Chronic Hepatitis B
Conditions
Brief summary
This randomized study will be conducted in two parts to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of subcutaneous administration of RO7062931. Part 1 will include only healthy participants and Part 2 will include only participants with chronic hepatitis B (CHB). Part 1 is an adaptive, single-ascending dose study with an adaptive dose-escalating schedule to determine the best dose to be evaluated in participants with CHB. Part 2 is an adaptive, parallel multiple-dose study comprised of three sub-parts which will be used to further refine the dose and dosing regimen, and to evaluate the safety and efficacy of RO7062931 when administered with standard-of-care (SoC) therapy.
Interventions
DRUGRO7062931
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.
DRUGPlacebo
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.
DRUGImmune Modulator
Participants in Part 2c will receive an immune modulator subcutaneously QW for up to 48 weeks.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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 reached a post-menopausal state and has not undergone surgical sterilization (removal of ovaries and/or uterus). * Men must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures during treatment and up to 105 days after the last dose, and agree to refrain from donating sperm. * Non-smoker (nor tobacco containing products) for at least 90 days prior to dosing on Day 1 and agree to remain as non-smoker during the study. FOR CHB PARTICIPANTS ONLY - PARTS 2a and 2b: * A BMI between 18 to 32 kg/m2 inclusive. * Chronic hepatitis B (HBV) infection. * Positive test for HBsAg for more than 6 months prior to randomization and HBsAg titer ≥ 10\^3 IU/mL at screening. * On entecavir, tenofovir, adefovir or telbivudine treatment for at least 6 months prior to randomization and will remain on stable treatment during the study. * HBV deoxyribonucleic acid (DNA) ≤ 90 IU/mL for at least the preceding 6 months. * Screening laboratory values (hematology, chemistry, urinalysis) obtained up to 56 days prior to first study treatment within normal ranges. * Liver biopsy, fibroscan® or equivalent test obtained within the past 6 months demonstrating liver disease consistent with chronic HBV infection without evidence of bridging fibrosis or cirrhosis * Women should be of non-childbearing potential. A woman is considered to be of childbearing potential if she is post-menarcheal but has not reached a post-menopausal state and has not undergone surgical sterilization (removal of ovaries and/or uterus). * Men must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures during treatment and up to 105 days after the last dose, and agree to refrain from donating sperm. FOR CHB PARTICIPANTS ONLY - PART 2c * BMI between 18 to 32 kg/m2 inclusive * CHB infection (HBsAg-positive for at least 6 months) * For NUC-suppressed CHB participants: Must have been treated with a single NUC for at least 12 months, and have been on the same NUC therapy for at least 3 months prior to screening; HBV DNA \<lower limit of quantification (LLOQ) at screening and in the 6 months prior to screening (at least one measurement must be \>30 days prior to screening); alanine aminotransferase (ALT) \</=2x upper limit of normal (ULN) for \>6 months prior to screening and confirmed at screening; total bilirubin within normal range at screening, except for patients with Gilbert's syndrome * For treatment-naive and immune-active participants: HBV DNA at screening \>/=2x10\^4 IU/mL for HBeAg positive participants, or \>/=2x10\^3 IU/mL for HBeAg negative participants; elevated serum ALT\>2 ULN to \</=5, 2 values within 6 months, at least one of which is at screening and that are at least 14 days apart; total bilirubin within normal range except for participants with Gilbert's syndrome * Screening laboratory values (hematology, chemistry, urinalysis) obtained up to 28 days prior to first study treatment within normal ranges * Liver biopsy, fibroscan, or equivalent test obtained within the last 6 months demonstrating liver disease consistent with chronic HBV infection without evidence of bridging fibrosis or cirrhosis * Women should be of non-childbearing potential * Men must agree to remain abstinent or use contraception, and agree to refrain from donating sperm
Exclusion criteria
FOR HEALTHY VOLUNTEERS ONLY - PART 1: * History of drug or alcohol abuse or dependence in previous 6 months. * Positive urine drug and alcohol screen or positive cotinine test at screening or Day -1. * Positive result on hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV) 1 and 2. * Confirmed blood pressure or resting pulse rate outside of accepted ranges. * Participation in an investigational drug or device study within 90 days prior to screening. * Donation of blood over 500 mL within three months prior to screening. * Any major illness within the one month, or any febrile illness within two weeks preceding the screening visit. * Alcohol consumption of more than 2 standard drinks per day on average. FOR CHB PARTICIPANTS ONLY - PARTS 2a and 2b: * History or other evidence of bleeding from esophageal varices. * Decompensated liver disease. * History of or suspicion of hepatocellular carcinoma or alpha fetoprotein (AFP) ≥ 13 ng/mL at Screening * History or other evidence of a medical condition associated with chronic liver disease other than HBV infection. * Documented history or other evidence of metabolic liver disease within one year of randomization or documented history of infection with hepatitis D virus. * Positive test for hepatitis A (IgM anti-HAV), hepatitis C, or HIV. * Organ transplantation. * Significant acute infection or any other clinically significant illness within 2 weeks of randomization. * Abnormal renal function. * Participation in an investigational drug or device study within 30 days prior to randomization. * Donation or loss of blood over 500 mL within 3 months prior to starting study medication. * Administration of any blood product within 3 months of randomization. * History or evidence of alcohol abuse (consumption of more than 2 standard drinks per day on average). FOR CHB PARTICIPANTS ONLY - PART 2c * History or other evidence of bleeding from esophageal varices * Evidence of liver cirrhosis or decompensated liver disease * One or more of the following laboratory abnormalities at screening: Total serum bilirubin \> ULN (except for participants with Gilbert's disease); international normalized ratio (INR) \> 1.1 ULN; serum albumin \< 3.5 g/dL; AFP \>13 ng/mL; positive results for anti-mitochondrial antibodies (AMA \> 1:80), anti-nuclear antibody (ANA \> 1:80), anti-smooth muscle antibody (ASMA \> 1:40), anti-thyroperoxidase antibodies (a-TPO), anti-thyroglobulin, or anti-platelet antibodies; thyroid stimulating hormone (TSH) outside of normal range; platelet count \<100,000 cells/mm\^3; hemoglobin \<12 g/dL (females) or \<13 g/dL (males); white blood cell count \<2500 cells/mm\^3; and neutrophil count \<1500 cells/mm\^3 * History or other evidence of a medical condition associated with chronic liver disease other than HBV infection * History of thyroid disease poorly controlled on prescribed medications or clinically relevant abnormal thyroid function tests * Documented history or other evidence of metabolic liver disease within one year of randomization * Positive test for hepatitis A, hepatitis C, or HIV * History of organ transplantation * Participation in an investigational drug or device study within 30 days prior to screening or previous treatment with an investigational agent for HBV within 6 months prior to screening * Significant acute infection or any other clinically significant illness within 2 weeks of randomization * Abnormal renal function, including serum creatinine \> ULN or calculated creatinine clearance \< 70 mL/min * Donation or loss of blood over 500 mL within 3 months prior to randomization * Administration of any blood product within 3 months prior to randomization * History of alcohol abuse and/or drug abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest | Up to day 113 | 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. |
| Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 1 | Screening, Days -1, 2, 8, 15, 29, 85 | 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. |
| Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2 | Screening, Days -1, 2, 8, 15, 29, at discontinuation, Days 36, 43, 57, 85, 113 | 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. |
| Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 1 (1,4,8,12h), Days 2 and 8, Follow Up Days 15, 29, 85 | 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. |
| Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 1 (1,4,8h), Days 2,8,15,22 (1h and 8h), Day 23, Day 29 (1,4,8h), Day 30, Follow Up Days 36, 43, 50, 57, 78, 85, 106, 113 | 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. |
| Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 1 (1,4,8,12h), Days 2 and 8, Follow Up Days 15, 29, 85 | 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. |
| Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 1 (1,4,8,12h), Days 2 and 8, Follow Up Days 15, 29, 85 | 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. |
| Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 1 (1,4,8h), Days 2,8,15,22 (1h and 8h), Day 23, Day 29 (1,4,8h), Day 30, Follow Up Days 36, 43, 50, 57, 78, 85, 106, 113 | 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. |
| Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 1 (1,4,8h), Days 2,8,15,22 (1h and 8h), Day 23, Day 29 (1,4,8h), Day 30, Follow Up Days 36, 43, 50, 57, 78, 85, 106, 113 | 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. |
| Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 1 (1,4,8h), Days 2,8,15,22 (1h and 8h), Day 23, Day 29 (1,4,8h), Day 30, Follow Up Days 36, 43, 50, 57, 78, 85, 106, 113 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-last After Multiple Ascending Doses - Part 2 | Days 1,22,29 | AUC0-last was calculated based on non-compartmental analysis. |
| Total Clearance (CL) After Multiple Ascending Doses - Part 2 | Days 1-113 | Apparent oral clearance was calculated from Dose/AUCinf. |
| Volume of Distribution (Vss) After Single Ascending Doses - Part 1 | Days 1-8 | Vss was calculated from dose/AUCinf |
| Volume of Distribution (Vss) After Multiple Ascending Doses - Part 2 | Days 1-113 | Vss was calculated from dose/AUCinf |
| Cmax After Multiple Ascending Doses - Part 2 | Days 1-113 | Cmax values are the the peak plasma concentration reached after administration of RO7062931. |
| Cumulative Amount Excreted Unchanged in Urine (Ae) After Multiple Ascending Doses - Part 2 | Days 1-113 | Ae: cumulative amount of drug excreted in urine over a 24 hour period or over defined time periods linked to the pools of urine collected. |
| Change From Baseline of Quantitative HBsAg (qHBsAg) (log10) After Multiple Ascending Doses - Part 2 | Days 1-113 | HBsAg is a viral parameter that can be affected by the action of RO7062931. A change from baseline in qHBsAg can indicate the drug's effect. |
| Summary of Maximum qHBsAg Decrease on Days 1-113 - Part 2 | Day 1 - Day 113 | HBsAg is a viral parameter that can be affected by the action of RO7062931. A change from baseline in qHBsAg can indicate the drug's effect. |
| Summary of Time to Maximum qHBsAg Decrease on Day 1-113 - Part 2 | Day 1 - Day 113 | HBsAg is a viral parameter that can be affected by the action of RO7062931. A change from baseline in qHBsAg can indicate the drug's effect. |
| Cumulative Amount Excreted Unchanged in Urine (Ae) After Single Ascending Doses - Part 1 | Hours 0-4, 0-8, 0-12, and 0-24 | Ae: cumulative amount of drug excreted in urine over a 24 hour period or over defined time periods linked to the pools of urine collected. |
| Maximum Plasma Concentration (Cmax) After Single Ascending Doses - Part 1 | Days 1-8 | Cmax values are the the peak plasma concentration reached after administration of RO7062931. |
| Terminal Elimination Half-Life (t1/2) After Single Ascending Doses - Part 1 | Days 1-8 | T1/2 was calculated based on non-compartmental analysis. |
| Time to Reach Maximum Plasma Concentration (Tmax) After Single-Ascending Doses - Part 1 | Days 1-8 | Tmax values are the amount of time to maximum concentration in plasma after administration of RO7062931. |
| Tmax After Multiple Ascending Doses - Part 2 | Days 1-113 | Tmax values are the amount of time to maximum concentration in plasma after administration of RO7062931. |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) After Single-Ascending Doses - Part 1 | Days 1-8 | AUC0-inf was calculated based on non-compartmental analysis. |
| AUC0-inf After Multiple Ascending Doses - Part 2 | Days 1,22,29 | AUC0-inf was calculated based on non-compartmental analysis. |
| Total Clearance (CL) After Single Ascending Doses - Part 1 | Days 1-8 | Apparent oral clearance was calculated from Dose/AUCinf. |
| Terminal Elimination Half-Life (t1/2) After Multiple Ascending Doses - Part 2 | Days 1-113 | T1/2 was calculated based on non-compartmental analysis. |
