First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4011499 in Healthy Participants

A Randomized, Double-Blind (Sponsor Unblinded), Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Orally Administered VH4011499 in Healthy Participants

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05393271

Enrollment

Registered

2022-05-26

Start date

2022-10-03

Completion date

2023-04-24

Last updated

2025-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

GSK4011499, VH4011499, First-time-in-human, HIV-1 capsid inhibitor, Single ascending doses, Multiple ascending doses, Drug-drug Interaction

Brief summary

This FTIH study aims to evaluate the safety, tolerability and PK of the novel investigational Human immunodeficiency virus (HIV)-1 capsid inhibitor VH4011499 in healthy adults. The study will be conducted in 3 parts: Part 1 will investigate single ascending doses (SAD) and Part 2 will investigate multiple ascending doses (MAD). Part 3 will investigate single dose of a new formulation of VH4011499. The transition from SAD to MAD will be based on the assessment of the Safety and Dose Escalation Committee.

Interventions

DRUGVH4011499

VH4011499 will be administered.

DRUGPlacebo

Placebo will be administered.

DRUGMidazolam

Midazolam will be administered

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

This is a double-blind (sponsor unblinded) study.

Intervention model description

This is a randomized and placebo-controlled study.

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Participants who are overtly healthy. * Participants must have two consecutive Severe Acute Respiratory Syndrome Coronavirus 2 (SARs-CoV-2) Polymerase chain reaction (PCR) negative results prior to dosing. * Participants must have body weight \> 50 kilograms (kg) and body mass index (BMI) within the range 19-32 kilograms per meter square (kg/m\^2). * Male or female participants (either of non-childbearing potential or of child-bearing potential and using acceptable contraception). * Capable of giving signed informed consent.

Exclusion criteria

* History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neurological or psychiatric disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study drug or interfering with the interpretation of data. * Abnormal blood pressure. * Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years. * Breast cancer within the past 10 years. * Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). * QT interval corrected for heart rate according to Fridericia's formula (QTcF) greater than (\>)450 milliseconds (msec). * Past or intended use of over-the-counter or prescription medication including herbal medications within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to dosing and for the duration of the study, unless in the opinion of the Investigator and Sponsor, the medication will not interfere with the study medications, procedures, or compromise participant safety. * Live vaccine(s) within 1 month prior to screening or plans to receive such vaccines during the study. * Exposure to more than 4 investigational products within 12 months prior to dosing. * Current enrollment or recent past participation in another investigational study. * ALT \>1.5 times upper limit of normal (ULN), total bilirubin \>1.5 times ULN, and/or estimated serum creatinine clearance less than 60 milliliters per minute. * History of or current infection with hepatitis B or hepatitis C. * Positive Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) test, having signs and symptoms, or having contact with known Coronavirus Disease-2019 (COVID-19) positive person/s within 14 days. * Positive HIV antibody test. * Use of tobacco or nicotine-containing products, regular alcohol consumption and/or regular use of known drugs of abuse. * Sensitivity to the study drug, or components thereof midazolam, excipients contained therein, benzodiazepines, or drug or other allergy that, contraindicates participation in the study.

Design outcomes

Primary

Measure	Time frame	Description
Part 1: Number of Participants With Adverse Events (AEs)	Up to Day 28	An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a study intervention whether or not considered related to the study intervention.
Part 2: Number of Participants With AEs	Up to Day 42	An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a study intervention whether or not considered related to the study intervention.
Part 3: Number of Participants With AEs	Up to Day 28	An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a study intervention whether or not considered related to the study intervention.
Part 1: Number of Participants With AEs by Severity	Up to Day 28	An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a study intervention whether or not considered related to the study intervention. The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AE was used for all AE severity grading, where Grade 1=Mild symptoms causing no or minimal interference with usual social & functional activities with intervention not indicated, 2=Moderate symptoms causing greater than minimal interference with usual social & functional activities with intervention indicated, 3=Severe symptoms causing inability to perform usual social & functional activities with intervention or hospitalization indicated, 4=Potentially life-threatening symptoms causing inability to perform basic self-care functions with intervention indicated to prevent permanent impairment, persistent disability or death, 5=Death.
Part 2: Number of Participants With AEs by Severity	Up to Day 42	An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a study intervention whether or not considered related to the study intervention. The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AE was used for all AE severity grading, where Grade 1=Mild symptoms causing no or minimal interference with usual social & functional activities with intervention not indicated, 2=Moderate symptoms causing greater than minimal interference with usual social & functional activities with intervention indicated, 3=Severe symptoms causing inability to perform usual social & functional activities with intervention or hospitalization indicated, 4=Potentially life-threatening symptoms causing inability to perform basic self-care functions with intervention indicated to prevent permanent impairment, persistent disability or death, 5=Death.
Part 3: Number of Participants With AEs by Severity	Up to Day 28	An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a study intervention whether or not considered related to the study intervention. The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AE was used for all AE severity grading, where Grade 1=Mild symptoms causing no or minimal interference with usual social & functional activities with intervention not indicated, 2=Moderate symptoms causing greater than minimal interference with usual social & functional activities with intervention indicated, 3=Severe symptoms causing inability to perform usual social & functional activities with intervention or hospitalization indicated, 4=Potentially life-threatening symptoms causing inability to perform basic self-care functions with intervention indicated to prevent permanent impairment, persistent disability or death, 5=Death.
Part 2: Number of Participants Discontinuing Treatment Due to AEs	Up to Day 42	Number of participants who discontinued treatment due to AEs are presented.
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Up to Day 28	Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of bilirubin.
Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	Up to Day 28	Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of ALT, ALP and AST.
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Up to Day 42	Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of bilirubin.
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	Up to Day 42	Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of ALT, ALP and AST
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Up to Day 28	Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of bilirubin.
Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	Up to Day 28	Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of ALT, ALP and AST
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	From Baseline (Day 1) and up to Day 28	Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of bilirubin. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.
Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	From Baseline (Day 1) and up to Day 28	Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of ALT, ALP and AST. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	From Baseline (Day 1) and up to Day 42	Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of bilirubin. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value. Standard Deviation (SD)=0.0000 is defined as following: if all participants analyzed for a specific parameter at a specific time point have the same value, then SD is equal with 0.0000.
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	From Baseline (Day 1) and up to Day 42	Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of ALT, ALP and AST. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value. SD=0.00 is defined as following: if all participants analyzed for a specific parameter at a specific time point have the same value, then SD is equal with 0.00.
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	From Baseline (Day 1) and up to Day 28	Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of bilirubin. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.
Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	From Baseline (Day 1) and up to Day 28	Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of ALT, ALP and AST. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.
Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Up to Day 28	Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of the liver panel parameters: ALT, ALP, AST, total bilirubin and direct bilirubin. The number of participants with any grade increase (from grade 1 \[mild\] to grade 4 \[potentially life-threatening\]) have been presented.
Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Up to Day 42	Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of the liver panel parameters: ALT, ALP, AST, total bilirubin and direct bilirubin. The number of participants with any grade increase (from grade 1 \[mild\] to grade 4 \[potentially life-threatening\]) have been presented.
Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Up to Day 28	Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of the liver panel parameters: ALT, ALP, AST, total bilirubin and direct bilirubin. The number of participants with any grade increase (from grade 1 \[mild\] to grade 4 \[potentially life-threatening\]) have been presented.
Part 1: Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to Infinity (0-inf) Following Single Dose Administration of VH4011499	At Day 1	Blood samples were collected as assessed by protocol, at specific time points for pharmacokinetic (PK) analysis to determine AUC(0-inf). For AUC, a linear trapezoidal method was employed for all incremental trapezoids arising from increasing concentrations and the logarithmic trapezoidal method was used for those arising from decreasing concentrations. Geometric Coefficient of Variation was expressed in percentages.
Part 2: AUC Over a Dosing Interval From Time of Dosing to the Time of the Subsequent Dose (0-t) Following Repeat Dose Administration of VH4011499	At Days 1 and 14 for Part 2 (MAD): VH4011499 200 mg PiB and Part 2 (MAD): VH4011499 400 mg PiB groups, and at Days 2 and 15 for Part 2 (MAD): VH4011499 300 mg + Midazolam PiB group	Blood samples were collected as assessed by protocol, at specific time points for PK analysis to determine AUC(0-t). For AUC, a linear trapezoidal method was employed for all incremental trapezoids arising from increasing concentrations and the logarithmic trapezoidal method was used for those arising from decreasing concentrations.
Part 1: Maximum Observed Plasma Concentration (Cmax) Following Single Dose Administration of VH4011499.	At Day 1	Blood samples were collected as assessed by protocol, at specific time points for PK analysis to determine Cmax.
Part 1: Time to Maximum Observed Plasma Concentration (Tmax) Following Single Dose Administration of VH4011499	At Day 1	Blood samples were collected as assessed by protocol, at specific time points for PK analysis to determine Tmax.
Part 1: Apparent Terminal Half-life (T1/2) Following Single Dose Administration of VH4011499	At Day 1	Blood samples were collected as assessed by protocol, at specific time points for PK analysis to determine T1/2.
Part 2: Cmax Following Repeat Dose Administration of VH4011499	At Days 1 and 14 for Part 2 (MAD): VH4011499 200 mg PiB and Part 2 (MAD): VH4011499 400 mg PiB groups, and at Days 2 and 15 for Part 2 (MAD): VH4011499 300 mg + Midazolam PiB group	Blood samples were collected as assessed by protocol, at specific time points for PK analysis to determine Cmax.
Part 2: Tmax Following Repeat Dose Administration of VH4011499	At Days 1 and 14 for Part 2 (MAD): VH4011499 200 mg PiB and Part 2 (MAD): VH4011499 400 mg PiB groups, and at Days 2 and 15 for Part 2 (MAD): VH4011499 300 mg + Midazolam PiB group	Blood samples were collected as assessed by protocol, at specific time points for PK analysis to determine Tmax.
Part 2: T1/2 Following Repeat Dose Administration of VH4011499	At Day 14 for Part 2 (MAD): VH4011499 200 mg PiB and Part 2 (MAD): VH4011499 400 mg PiB groups, and at Day 15 for Part 2 (MAD): VH4011499 300 mg + Midazolam PiB group	Blood samples were collected as assessed by protocol, at specific time points for PK analysis to determine T1/2.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB) Healthy participants were given a single dose of placebo on Day 1 and were followed up until Day 28.	10
Part 1 (SAD): VH4011499 25 mg PiB Healthy participants were given a single dose of 25 mg VH4011499 on Day 1 and were followed up until Day 28.	6
Part 1 (SAD): VH4011499 125 mg PiB Healthy participants were given a single dose of 125 mg VH4011499 on Day 1 and were followed up until Day 28.	6
Part 1 (SAD): VH4011499 200 mg PiB Healthy participants were given a single dose of 200 mg VH4011499 on Day 1 and were followed up until Day 28.	6
Part 1 (SAD): VH4011499 625 mg PiB Healthy participants were given a single dose of 625 mg VH4011499 on Day 1 and were followed up until Day 28.	6
Part 1 (SAD): VH4011499 1875 mg PiB Healthy participants were given a single dose of 1875 mg VH4011499 on Day 1 and were followed up until Day 28.	6
Part 2 Multiple Ascending Dose (MAD): Placebo PiB Healthy participants were given a dose of placebo once daily for a 14-day period and were followed up until Day 42.	7
Part 2 (MAD): VH4011499 200 mg PiB Healthy participants were given a dose of VH4011499 200 mg PiB once daily for a 14-day period and were followed up until Day 42.	6
Part 2 (MAD): VH4011499 300 mg + Midazolam (MDZ) PiB Healthy participants were given a dose of VH4011499 300 mg once daily and a single dose of Midazolam on Days 1, 2, and 15, and were followed up until Day 42.	8
Part 2 (MAD): VH4011499 400 mg PiB Healthy participants were given a dose of VH4011499 400 mg PiB once daily for a 14-day period and were followed up until Day 42.	6
Part 3 (Single Dose): VH4011499 200 mg Tablet Healthy participants were given a dose of VH4011499 200 mg tablet on Day 1 and were followed up until Day 28.	6
Total	73

