Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RO7062931 · 2 trials · 2 indications
Adverse events of special interest for this study include the following: * Cases of an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice * Suspected transmission of an infectious agent by the study drug * Severe injection site reactions * Renal adverse events
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.
Table entries provide the percentage of Participants with a during treatment assessment abnormality in the direction specified regardless of this abnormality at baseline. Abnormalities reported in Participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
Table entries provide the percentage of Participants with a during treatment assessment abnormality in the direction specified regardless of this abnormality at baseline. Abnormalities reported in Participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
Table entries provide the percentage of Participants with a during treatment assessment abnormality in the direction specified regardless of this abnormality at baseline. Abnormalities reported in Participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| RO7062931 0.3mg/kg | EXPERIMENTAL | Participants will receive subcutaneously (SC) 0.3 milligram per kilogram (mg/kg) of RO7062931. |
| RO7062931 1.0mg/kg | EXPERIMENTAL | Participants will receive subcutaneously (SC) 1.0 milligram per kilogram (mg/kg) of RO7062931. |
| RO7062931 2.0mg/kg | EXPERIMENTAL | Participants will receive subcutaneously (SC) 2.0 milligram per kilogram (mg/kg) of RO7062931. |
| RO7062931 4.0mg/kg | EXPERIMENTAL | Participants will receive subcutaneously (SC) 4.0 milligram per kilogram (mg/kg) of RO7062931. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo. |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| RO7062931 | DRUG | RO7062931 will be administered SC in single ascending doses with starting of 0.3 mg/kg and subsequent doses of 1.0 mg/kg, 2.0 mg/kg and 3.0 mg/kg, respectively. Additional (optional) dose of 4.0 mg/kg may be administered based on safety, tolerability and PK data. |
| Placebo | DRUG | Matching placebo will be administered subcutaneously (SC). |
| Immune Modulator | DRUG | Participants in Part 2c will receive an immune modulator subcutaneously QW for up to 48 weeks. |
Inclusion Criteria: * Chinese healthy male and female (of non-childbearing potential) volunteers. * A Body Mass Index (BMI) between 19 to 27 kilogram per square meter (kg/m2) inclusive and a body weight of at least 45 kg. * Women should be of non-childbearing potential. These include those who have...
RO7062931 is an investigational small molecule being studied for use in chronic hepatitis B and in healthy participants. It is in Phase 1 clinical development by Roche Holding AG (ticker: RHHBY). The drug is not approved and remains under investigation for safety, tolerability, and pharmacokinetics.
RO7062931 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The drug is an investigational small molecule in Phase 1 clinical development for chronic hepatitis B and healthy participants. Roche is conducting clinical trials to evaluate its safety and pharmacokinetics.
RO7062931 is in Phase 1 clinical development. It is an investigational small molecule being studied for chronic hepatitis B and in healthy participants. The drug is not FDA approved and remains in early-stage clinical trials to assess safety, tolerability, and pharmacokinetics.
RO7062931 has been studied in two completed Phase 1 trials. NCT03038113 evaluated safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers and subjects with chronic hepatitis B across multiple countries. NCT03505190 evaluated safety, tolerability, and pharmacokinetics in healthy Chinese volunteers in Hong Kong.
RO7062931 is the primary name for this investigational small molecule being developed by Roche Holding AG. No alternative names have been reported for this drug. It is being studied in Phase 1 clinical trials for chronic hepatitis B and in healthy participants.