| Area Under the Plasma Concentration-Time Curve From Time Zero Until the Last Quantifiable Time-Point (AUC0-last) After Single Ascending Doses - Part 1 | Days 1-8 | AUC0-last was calculated based on non-compartmental analysis. |
Countries
Australia, Hong Kong, New Zealand, Singapore, South Korea, Taiwan, Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Part 1 - RO7062931 0.1 mg/kg Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931. | 8 |
| Part 1 - RO7062931 0.3 mg/kg Participants received a single SC injection of 0.3 mg/kg RO7062931. | 8 |
| Part 1 - RO7062931 1.0 mg/kg Participants received a single SC injection of 1.0 mg/kg RO7062931. | 8 |
| Part 1 - RO7062931 2.0 mg/kg Participants received a single SC injection of 2.0 mg/kg RO7062931. | 8 |
| Part 1 - RO7062931 3.0 mg/kg Participants received a single SC injection of 3.0 mg/kg RO7062931. | 8 |
| Part 1 - RO7062931 4.0 mg/kg Participants received a single SC injection of 4.0 mg/kg RO7062931. | 8 |
| Part 1 - Placebo Participants received a single SC injection of placebo matched to RO7062931. | 12 |
| Part 2a - RO7062931 0.5 mg/kg Q1M Participants received two QM SC injections of 0.5 mg/kg RO7062931. | 6 |
| Part 2a - RO7062931 1.5 mg/kg Q1M Participants received 2 QM SC injections of 1.5 mg/kg RO7062931. | 7 |
| Part 2a - RO7062931 3.0 mg/kg Q1M Participants received 2 QM SC injections of 3.0 mg/kg RO7062931. | 6 |
| Part 2b - RO7062931 3.0 mg/kg QW Participants received five QW SC injections of 3.0 mg/kg RO7062931. | 14 |
| Part 2b - RO7062931 3.0 mg/kg Q2W Participants received three Q2W SC injections of 3.0 mg/kg RO7062931. | 7 |
| Part 2b - RO7062931 4.0 mg/kg QW Participants received four QW SC injections of 4.0 mg/kg RO7062931. | 4 |
| Part 2 - Placebo Participants received SC placebo matched to RO7062931 over a 4-week period. | 15 |
| Total | 119 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Part 1 - RO7062931 0.1 mg/kg | Part 1 - RO7062931 0.3 mg/kg | Part 1 - RO7062931 1.0 mg/kg | Part 1 - RO7062931 2.0 mg/kg | Part 1 - RO7062931 3.0 mg/kg | Part 1 - RO7062931 4.0 mg/kg | Part 1 - Placebo | Part 2a - RO7062931 0.5 mg/kg Q1M | Part 2a - RO7062931 1.5 mg/kg Q1M | Part 2a - RO7062931 3.0 mg/kg Q1M | Part 2b - RO7062931 3.0 mg/kg QW | Part 2b - RO7062931 3.0 mg/kg Q2W | Part 2b - RO7062931 4.0 mg/kg QW | Part 2 - Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 29.8 Years STANDARD_DEVIATION 11.9 | 29.0 Years STANDARD_DEVIATION 11.4 | 34.0 Years STANDARD_DEVIATION 11.4 | 30.4 Years STANDARD_DEVIATION 13.6 | 24.8 Years STANDARD_DEVIATION 7.9 | 23.4 Years STANDARD_DEVIATION 3.5 | 31.6 Years STANDARD_DEVIATION 9 | 42.0 Years STANDARD_DEVIATION 5.3 | 42.7 Years STANDARD_DEVIATION 11.1 | 47.8 Years STANDARD_DEVIATION 7.2 | 46.1 Years STANDARD_DEVIATION 12.1 | 44.9 Years STANDARD_DEVIATION 8.7 | 48.5 Years STANDARD_DEVIATION 6.9 | 44.7 Years STANDARD_DEVIATION 9 | 37.1 Years STANDARD_DEVIATION 12.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 8 Participants | 8 Participants | 8 Participants | 8 Participants | 7 Participants | 10 Participants | 6 Participants | 7 Participants | 6 Participants | 14 Participants | 7 Participants | 4 Participants | 15 Participants | 114 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 3 Participants | 4 Participants | 3 Participants | 5 Participants | 6 Participants | 4 Participants | 14 Participants | 6 Participants | 3 Participants | 15 Participants | 68 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 7 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 4 Participants | 5 Participants | 6 Participants | 5 Participants | 4 Participants | 4 Participants | 9 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 38 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 8 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 7 Participants | 8 Participants | 8 Participants | 8 Participants | 12 Participants | 6 Participants | 6 Participants | 4 Participants | 12 Participants | 7 Participants | 3 Participants | 14 Participants | 111 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 12 | 0 / 6 | 0 / 7 | 0 / 6 | 0 / 14 | 0 / 7 | 0 / 4 | 0 / 15 |
| other Total, other adverse events | 6 / 8 | 7 / 8 | 3 / 8 | 6 / 8 | 7 / 8 | 4 / 8 | 7 / 12 | 2 / 6 | 6 / 7 | 4 / 6 | 10 / 14 | 4 / 7 | 3 / 4 | 8 / 15 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 12 | 0 / 6 | 0 / 7 | 0 / 6 | 0 / 14 | 0 / 7 | 0 / 4 | 0 / 15 |
Outcome results
Primary
Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest
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.
Time frame: Up to day 113
Population: Safety population: All study subjects that received at least one dose of study medication, whether prematurely withdrawn from the study or not.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest | AEs of Special Interest | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest | AEs | 75.0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest | AEs of Special Interest | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest | AEs | 87.5 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest | AEs of Special Interest | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest | AEs | 37.5 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest | AEs | 75.0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest | AEs of Special Interest | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest | AEs of Special Interest | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest | AEs | 87.5 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest | AEs of Special Interest | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest | AEs | 50.0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest | AEs of Special Interest | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest | AEs | 58.3 Percentage of Participants |
| Part 2a - RO7062931 0.5 mg/kg Q1M | Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest | AEs of Special Interest | 0 Percentage of Participants |
| Part 2a - RO7062931 0.5 mg/kg Q1M | Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest | AEs | 33.3 Percentage of Participants |
| Part 2a - RO7062931 1.5 mg/kg Q1M | Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest | AEs | 85.7 Percentage of Participants |
| Part 2a - RO7062931 1.5 mg/kg Q1M | Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest | AEs of Special Interest | 0 Percentage of Participants |
| Part 2a - RO7062931 3.0 mg/kg Q1M | Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest | AEs | 66.7 Percentage of Participants |
| Part 2a - RO7062931 3.0 mg/kg Q1M | Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest | AEs of Special Interest | 0 Percentage of Participants |
| Part 2b - RO7062931 3.0 mg/kg QW | Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest | AEs of Special Interest | 0 Percentage of Participants |
| Part 2b - RO7062931 3.0 mg/kg QW | Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest | AEs | 71.4 Percentage of Participants |
| Part 2b - RO7062931 3.0 mg/kg Q2W | Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest | AEs | 57.1 Percentage of Participants |
| Part 2b - RO7062931 3.0 mg/kg Q2W | Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest | AEs of Special Interest | 0 Percentage of Participants |
| Part 2b - RO7062931 4.0 mg/kg QW | Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest | AEs | 75.0 Percentage of Participants |
| Part 2b - RO7062931 4.0 mg/kg QW | Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest | AEs of Special Interest | 0 Percentage of Participants |
| Part 2 - Placebo | Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest | AEs | 53.3 Percentage of Participants |
| Part 2 - Placebo | Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest | AEs of Special Interest | 0 Percentage of Participants |
Primary
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1
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.
Time frame: Day 1 (1,4,8,12h), Days 2 and 8, Follow Up Days 15, 29, 85
Population: Safety population: All study subjects that received at least one dose of study medication, whether prematurely withdrawn from the study or not.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 1 - 8h | 37.5 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 1 - 4h | 25.0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Extended Follow-Up | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Follow-up Day 29 | 25.0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Follow-up Day 15 | 12.5 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 8 - 168h | 12.5 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 2 - 24h | 37.5 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 1 - 1h | 37.5 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Baseline | 12.5 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 1 - 12h | 25.0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 1 - 1h | 50.0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Baseline | 50.0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 1 - 4h | 25.0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 1 - 8h | 50.0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 1 - 12h | 50.0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 2 - 24h | 50.0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 8 - 168h | 50.0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Follow-up Day 15 | 12.5 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Follow-up Day 29 | 25.0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Extended Follow-Up | 12.5 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Follow-up Day 29 | 14.3 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 8 - 168h | 25.0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 1 - 1h | 12.5 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 1 - 12h | 25.0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Follow-up Day 15 | 12.5 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Baseline | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 1 - 4h | 12.5 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Extended Follow-Up | 28.6 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 2 - 24h | 12.5 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 1 - 8h | 25.0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 1 - 1h | 25.0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Baseline | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 1 - 8h | 12.5 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Extended Follow-Up | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 1 - 12h | 25.0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 8 - 168h | 37.5 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Follow-up Day 15 | 25.0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 2 - 24h | 12.5 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Follow-up Day 29 | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 1 - 4h | 25.0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Baseline | 37.5 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Follow-up Day 15 | 12.5 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 1 - 4h | 25.0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 1 - 12h | 37.5 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 1 - 1h | 37.5 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 2 - 24h | 25.0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Follow-up Day 29 | 25.0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 8 - 168h | 25.0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 1 - 8h | 25.0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Extended Follow-Up | 25.0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Extended Follow-Up | 25.0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 1 - 8h | 25.0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 1 - 12h | 12.5 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 2 - 24h | 25.0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Baseline | 25.0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 8 - 168h | 25.0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Follow-up Day 15 | 12.5 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Follow-up Day 29 | 25.0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 1 - 1h | 25.0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 1 - 4h | 12.5 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 2 - 24h | 50.0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Extended Follow-Up | 50.0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 1 - 8h | 58.3 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 1 - 1h | 41.7 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Baseline | 16.7 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Follow-up Day 29 | 36.4 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 1 - 12h | 58.3 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 1 - 4h | 50.0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Follow-up Day 15 | 16.7 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1 | Day 8 - 168h | 41.7 Percentage of Participants |
Primary
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2
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.