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005	FG006	FG007	FG008	FG009	FG010
Overall Study	Physician Decision	0	0	0	0	0	0	1	0	0	0	0

Baseline characteristics

Characteristic	Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1 (SAD): VH4011499 25 mg PiB	Part 1 (SAD): VH4011499 125 mg PiB	Part 1 (SAD): VH4011499 200 mg PiB	Part 1 (SAD): VH4011499 625 mg PiB	Part 1 (SAD): VH4011499 1875 mg PiB	Part 2 Multiple Ascending Dose (MAD): Placebo PiB	Part 2 (MAD): VH4011499 200 mg PiB	Part 2 (MAD): VH4011499 300 mg + Midazolam (MDZ) PiB	Part 2 (MAD): VH4011499 400 mg PiB	Part 3 (Single Dose): VH4011499 200 mg Tablet	Total
Age, Continuous	37.8 Years STANDARD_DEVIATION 11.17	35.3 Years STANDARD_DEVIATION 6.12	36.5 Years STANDARD_DEVIATION 7.48	45.8 Years STANDARD_DEVIATION 8.08	40.0 Years STANDARD_DEVIATION 12.05	39.8 Years STANDARD_DEVIATION 7.78	37.6 Years STANDARD_DEVIATION 11.18	35.5 Years STANDARD_DEVIATION 13.1	38.9 Years STANDARD_DEVIATION 11.81	32.3 Years STANDARD_DEVIATION 3.83	37.2 Years STANDARD_DEVIATION 9.91	37.9 Years STANDARD_DEVIATION 9.72
Race/Ethnicity, Customized Asian	2 Participants	0 Participants	0 Participants	2 Participants	0 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	7 Participants
Race/Ethnicity, Customized Black or African American	3 Participants	3 Participants	3 Participants	1 Participants	2 Participants	1 Participants	3 Participants	3 Participants	5 Participants	4 Participants	1 Participants	29 Participants
Race/Ethnicity, Customized Multiple	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	6 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Race/Ethnicity, Customized White	5 Participants	2 Participants	2 Participants	2 Participants	4 Participants	1 Participants	3 Participants	3 Participants	3 Participants	2 Participants	3 Participants	30 Participants
Sex/Gender, Customized Female	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	5 Participants
Sex/Gender, Customized Male	9 Participants	6 Participants	6 Participants	5 Participants	5 Participants	6 Participants	7 Participants	5 Participants	7 Participants	6 Participants	6 Participants	68 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
deaths Total, all-cause mortality	0 / 10	0 / 6	0 / 6	0 / 6	0 / 6	0 / 6	0 / 7	0 / 6	0 / 8	0 / 6	0 / 6
other Total, other adverse events	3 / 10	2 / 6	1 / 6	3 / 6	1 / 6	1 / 6	2 / 7	3 / 6	3 / 8	2 / 6	1 / 6
serious Total, serious adverse events	1 / 10	0 / 6	0 / 6	0 / 6	0 / 6	0 / 6	0 / 7	0 / 6	0 / 8	0 / 6	0 / 6

Outcome results

Primary

Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)

Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of ALT, ALP and AST.

Time frame: Up to Day 28

Population: The analysis was performed on the Safety Set which included all enrolled participants in Part 1 (SAD) who received at least 1 full or partial dose of study treatment. The participants were analyzed according to the treatment they received.

