Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RO7020531 · 2 trials · 2 indications
An Adverse Event (AE) is defined as 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, recurrence of an intermittent medical condition, any deterioration in a laboratory value or other clinical test or adverse events that are related to a protocol-mandated intervention, including those that occur prior to assignment of study treatment.
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 |
|---|---|---|
| Single Ascending Dose (SAD): Placebo | EXPERIMENTAL | In SAD Cohorts 1-4, there will be eight participants in total receiving placebo, two in each cohort. |
| SAD: Cohort 1 | EXPERIMENTAL | Eight participants will be administered 40mg RO7020531 orally on Day 1. |
| SAD: Cohort 2 | EXPERIMENTAL | Eight participants will be administered 100mg RO7020531 orally on Day 1. |
| SAD: Cohort 3 | EXPERIMENTAL | Eight participants will be administered 140mg RO7020531 orally on Day 1. |
| SAD: Cohort 4 | EXPERIMENTAL | Eight participants will be administered 170mg RO7020531 orally on Day 1. |
| Multiple Ascending Dose (MAD): Placebo | EXPERIMENTAL | In MAD Cohorts 1-3, there will be six participants in total receiving placebo, two in each cohort. |
| MAD: Cohort 1 | EXPERIMENTAL | Eight participants will be administered 100mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days. |
| MAD: Cohorts 2 and 3 | EXPERIMENTAL | Sixteen participants will be administered 150mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days. |
| 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 |
|---|---|---|
| RO7020531 | DRUG | 4 SAD Cohorts with individual dosages of 40, 100, 140 and 170 mg hard capsules and 3 MAD Cohorts with dosages of 100 and 150mg hard capsules, will be administered orally as per the dosing schedules described above. |
| Placebo | DRUG | Placebo hard capsules will be administered orally as per the dosing schedules described above. |
Inclusion Criteria * Chinese healthy male and female participants. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, an...
RO7020531 is an investigational small molecule being studied for chronic Hepatitis B. It is being evaluated in healthy participants and in participants with chronic Hepatitis B to assess safety, tolerability, pharmacokinetics, and pharmacodynamics after single and multiple doses.
RO7020531 is being developed by Roche Holding AG, traded on the OTC market under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug's safety and tolerability in healthy participants and in those with chronic Hepatitis B.
RO7020531 is in Phase 1 clinical development. It is investigational and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, one involving healthy volunteers and participants with chronic Hepatitis B, and another in Chinese healthy participants.
RO7020531 has been studied in two completed Phase 1 trials. NCT02956850 assessed safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers and participants with chronic Hepatitis B across multiple countries. NCT03530917 evaluated single and multiple ascending doses in Chinese healthy participants.
No alternative names for RO7020531 have been disclosed in the clinical trial records. The drug is identified solely by its code name RO7020531 in the studies conducted by Roche.