Time frame: Day 1 (1,4,8h), Days 2,8,15,22 (1h and 8h), Day 23, Day 29 (1,4,8h), Day 30, Follow Up Days 36, 43, 50, 57, 78, 85, 106, 113
Population: Safety population: All study subjects that received at least one dose of study medication, whether prematurely withdrawn from the study or not.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 2 - 24h | 33.3 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 29 | 66.7 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 1 - 1h | 66.7 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Baseline | 33.3 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 8 | 66.7 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 30 - 24h | 66.7 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Follow-up Day 57 | 66.7 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Follow-up Day 85 | 33.3 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 1 - 4h | 33.3 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 1 - 8h | 50.0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 29 - 8h | 16.7 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Follow-up Day 113 | 66.7 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Follow-up Day 43 | 83.3 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 29 - 4h | 50.0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 29 - 1h | 83.3 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 1 - 4h | 42.9 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 30 - 24h | 16.7 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 29 | 50.0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 1 - 1h | 42.9 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 1 - 8h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 29 - 1h | 16.7 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Follow-up Day 113 | 14.3 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 8 | 57.1 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Follow-up Day 43 | 14.3 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Baseline | 14.3 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 29 - 4h | 33.3 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Follow-up Day 85 | 14.3 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Follow-up Day 57 | 14.3 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 2 - 24h | 28.6 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 29 - 8h | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 29 - 4h | 16.7 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Follow-up Day 57 | 66.7 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Baseline | 50.0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Follow-up Day 85 | 66.7 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Follow-up Day 113 | 50.0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 30 - 24h | 100 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 1 - 8h | 33.3 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 2 - 24h | 50.0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 8 | 50.0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 1 - 1h | 50.0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 29 | 83.3 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 29 - 1h | 50.0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 29 - 8h | 66.7 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 1 - 4h | 66.7 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Follow-up Day 43 | 16.7 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Follow-up Day 43 | 57.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 22 | 50.0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 1 - 4h | 64.3 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 29 - 1h | 64.3 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Follow-up Day 85 | 50.0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Follow-up Day 113 | 42.9 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 1 - 8h | 50.0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Follow-up Day 57 | 57.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 29 - 4h | 57.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 29 - 8h | 64.3 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 1 - 1h | 57.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 2 - 24h | 57.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Baseline | 50.0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 15 | 50.0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 29 | 50.0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 8 | 57.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 30 - 24h | 50.0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 15 | 83.3 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Baseline | 100 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 2 - 24h | 57.1 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 1 - 4h | 57.1 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 29 | 83.3 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 1 - 1h | 85.7 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 1 - 8h | 100 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 29 - 1h | 83.3 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Follow-up Day 113 | 71.4 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 29 - 4h | 66.7 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Follow-up Day 85 | 57.1 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 29 - 8h | 66.7 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 30 - 24h | 66.7 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Follow-up Day 57 | 71.4 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Follow-up Day 43 | 57.1 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 8 | 66.7 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 15 | 50.0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 22 - 8h | 50.0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Follow-up Day 78 | 25.0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 1 - 4h | 50.0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 22 - 1h | 75.0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 8 | 25.0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Baseline | 50.0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Follow-up Day 36 | 75.0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Follow-up Day 50 | 50.0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 22 | 75.0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 1 - 1h | 75.0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Follow-up Day 106 | 50.0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 2 - 24h | 50.0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 1 - 8h | 25.0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 23 - 24h | 50.0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Follow-up Day 113 | 46.2 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Baseline | 46.7 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 1 - 1h | 40.0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 1 - 4h | 33.3 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 1 - 8h | 26.7 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 2 - 24h | 33.3 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 8 | 33.3 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 15 | 71.4 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 22 | 80.0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 22 - 1h | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 22 - 8h | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 23 - 24h | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 29 | 50.0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 29 - 1h | 58.3 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 29 - 4h | 25.0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 29 - 8h | 16.7 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Day 30 - 24h | 41.7 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Follow-up Day 36 | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Follow-up Day 43 | 38.5 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Follow-up Day 50 | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Follow-up Day 57 | 53.8 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Follow-up Day 78 | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Follow-up Day 85 | 38.5 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2 | Follow-up Day 106 | 0 Percentage of Participants |
Primary
Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 1
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.
Time frame: Screening, Days -1, 2, 8, 15, 29, 85
Population: Safety population: All study subjects that received at least one dose of study medication, whether prematurely withdrawn from the study or not.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 1 | SGOT/AST - High | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 1 | Chloride - Low | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 1 | HDL Cholesterol - Low | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 1 | Triglycerides - High | 12.5 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 1 | Triglycerides - High | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 1 | HDL Cholesterol - Low | 12.5 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 1 | SGOT/AST - High | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 1 | Chloride - Low | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 1 | HDL Cholesterol - Low | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 1 | Chloride - Low | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 1 | SGOT/AST - High | 12.5 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 1 | Triglycerides - High | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 1 | SGOT/AST - High | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 1 | Chloride - Low | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 1 | HDL Cholesterol - Low | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 1 | Triglycerides - High | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 1 | SGOT/AST - High | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 1 | Triglycerides - High | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 1 | Chloride - Low | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 1 | HDL Cholesterol - Low | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 1 | Chloride - Low | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 1 | SGOT/AST - High | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 1 | HDL Cholesterol - Low | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 1 | Triglycerides - High | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 1 | HDL Cholesterol - Low | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 1 | SGOT/AST - High | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 1 | Chloride - Low | 8.3 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 1 | Triglycerides - High | 0 Percentage of Participants |
Primary
Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2
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.
Time frame: Screening, Days -1, 2, 8, 15, 29, at discontinuation, Days 36, 43, 57, 85, 113
Population: Safety population: All study subjects that received at least one dose of study medication, whether prematurely withdrawn from the study or not.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2 | Glucose, Fasting - High | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2 | SGPT/ALT - High | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2 | Triglycerides - High | 100 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2 | SGOT/AST - High | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2 | Bicorbonate HCO3 - Low | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2 | Activated Partial Thromboplastin Time - High | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2 | SGOT/AST - High | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2 | Bicorbonate HCO3 - Low | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2 | SGPT/ALT - High | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2 | Activated Partial Thromboplastin Time - High | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2 | Glucose, Fasting - High | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2 | Bicorbonate HCO3 - Low | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2 | SGOT/AST - High | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2 | SGPT/ALT - High | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2 | Activated Partial Thromboplastin Time - High | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2 | Glucose, Fasting - High | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2 | SGOT/AST - High | 7.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2 | Bicorbonate HCO3 - Low | 7.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2 | Glucose, Fasting - High | 7.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2 | SGPT/ALT - High | 14.3 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2 | Activated Partial Thromboplastin Time - High | 7.1 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2 | Triglycerides - High | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2 | SGPT/ALT - High | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2 | SGOT/AST - High | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2 | Bicorbonate HCO3 - Low | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2 | Glucose, Fasting - High | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2 | Activated Partial Thromboplastin Time - High | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2 | Glucose, Fasting - High | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2 | Bicorbonate HCO3 - Low | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2 | SGOT/AST - High | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2 | SGPT/ALT - High | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2 | Activated Partial Thromboplastin Time - High | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2 | SGPT/ALT - High | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2 | Bicorbonate HCO3 - Low | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2 | Glucose, Fasting - High | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2 | SGOT/AST - High | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2 | Activated Partial Thromboplastin Time - High | 0 Percentage of Participants |
Primary
Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2
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.
Time frame: Day 1 (1,4,8h), Days 2,8,15,22 (1h and 8h), Day 23, Day 29 (1,4,8h), Day 30, Follow Up Days 36, 43, 50, 57, 78, 85, 106, 113
Population: Safety population: All study subjects that received at least one dose of study medication, whether prematurely withdrawn from the study or not.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 29 - 4h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 1 - 4h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 8 | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 1 - 1h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 29 - 1h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 30 - 24h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Follow-up Day 85 | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Follow-up Day 113 | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 1 - 8h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Follow-up Day 43 | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Follow-up Day 57 | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 29 - 8h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 29 | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Baseline | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 2 - 24h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 1 - 1h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 2 - 24h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Follow-up Day 85 | 14.3 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 8 | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Follow-up Day 43 | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 29 - 1h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Follow-up Day 113 | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 1 - 4h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 30 - 24h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Follow-up Day 57 | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Baseline | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 1 - 8h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 29 - 8h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 29 | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 29 - 4h | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 29 - 8h | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 30 - 24h | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Follow-up Day 43 | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 1 - 1h | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 1 - 4h | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 1 - 8h | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Follow-up Day 113 | 33.3 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 2 - 24h | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Baseline | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 8 | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Follow-up Day 85 | 33.3 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Follow-up Day 57 | 50.0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 29 | 16.7 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 29 - 1h | 33.3 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 29 - 4h | 33.3 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Follow-up Day 57 | 7.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 1 - 4h | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Follow-up Day 85 | 7.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 22 | 7.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 29 - 1h | 7.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Follow-up Day 113 | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 1 - 1h | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 1 - 8h | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 30 - 24h | 7.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 29 - 8h | 7.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 29 - 4h | 7.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 8 | 7.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Follow-up Day 43 | 7.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Baseline | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 29 | 7.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 15 | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 2 - 24h | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 29 | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Baseline | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 2 - 24h | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Follow-up Day 113 | 14.3 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Follow-up Day 57 | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Follow-up Day 85 | 14.3 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Follow-up Day 43 | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 1 - 8h | 14.3 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 15 | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 1 - 4h | 14.3 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 1 - 1h | 14.3 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 29 - 8h | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 29 - 1h | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 30 - 24h | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 8 | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 29 - 4h | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 1 - 8h | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Baseline | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 1 - 1h | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 1 - 4h | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 2 - 24h | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 8 | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 15 | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 22 | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 22 - 1h | 25.0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 22 - 8h | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 23 - 24h | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Follow-up Day 36 | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Follow-up Day 50 | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Follow-up Day 78 | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Follow-up Day 106 | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 29 - 4h | 8.3 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Follow-up Day 43 | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 1 - 1h | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Follow-up Day 50 | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 29 - 1h | 8.3 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 29 | 8.3 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 23 - 24h | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 22 - 8h | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 22 - 1h | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Follow-up Day 57 | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Baseline | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Follow-up Day 78 | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 22 | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 15 | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 8 | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 2 - 24h | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 1 - 8h | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Follow-up Day 85 | 7.7 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Follow-up Day 113 | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Follow-up Day 106 | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 1 - 4h | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Follow-up Day 36 | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 30 - 24h | 8.3 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2 | Day 29 - 8h | 0 Percentage of Participants |
Primary
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1
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.