Arm	Measure	Group	Value (MEAN)	Dispersion
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 6	17.4 International Units per Liter (IU/L)	Standard Deviation 6.45
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 5	16.1 International Units per Liter (IU/L)	Standard Deviation 5.36
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 2	14.2 International Units per Liter (IU/L)	Standard Deviation 4.96
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 14	18.0 International Units per Liter (IU/L)	Standard Deviation 5.61
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 4	16.0 International Units per Liter (IU/L)	Standard Deviation 6.36
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 3	15.7 International Units per Liter (IU/L)	Standard Deviation 5.56
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 3	53.1 International Units per Liter (IU/L)	Standard Deviation 16.11
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 7	16.0 International Units per Liter (IU/L)	Standard Deviation 3.62
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 4	54.5 International Units per Liter (IU/L)	Standard Deviation 15.63
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 28	20.3 International Units per Liter (IU/L)	Standard Deviation 10.19
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 6	15.1 International Units per Liter (IU/L)	Standard Deviation 3.41
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 5	15.2 International Units per Liter (IU/L)	Standard Deviation 2.53
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 5	53.9 International Units per Liter (IU/L)	Standard Deviation 14.89
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 4	15.1 International Units per Liter (IU/L)	Standard Deviation 3.31
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 6	54.2 International Units per Liter (IU/L)	Standard Deviation 15.85
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 2	52.3 International Units per Liter (IU/L)	Standard Deviation 17.23
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 3	15.3 International Units per Liter (IU/L)	Standard Deviation 3.16
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 2	14.2 International Units per Liter (IU/L)	Standard Deviation 3.43
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 7	54.6 International Units per Liter (IU/L)	Standard Deviation 15.88
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Baseline (Day 1)	15.0 International Units per Liter (IU/L)	Standard Deviation 3.53
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 14	52.8 International Units per Liter (IU/L)	Standard Deviation 16.59
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Baseline (Day 1)	56.4 International Units per Liter (IU/L)	Standard Deviation 20.82
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 28	24.9 International Units per Liter (IU/L)	Standard Deviation 17.39
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 21	20.5 International Units per Liter (IU/L)	Standard Deviation 11.4
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 21	58.5 International Units per Liter (IU/L)	Standard Deviation 22.15
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 14	19.7 International Units per Liter (IU/L)	Standard Deviation 6.4
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 28	56.1 International Units per Liter (IU/L)	Standard Deviation 17.62
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 21	18.6 International Units per Liter (IU/L)	Standard Deviation 10.07
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 7	18.7 International Units per Liter (IU/L)	Standard Deviation 7.56
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Baseline (Day 1)	13.9 International Units per Liter (IU/L)	Standard Deviation 4.38
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 14	21.2 International Units per Liter (IU/L)	Standard Deviation 9.5
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Baseline (Day 1)	28.5 International Units per Liter (IU/L)	Standard Deviation 16.01
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 14	17.4 International Units per Liter (IU/L)	Standard Deviation 6.66
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 5	27.2 International Units per Liter (IU/L)	Standard Deviation 16.82
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 6	53.3 International Units per Liter (IU/L)	Standard Deviation 17.45
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 4	30.0 International Units per Liter (IU/L)	Standard Deviation 19.93
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 28	59.0 International Units per Liter (IU/L)	Standard Deviation 19.38
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 2	34.0 International Units per Liter (IU/L)	Standard Deviation 24.66
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 21	26.0 International Units per Liter (IU/L)	Standard Deviation 20.25
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 2	23.0 International Units per Liter (IU/L)	Standard Deviation 13.55
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 3	33.7 International Units per Liter (IU/L)	Standard Deviation 25.95
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 7	23.5 International Units per Liter (IU/L)	Standard Deviation 12.63
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 6	24.7 International Units per Liter (IU/L)	Standard Deviation 14.35
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 3	54.8 International Units per Liter (IU/L)	Standard Deviation 19.36
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 28	32.0 International Units per Liter (IU/L)	Standard Deviation 26.5
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 7	17.0 International Units per Liter (IU/L)	Standard Deviation 5.14
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 7	54.2 International Units per Liter (IU/L)	Standard Deviation 17.52
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 6	14.8 International Units per Liter (IU/L)	Standard Deviation 3.97
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 2	56.3 International Units per Liter (IU/L)	Standard Deviation 20.54
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 4	55.5 International Units per Liter (IU/L)	Standard Deviation 19.27
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Baseline (Day 1)	20.7 International Units per Liter (IU/L)	Standard Deviation 9.65
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 21	58.8 International Units per Liter (IU/L)	Standard Deviation 21.48
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 5	15.5 International Units per Liter (IU/L)	Standard Deviation 4.51
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 28	28.2 International Units per Liter (IU/L)	Standard Deviation 24.81
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Baseline (Day 1)	57.2 International Units per Liter (IU/L)	Standard Deviation 18.96
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 5	54.0 International Units per Liter (IU/L)	Standard Deviation 17.55
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 21	18.4 International Units per Liter (IU/L)	Standard Deviation 6.15
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 4	17.5 International Units per Liter (IU/L)	Standard Deviation 6.83
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 14	59.6 International Units per Liter (IU/L)	Standard Deviation 24.99
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 3	21.0 International Units per Liter (IU/L)	Standard Deviation 9.86
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 14	53.2 International Units per Liter (IU/L)	Standard Deviation 7.14
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Baseline (Day 1)	53.7 International Units per Liter (IU/L)	Standard Deviation 6.5
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 2	51.2 International Units per Liter (IU/L)	Standard Deviation 5.34
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 3	50.7 International Units per Liter (IU/L)	Standard Deviation 6.86
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 4	52.5 International Units per Liter (IU/L)	Standard Deviation 6.53
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 5	52.2 International Units per Liter (IU/L)	Standard Deviation 7.22
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 6	52.3 International Units per Liter (IU/L)	Standard Deviation 8.36
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 7	49.4 International Units per Liter (IU/L)	Standard Deviation 4.56
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 21	52.8 International Units per Liter (IU/L)	Standard Deviation 6.24
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 28	55.7 International Units per Liter (IU/L)	Standard Deviation 7.61
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Baseline (Day 1)	24.7 International Units per Liter (IU/L)	Standard Deviation 9.03
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 2	23.2 International Units per Liter (IU/L)	Standard Deviation 8.98
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 3	22.3 International Units per Liter (IU/L)	Standard Deviation 8.04
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 4	23.2 International Units per Liter (IU/L)	Standard Deviation 7.31
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 5	22.2 International Units per Liter (IU/L)	Standard Deviation 6.79
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 6	22.0 International Units per Liter (IU/L)	Standard Deviation 5.44
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 7	23.6 International Units per Liter (IU/L)	Standard Deviation 5.46
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 14	21.5 International Units per Liter (IU/L)	Standard Deviation 6.09
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 21	24.8 International Units per Liter (IU/L)	Standard Deviation 10.55
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 28	23.8 International Units per Liter (IU/L)	Standard Deviation 6.62
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Baseline (Day 1)	20.3 International Units per Liter (IU/L)	Standard Deviation 3.27
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 2	19.2 International Units per Liter (IU/L)	Standard Deviation 3.66
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 3	18.2 International Units per Liter (IU/L)	Standard Deviation 3.49
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 4	19.3 International Units per Liter (IU/L)	Standard Deviation 3.61
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 5	18.5 International Units per Liter (IU/L)	Standard Deviation 3.02
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 6	18.3 International Units per Liter (IU/L)	Standard Deviation 3.56
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 7	19.0 International Units per Liter (IU/L)	Standard Deviation 2.55
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 14	20.7 International Units per Liter (IU/L)	Standard Deviation 5.65
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 21	20.8 International Units per Liter (IU/L)	Standard Deviation 2.56
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 28	22.8 International Units per Liter (IU/L)	Standard Deviation 5.85
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 14	17.4 International Units per Liter (IU/L)	Standard Deviation 2.3
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 7	65.0 International Units per Liter (IU/L)	Standard Deviation 10.64
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Baseline (Day 1)	16.0 International Units per Liter (IU/L)	Standard Deviation 4.34
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Baseline (Day 1)	16.2 International Units per Liter (IU/L)	Standard Deviation 2.64
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 5	16.2 International Units per Liter (IU/L)	Standard Deviation 6.11
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 4	65.0 International Units per Liter (IU/L)	Standard Deviation 9.82
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 5	14.2 International Units per Liter (IU/L)	Standard Deviation 2.04
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 21	66.8 International Units per Liter (IU/L)	Standard Deviation 11.72
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 21	17.5 International Units per Liter (IU/L)	Standard Deviation 2.07
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 2	14.3 International Units per Liter (IU/L)	Standard Deviation 3.01
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 4	15.8 International Units per Liter (IU/L)	Standard Deviation 5.78
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 4	14.0 International Units per Liter (IU/L)	Standard Deviation 2.28
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 6	65.0 International Units per Liter (IU/L)	Standard Deviation 9.9
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 5	62.2 International Units per Liter (IU/L)	Standard Deviation 9.41
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 14	16.4 International Units per Liter (IU/L)	Standard Deviation 3.44
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 3	14.0 International Units per Liter (IU/L)	Standard Deviation 2.37
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 28	68.5 International Units per Liter (IU/L)	Standard Deviation 12.14
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 2	16.0 International Units per Liter (IU/L)	Standard Deviation 4.98
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 3	16.5 International Units per Liter (IU/L)	Standard Deviation 5.92
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 28	15.7 International Units per Liter (IU/L)	Standard Deviation 2.42
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 2	59.3 International Units per Liter (IU/L)	Standard Deviation 5.99
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 21	18.2 International Units per Liter (IU/L)	Standard Deviation 3.92
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 6	17.2 International Units per Liter (IU/L)	Standard Deviation 6.49
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 7	14.7 International Units per Liter (IU/L)	Standard Deviation 2.42
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 14	63.6 International Units per Liter (IU/L)	Standard Deviation 9.71
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 3	58.2 International Units per Liter (IU/L)	Standard Deviation 6.91
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 6	14.3 International Units per Liter (IU/L)	Standard Deviation 2.07
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 28	16.8 International Units per Liter (IU/L)	Standard Deviation 5.42
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 7	17.3 International Units per Liter (IU/L)	Standard Deviation 6.53
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Baseline (Day 1)	63.0 International Units per Liter (IU/L)	Standard Deviation 5.14
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Baseline (Day 1)	72.0 International Units per Liter (IU/L)	Standard Deviation 29.39
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 28	68.7 International Units per Liter (IU/L)	Standard Deviation 20.75
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 6	17.8 International Units per Liter (IU/L)	Standard Deviation 8.33
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 14	17.6 International Units per Liter (IU/L)	Standard Deviation 3.21
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 7	18.2 International Units per Liter (IU/L)	Standard Deviation 9.15
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 21	70.2 International Units per Liter (IU/L)	Standard Deviation 20.49
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 14	21.6 International Units per Liter (IU/L)	Standard Deviation 9.24
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 14	77.2 International Units per Liter (IU/L)	Standard Deviation 22.62
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 21	19.5 International Units per Liter (IU/L)	Standard Deviation 9.71
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 28	18.5 International Units per Liter (IU/L)	Standard Deviation 7.48
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 7	66.7 International Units per Liter (IU/L)	Standard Deviation 22.71
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 28	15.8 International Units per Liter (IU/L)	Standard Deviation 2.71
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Baseline (Day 1)	20.0 International Units per Liter (IU/L)	Standard Deviation 8.07
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 6	67.5 International Units per Liter (IU/L)	Standard Deviation 18.72
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 2	15.0 International Units per Liter (IU/L)	Standard Deviation 3.29
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 21	15.8 International Units per Liter (IU/L)	Standard Deviation 3.06
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 3	14.7 International Units per Liter (IU/L)	Standard Deviation 2.16
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 5	68.0 International Units per Liter (IU/L)	Standard Deviation 21.56
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 4	14.8 International Units per Liter (IU/L)	Standard Deviation 2.64
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 4	69.5 International Units per Liter (IU/L)	Standard Deviation 24.6
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 5	14.8 International Units per Liter (IU/L)	Standard Deviation 2.4
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 6	15.0 International Units per Liter (IU/L)	Standard Deviation 1.79
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 3	66.3 International Units per Liter (IU/L)	Standard Deviation 21.08
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 7	14.8 International Units per Liter (IU/L)	Standard Deviation 2.48
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 2	19.5 International Units per Liter (IU/L)	Standard Deviation 10.56
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 3	17.5 International Units per Liter (IU/L)	Standard Deviation 8.8
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 2	67.8 International Units per Liter (IU/L)	Standard Deviation 22.63
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 4	18.0 International Units per Liter (IU/L)	Standard Deviation 8.72
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Baseline (Day 1)	23.8 International Units per Liter (IU/L)	Standard Deviation 13.11
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 5	18.2 International Units per Liter (IU/L)	Standard Deviation 9.33
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Baseline (Day 1)	21.7 International Units per Liter (IU/L)	Standard Deviation 4.27
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 3	51.7 International Units per Liter (IU/L)	Standard Deviation 8.12
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 28	18.2 International Units per Liter (IU/L)	Standard Deviation 3.54
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Baseline (Day 1)	55.0 International Units per Liter (IU/L)	Standard Deviation 8.07
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 14	19.5 International Units per Liter (IU/L)	Standard Deviation 4.76
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 6	17.2 International Units per Liter (IU/L)	Standard Deviation 3.31
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 6	19.2 International Units per Liter (IU/L)	Standard Deviation 4.49
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 7	54.0 International Units per Liter (IU/L)	Standard Deviation 10
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 28	19.8 International Units per Liter (IU/L)	Standard Deviation 4.49
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 21	18.7 International Units per Liter (IU/L)	Standard Deviation 3.61
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 4	20.3 International Units per Liter (IU/L)	Standard Deviation 7.28
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 7	19.2 International Units per Liter (IU/L)	Standard Deviation 5.19
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 2	21.8 International Units per Liter (IU/L)	Standard Deviation 8.93
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 5	19.2 International Units per Liter (IU/L)	Standard Deviation 4.96
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 2	48.8 International Units per Liter (IU/L)	Standard Deviation 7.05
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 14	53.2 International Units per Liter (IU/L)	Standard Deviation 7.83
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 7	20.0 International Units per Liter (IU/L)	Standard Deviation 5.59
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 3	17.8 International Units per Liter (IU/L)	Standard Deviation 4.45
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 3	20.5 International Units per Liter (IU/L)	Standard Deviation 8.48
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 5	53.0 International Units per Liter (IU/L)	Standard Deviation 9.34
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 21	19.0 International Units per Liter (IU/L)	Standard Deviation 3.46
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 2	18.3 International Units per Liter (IU/L)	Standard Deviation 5.57
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Day 14	19.7 International Units per Liter (IU/L)	Standard Deviation 3.72
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 4	17.8 International Units per Liter (IU/L)	Standard Deviation 3.54
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 4	52.7 International Units per Liter (IU/L)	Standard Deviation 8.21
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALT, Baseline (Day 1)	21.7 International Units per Liter (IU/L)	Standard Deviation 3.44
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 28	51.5 International Units per Liter (IU/L)	Standard Deviation 7.77
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 6	52.7 International Units per Liter (IU/L)	Standard Deviation 9.14
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	ALP, Day 21	51.3 International Units per Liter (IU/L)	Standard Deviation 6.71
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	AST, Day 5	17.0 International Units per Liter (IU/L)	Standard Deviation 2.76

