Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RO7062931 · 1 trial · 1 indication
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 |
|---|---|---|
| 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 | Administered subcutaneously in Parts 1 and 2. Part 1 will be administered in single-ascending doses after 0.1 mg/kg starting dose. Subsequent doses of 0.3, 1, 2 and 4 mg/kg may be administered based upon tolerability. In Part 2a, participants will receive two monthly doses of either 0.4, 0.8, 1.2 times the saturation dose or placebo. In Part 2b, a dose selected from Part 2a will be administered to participants randomized into 4 cohorts QW or Q2W. In Part 2c, participants will receive RO7062831 QW on top of another therapy for up to 24 or 48 weeks. |
| Placebo | DRUG | Part 1 cohorts: active drug vs placebo 4:1. Part 2a 4 parallel cohorts of 3 active drug doses and placebo in 1:1:1:1. Part 2b active drug vs placebo in 3:1 in 2 parallel cohorts. |
| Immune Modulator | DRUG | Participants in Part 2c will receive an immune modulator subcutaneously QW for up to 48 weeks. |
Inclusion Criteria: FOR HEALTHY VOLUNTEERS ONLY - PART 1 - * A Body Mass Index (BMI) between 18 to 30 kg/m2 inclusive and a body weight of at least 50 kg. * Women should be of non-childbearing potential. A woman is considered to be of childbearing potential if she is post-menarcheal but has not re...
RO7062931 is an investigational small molecule developed by Roche Holding AG for chronic hepatitis B. It has been studied in a Phase 1 clinical trial that evaluated its safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers and subjects with chronic hepatitis B.
RO7062931 is being developed for the treatment of chronic hepatitis B, a viral infection of the liver. It is not yet approved for any indication and remains an investigational therapy in clinical development.
RO7062931 is developed by Roche Holding AG, a pharmaceutical company traded on the OTC market under the ticker RHHBY. Roche is responsible for the research and clinical development of the drug.
RO7062931 is in Phase 1 clinical development. A single Phase 1 trial has been completed, and no active trials are currently listed. The drug has not been approved by the FDA or any regulatory agency.
RO7062931 has been studied in one completed Phase 1 trial, NCT03038113, titled "A Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of RO7062931 in Healthy Volunteers and Subjects With Chronic Hepatitis B." The trial enrolled 119 participants across Australia, Hong Kong, New Zealand, Singapore, South Korea, Taiwan, and Thailand.