Time frame: Day 1 (1,4,8,12h), Days 2 and 8, Follow Up Days 15, 29, 85
Population: Safety population: All study subjects that received at least one dose of study medication, whether prematurely withdrawn from the study or not.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Baseline | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 1 - 8h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Extended Follow-Up | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Follow-up Day 15 | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 1 - 12h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 8 - 168h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 1 - 4h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Follow-up Day 29 | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 1 - 1h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 2 - 24h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 1 - 1h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 1 - 8h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Extended Follow-Up | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Follow-up Day 29 | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 1 - 12h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Baseline | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Follow-up Day 15 | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 8 - 168h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 1 - 4h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 2 - 24h | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 1 - 4h | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 1 - 8h | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Baseline | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 1 - 1h | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 1 - 12h | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 2 - 24h | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 8 - 168h | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Follow-up Day 15 | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Follow-up Day 29 | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Extended Follow-Up | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Baseline | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 1 - 12h | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 1 - 4h | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 2 - 24h | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Extended Follow-Up | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 8 - 168h | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 1 - 1h | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Follow-up Day 15 | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Follow-up Day 29 | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 1 - 8h | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Baseline | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Extended Follow-Up | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 1 - 12h | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Follow-up Day 15 | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 1 - 8h | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Follow-up Day 29 | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 8 - 168h | 12.5 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 2 - 24h | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 1 - 4h | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 1 - 1h | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 2 - 24h | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 1 - 1h | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 1 - 4h | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 8 - 168h | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 1 - 8h | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Follow-up Day 15 | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Baseline | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Extended Follow-Up | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Follow-up Day 29 | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 1 - 12h | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Follow-up Day 15 | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 1 - 1h | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 1 - 8h | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 2 - 24h | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 1 - 12h | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 8 - 168h | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Baseline | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Follow-up Day 29 | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Extended Follow-Up | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1 | Day 1 - 4h | 0 Percentage of Participants |
Primary
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2
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.
Time frame: Day 1 (1,4,8h), Days 2,8,15,22 (1h and 8h), Day 23, Day 29 (1,4,8h), Day 30, Follow Up Days 36, 43, 50, 57, 78, 85, 106, 113
Population: Safety population: All study subjects that received at least one dose of study medication, whether prematurely withdrawn from the study or not.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Baseline | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 29 - 8h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 1 - 8h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Follow-up Day 113 | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 30 - 24h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Follow-up Day 85 | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 1 - 1h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 29 - 4h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Follow-up Day 57 | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Follow-up Day 43 | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 8 | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 29 - 1h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 1 - 4h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 29 | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 2 - 24h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Follow-up Day 57 | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 1 - 4h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 1 - 1h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 8 | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 30 - 24h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Follow-up Day 85 | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Baseline | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 29 - 8h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 2 - 24h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Follow-up Day 113 | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Follow-up Day 43 | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 29 - 4h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 1 - 8h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 29 - 1h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 29 | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 1 - 4h | 33.3 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Follow-up Day 57 | 16.7 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Follow-up Day 85 | 16.7 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Baseline | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Follow-up Day 113 | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 1 - 8h | 16.7 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 2 - 24h | 16.7 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 8 | 16.7 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 1 - 1h | 16.7 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 29 | 16.7 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 29 - 1h | 16.7 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 29 - 4h | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 29 - 8h | 16.7 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 30 - 24h | 16.7 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Follow-up Day 43 | 16.7 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 8 | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 1 - 8h | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 1 - 4h | 7.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 29 - 1h | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Baseline | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Follow-up Day 57 | 7.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Follow-up Day 113 | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 29 | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 29 - 4h | 7.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 15 | 7.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 1 - 1h | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 22 | 7.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 30 - 24h | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Follow-up Day 43 | 7.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 29 - 8h | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Follow-up Day 85 | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 2 - 24h | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 29 - 8h | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Follow-up Day 43 | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 30 - 24h | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 1 - 4h | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Baseline | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 8 | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 15 | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 29 | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 1 - 1h | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 1 - 8h | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 29 - 1h | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Follow-up Day 113 | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 2 - 24h | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 29 - 4h | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Follow-up Day 57 | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Follow-up Day 85 | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Follow-up Day 36 | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 2 - 24h | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 22 | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 22 - 1h | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 22 - 8h | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 23 - 24h | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 1 - 8h | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Follow-up Day 50 | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 1 - 1h | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Follow-up Day 106 | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 1 - 4h | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Follow-up Day 78 | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 15 | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 8 | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Baseline | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Follow-up Day 113 | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Baseline | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 1 - 1h | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 1 - 4h | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 1 - 8h | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 2 - 24h | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 8 | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 15 | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 22 | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 22 - 1h | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 22 - 8h | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 23 - 24h | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 29 | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 29 - 4h | 8.3 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 29 - 8h | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 30 - 24h | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Follow-up Day 36 | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Follow-up Day 43 | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Follow-up Day 50 | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Follow-up Day 57 | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Follow-up Day 78 | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Follow-up Day 85 | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Follow-up Day 106 | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2 | Day 29 - 1h | 8.3 Percentage of Participants |
Primary
Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1
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.
Time frame: Day 1 (1,4,8,12h), Days 2 and 8, Follow Up Days 15, 29, 85
Population: Safety population: All study subjects that received at least one dose of study medication, whether prematurely withdrawn from the study or not.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 1 - 8h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 1 - 4h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Extended Follow-Up | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Follow-up Day 29 | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Follow-up Day 15 | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 8 - 168h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 2 - 24h | 12.5 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 1 - 1h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Baseline | 12.5 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 1 - 12h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 1 - 1h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Baseline | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 1 - 4h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 1 - 8h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 1 - 12h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 2 - 24h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 8 - 168h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Follow-up Day 15 | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Follow-up Day 29 | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Extended Follow-Up | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Follow-up Day 29 | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 8 - 168h | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 1 - 1h | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 1 - 12h | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Follow-up Day 15 | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Baseline | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 1 - 4h | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Extended Follow-Up | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 2 - 24h | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 1 - 8h | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 1 - 1h | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Baseline | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 1 - 8h | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Extended Follow-Up | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 1 - 12h | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 8 - 168h | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Follow-up Day 15 | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 2 - 24h | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Follow-up Day 29 | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 1 - 4h | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Baseline | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Follow-up Day 15 | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 1 - 4h | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 1 - 12h | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 1 - 1h | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 2 - 24h | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Follow-up Day 29 | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 8 - 168h | 12.5 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 1 - 8h | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Extended Follow-Up | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Extended Follow-Up | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 1 - 8h | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 1 - 12h | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 2 - 24h | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Baseline | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 8 - 168h | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Follow-up Day 15 | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Follow-up Day 29 | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 1 - 1h | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 1 - 4h | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 2 - 24h | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Extended Follow-Up | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 1 - 8h | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 1 - 1h | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Baseline | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Follow-up Day 29 | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 1 - 12h | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 1 - 4h | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Follow-up Day 15 | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1 | Day 8 - 168h | 0 Percentage of Participants |
Primary
Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2
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.
Time frame: Day 1 (1,4,8h), Days 2,8,15,22 (1h and 8h), Day 23, Day 29 (1,4,8h), Day 30, Follow Up Days 36, 43, 50, 57, 78, 85, 106, 113
Population: Safety population: All study subjects that received at least one dose of study medication, whether prematurely withdrawn from the study or not.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 29 - 1h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 8 | 16.7 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Follow-up Day 57 | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 1 - 4h | 16.7 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 2 - 24h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 29 | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Baseline | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Follow-up Day 113 | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 1 - 1h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Follow-up Day 43 | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 1 - 8h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 29 - 8h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 29 - 4h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Follow-up Day 85 | 0 Percentage of Participants |
| Part 1 - RO7062931 0.1 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 30 - 24h | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 30 - 24h | 16.7 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 2 - 24h | 14.3 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 1 - 1h | 14.3 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 29 - 8h | 16.7 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 8 | 14.3 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 29 - 1h | 16.7 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Baseline | 14.3 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 29 - 4h | 16.7 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 29 | 16.7 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Follow-up Day 57 | 14.3 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 1 - 4h | 14.3 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Follow-up Day 113 | 14.3 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Follow-up Day 43 | 0 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 1 - 8h | 16.7 Percentage of Participants |
| Part 1 - RO7062931 0.3 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Follow-up Day 85 | 14.3 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 1 - 8h | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 29 - 1h | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Follow-up Day 113 | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 29 | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 1 - 1h | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Follow-up Day 85 | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Follow-up Day 57 | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 1 - 4h | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Follow-up Day 43 | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Baseline | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 30 - 24h | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 29 - 8h | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 2 - 24h | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 29 - 4h | 0 Percentage of Participants |
| Part 1 - RO7062931 1.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 8 | 0 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 1 - 8h | 7.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Baseline | 7.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 1 - 1h | 7.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 1 - 4h | 7.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 2 - 24h | 7.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 8 | 7.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 15 | 7.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 22 | 7.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 29 | 7.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 29 - 1h | 7.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 29 - 4h | 7.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 29 - 8h | 7.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 30 - 24h | 7.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Follow-up Day 43 | 7.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Follow-up Day 57 | 7.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Follow-up Day 85 | 7.1 Percentage of Participants |
| Part 1 - RO7062931 2.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Follow-up Day 113 | 7.1 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Baseline | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 29 - 8h | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 1 - 4h | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 29 - 1h | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 1 - 8h | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Follow-up Day 85 | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 30 - 24h | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Follow-up Day 113 | 14.3 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 8 | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Follow-up Day 57 | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 1 - 1h | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 29 - 4h | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Follow-up Day 43 | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 29 | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 2 - 24h | 0 Percentage of Participants |
| Part 1 - RO7062931 3.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 15 | 0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 23 - 24h | 25.0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 22 | 25.0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 15 | 25.0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Follow-up Day 106 | 25.0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 2 - 24h | 25.0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 1 - 8h | 25.0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 8 | 25.0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Follow-up Day 36 | 25.0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 1 - 4h | 25.0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Follow-up Day 50 | 25.0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 1 - 1h | 25.0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Follow-up Day 78 | 25.0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Baseline | 25.0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 22 - 8h | 25.0 Percentage of Participants |
| Part 1 - RO7062931 4.0 mg/kg | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 22 - 1h | 25.0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 29 - 4h | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Follow-up Day 43 | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 23 - 24h | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Follow-up Day 50 | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 1 - 1h | 6.7 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 22 - 1h | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Follow-up Day 106 | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Follow-up Day 113 | 15.4 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 2 - 24h | 6.7 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Follow-up Day 57 | 7.1 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 15 | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Follow-up Day 78 | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Baseline | 6.7 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 22 | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 8 | 6.7 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 29 - 1h | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Follow-up Day 85 | 7.1 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 30 - 24h | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 22 - 8h | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Follow-up Day 36 | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 1 - 4h | 6.7 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 29 | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 29 - 8h | 0 Percentage of Participants |
| Part 1 - Placebo | Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2 | Day 1 - 8h | 6.7 Percentage of Participants |
Secondary
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) After Single-Ascending Doses - Part 1
AUC0-inf was calculated based on non-compartmental analysis.