Primary

Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin

Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of bilirubin.

Time frame: Up to Day 28

Arm	Measure	Group	Value (MEAN)	Dispersion
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 14	1.8620 Micromoles per Liter (μmol/L)	Standard Deviation 0.99872
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 5	11.0637 Micromoles per Liter (μmol/L)	Standard Deviation 3.5045
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 14	9.1390 Micromoles per Liter (μmol/L)	Standard Deviation 4.16071
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Baseline (Day 1)	9.4050 Micromoles per Liter (μmol/L)	Standard Deviation 3.14793
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 28	9.5247 Micromoles per Liter (μmol/L)	Standard Deviation 3.74733
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 5	2.0007 Micromoles per Liter (μmol/L)	Standard Deviation 0.75641
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 2	1.9152 Micromoles per Liter (μmol/L)	Standard Deviation 0.88964
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 3	1.9665 Micromoles per Liter (μmol/L)	Standard Deviation 0.99465
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 28	1.7613 Micromoles per Liter (μmol/L)	Standard Deviation 0.75641
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Baseline (Day 1)	2.0520 Micromoles per Liter (μmol/L)	Standard Deviation 0.721
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 2	10.7901 Micromoles per Liter (μmol/L)	Standard Deviation 3.16075
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 6	1.8639 Micromoles per Liter (μmol/L)	Standard Deviation 0.76239
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 3	10.4310 Micromoles per Liter (μmol/L)	Standard Deviation 2.89748
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 4	9.6444 Micromoles per Liter (μmol/L)	Standard Deviation 3.82385
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 7	11.3373 Micromoles per Liter (μmol/L)	Standard Deviation 3.34901
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 21	9.3195 Micromoles per Liter (μmol/L)	Standard Deviation 4.07958
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 21	1.7955 Micromoles per Liter (μmol/L)	Standard Deviation 0.95123
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 7	2.1375 Micromoles per Liter (μmol/L)	Standard Deviation 0.84256
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 4	1.6416 Micromoles per Liter (μmol/L)	Standard Deviation 0.86895
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 6	10.1574 Micromoles per Liter (μmol/L)	Standard Deviation 3.09505
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 4	2.7075 Micromoles per Liter (μmol/L)	Standard Deviation 0.783
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 21	9.7128 Micromoles per Liter (μmol/L)	Standard Deviation 2.89793
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 14	2.3256 Micromoles per Liter (μmol/L)	Standard Deviation 1.03027
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 6	12.3690 Micromoles per Liter (μmol/L)	Standard Deviation 2.20495
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 2	2.7075 Micromoles per Liter (μmol/L)	Standard Deviation 0.52335
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 21	2.3256 Micromoles per Liter (μmol/L)	Standard Deviation 0.75123
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 28	2.1945 Micromoles per Liter (μmol/L)	Standard Deviation 0.46412
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 3	11.9985 Micromoles per Liter (μmol/L)	Standard Deviation 3.0232
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 5	12.4260 Micromoles per Liter (μmol/L)	Standard Deviation 2.91938
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 28	10.4595 Micromoles per Liter (μmol/L)	Standard Deviation 2.49312
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Baseline (Day 1)	12.8250 Micromoles per Liter (μmol/L)	Standard Deviation 5.59356
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 3	2.5650 Micromoles per Liter (μmol/L)	Standard Deviation 0.6489
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 4	11.2290 Micromoles per Liter (μmol/L)	Standard Deviation 2.62398
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 5	2.7930 Micromoles per Liter (μmol/L)	Standard Deviation 0.84237
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 2	11.9415 Micromoles per Liter (μmol/L)	Standard Deviation 2.89069
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 6	2.8785 Micromoles per Liter (μmol/L)	Standard Deviation 0.9577
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 14	9.4050 Micromoles per Liter (μmol/L)	Standard Deviation 4.37138
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Baseline (Day 1)	2.8500 Micromoles per Liter (μmol/L)	Standard Deviation 1.39621
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 7	13.1670 Micromoles per Liter (μmol/L)	Standard Deviation 3.67391
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 7	2.9640 Micromoles per Liter (μmol/L)	Standard Deviation 0.76982
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 2	14.0790 Micromoles per Liter (μmol/L)	Standard Deviation 5.3122
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 4	12.6825 Micromoles per Liter (μmol/L)	Standard Deviation 6.84634
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 7	16.1766 Micromoles per Liter (μmol/L)	Standard Deviation 4.75214
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 5	14.6490 Micromoles per Liter (μmol/L)	Standard Deviation 4.95448
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 3	1.8525 Micromoles per Liter (μmol/L)	Standard Deviation 0.45134
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 6	14.5350 Micromoles per Liter (μmol/L)	Standard Deviation 4.44205
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Baseline (Day 1)	2.2800 Micromoles per Liter (μmol/L)	Standard Deviation 0.88304
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 4	1.9095 Micromoles per Liter (μmol/L)	Standard Deviation 0.48867
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 5	2.3085 Micromoles per Liter (μmol/L)	Standard Deviation 0.51584
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 6	2.5365 Micromoles per Liter (μmol/L)	Standard Deviation 0.69601
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 21	11.0580 Micromoles per Liter (μmol/L)	Standard Deviation 2.83606
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 7	2.8044 Micromoles per Liter (μmol/L)	Standard Deviation 0.39367
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 14	1.9095 Micromoles per Liter (μmol/L)	Standard Deviation 0.64362
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 21	2.1660 Micromoles per Liter (μmol/L)	Standard Deviation 0.50341
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 2	1.9950 Micromoles per Liter (μmol/L)	Standard Deviation 0.59891
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 28	1.8810 Micromoles per Liter (μmol/L)	Standard Deviation 0.4326
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 14	9.9750 Micromoles per Liter (μmol/L)	Standard Deviation 3.82011
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Baseline (Day 1)	10.5450 Micromoles per Liter (μmol/L)	Standard Deviation 4.76555
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 28	9.0345 Micromoles per Liter (μmol/L)	Standard Deviation 1.56132
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 3	15.1620 Micromoles per Liter (μmol/L)	Standard Deviation 7.84192
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 3	11.3145 Micromoles per Liter (μmol/L)	Standard Deviation 2.7898
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 14	1.4022 Micromoles per Liter (μmol/L)	Standard Deviation 0.44262
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 7	1.6815 Micromoles per Liter (μmol/L)	Standard Deviation 0.67899
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 5	9.9180 Micromoles per Liter (μmol/L)	Standard Deviation 2.30692
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Baseline (Day 1)	11.6850 Micromoles per Liter (μmol/L)	Standard Deviation 2.27286
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 28	9.7185 Micromoles per Liter (μmol/L)	Standard Deviation 2.67858
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 6	1.9380 Micromoles per Liter (μmol/L)	Standard Deviation 0.5149
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 21	8.2365 Micromoles per Liter (μmol/L)	Standard Deviation 2.10661
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 5	1.7670 Micromoles per Liter (μmol/L)	Standard Deviation 0.35322
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Baseline (Day 1)	1.9950 Micromoles per Liter (μmol/L)	Standard Deviation 0.6981
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 2	10.8015 Micromoles per Liter (μmol/L)	Standard Deviation 2.3029
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 7	9.5475 Micromoles per Liter (μmol/L)	Standard Deviation 4.17523
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 4	1.6245 Micromoles per Liter (μmol/L)	Standard Deviation 0.81472
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 3	1.7385 Micromoles per Liter (μmol/L)	Standard Deviation 0.56628
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 6	10.9725 Micromoles per Liter (μmol/L)	Standard Deviation 2.79189
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 14	7.5582 Micromoles per Liter (μmol/L)	Standard Deviation 2.48215
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 21	1.4820 Micromoles per Liter (μmol/L)	Standard Deviation 0.27924
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 4	10.1460 Micromoles per Liter (μmol/L)	Standard Deviation 4.3686
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 28	1.7670 Micromoles per Liter (μmol/L)	Standard Deviation 0.45457
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 2	1.9665 Micromoles per Liter (μmol/L)	Standard Deviation 0.49265
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 5	12.4545 Micromoles per Liter (μmol/L)	Standard Deviation 3.75331
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Baseline (Day 1)	2.5650 Micromoles per Liter (μmol/L)	Standard Deviation 0.93661
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 2	2.4510 Micromoles per Liter (μmol/L)	Standard Deviation 0.57905
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 3	2.3940 Micromoles per Liter (μmol/L)	Standard Deviation 0.66668
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 4	2.1375 Micromoles per Liter (μmol/L)	Standard Deviation 0.65562
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 5	2.3940 Micromoles per Liter (μmol/L)	Standard Deviation 0.70919
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 6	2.2515 Micromoles per Liter (μmol/L)	Standard Deviation 0.63447
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 7	2.5650 Micromoles per Liter (μmol/L)	Standard Deviation 0.74144
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 14	1.9494 Micromoles per Liter (μmol/L)	Standard Deviation 0.25933
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 21	1.7385 Micromoles per Liter (μmol/L)	Standard Deviation 0.27396
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 28	1.8525 Micromoles per Liter (μmol/L)	Standard Deviation 0.77549
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Baseline (Day 1)	11.9700 Micromoles per Liter (μmol/L)	Standard Deviation 2.64912
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 2	13.5945 Micromoles per Liter (μmol/L)	Standard Deviation 3.91997
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 3	12.5115 Micromoles per Liter (μmol/L)	Standard Deviation 3.76109
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 4	10.9155 Micromoles per Liter (μmol/L)	Standard Deviation 3.62974
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 14	8.2422 Micromoles per Liter (μmol/L)	Standard Deviation 1.28762
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 6	12.1980 Micromoles per Liter (μmol/L)	Standard Deviation 4.57011
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 7	12.4545 Micromoles per Liter (μmol/L)	Standard Deviation 4.05153
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 21	8.0370 Micromoles per Liter (μmol/L)	Standard Deviation 1.67894
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 28	9.1770 Micromoles per Liter (μmol/L)	Standard Deviation 2.78613
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 3	17.1000 Micromoles per Liter (μmol/L)	Standard Deviation 7.15263
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Baseline (Day 1)	3.1350 Micromoles per Liter (μmol/L)	Standard Deviation 1.28724
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 7	18.1260 Micromoles per Liter (μmol/L)	Standard Deviation 6.43469
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 2	18.5250 Micromoles per Liter (μmol/L)	Standard Deviation 9.28747
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Baseline (Day 1)	13.6800 Micromoles per Liter (μmol/L)	Standard Deviation 6.11788
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 28	2.6220 Micromoles per Liter (μmol/L)	Standard Deviation 1.56226
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 21	2.2230 Micromoles per Liter (μmol/L)	Standard Deviation 1.0815
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 14	10.2885 Micromoles per Liter (μmol/L)	Standard Deviation 4.38563
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 14	2.0805 Micromoles per Liter (μmol/L)	Standard Deviation 0.93296
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 7	3.3630 Micromoles per Liter (μmol/L)	Standard Deviation 1.19292
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 6	3.0210 Micromoles per Liter (μmol/L)	Standard Deviation 1.28724
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 5	3.2205 Micromoles per Liter (μmol/L)	Standard Deviation 1.33519
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 28	13.4805 Micromoles per Liter (μmol/L)	Standard Deviation 9.10929
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 21	10.5735 Micromoles per Liter (μmol/L)	Standard Deviation 4.85401
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 4	2.7075 Micromoles per Liter (μmol/L)	Standard Deviation 1.01693
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 3	3.1350 Micromoles per Liter (μmol/L)	Standard Deviation 1.34501
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 2	3.2205 Micromoles per Liter (μmol/L)	Standard Deviation 1.41183
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 6	16.0455 Micromoles per Liter (μmol/L)	Standard Deviation 6.69431
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 5	17.7270 Micromoles per Liter (μmol/L)	Standard Deviation 7.77602
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 4	15.6465 Micromoles per Liter (μmol/L)	Standard Deviation 7.08175

