and NCT04729309 a mass balance and bioavailability study. All trials are completed.
RO7049389 is a small molecule being investigated for chronic hepatitis B. While its specific molecular target has not been disclosed in the available information, it is being studied for its antiviral activity against the hepatitis B virus in early-stage clinical trials.
RO7049389 is the only name provided for this investigational drug. No alternative names or brand names have been associated with it in the clinical trial data. It is identified solely by its development code RO7049389.