Time frame: Days 1-8
Population: The PK analysis population included participants that did not significantly violate eligibility criteria and/or deviate significantly from the protocol. Participants with incomplete or unavailable data were excluded from analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1 - RO7062931 0.1 mg/kg | Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) After Single-Ascending Doses - Part 1 | 39.21 h*nmol/L | Geometric Coefficient of Variation 14 |
| Part 1 - RO7062931 0.3 mg/kg | Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) After Single-Ascending Doses - Part 1 | 92.72 h*nmol/L | Geometric Coefficient of Variation 14.1 |
| Part 1 - RO7062931 1.0 mg/kg | Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) After Single-Ascending Doses - Part 1 | 308.48 h*nmol/L | Geometric Coefficient of Variation 13.2 |
| Part 1 - RO7062931 2.0 mg/kg | Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) After Single-Ascending Doses - Part 1 | 792.36 h*nmol/L | Geometric Coefficient of Variation 19.1 |
| Part 1 - RO7062931 3.0 mg/kg | Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) After Single-Ascending Doses - Part 1 | 2478.56 h*nmol/L | Geometric Coefficient of Variation 8.7 |
| Part 1 - RO7062931 4.0 mg/kg | Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) After Single-Ascending Doses - Part 1 | 1257.23 h*nmol/L | Geometric Coefficient of Variation 19.4 |
Secondary
Area Under the Plasma Concentration-Time Curve From Time Zero Until the Last Quantifiable Time-Point (AUC0-last) After Single Ascending Doses - Part 1
AUC0-last was calculated based on non-compartmental analysis.
Time frame: Days 1-8
Population: The PK analysis population included participants that did not significantly violate eligibility criteria and/or deviate significantly from the protocol. Participants with incomplete or unavailable data were excluded from analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1 - RO7062931 0.1 mg/kg | Area Under the Plasma Concentration-Time Curve From Time Zero Until the Last Quantifiable Time-Point (AUC0-last) After Single Ascending Doses - Part 1 | 39.10 (hr*nmol/L) | Geometric Coefficient of Variation 14 |
| Part 1 - RO7062931 0.3 mg/kg | Area Under the Plasma Concentration-Time Curve From Time Zero Until the Last Quantifiable Time-Point (AUC0-last) After Single Ascending Doses - Part 1 | 92.62 (hr*nmol/L) | Geometric Coefficient of Variation 14.1 |
| Part 1 - RO7062931 1.0 mg/kg | Area Under the Plasma Concentration-Time Curve From Time Zero Until the Last Quantifiable Time-Point (AUC0-last) After Single Ascending Doses - Part 1 | 310.69 (hr*nmol/L) | Geometric Coefficient of Variation 12.9 |
| Part 1 - RO7062931 2.0 mg/kg | Area Under the Plasma Concentration-Time Curve From Time Zero Until the Last Quantifiable Time-Point (AUC0-last) After Single Ascending Doses - Part 1 | 789.27 (hr*nmol/L) | Geometric Coefficient of Variation 19.1 |
| Part 1 - RO7062931 3.0 mg/kg | Area Under the Plasma Concentration-Time Curve From Time Zero Until the Last Quantifiable Time-Point (AUC0-last) After Single Ascending Doses - Part 1 | 2448.99 (hr*nmol/L) | Geometric Coefficient of Variation 8.1 |
| Part 1 - RO7062931 4.0 mg/kg | Area Under the Plasma Concentration-Time Curve From Time Zero Until the Last Quantifiable Time-Point (AUC0-last) After Single Ascending Doses - Part 1 | 1253.26 (hr*nmol/L) | Geometric Coefficient of Variation 19.3 |
Secondary
AUC0-inf After Multiple Ascending Doses - Part 2
AUC0-inf was calculated based on non-compartmental analysis.
Time frame: Days 1,22,29
Population: The PK analysis population included participants that did not significantly violate eligibility criteria and/or deviate significantly from the protocol. Participants with incomplete or unavailable data were excluded from analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 - RO7062931 0.1 mg/kg | AUC0-inf After Multiple Ascending Doses - Part 2 | Day 1 | 175.30 h*nmol/L | Geometric Coefficient of Variation 6.9 |
| Part 1 - RO7062931 0.1 mg/kg | AUC0-inf After Multiple Ascending Doses - Part 2 | Day 29 | 180.34 h*nmol/L | Geometric Coefficient of Variation 13.3 |
| Part 1 - RO7062931 0.3 mg/kg | AUC0-inf After Multiple Ascending Doses - Part 2 | Day 1 | 567.07 h*nmol/L | Geometric Coefficient of Variation 41.5 |
| Part 1 - RO7062931 0.3 mg/kg | AUC0-inf After Multiple Ascending Doses - Part 2 | Day 29 | 680.80 h*nmol/L | Geometric Coefficient of Variation 8.8 |
| Part 1 - RO7062931 1.0 mg/kg | AUC0-inf After Multiple Ascending Doses - Part 2 | Day 29 | 1636.76 h*nmol/L | Geometric Coefficient of Variation 11 |
| Part 1 - RO7062931 1.0 mg/kg | AUC0-inf After Multiple Ascending Doses - Part 2 | Day 1 | 1606.49 h*nmol/L | Geometric Coefficient of Variation 26.4 |
| Part 1 - RO7062931 2.0 mg/kg | AUC0-inf After Multiple Ascending Doses - Part 2 | Day 29 | 1475.19 h*nmol/L | Geometric Coefficient of Variation 30.3 |
| Part 1 - RO7062931 2.0 mg/kg | AUC0-inf After Multiple Ascending Doses - Part 2 | Day 1 | 1434.39 h*nmol/L | Geometric Coefficient of Variation 13.6 |
| Part 1 - RO7062931 3.0 mg/kg | AUC0-inf After Multiple Ascending Doses - Part 2 | Day 29 | 1541.85 h*nmol/L | Geometric Coefficient of Variation 26.9 |
| Part 1 - RO7062931 3.0 mg/kg | AUC0-inf After Multiple Ascending Doses - Part 2 | Day 1 | 1857.98 h*nmol/L | Geometric Coefficient of Variation 41.2 |
| Part 1 - RO7062931 4.0 mg/kg | AUC0-inf After Multiple Ascending Doses - Part 2 | Day 22 | 2199.57 h*nmol/L | Geometric Coefficient of Variation 16.7 |
| Part 1 - RO7062931 4.0 mg/kg | AUC0-inf After Multiple Ascending Doses - Part 2 | Day 1 | 2371.66 h*nmol/L | Geometric Coefficient of Variation 15.2 |
Secondary
AUC0-last After Multiple Ascending Doses - Part 2
AUC0-last was calculated based on non-compartmental analysis.
Time frame: Days 1,22,29
Population: The PK analysis population included participants that did not significantly violate eligibility criteria and/or deviate significantly from the protocol. Participants with incomplete or unavailable data were excluded from analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 - RO7062931 0.1 mg/kg | AUC0-last After Multiple Ascending Doses - Part 2 | Day 1 | 147.30 hr*nmol/L | Geometric Coefficient of Variation 28.8 |
| Part 1 - RO7062931 0.1 mg/kg | AUC0-last After Multiple Ascending Doses - Part 2 | Day 29 | 141.35 hr*nmol/L | Geometric Coefficient of Variation 52.6 |
| Part 1 - RO7062931 0.3 mg/kg | AUC0-last After Multiple Ascending Doses - Part 2 | Day 1 | 555.16 hr*nmol/L | Geometric Coefficient of Variation 34.8 |
| Part 1 - RO7062931 0.3 mg/kg | AUC0-last After Multiple Ascending Doses - Part 2 | Day 29 | 662.95 hr*nmol/L | Geometric Coefficient of Variation 20.5 |
| Part 1 - RO7062931 1.0 mg/kg | AUC0-last After Multiple Ascending Doses - Part 2 | Day 29 | 1633.64 hr*nmol/L | Geometric Coefficient of Variation 11 |
| Part 1 - RO7062931 1.0 mg/kg | AUC0-last After Multiple Ascending Doses - Part 2 | Day 1 | 1603.81 hr*nmol/L | Geometric Coefficient of Variation 26.4 |
| Part 1 - RO7062931 2.0 mg/kg | AUC0-last After Multiple Ascending Doses - Part 2 | Day 29 | 1470.64 hr*nmol/L | Geometric Coefficient of Variation 30.5 |
| Part 1 - RO7062931 2.0 mg/kg | AUC0-last After Multiple Ascending Doses - Part 2 | Day 1 | 1458.57 hr*nmol/L | Geometric Coefficient of Variation 12.9 |
| Part 1 - RO7062931 3.0 mg/kg | AUC0-last After Multiple Ascending Doses - Part 2 | Day 29 | 1539.73 hr*nmol/L | Geometric Coefficient of Variation 27 |
| Part 1 - RO7062931 3.0 mg/kg | AUC0-last After Multiple Ascending Doses - Part 2 | Day 1 | 1929.56 hr*nmol/L | Geometric Coefficient of Variation 49.9 |
| Part 1 - RO7062931 4.0 mg/kg | AUC0-last After Multiple Ascending Doses - Part 2 | Day 22 | 2195.18 hr*nmol/L | Geometric Coefficient of Variation 16.6 |
| Part 1 - RO7062931 4.0 mg/kg | AUC0-last After Multiple Ascending Doses - Part 2 | Day 1 | 2279.78 hr*nmol/L | Geometric Coefficient of Variation 14.7 |
Secondary
Change From Baseline of Quantitative HBsAg (qHBsAg) (log10) After Multiple Ascending Doses - Part 2
HBsAg is a viral parameter that can be affected by the action of RO7062931. A change from baseline in qHBsAg can indicate the drug's effect.
