Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RO7020531 · 1 trial · 1 indication
An AE is any untoward medical occurrence in a clinical investigation healthy volunteer (HV)/participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product, any new disease or exacerbation of an existing disease (a worsening in the character, frequency, or severity of a known condition and recurrence of an intermittent medical condition (e.g., headache) not present at baseline.
An AE is any untoward medical occurrence in a clinical investigation healthy volunteer (HV)/participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product, any new disease or exacerbation of an existing disease (a worsening in the character, frequency, or severity of a known condition and recurrence of an intermittent medical condition (e.g., headache) not present at baseline.
An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product, any new disease or exacerbation of an existing disease (a worsening in the character, frequency, or severity of a known condition and recurrence of an intermittent medical condition (e.g., headache) not present at baseline.
For all laboratory parameters included, there exists a Roche predefined standard reference range. Laboratory values falling outside this standard reference range were labeled "H" for high or "L" for low in HV/participant listings of laboratory data.
For all laboratory parameters included, there exists a Roche predefined standard reference range. Laboratory values falling outside this standard reference range were labeled "H" for high or "L" for low in HV/participant listings of laboratory data.
For all laboratory parameters included, there exists a Roche predefined standard reference range. Laboratory values falling outside this standard reference range were labeled "H" for high or "L" for low in HV/participant listings of laboratory data.
Triplicate 12-lead ECGs were obtained after the participant has been in a supine position for at least 10 minutes. Clinically significant RO7020531-related changes included confirmation of mean QTc 500 milliseconds (msec) or 60 msec longer than the pre-dose baseline.
Triplicate 12-lead ECGs were obtained after the participants has been in a supine position for at least 10 minutes. Clinically significant RO7020531-related changes included confirmation of mean QTc 500 msec or 60 msec longer than the pre-dose baseline.
Triplicate 12-lead ECGs were obtained after the participant has been in a supine position for at least 10 minutes. Clinically significant RO7020531-related changes included confirmation of mean QTc 500 msec or 60 msec longer than the pre-dose baseline.
Vital signs include blood pressure, pulse rate, respiratory rate and body temperature. Blood pressure, respiratory rate and pulse rate were obtained after the participant had been in a supine or sitting position for at least 5 minutes. Blood pressure measurement were performed in triplicate (can be as short as 20 second to 1 minute interval between measurements).
Vital signs include blood pressure, pulse rate, respiratory rate and body temperature. Blood pressure, respiratory rate and pulse rate were obtained after the participant had been in a supine or sitting position for at least 5 minutes. Blood pressure measurement were performed in triplicate (can be as short as 20 second to 1 minute interval between measurements).
Vital signs include blood pressure, pulse rate, respiratory rate and body temperature. Blood pressure, respiratory rate and pulse rate were obtained after the participant had been in a supine or sitting position for at least 5 minutes. Blood pressure measurement were performed in triplicate (can be as short as 20 second to 1 minute interval between measurements).
| Arm | Type | Description |
|---|---|---|
| Part I: SAD in Healthy Volunteers | EXPERIMENTAL | Healthy volunteers will receive single dose of RO7020531 or matching placebo orally on Day 1 of each cohort. A planned dose-escalation sequence for SAD is 3 milligrams (mg), 10 mg, 20 mg, 40 mg, 60 mg, 100 mg, 140 mg, and 170 mg. |
| Part I: MAD in Healthy Volunteers | EXPERIMENTAL | Healthy volunteers will receive RO7020531 (100 mg, 140 mg, and 170 mg as selected based on safety, pharmacokinetic (PK) and pharmacodynamic (PD) data of SAD cohorts) or matching placebo orally every other day (QOD) from Day 1 through to Day 13. |
| Part II: CHB Participants | EXPERIMENTAL | CHB participants will receive RO7020531 (150 mg and 170 mg as selected based on safety, PK and PD data of MAD cohorts) or matching placebo orally QOD from Day 1 through to Day 41, unless in Cohort 4 in case of once a week (QW) dosing as dose modification. |
| Name | Type | Description |
|---|---|---|
| Placebo | OTHER | Placebo matching to RO7020531 will be administered as per schedule specified in the respective arm. |
| RO7020531 | DRUG | RO7020531 will be administered as per schedule specified in the respective arm. |
Inclusion Criteria: Part 1: SAD and MAD in Healthy Volunteers * Non-smokers, or use of less than (\<) 10 cigarettes (or equivalent nicotine-containing product) per day * Negative Anti-Nuclear Antibody (ANA) test; or positive with dilutions not greater than 1:40 and with no associated history or sy...
RO7020531 is an investigational small molecule developed by Roche Holding AG for chronic hepatitis B. It is a Phase 1 clinical candidate that has been studied in healthy volunteers and in participants with chronic hepatitis B. It is not an approved medicine and remains in clinical development.
RO7020531 is being studied for the treatment of chronic hepatitis B, an infectious disease of the liver. Its only recorded clinical trial enrolled healthy volunteers and participants with chronic hepatitis B to assess safety, tolerability, pharmacokinetics and pharmacodynamics. It has no approved indication.
RO7020531 is developed by Roche Holding AG, which trades over the counter in the United States under the ticker RHHBY. Roche is the sponsor of the compound's clinical program in chronic hepatitis B.
RO7020531 is in Phase 1. One Phase 1 trial has been completed, and no active trials are currently listed. The compound is investigational and has not been approved by the FDA or any other regulator for chronic hepatitis B or any other indication.
RO7020531 has been evaluated in one completed Phase 1 trial, NCT02956850, titled a study in healthy volunteers and participants with chronic hepatitis B to assess safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses. It was randomized, double blind, controlled, and enrolled 160 participants across sites in Europe, Asia and New Zealand.