Primary

Part 1: Apparent Terminal Half-life (T1/2) Following Single Dose Administration of VH4011499

Blood samples were collected as assessed by protocol, at specific time points for PK analysis to determine T1/2.

Time frame: At Day 1

Population: The analysis was performed on the VH4011499 PK Set which included all participants in the Part 1 (SAD) Safety Set who received at least 1 full dose of study treatment with at least one non-missing PK assessment. The participants were analyzed according to the treatment they received.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Apparent Terminal Half-life (T1/2) Following Single Dose Administration of VH4011499	63.97 hours	Geometric Coefficient of Variation 21.07
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Apparent Terminal Half-life (T1/2) Following Single Dose Administration of VH4011499	54.44 hours	Geometric Coefficient of Variation 23.86
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Apparent Terminal Half-life (T1/2) Following Single Dose Administration of VH4011499	61.61 hours	Geometric Coefficient of Variation 29.57
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Apparent Terminal Half-life (T1/2) Following Single Dose Administration of VH4011499	66.32 hours	Geometric Coefficient of Variation 24.75
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Apparent Terminal Half-life (T1/2) Following Single Dose Administration of VH4011499	55.90 hours	Geometric Coefficient of Variation 25.33

Primary

Part 1: Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to Infinity (0-inf) Following Single Dose Administration of VH4011499

Blood samples were collected as assessed by protocol, at specific time points for pharmacokinetic (PK) analysis to determine AUC(0-inf). For AUC, a linear trapezoidal method was employed for all incremental trapezoids arising from increasing concentrations and the logarithmic trapezoidal method was used for those arising from decreasing concentrations. Geometric Coefficient of Variation was expressed in percentages.

Time frame: At Day 1

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to Infinity (0-inf) Following Single Dose Administration of VH4011499	2759.51 Hour nanogram per milliliter (h*ng/mL)	Geometric Coefficient of Variation 53.69
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to Infinity (0-inf) Following Single Dose Administration of VH4011499	8458.88 Hour nanogram per milliliter (h*ng/mL)	Geometric Coefficient of Variation 20.39
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to Infinity (0-inf) Following Single Dose Administration of VH4011499	11627.63 Hour nanogram per milliliter (h*ng/mL)	Geometric Coefficient of Variation 36.01
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to Infinity (0-inf) Following Single Dose Administration of VH4011499	24391.58 Hour nanogram per milliliter (h*ng/mL)	Geometric Coefficient of Variation 34.16
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to Infinity (0-inf) Following Single Dose Administration of VH4011499	36327.28 Hour nanogram per milliliter (h*ng/mL)	Geometric Coefficient of Variation 48.29