Time frame: Days 1-113
Population: Participants that did not complete planned treatment and/or discontinued from the study were not included in this end point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 - RO7062931 0.1 mg/kg | Change From Baseline of Quantitative HBsAg (qHBsAg) (log10) After Multiple Ascending Doses - Part 2 | Baseline value | 3.39 IU/mL | Standard Deviation 0.36 |
| Part 1 - RO7062931 0.1 mg/kg | Change From Baseline of Quantitative HBsAg (qHBsAg) (log10) After Multiple Ascending Doses - Part 2 | Final change from baseline | -0.04 IU/mL | Standard Deviation 0.057 |
| Part 1 - RO7062931 0.3 mg/kg | Change From Baseline of Quantitative HBsAg (qHBsAg) (log10) After Multiple Ascending Doses - Part 2 | Baseline value | 3.37 IU/mL | Standard Deviation 0.272 |
| Part 1 - RO7062931 0.3 mg/kg | Change From Baseline of Quantitative HBsAg (qHBsAg) (log10) After Multiple Ascending Doses - Part 2 | Final change from baseline | -0.05 IU/mL | Standard Deviation 0.072 |
| Part 1 - RO7062931 1.0 mg/kg | Change From Baseline of Quantitative HBsAg (qHBsAg) (log10) After Multiple Ascending Doses - Part 2 | Baseline value | 3.37 IU/mL | Standard Deviation 0.134 |
| Part 1 - RO7062931 1.0 mg/kg | Change From Baseline of Quantitative HBsAg (qHBsAg) (log10) After Multiple Ascending Doses - Part 2 | Final change from baseline | -0.03 IU/mL | Standard Deviation 0.053 |
| Part 1 - RO7062931 2.0 mg/kg | Change From Baseline of Quantitative HBsAg (qHBsAg) (log10) After Multiple Ascending Doses - Part 2 | Baseline value | 3.68 IU/mL | Standard Deviation 0.381 |
| Part 1 - RO7062931 2.0 mg/kg | Change From Baseline of Quantitative HBsAg (qHBsAg) (log10) After Multiple Ascending Doses - Part 2 | Final change from baseline | -0.09 IU/mL | Standard Deviation 0.09 |
| Part 1 - RO7062931 3.0 mg/kg | Change From Baseline of Quantitative HBsAg (qHBsAg) (log10) After Multiple Ascending Doses - Part 2 | Baseline value | 3.76 IU/mL | Standard Deviation 0.285 |
| Part 1 - RO7062931 3.0 mg/kg | Change From Baseline of Quantitative HBsAg (qHBsAg) (log10) After Multiple Ascending Doses - Part 2 | Final change from baseline | -0.02 IU/mL | Standard Deviation 0.07 |
| Part 1 - RO7062931 4.0 mg/kg | Change From Baseline of Quantitative HBsAg (qHBsAg) (log10) After Multiple Ascending Doses - Part 2 | Baseline value | 3.69 IU/mL | Standard Deviation 0.274 |
| Part 1 - RO7062931 4.0 mg/kg | Change From Baseline of Quantitative HBsAg (qHBsAg) (log10) After Multiple Ascending Doses - Part 2 | Final change from baseline | -0.16 IU/mL | Standard Deviation 0.088 |
| Part 1 - Placebo | Change From Baseline of Quantitative HBsAg (qHBsAg) (log10) After Multiple Ascending Doses - Part 2 | Baseline value | 3.55 IU/mL | Standard Deviation 0.421 |
| Part 1 - Placebo | Change From Baseline of Quantitative HBsAg (qHBsAg) (log10) After Multiple Ascending Doses - Part 2 | Final change from baseline | -0.01 IU/mL | Standard Deviation 0.046 |
Secondary
Cmax After Multiple Ascending Doses - Part 2
Cmax values are the the peak plasma concentration reached after administration of RO7062931.
Time frame: Days 1-113
Population: The PK analysis population included participants that did not significantly violate eligibility criteria and/or deviate significantly from the protocol. Participants with incomplete or unavailable data were excluded from analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 - RO7062931 0.1 mg/kg | Cmax After Multiple Ascending Doses - Part 2 | First Dose | 21.17 mg/kg | Geometric Coefficient of Variation 46.4 |
| Part 1 - RO7062931 0.1 mg/kg | Cmax After Multiple Ascending Doses - Part 2 | Last Dose | 18.56 mg/kg | Geometric Coefficient of Variation 69.1 |
| Part 1 - RO7062931 0.3 mg/kg | Cmax After Multiple Ascending Doses - Part 2 | First Dose | 72.44 mg/kg | Geometric Coefficient of Variation 57.8 |
| Part 1 - RO7062931 0.3 mg/kg | Cmax After Multiple Ascending Doses - Part 2 | Last Dose | 82.11 mg/kg | Geometric Coefficient of Variation 37.6 |
| Part 1 - RO7062931 1.0 mg/kg | Cmax After Multiple Ascending Doses - Part 2 | First Dose | 169.56 mg/kg | Geometric Coefficient of Variation 43.9 |
| Part 1 - RO7062931 1.0 mg/kg | Cmax After Multiple Ascending Doses - Part 2 | Last Dose | 194.72 mg/kg | Geometric Coefficient of Variation 15.8 |
| Part 1 - RO7062931 2.0 mg/kg | Cmax After Multiple Ascending Doses - Part 2 | First Dose | 158.61 mg/kg | Geometric Coefficient of Variation 37.9 |
| Part 1 - RO7062931 2.0 mg/kg | Cmax After Multiple Ascending Doses - Part 2 | Last Dose | 164.83 mg/kg | Geometric Coefficient of Variation 65 |
| Part 1 - RO7062931 3.0 mg/kg | Cmax After Multiple Ascending Doses - Part 2 | First Dose | 218.05 mg/kg | Geometric Coefficient of Variation 64.4 |
| Part 1 - RO7062931 3.0 mg/kg | Cmax After Multiple Ascending Doses - Part 2 | Last Dose | 190.83 mg/kg | Geometric Coefficient of Variation 35.6 |
| Part 1 - RO7062931 4.0 mg/kg | Cmax After Multiple Ascending Doses - Part 2 | First Dose | 232.54 mg/kg | Geometric Coefficient of Variation 10.6 |
| Part 1 - RO7062931 4.0 mg/kg | Cmax After Multiple Ascending Doses - Part 2 | Last Dose | 250.72 mg/kg | Geometric Coefficient of Variation 23.4 |
Secondary
Cumulative Amount Excreted Unchanged in Urine (Ae) After Multiple Ascending Doses - Part 2
Ae: cumulative amount of drug excreted in urine over a 24 hour period or over defined time periods linked to the pools of urine collected.
Time frame: Days 1-113
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1 - RO7062931 0.1 mg/kg | Cumulative Amount Excreted Unchanged in Urine (Ae) After Multiple Ascending Doses - Part 2 | 48.45 nmol | Geometric Coefficient of Variation 22.48 |
| Part 1 - RO7062931 0.3 mg/kg | Cumulative Amount Excreted Unchanged in Urine (Ae) After Multiple Ascending Doses - Part 2 | 183.38 nmol | Geometric Coefficient of Variation 67.53 |
| Part 1 - RO7062931 1.0 mg/kg | Cumulative Amount Excreted Unchanged in Urine (Ae) After Multiple Ascending Doses - Part 2 | 587.05 nmol | Geometric Coefficient of Variation 294.65 |
| Part 1 - RO7062931 2.0 mg/kg | Cumulative Amount Excreted Unchanged in Urine (Ae) After Multiple Ascending Doses - Part 2 | 790.51 nmol | Geometric Coefficient of Variation 402.06 |
| Part 1 - RO7062931 3.0 mg/kg | Cumulative Amount Excreted Unchanged in Urine (Ae) After Multiple Ascending Doses - Part 2 | 615.33 nmol | Geometric Coefficient of Variation 432.78 |
| Part 1 - RO7062931 4.0 mg/kg | Cumulative Amount Excreted Unchanged in Urine (Ae) After Multiple Ascending Doses - Part 2 | 1146.02 nmol | Geometric Coefficient of Variation 177.61 |
Secondary
Cumulative Amount Excreted Unchanged in Urine (Ae) After Single Ascending Doses - Part 1
Ae: cumulative amount of drug excreted in urine over a 24 hour period or over defined time periods linked to the pools of urine collected.
Time frame: Hours 0-4, 0-8, 0-12, and 0-24
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 - RO7062931 0.1 mg/kg | Cumulative Amount Excreted Unchanged in Urine (Ae) After Single Ascending Doses - Part 1 | Accumulation Interval 0-4 (h) | 6180.14 pmol | Geometric Coefficient of Variation 85 |
| Part 1 - RO7062931 0.1 mg/kg | Cumulative Amount Excreted Unchanged in Urine (Ae) After Single Ascending Doses - Part 1 | Accumulation Interval 0-8 (h) | 9028.41 pmol | Geometric Coefficient of Variation 50.4 |
| Part 1 - RO7062931 0.1 mg/kg | Cumulative Amount Excreted Unchanged in Urine (Ae) After Single Ascending Doses - Part 1 | Accumulation Interval 0-12 (h) | 10399.04 pmol | Geometric Coefficient of Variation 40.7 |
| Part 1 - RO7062931 0.1 mg/kg | Cumulative Amount Excreted Unchanged in Urine (Ae) After Single Ascending Doses - Part 1 | Accumulation Interval 0-24 (h) | 11043.57 pmol | Geometric Coefficient of Variation 38.9 |
| Part 1 - RO7062931 0.3 mg/kg | Cumulative Amount Excreted Unchanged in Urine (Ae) After Single Ascending Doses - Part 1 | Accumulation Interval 0-12 (h) | 28335.16 pmol | Geometric Coefficient of Variation 27.6 |
| Part 1 - RO7062931 0.3 mg/kg | Cumulative Amount Excreted Unchanged in Urine (Ae) After Single Ascending Doses - Part 1 | Accumulation Interval 0-8 (h) | 25608.73 pmol | Geometric Coefficient of Variation 25.2 |
| Part 1 - RO7062931 0.3 mg/kg | Cumulative Amount Excreted Unchanged in Urine (Ae) After Single Ascending Doses - Part 1 | Accumulation Interval 0-4 (h) | 17111.86 pmol | Geometric Coefficient of Variation 29.4 |
| Part 1 - RO7062931 0.3 mg/kg | Cumulative Amount Excreted Unchanged in Urine (Ae) After Single Ascending Doses - Part 1 | Accumulation Interval 0-24 (h) | 29221.86 pmol | Geometric Coefficient of Variation 28.6 |
| Part 1 - RO7062931 1.0 mg/kg | Cumulative Amount Excreted Unchanged in Urine (Ae) After Single Ascending Doses - Part 1 | Accumulation Interval 0-24 (h) | 155256.07 pmol | Geometric Coefficient of Variation 38.9 |
| Part 1 - RO7062931 1.0 mg/kg | Cumulative Amount Excreted Unchanged in Urine (Ae) After Single Ascending Doses - Part 1 | Accumulation Interval 0-12 (h) | 143182.68 pmol | Geometric Coefficient of Variation 42.8 |
| Part 1 - RO7062931 1.0 mg/kg | Cumulative Amount Excreted Unchanged in Urine (Ae) After Single Ascending Doses - Part 1 | Accumulation Interval 0-8 (h) | 117472.78 pmol | Geometric Coefficient of Variation 52.5 |
| Part 1 - RO7062931 1.0 mg/kg | Cumulative Amount Excreted Unchanged in Urine (Ae) After Single Ascending Doses - Part 1 | Accumulation Interval 0-4 (h) | 50248.03 pmol | Geometric Coefficient of Variation 97 |
| Part 1 - RO7062931 2.0 mg/kg | Cumulative Amount Excreted Unchanged in Urine (Ae) After Single Ascending Doses - Part 1 | Accumulation Interval 0-4 (h) | 108870.36 pmol | Geometric Coefficient of Variation 95.4 |
| Part 1 - RO7062931 2.0 mg/kg | Cumulative Amount Excreted Unchanged in Urine (Ae) After Single Ascending Doses - Part 1 | Accumulation Interval 0-24 (h) | 275688.93 pmol | Geometric Coefficient of Variation 68.3 |
| Part 1 - RO7062931 2.0 mg/kg | Cumulative Amount Excreted Unchanged in Urine (Ae) After Single Ascending Doses - Part 1 | Accumulation Interval 0-8 (h) | 202181.27 pmol | Geometric Coefficient of Variation 80.6 |
| Part 1 - RO7062931 2.0 mg/kg | Cumulative Amount Excreted Unchanged in Urine (Ae) After Single Ascending Doses - Part 1 | Accumulation Interval 0-12 (h) | 249381.19 pmol | Geometric Coefficient of Variation 72.6 |
| Part 1 - RO7062931 3.0 mg/kg | Cumulative Amount Excreted Unchanged in Urine (Ae) After Single Ascending Doses - Part 1 | Accumulation Interval 0-12 (h) | 1148178.69 pmol | Geometric Coefficient of Variation 38.2 |
| Part 1 - RO7062931 3.0 mg/kg | Cumulative Amount Excreted Unchanged in Urine (Ae) After Single Ascending Doses - Part 1 | Accumulation Interval 0-24 (h) | 1235241.74 pmol | Geometric Coefficient of Variation 33.9 |
| Part 1 - RO7062931 3.0 mg/kg | Cumulative Amount Excreted Unchanged in Urine (Ae) After Single Ascending Doses - Part 1 | Accumulation Interval 0-8 (h) | 930967.60 pmol | Geometric Coefficient of Variation 42.2 |
| Part 1 - RO7062931 3.0 mg/kg | Cumulative Amount Excreted Unchanged in Urine (Ae) After Single Ascending Doses - Part 1 | Accumulation Interval 0-4 (h) | 317169.45 pmol | Geometric Coefficient of Variation 62.1 |
| Part 1 - RO7062931 4.0 mg/kg | Cumulative Amount Excreted Unchanged in Urine (Ae) After Single Ascending Doses - Part 1 | Accumulation Interval 0-8 (h) | 458520.65 pmol | Geometric Coefficient of Variation 21.2 |
| Part 1 - RO7062931 4.0 mg/kg | Cumulative Amount Excreted Unchanged in Urine (Ae) After Single Ascending Doses - Part 1 | Accumulation Interval 0-12 (h) | 592833.26 pmol | Geometric Coefficient of Variation 13.5 |
| Part 1 - RO7062931 4.0 mg/kg | Cumulative Amount Excreted Unchanged in Urine (Ae) After Single Ascending Doses - Part 1 | Accumulation Interval 0-24 (h) | 647368.11 pmol | Geometric Coefficient of Variation 12.1 |
| Part 1 - RO7062931 4.0 mg/kg | Cumulative Amount Excreted Unchanged in Urine (Ae) After Single Ascending Doses - Part 1 | Accumulation Interval 0-4 (h) | 206781.39 pmol | Geometric Coefficient of Variation 34.4 |
Secondary
Maximum Plasma Concentration (Cmax) After Single Ascending Doses - Part 1
Cmax values are the the peak plasma concentration reached after administration of RO7062931.