Primary

Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST

Time frame: From Baseline (Day 1) and up to Day 28

Arm	Measure	Group	Value (MEAN)	Dispersion
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 6	3.5 μmol/L	Standard Deviation 4.97
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 5	2.2 μmol/L	Standard Deviation 3.49
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 2	0.3 μmol/L	Standard Deviation 1.89
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 14	2.7 μmol/L	Standard Deviation 5.79
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 4	2.1 μmol/L	Standard Deviation 3.87
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 3	1.8 μmol/L	Standard Deviation 2.44
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 3	-3.3 μmol/L	Standard Deviation 6
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 7	1.0 μmol/L	Standard Deviation 3.16
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 4	-1.9 μmol/L	Standard Deviation 7.74
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 28	5.3 μmol/L	Standard Deviation 8.63
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 6	0.1 μmol/L	Standard Deviation 2.18
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 5	0.2 μmol/L	Standard Deviation 2.44
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 5	-2.5 μmol/L	Standard Deviation 7.35
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 4	0.1 μmol/L	Standard Deviation 2.33
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 6	-2.2 μmol/L	Standard Deviation 7.07
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 2	-4.1 μmol/L	Standard Deviation 6.35
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 3	0.3 μmol/L	Standard Deviation 2.54
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 2	-0.8 μmol/L	Standard Deviation 1.32
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 7	-1.8 μmol/L	Standard Deviation 8.01
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Baseline (Day 1)	15.0 μmol/L	Standard Deviation 3.53
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 14	0.4 μmol/L	Standard Deviation 5.77
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Baseline (Day 1)	56.4 μmol/L	Standard Deviation 20.82
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 28	11.0 μmol/L	Standard Deviation 17.58
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 21	6.6 μmol/L	Standard Deviation 8.78
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 21	2.1 μmol/L	Standard Deviation 12.14
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 14	5.3 μmol/L	Standard Deviation 5.48
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 28	-0.3 μmol/L	Standard Deviation 7.06
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 21	3.6 μmol/L	Standard Deviation 7.57
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 7	4.8 μmol/L	Standard Deviation 5.96
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Baseline (Day 1)	13.9 μmol/L	Standard Deviation 4.38
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 14	-7.0 μmol/L	Standard Deviation 9.41
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Baseline (Day 1)	28.5 μmol/L	Standard Deviation 16.01
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 14	-3.6 μmol/L	Standard Deviation 5.03
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 5	-1.3 μmol/L	Standard Deviation 3.72
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 6	-3.8 μmol/L	Standard Deviation 3.54
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 4	1.5 μmol/L	Standard Deviation 6.02
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 28	1.8 μmol/L	Standard Deviation 3.87
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 2	5.5 μmol/L	Standard Deviation 11.26
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 21	-2.2 μmol/L	Standard Deviation 13.5
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 2	2.3 μmol/L	Standard Deviation 9.03
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 3	5.2 μmol/L	Standard Deviation 13.04
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 7	-5.0 μmol/L	Standard Deviation 5.37
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 6	-3.8 μmol/L	Standard Deviation 3.87
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 3	-2.3 μmol/L	Standard Deviation 3.39
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 28	11.3 μmol/L	Standard Deviation 17.81
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 7	-3.7 μmol/L	Standard Deviation 7.84
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 7	-3.0 μmol/L	Standard Deviation 4.2
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 6	-5.8 μmol/L	Standard Deviation 6.11
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 2	-0.8 μmol/L	Standard Deviation 3.13
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 4	-1.7 μmol/L	Standard Deviation 3.39
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Baseline (Day 1)	20.7 μmol/L	Standard Deviation 9.65
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 21	0.0 μmol/L	Standard Deviation 4.9
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 5	-5.2 μmol/L	Standard Deviation 5.56
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 28	-0.3 μmol/L	Standard Deviation 15.47
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Baseline (Day 1)	57.2 μmol/L	Standard Deviation 18.96
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 5	-3.2 μmol/L	Standard Deviation 4.07
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 21	-2.6 μmol/L	Standard Deviation 6.11
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 4	-3.2 μmol/L	Standard Deviation 3.76
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 14	0.8 μmol/L	Standard Deviation 8.58
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 3	0.3 μmol/L	Standard Deviation 6.35
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 14	-0.5 μmol/L	Standard Deviation 5.75
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Baseline (Day 1)	53.7 μmol/L	Standard Deviation 6.5
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 2	-2.5 μmol/L	Standard Deviation 3.27
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 3	-3.0 μmol/L	Standard Deviation 5.06
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 4	-1.2 μmol/L	Standard Deviation 5.19
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 5	-1.5 μmol/L	Standard Deviation 4.09
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 6	-1.3 μmol/L	Standard Deviation 5.43
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 7	-3.2 μmol/L	Standard Deviation 4.32
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 21	-0.8 μmol/L	Standard Deviation 3.19
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 28	2.0 μmol/L	Standard Deviation 8.72
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Baseline (Day 1)	24.7 μmol/L	Standard Deviation 9.03
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 2	-1.5 μmol/L	Standard Deviation 3.39
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 3	-2.3 μmol/L	Standard Deviation 3.08
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 4	-1.5 μmol/L	Standard Deviation 4.28
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 5	-2.5 μmol/L	Standard Deviation 3.73
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 6	-2.7 μmol/L	Standard Deviation 5.54
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 7	-3.6 μmol/L	Standard Deviation 5.41
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 14	-3.2 μmol/L	Standard Deviation 4.45
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 21	0.2 μmol/L	Standard Deviation 8.4
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 28	-0.8 μmol/L	Standard Deviation 4.12
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Baseline (Day 1)	20.3 μmol/L	Standard Deviation 3.27
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 2	-1.2 μmol/L	Standard Deviation 2.04
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 3	-2.2 μmol/L	Standard Deviation 1.94
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 4	-1.0 μmol/L	Standard Deviation 2.1
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 5	-1.8 μmol/L	Standard Deviation 0.75
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 6	-2.0 μmol/L	Standard Deviation 2.1
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 7	-2.0 μmol/L	Standard Deviation 1.58
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 14	0.3 μmol/L	Standard Deviation 2.88
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 21	0.5 μmol/L	Standard Deviation 4.51
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 28	2.5 μmol/L	Standard Deviation 4.28
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 14	0.8 μmol/L	Standard Deviation 0.84
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 7	2.0 μmol/L	Standard Deviation 6.63
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Baseline (Day 1)	16.0 μmol/L	Standard Deviation 4.34
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Baseline (Day 1)	16.2 μmol/L	Standard Deviation 2.64
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 5	0.2 μmol/L	Standard Deviation 2.48
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 4	2.0 μmol/L	Standard Deviation 6.39
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 5	-2.0 μmol/L	Standard Deviation 2.28
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 21	3.8 μmol/L	Standard Deviation 8.4
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 21	1.3 μmol/L	Standard Deviation 2.34
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 2	-1.8 μmol/L	Standard Deviation 1.83
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 4	-0.2 μmol/L	Standard Deviation 2.23
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 4	-2.2 μmol/L	Standard Deviation 2.32
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 6	2.0 μmol/L	Standard Deviation 6.42
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 5	-0.8 μmol/L	Standard Deviation 5.98
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 14	0.8 μmol/L	Standard Deviation 2.17
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 3	-2.2 μmol/L	Standard Deviation 2.64
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 28	5.5 μmol/L	Standard Deviation 8.48
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 2	0.0 μmol/L	Standard Deviation 1.55
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 3	0.5 μmol/L	Standard Deviation 2.43
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 28	-0.5 μmol/L	Standard Deviation 2.43
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 2	-3.7 μmol/L	Standard Deviation 3.5
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 21	2.2 μmol/L	Standard Deviation 3.6
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 6	1.2 μmol/L	Standard Deviation 3.19
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 7	-1.5 μmol/L	Standard Deviation 2.17
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 14	0.0 μmol/L	Standard Deviation 5.15
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 3	-4.8 μmol/L	Standard Deviation 4.02
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 6	-1.8 μmol/L	Standard Deviation 2.64
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 28	0.8 μmol/L	Standard Deviation 3.19
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 7	1.3 μmol/L	Standard Deviation 2.73
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Baseline (Day 1)	63.0 μmol/L	Standard Deviation 5.14
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Baseline (Day 1)	72.0 μmol/L	Standard Deviation 29.39
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 28	-3.3 μmol/L	Standard Deviation 9.4
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 6	-6.0 μmol/L	Standard Deviation 7.72
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 14	-3.0 μmol/L	Standard Deviation 6.28
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 7	-5.7 μmol/L	Standard Deviation 7.45
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 21	-1.8 μmol/L	Standard Deviation 11.48
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 14	-1.0 μmol/L	Standard Deviation 6.16
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 14	0.0 μmol/L	Standard Deviation 7.35
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 21	-4.3 μmol/L	Standard Deviation 6.89
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 28	-5.3 μmol/L	Standard Deviation 8.85
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 7	-5.3 μmol/L	Standard Deviation 9.77
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 28	-4.2 μmol/L	Standard Deviation 7.44
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Baseline (Day 1)	20.0 μmol/L	Standard Deviation 8.07
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 6	-4.5 μmol/L	Standard Deviation 12.88
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 2	-5.0 μmol/L	Standard Deviation 5.44
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 21	-4.2 μmol/L	Standard Deviation 5.78
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 3	-5.3 μmol/L	Standard Deviation 6.83
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 5	-4.0 μmol/L	Standard Deviation 9.27
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 4	-5.2 μmol/L	Standard Deviation 6.62
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 4	-2.5 μmol/L	Standard Deviation 7.48
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 5	-5.2 μmol/L	Standard Deviation 6.88
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 6	-5.0 μmol/L	Standard Deviation 7.24
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 3	-5.7 μmol/L	Standard Deviation 9.37
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 7	-5.2 μmol/L	Standard Deviation 7.08
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 2	-4.3 μmol/L	Standard Deviation 3.78
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 3	-6.3 μmol/L	Standard Deviation 5.2
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 2	-4.2 μmol/L	Standard Deviation 7.41
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 4	-5.8 μmol/L	Standard Deviation 5.64
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Baseline (Day 1)	23.8 μmol/L	Standard Deviation 13.11
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 5	-5.7 μmol/L	Standard Deviation 6.35
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Baseline (Day 1)	21.7 μmol/L	Standard Deviation 4.27
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 3	-3.3 μmol/L	Standard Deviation 3.39
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 28	-3.5 μmol/L	Standard Deviation 2.43
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Baseline (Day 1)	55.0 μmol/L	Standard Deviation 8.07
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 14	-2.2 μmol/L	Standard Deviation 4.96
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 6	-4.5 μmol/L	Standard Deviation 3.21
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 6	-2.5 μmol/L	Standard Deviation 5.39
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 7	-1.0 μmol/L	Standard Deviation 3.16
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 28	-1.8 μmol/L	Standard Deviation 3.19
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 21	-3.0 μmol/L	Standard Deviation 4.47
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 4	-1.3 μmol/L	Standard Deviation 6.47
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 7	-2.5 μmol/L	Standard Deviation 3.78
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 2	0.2 μmol/L	Standard Deviation 7.19
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 5	-2.5 μmol/L	Standard Deviation 5.21
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 2	-6.2 μmol/L	Standard Deviation 2.71
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 14	-1.8 μmol/L	Standard Deviation 3.13
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 7	-1.7 μmol/L	Standard Deviation 6.71
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 3	-3.8 μmol/L	Standard Deviation 4.31
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 3	-1.2 μmol/L	Standard Deviation 7.14
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 5	-2.0 μmol/L	Standard Deviation 3.46
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 21	-2.7 μmol/L	Standard Deviation 2.73
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 2	-3.3 μmol/L	Standard Deviation 4.84
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 14	-2.0 μmol/L	Standard Deviation 5.18
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 4	-3.8 μmol/L	Standard Deviation 4.02
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 4	-2.3 μmol/L	Standard Deviation 2.73
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Baseline (Day 1)	21.7 μmol/L	Standard Deviation 3.44
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 28	-3.5 μmol/L	Standard Deviation 3.56
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 6	-2.3 μmol/L	Standard Deviation 3.39
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 21	-3.7 μmol/L	Standard Deviation 3.44
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 5	-4.7 μmol/L	Standard Deviation 3.27

Primary

Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin

Time frame: From Baseline (Day 1) and up to Day 28

Arm	Measure	Group	Value (MEAN)	Dispersion
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 6	0.7524 IU/L	Standard Deviation 2.27886
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 14	-0.2280 IU/L	Standard Deviation 0.61655
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 7	0.0855 IU/L	Standard Deviation 0.56571
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 28	-0.2907 IU/L	Standard Deviation 0.39532
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 5	-0.0513 IU/L	Standard Deviation 0.58157
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 3	-0.0855 IU/L	Standard Deviation 0.99465
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 7	1.9323 IU/L	Standard Deviation 2.55682
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 5	1.6587 IU/L	Standard Deviation 2.37773
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 14	-0.3610 IU/L	Standard Deviation 1.9146
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 2	-0.1368 IU/L	Standard Deviation 0.54553
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 6	-0.1881 IU/L	Standard Deviation 0.49331
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 28	0.1197 IU/L	Standard Deviation 1.42169
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 3	1.0260 IU/L	Standard Deviation 2.05042
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 4	0.2394 IU/L	Standard Deviation 2.41185
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 21	-0.2565 IU/L	Standard Deviation 0.50502
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Baseline (Day 1)	2.0520 IU/L	Standard Deviation 0.721
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 2	1.3851 IU/L	Standard Deviation 2.24764
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 21	-0.0855 IU/L	Standard Deviation 2.10399
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 4	-0.4104 IU/L	Standard Deviation 0.49822
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Baseline (Day 1)	9.4050 IU/L	Standard Deviation 3.14793
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 4	-1.5960 IU/L	Standard Deviation 5.05381
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Baseline (Day 1)	12.8250 IU/L	Standard Deviation 5.59356
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 2	-0.8835 IU/L	Standard Deviation 4.85401
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 3	-0.8265 IU/L	Standard Deviation 5.51609
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 3	-0.2850 IU/L	Standard Deviation 1.53963
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Baseline (Day 1)	2.8500 IU/L	Standard Deviation 1.39621
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 21	-2.5992 IU/L	Standard Deviation 5.51776
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 4	-0.1425 IU/L	Standard Deviation 1.53868
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 14	-2.9070 IU/L	Standard Deviation 6.29108
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 5	-0.0570 IU/L	Standard Deviation 1.84384
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 28	-2.3655 IU/L	Standard Deviation 7.17501
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 6	0.0285 IU/L	Standard Deviation 2.01872
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 7	0.3420 IU/L	Standard Deviation 6.36984
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 7	0.1140 IU/L	Standard Deviation 1.77928
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 2	-0.1425 IU/L	Standard Deviation 1.54248
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 6	-0.4560 IU/L	Standard Deviation 6.19451
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 14	-0.4104 IU/L	Standard Deviation 1.21277
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 21	-0.4104 IU/L	Standard Deviation 1.12523
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 5	-0.3990 IU/L	Standard Deviation 5.95676
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 28	-0.6555 IU/L	Standard Deviation 1.80457
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 6	3.9900 IU/L	Standard Deviation 6.70064
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Baseline (Day 1)	10.5450 IU/L	Standard Deviation 4.76555
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 28	-1.5105 IU/L	Standard Deviation 4.15838
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 28	-0.3990 IU/L	Standard Deviation 0.98331
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 14	-0.3705 IU/L	Standard Deviation 1.1104
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 2	-0.2850 IU/L	Standard Deviation 0.84237
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 4	-0.3705 IU/L	Standard Deviation 0.90754
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 5	4.1040 IU/L	Standard Deviation 5.26169
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 3	-0.4275 IU/L	Standard Deviation 0.90968
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 21	0.5130 IU/L	Standard Deviation 3.87835
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 21	-0.1140 IU/L	Standard Deviation 1.09047
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Baseline (Day 1)	2.2800 IU/L	Standard Deviation 0.88304
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 6	0.2565 IU/L	Standard Deviation 1.30117
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 7	5.2326 IU/L	Standard Deviation 5.27972
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 4	2.1375 IU/L	Standard Deviation 6.66747
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 5	0.0285 IU/L	Standard Deviation 1.02267
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 14	-0.5700 IU/L	Standard Deviation 4.06486
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 3	4.6170 IU/L	Standard Deviation 7.54418
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 7	0.4104 IU/L	Standard Deviation 1.00148
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 2	3.5340 IU/L	Standard Deviation 4.59817
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 3	-0.3705 IU/L	Standard Deviation 1.79482
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Baseline (Day 1)	1.9950 IU/L	Standard Deviation 0.6981
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 2	-0.0285 IU/L	Standard Deviation 0.45134
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 3	-0.2565 IU/L	Standard Deviation 0.35459
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 4	-0.3705 IU/L	Standard Deviation 0.62518
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 5	-0.2280 IU/L	Standard Deviation 0.73085
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 6	-0.0570 IU/L	Standard Deviation 0.56886
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 7	-0.3135 IU/L	Standard Deviation 0.47656
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 14	-0.6498 IU/L	Standard Deviation 0.89999
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 21	-0.5130 IU/L	Standard Deviation 0.72549
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 28	-0.2280 IU/L	Standard Deviation 0.70643
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Baseline (Day 1)	11.6850 IU/L	Standard Deviation 2.27286
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 2	-0.8835 IU/L	Standard Deviation 2.06171
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 4	-1.5390 IU/L	Standard Deviation 3.11577
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 5	-1.7670 IU/L	Standard Deviation 2.50541
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 6	-0.7125 IU/L	Standard Deviation 1.83031
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 7	-2.1375 IU/L	Standard Deviation 2.49859
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 14	-4.0698 IU/L	Standard Deviation 3.91698
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 21	-3.4485 IU/L	Standard Deviation 2.88056
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 28	-1.9665 IU/L	Standard Deviation 3.3277
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 28	-0.7125 IU/L	Standard Deviation 0.77549
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 4	-1.0545 IU/L	Standard Deviation 2.33568
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 21	-0.8265 IU/L	Standard Deviation 0.88138
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 2	-0.1140 IU/L	Standard Deviation 0.62752
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 5	0.4845 IU/L	Standard Deviation 1.97774
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 14	-0.7866 IU/L	Standard Deviation 0.98678
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 7	0.0000 IU/L	Standard Deviation 0.61179
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 6	0.2280 IU/L	Standard Deviation 3.36078
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 6	-0.3135 IU/L	Standard Deviation 0.63447
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Baseline (Day 1)	2.5650 IU/L	Standard Deviation 0.93661
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 7	0.4845 IU/L	Standard Deviation 2.42655
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 5	-0.1710 IU/L	Standard Deviation 0.66668
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 4	-0.4275 IU/L	Standard Deviation 0.55936
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 14	-3.7278 IU/L	Standard Deviation 3.46966
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 3	-0.1710 IU/L	Standard Deviation 0.78734
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 28	-2.7930 IU/L	Standard Deviation 2.6351
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 21	-3.9330 IU/L	Standard Deviation 2.82228
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 2	1.6245 IU/L	Standard Deviation 2.72261
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 3	0.5415 IU/L	Standard Deviation 2.92088
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Baseline (Day 1)	11.9700 IU/L	Standard Deviation 2.64912
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 2	0.0855 IU/L	Standard Deviation 0.79289
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 21	-3.1065 IU/L	Standard Deviation 3.89102
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 7	4.4460 IU/L	Standard Deviation 6.95867
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 4	1.9665 IU/L	Standard Deviation 5.79158
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 21	-0.9120 IU/L	Standard Deviation 0.97735
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Baseline (Day 1)	13.6800 IU/L	Standard Deviation 6.11788
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 14	-1.0545 IU/L	Standard Deviation 1.05087
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 4	-0.4275 IU/L	Standard Deviation 0.84985
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 28	-0.5130 IU/L	Standard Deviation 1.16982
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 5	4.0470 IU/L	Standard Deviation 7.46913
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 28	-0.1995 IU/L	Standard Deviation 5.55096
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 7	0.2280 IU/L	Standard Deviation 1.21719
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 2	4.8450 IU/L	Standard Deviation 6.74934
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Baseline (Day 1)	3.1350 IU/L	Standard Deviation 1.28724
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 14	-3.3915 IU/L	Standard Deviation 4.65725
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 6	2.3655 IU/L	Standard Deviation 8.26581
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 6	-0.1140 IU/L	Standard Deviation 1.30976
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 3	0.0000 IU/L	Standard Deviation 1.14965
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 5	0.0855 IU/L	Standard Deviation 1.00148
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 3	3.4200 IU/L	Standard Deviation 7.47252

Primary

Part 1: Maximum Observed Plasma Concentration (Cmax) Following Single Dose Administration of VH4011499.