Time frame: Days 1-8
Population: The PK analysis population included participants that did not significantly violate eligibility criteria and/or deviate significantly from the protocol. Participants with incomplete or unavailable data were excluded from analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1 - RO7062931 0.1 mg/kg | Maximum Plasma Concentration (Cmax) After Single Ascending Doses - Part 1 | 7.78 nmol/L | Geometric Coefficient of Variation 40.2 |
| Part 1 - RO7062931 0.3 mg/kg | Maximum Plasma Concentration (Cmax) After Single Ascending Doses - Part 1 | 19.53 nmol/L | Geometric Coefficient of Variation 28.1 |
| Part 1 - RO7062931 1.0 mg/kg | Maximum Plasma Concentration (Cmax) After Single Ascending Doses - Part 1 | 41.69 nmol/L | Geometric Coefficient of Variation 30.8 |
| Part 1 - RO7062931 2.0 mg/kg | Maximum Plasma Concentration (Cmax) After Single Ascending Doses - Part 1 | 103.68 nmol/L | Geometric Coefficient of Variation 34 |
| Part 1 - RO7062931 3.0 mg/kg | Maximum Plasma Concentration (Cmax) After Single Ascending Doses - Part 1 | 312.53 nmol/L | Geometric Coefficient of Variation 22.2 |
| Part 1 - RO7062931 4.0 mg/kg | Maximum Plasma Concentration (Cmax) After Single Ascending Doses - Part 1 | 153.53 nmol/L | Geometric Coefficient of Variation 25.3 |
Secondary
Summary of Maximum qHBsAg Decrease on Days 1-113 - Part 2
HBsAg is a viral parameter that can be affected by the action of RO7062931. A change from baseline in qHBsAg can indicate the drug's effect.
Time frame: Day 1 - Day 113
Population: Participants that did not complete planned treatment and/or discontinued from the study were not included in this end point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1 - RO7062931 0.1 mg/kg | Summary of Maximum qHBsAg Decrease on Days 1-113 - Part 2 | -0.105 IU/mL | Standard Deviation 0.0325 |
| Part 1 - RO7062931 0.3 mg/kg | Summary of Maximum qHBsAg Decrease on Days 1-113 - Part 2 | -0.360 IU/mL | Standard Deviation 0.3752 |
| Part 1 - RO7062931 1.0 mg/kg | Summary of Maximum qHBsAg Decrease on Days 1-113 - Part 2 | -0.279 IU/mL | Standard Deviation 0.0988 |
| Part 1 - RO7062931 2.0 mg/kg | Summary of Maximum qHBsAg Decrease on Days 1-113 - Part 2 | -0.495 IU/mL | Standard Deviation 0.2093 |
| Part 1 - RO7062931 3.0 mg/kg | Summary of Maximum qHBsAg Decrease on Days 1-113 - Part 2 | -0.394 IU/mL | Standard Deviation 0.1586 |
| Part 1 - RO7062931 4.0 mg/kg | Summary of Maximum qHBsAg Decrease on Days 1-113 - Part 2 | -0.336 IU/mL | Standard Deviation 0.1685 |
| Part 1 - Placebo | Summary of Maximum qHBsAg Decrease on Days 1-113 - Part 2 | -0.101 IU/mL | Standard Deviation 0.0714 |
Secondary
Summary of Time to Maximum qHBsAg Decrease on Day 1-113 - Part 2
HBsAg is a viral parameter that can be affected by the action of RO7062931. A change from baseline in qHBsAg can indicate the drug's effect.
Time frame: Day 1 - Day 113
Population: Participants that did not complete planned treatment and/or discontinued from the study were not included in this end point.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1 - RO7062931 0.1 mg/kg | Summary of Time to Maximum qHBsAg Decrease on Day 1-113 - Part 2 | 49.5 Days |
| Part 1 - RO7062931 0.3 mg/kg | Summary of Time to Maximum qHBsAg Decrease on Day 1-113 - Part 2 | 43.0 Days |
| Part 1 - RO7062931 1.0 mg/kg | Summary of Time to Maximum qHBsAg Decrease on Day 1-113 - Part 2 | 43.0 Days |
| Part 1 - RO7062931 2.0 mg/kg | Summary of Time to Maximum qHBsAg Decrease on Day 1-113 - Part 2 | 43.0 Days |
| Part 1 - RO7062931 3.0 mg/kg | Summary of Time to Maximum qHBsAg Decrease on Day 1-113 - Part 2 | 39.5 Days |
| Part 1 - RO7062931 4.0 mg/kg | Summary of Time to Maximum qHBsAg Decrease on Day 1-113 - Part 2 | 61.0 Days |
Secondary
Terminal Elimination Half-Life (t1/2) After Multiple Ascending Doses - Part 2
T1/2 was calculated based on non-compartmental analysis.
Time frame: Days 1-113
Population: The PK analysis population included participants that did not significantly violate eligibility criteria and/or deviate significantly from the protocol. Participants with incomplete or unavailable data were excluded from analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 - RO7062931 0.1 mg/kg | Terminal Elimination Half-Life (t1/2) After Multiple Ascending Doses - Part 2 | First Dose | 2.99 Hours (h) | Geometric Coefficient of Variation 13.1 |
| Part 1 - RO7062931 0.1 mg/kg | Terminal Elimination Half-Life (t1/2) After Multiple Ascending Doses - Part 2 | Last Dose | 3.86 Hours (h) | Geometric Coefficient of Variation 107.8 |
| Part 1 - RO7062931 0.3 mg/kg | Terminal Elimination Half-Life (t1/2) After Multiple Ascending Doses - Part 2 | First Dose | 18.81 Hours (h) | Geometric Coefficient of Variation 32 |
| Part 1 - RO7062931 0.3 mg/kg | Terminal Elimination Half-Life (t1/2) After Multiple Ascending Doses - Part 2 | Last Dose | NA Hours (h) | — |
| Part 1 - RO7062931 1.0 mg/kg | Terminal Elimination Half-Life (t1/2) After Multiple Ascending Doses - Part 2 | First Dose | 88.59 Hours (h) | Geometric Coefficient of Variation 94.1 |
| Part 1 - RO7062931 1.0 mg/kg | Terminal Elimination Half-Life (t1/2) After Multiple Ascending Doses - Part 2 | Last Dose | 119.45 Hours (h) | Geometric Coefficient of Variation 58.8 |
| Part 1 - RO7062931 2.0 mg/kg | Terminal Elimination Half-Life (t1/2) After Multiple Ascending Doses - Part 2 | First Dose | NA Hours (h) | — |
| Part 1 - RO7062931 2.0 mg/kg | Terminal Elimination Half-Life (t1/2) After Multiple Ascending Doses - Part 2 | Last Dose | 172.20 Hours (h) | Geometric Coefficient of Variation 26.7 |
| Part 1 - RO7062931 3.0 mg/kg | Terminal Elimination Half-Life (t1/2) After Multiple Ascending Doses - Part 2 | First Dose | 37.96 Hours (h) | Geometric Coefficient of Variation 62.1 |
| Part 1 - RO7062931 3.0 mg/kg | Terminal Elimination Half-Life (t1/2) After Multiple Ascending Doses - Part 2 | Last Dose | 62.08 Hours (h) | Geometric Coefficient of Variation 91.8 |
| Part 1 - RO7062931 4.0 mg/kg | Terminal Elimination Half-Life (t1/2) After Multiple Ascending Doses - Part 2 | First Dose | 15.09 Hours (h) | Geometric Coefficient of Variation 4.3 |
| Part 1 - RO7062931 4.0 mg/kg | Terminal Elimination Half-Life (t1/2) After Multiple Ascending Doses - Part 2 | Last Dose | 152.79 Hours (h) | Geometric Coefficient of Variation 28.7 |
Secondary
Terminal Elimination Half-Life (t1/2) After Single Ascending Doses - Part 1
T1/2 was calculated based on non-compartmental analysis.
Time frame: Days 1-8
Population: The PK analysis population included participants that did not significantly violate eligibility criteria and/or deviate significantly from the protocol. Participants with incomplete or unavailable data were excluded from analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1 - RO7062931 0.1 mg/kg | Terminal Elimination Half-Life (t1/2) After Single Ascending Doses - Part 1 | 3.77 Hours (h) | Geometric Coefficient of Variation 65.4 |
| Part 1 - RO7062931 0.3 mg/kg | Terminal Elimination Half-Life (t1/2) After Single Ascending Doses - Part 1 | 3.99 Hours (h) | Geometric Coefficient of Variation 38.3 |
| Part 1 - RO7062931 1.0 mg/kg | Terminal Elimination Half-Life (t1/2) After Single Ascending Doses - Part 1 | 44.32 Hours (h) | Geometric Coefficient of Variation 170.4 |
| Part 1 - RO7062931 2.0 mg/kg | Terminal Elimination Half-Life (t1/2) After Single Ascending Doses - Part 1 | 97.06 Hours (h) | Geometric Coefficient of Variation 35.9 |
| Part 1 - RO7062931 3.0 mg/kg | Terminal Elimination Half-Life (t1/2) After Single Ascending Doses - Part 1 | 115.24 Hours (h) | Geometric Coefficient of Variation 60.4 |
| Part 1 - RO7062931 4.0 mg/kg | Terminal Elimination Half-Life (t1/2) After Single Ascending Doses - Part 1 | 85.70 Hours (h) | Geometric Coefficient of Variation 29.7 |
Secondary
Time to Reach Maximum Plasma Concentration (Tmax) After Single-Ascending Doses - Part 1
Tmax values are the amount of time to maximum concentration in plasma after administration of RO7062931.
Time frame: Days 1-8
Population: The PK analysis population included participants that did not significantly violate eligibility criteria and/or deviate significantly from the protocol. Participants with incomplete or unavailable data were excluded from analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1 - RO7062931 0.1 mg/kg | Time to Reach Maximum Plasma Concentration (Tmax) After Single-Ascending Doses - Part 1 | 1.75 Hours (h) |
| Part 1 - RO7062931 0.3 mg/kg | Time to Reach Maximum Plasma Concentration (Tmax) After Single-Ascending Doses - Part 1 | 2.00 Hours (h) |
| Part 1 - RO7062931 1.0 mg/kg | Time to Reach Maximum Plasma Concentration (Tmax) After Single-Ascending Doses - Part 1 | 3.00 Hours (h) |
| Part 1 - RO7062931 2.0 mg/kg | Time to Reach Maximum Plasma Concentration (Tmax) After Single-Ascending Doses - Part 1 | 2.00 Hours (h) |
| Part 1 - RO7062931 3.0 mg/kg | Time to Reach Maximum Plasma Concentration (Tmax) After Single-Ascending Doses - Part 1 | 3.00 Hours (h) |
| Part 1 - RO7062931 4.0 mg/kg | Time to Reach Maximum Plasma Concentration (Tmax) After Single-Ascending Doses - Part 1 | 2.00 Hours (h) |
Secondary
Tmax After Multiple Ascending Doses - Part 2
Tmax values are the amount of time to maximum concentration in plasma after administration of RO7062931.
Time frame: Days 1-113
Population: The PK analysis population included participants that did not significantly violate eligibility criteria and/or deviate significantly from the protocol. Participants with incomplete or unavailable data were excluded from analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1 - RO7062931 0.1 mg/kg | Tmax After Multiple Ascending Doses - Part 2 | First Dose | 2.98 Hours (h) |
| Part 1 - RO7062931 0.1 mg/kg | Tmax After Multiple Ascending Doses - Part 2 | Last Dose | 3.04 Hours (h) |
| Part 1 - RO7062931 0.3 mg/kg | Tmax After Multiple Ascending Doses - Part 2 | First Dose | 2.00 Hours (h) |
| Part 1 - RO7062931 0.3 mg/kg | Tmax After Multiple Ascending Doses - Part 2 | Last Dose | 3.00 Hours (h) |
| Part 1 - RO7062931 1.0 mg/kg | Tmax After Multiple Ascending Doses - Part 2 | First Dose | 2.00 Hours (h) |
| Part 1 - RO7062931 1.0 mg/kg | Tmax After Multiple Ascending Doses - Part 2 | Last Dose | 4.00 Hours (h) |
| Part 1 - RO7062931 2.0 mg/kg | Tmax After Multiple Ascending Doses - Part 2 | First Dose | 4.00 Hours (h) |
| Part 1 - RO7062931 2.0 mg/kg | Tmax After Multiple Ascending Doses - Part 2 | Last Dose | 1.97 Hours (h) |
| Part 1 - RO7062931 3.0 mg/kg | Tmax After Multiple Ascending Doses - Part 2 | First Dose | 3.98 Hours (h) |
| Part 1 - RO7062931 3.0 mg/kg | Tmax After Multiple Ascending Doses - Part 2 | Last Dose | 2.94 Hours (h) |
| Part 1 - RO7062931 4.0 mg/kg | Tmax After Multiple Ascending Doses - Part 2 | First Dose | 2.00 Hours (h) |
| Part 1 - RO7062931 4.0 mg/kg | Tmax After Multiple Ascending Doses - Part 2 | Last Dose | 2.95 Hours (h) |
Secondary
Total Clearance (CL) After Multiple Ascending Doses - Part 2
Apparent oral clearance was calculated from Dose/AUCinf.
Time frame: Days 1-113
Population: The PK analysis population included participants that did not significantly violate eligibility criteria and/or deviate significantly from the protocol. Participants with incomplete or unavailable data were excluded from analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1 - RO7062931 0.1 mg/kg | Total Clearance (CL) After Multiple Ascending Doses - Part 2 | 31.12 L/h | Geometric Coefficient of Variation 10.2 |
| Part 1 - RO7062931 0.3 mg/kg | Total Clearance (CL) After Multiple Ascending Doses - Part 2 | NA L/h | — |
| Part 1 - RO7062931 1.0 mg/kg | Total Clearance (CL) After Multiple Ascending Doses - Part 2 | 18.12 L/h | Geometric Coefficient of Variation 27.2 |
| Part 1 - RO7062931 2.0 mg/kg | Total Clearance (CL) After Multiple Ascending Doses - Part 2 | 21.76 L/h | Geometric Coefficient of Variation 42 |
| Part 1 - RO7062931 3.0 mg/kg | Total Clearance (CL) After Multiple Ascending Doses - Part 2 | 19.37 L/h | Geometric Coefficient of Variation 43.5 |
| Part 1 - RO7062931 4.0 mg/kg | Total Clearance (CL) After Multiple Ascending Doses - Part 2 | 18.75 L/h | Geometric Coefficient of Variation 34.5 |
Secondary
Total Clearance (CL) After Single Ascending Doses - Part 1
Apparent oral clearance was calculated from Dose/AUCinf.
Time frame: Days 1-8
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1 - RO7062931 0.1 mg/kg | Total Clearance (CL) After Single Ascending Doses - Part 1 | 26.68 L/h | Geometric Coefficient of Variation 21.3 |
| Part 1 - RO7062931 0.3 mg/kg | Total Clearance (CL) After Single Ascending Doses - Part 1 | 35.97 L/h | Geometric Coefficient of Variation 24.7 |
| Part 1 - RO7062931 1.0 mg/kg | Total Clearance (CL) After Single Ascending Doses - Part 1 | 37.36 L/h | Geometric Coefficient of Variation 29.9 |
| Part 1 - RO7062931 2.0 mg/kg | Total Clearance (CL) After Single Ascending Doses - Part 1 | 26.9 L/h | Geometric Coefficient of Variation 20.8 |
| Part 1 - RO7062931 3.0 mg/kg | Total Clearance (CL) After Single Ascending Doses - Part 1 | 16.15 L/h | Geometric Coefficient of Variation 18.4 |
| Part 1 - RO7062931 4.0 mg/kg | Total Clearance (CL) After Single Ascending Doses - Part 1 | 23.46 L/h | Geometric Coefficient of Variation 19.3 |
Secondary
Volume of Distribution (Vss) After Multiple Ascending Doses - Part 2
Vss was calculated from dose/AUCinf
Time frame: Days 1-113
Population: The PK analysis population included participants that did not significantly violate eligibility criteria and/or deviate significantly from the protocol. Participants with incomplete or unavailable data were excluded from analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1 - RO7062931 0.1 mg/kg | Volume of Distribution (Vss) After Multiple Ascending Doses - Part 2 | 173.27 Liters (L) | Geometric Coefficient of Variation 119.8 |
| Part 1 - RO7062931 0.3 mg/kg | Volume of Distribution (Vss) After Multiple Ascending Doses - Part 2 | NA Liters (L) | — |
| Part 1 - RO7062931 1.0 mg/kg | Volume of Distribution (Vss) After Multiple Ascending Doses - Part 2 | 3122.3 Liters (L) | Geometric Coefficient of Variation 46.8 |
| Part 1 - RO7062931 2.0 mg/kg | Volume of Distribution (Vss) After Multiple Ascending Doses - Part 2 | 5405.97 Liters (L) | Geometric Coefficient of Variation 53.8 |
| Part 1 - RO7062931 3.0 mg/kg | Volume of Distribution (Vss) After Multiple Ascending Doses - Part 2 | 1734.46 Liters (L) | Geometric Coefficient of Variation 86.9 |
| Part 1 - RO7062931 4.0 mg/kg | Volume of Distribution (Vss) After Multiple Ascending Doses - Part 2 | 4131.91 Liters (L) | Geometric Coefficient of Variation 22.9 |
Secondary
Volume of Distribution (Vss) After Single Ascending Doses - Part 1
Vss was calculated from dose/AUCinf
Time frame: Days 1-8
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1 - RO7062931 0.1 mg/kg | Volume of Distribution (Vss) After Single Ascending Doses - Part 1 | 145.22 Liters (L) | Geometric Coefficient of Variation 61.2 |
| Part 1 - RO7062931 0.3 mg/kg | Volume of Distribution (Vss) After Single Ascending Doses - Part 1 | 206.96 Liters (L) | Geometric Coefficient of Variation 35.2 |
| Part 1 - RO7062931 1.0 mg/kg | Volume of Distribution (Vss) After Single Ascending Doses - Part 1 | 2389.08 Liters (L) | Geometric Coefficient of Variation 228.8 |
| Part 1 - RO7062931 2.0 mg/kg | Volume of Distribution (Vss) After Single Ascending Doses - Part 1 | 3767.16 Liters (L) | Geometric Coefficient of Variation 34.4 |
| Part 1 - RO7062931 3.0 mg/kg | Volume of Distribution (Vss) After Single Ascending Doses - Part 1 | 2684.87 Liters (L) | Geometric Coefficient of Variation 56.8 |
| Part 1 - RO7062931 4.0 mg/kg | Volume of Distribution (Vss) After Single Ascending Doses - Part 1 | 2900.19 Liters (L) | Geometric Coefficient of Variation 13.9 |