Blood samples were collected as assessed by protocol, at specific time points for PK analysis to determine Cmax.

Time frame: At Day 1

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Maximum Observed Plasma Concentration (Cmax) Following Single Dose Administration of VH4011499.	26.85 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 26.18
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Maximum Observed Plasma Concentration (Cmax) Following Single Dose Administration of VH4011499.	106.90 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 17.24
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Maximum Observed Plasma Concentration (Cmax) Following Single Dose Administration of VH4011499.	168.88 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 36.25
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Maximum Observed Plasma Concentration (Cmax) Following Single Dose Administration of VH4011499.	328.95 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 37.97
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Maximum Observed Plasma Concentration (Cmax) Following Single Dose Administration of VH4011499.	557.81 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 52.86

Primary

Part 1: Number of Participants With Adverse Events (AEs)

An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a study intervention whether or not considered related to the study intervention.

Time frame: Up to Day 28

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Number of Participants With Adverse Events (AEs)	3 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Number of Participants With Adverse Events (AEs)	2 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Number of Participants With Adverse Events (AEs)	1 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Number of Participants With Adverse Events (AEs)	3 Participants
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Number of Participants With Adverse Events (AEs)	1 Participants
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Number of Participants With Adverse Events (AEs)	1 Participants

Primary

Part 1: Number of Participants With AEs by Severity

An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a study intervention whether or not considered related to the study intervention. The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AE was used for all AE severity grading, where Grade 1=Mild symptoms causing no or minimal interference with usual social & functional activities with intervention not indicated, 2=Moderate symptoms causing greater than minimal interference with usual social & functional activities with intervention indicated, 3=Severe symptoms causing inability to perform usual social & functional activities with intervention or hospitalization indicated, 4=Potentially life-threatening symptoms causing inability to perform basic self-care functions with intervention indicated to prevent permanent impairment, persistent disability or death, 5=Death.

Time frame: Up to Day 28

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Number of Participants With AEs by Severity	Grade 5	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Number of Participants With AEs by Severity	Grade 1	1 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Number of Participants With AEs by Severity	Grade 3	1 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Number of Participants With AEs by Severity	Grade 4	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Number of Participants With AEs by Severity	Grade 2	1 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Number of Participants With AEs by Severity	Grade 2	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Number of Participants With AEs by Severity	Grade 5	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Number of Participants With AEs by Severity	Grade 1	1 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Number of Participants With AEs by Severity	Grade 3	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Number of Participants With AEs by Severity	Grade 4	1 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Number of Participants With AEs by Severity	Grade 2	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Number of Participants With AEs by Severity	Grade 1	1 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Number of Participants With AEs by Severity	Grade 5	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Number of Participants With AEs by Severity	Grade 4	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Number of Participants With AEs by Severity	Grade 3	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Number of Participants With AEs by Severity	Grade 3	1 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Number of Participants With AEs by Severity	Grade 2	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Number of Participants With AEs by Severity	Grade 5	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Number of Participants With AEs by Severity	Grade 1	2 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Number of Participants With AEs by Severity	Grade 4	0 Participants
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Number of Participants With AEs by Severity	Grade 2	0 Participants
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Number of Participants With AEs by Severity	Grade 1	1 Participants
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Number of Participants With AEs by Severity	Grade 3	0 Participants
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Number of Participants With AEs by Severity	Grade 4	0 Participants
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Number of Participants With AEs by Severity	Grade 5	0 Participants
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Number of Participants With AEs by Severity	Grade 3	0 Participants
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Number of Participants With AEs by Severity	Grade 1	1 Participants
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Number of Participants With AEs by Severity	Grade 2	0 Participants
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Number of Participants With AEs by Severity	Grade 5	0 Participants
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Number of Participants With AEs by Severity	Grade 4	0 Participants

Primary

Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters

Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of the liver panel parameters: ALT, ALP, AST, total bilirubin and direct bilirubin. The number of participants with any grade increase (from grade 1 \[mild\] to grade 4 \[potentially life-threatening\]) have been presented.

Time frame: Up to Day 28

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 4	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 4	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 3	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 2	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 1	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 3	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 1	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 3	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 2	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 2	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 2	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 4	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 1	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 2	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 1	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 1	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 4	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 3	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 4	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 2	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 4	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 1	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 1	2 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 4	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 2	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 1	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 4	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 2	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 1	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 2	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 4	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 4	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 1	2 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 2	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 4	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 4	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 2	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 4	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 2	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 4	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 1	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 1	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 2	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 1	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 2	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 1	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 2	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 1	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 4	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 1	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 1	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 2	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 4	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 1	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 2	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 4	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 1	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 2	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 4	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 2	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 4	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 1	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 2	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 4	0 Participants
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 2	0 Participants
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 2	0 Participants
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 1	0 Participants
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 2	0 Participants
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 4	0 Participants
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 4	0 Participants
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 2	0 Participants
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 1	0 Participants
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 1	0 Participants
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 1	0 Participants
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 4	0 Participants
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 2	0 Participants
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 4	0 Participants
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 4	0 Participants
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 1	0 Participants
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 2	0 Participants
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 1	0 Participants
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 2	0 Participants
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 1	0 Participants
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 4	0 Participants
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 4	0 Participants
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 2	0 Participants
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 4	0 Participants
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 4	0 Participants
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 1	0 Participants
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 2	0 Participants
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 4	0 Participants
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 2	0 Participants
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 1	0 Participants
Part 1 (SAD): VH4011499 1875 mg PiB	Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 1	0 Participants

Primary

Part 1: Time to Maximum Observed Plasma Concentration (Tmax) Following Single Dose Administration of VH4011499

Blood samples were collected as assessed by protocol, at specific time points for PK analysis to determine Tmax.

Time frame: At Day 1

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 1: Time to Maximum Observed Plasma Concentration (Tmax) Following Single Dose Administration of VH4011499	11.30 hours	Geometric Coefficient of Variation 9.51
Part 1 (SAD): VH4011499 25 mg PiB	Part 1: Time to Maximum Observed Plasma Concentration (Tmax) Following Single Dose Administration of VH4011499	10.26 hours	Geometric Coefficient of Variation 14.77
Part 1 (SAD): VH4011499 125 mg PiB	Part 1: Time to Maximum Observed Plasma Concentration (Tmax) Following Single Dose Administration of VH4011499	9.28 hours	Geometric Coefficient of Variation 11.56
Part 1 (SAD): VH4011499 200 mg PiB	Part 1: Time to Maximum Observed Plasma Concentration (Tmax) Following Single Dose Administration of VH4011499	7.86 hours	Geometric Coefficient of Variation 22.83
Part 1 (SAD): VH4011499 625 mg PiB	Part 1: Time to Maximum Observed Plasma Concentration (Tmax) Following Single Dose Administration of VH4011499	8.79 hours	Geometric Coefficient of Variation 24.6

Primary

Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST

Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of ALT, ALP and AST

Time frame: Up to Day 42

Population: The analysis was performed on the Safety Set which included all enrolled participants in Part 2 (MAD) who received at least 1 full or partial dose of study treatment. The participants were analyzed according to the treatment they received. Only those participants with data available at the specified timepoints were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 28	20.6 IU/L	Standard Deviation 9.29
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 3	19.0 IU/L	Standard Deviation 8.49
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 2	19.8 IU/L	Standard Deviation 6.3
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Baseline (Day 1)	56.0 IU/L	Standard Deviation 16.78
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 14	17.3 IU/L	Standard Deviation 3.1
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 3	23.5 IU/L	Standard Deviation 12.02
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 6	47.0 IU/L	Standard Deviation 18.38
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 5	17.0 IU/L	Standard Deviation 5.35
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 12	47.0 IU/L	Standard Deviation 18.38
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 12	16.5 IU/L	Standard Deviation 4.95
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 6	19.5 IU/L	Standard Deviation 9.19
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 6	16.0 IU/L	Standard Deviation 7.07
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 7	16.0 IU/L	Standard Deviation 4.24
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 14	51.8 IU/L	Standard Deviation 12.76
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 42	24.2 IU/L	Standard Deviation 10.38
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 8	20.5 IU/L	Standard Deviation 7.78
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 7	50.3 IU/L	Standard Deviation 12.04
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 11	15.3 IU/L	Standard Deviation 3.77
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 28	20.2 IU/L	Standard Deviation 4.27
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 11	15.5 IU/L	Standard Deviation 2.38
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 12	18.0 IU/L	Standard Deviation 8.49
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 15	50.5 IU/L	Standard Deviation 23.33
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 14	16.8 IU/L	Standard Deviation 4.19
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 42	21.7 IU/L	Standard Deviation 4.93
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 8	17.0 IU/L	Standard Deviation 5.66
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 15	26.0 IU/L	Standard Deviation 16.97
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 35	20.0 IU/L	Standard Deviation 6.63
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 21	16.0 IU/L	Standard Deviation 5.35
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 21	49.5 IU/L	Standard Deviation 12.4
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 22	19.5 IU/L	Standard Deviation 10.61
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 8	47.0 IU/L	Standard Deviation 18.38
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 22	18.0 IU/L	Standard Deviation 4.24
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 22	47.0 IU/L	Standard Deviation 18.38
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 3	47.0 IU/L	Standard Deviation 18.38
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 28	53.4 IU/L	Standard Deviation 11.67
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 11	50.3 IU/L	Standard Deviation 12.92
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 2	53.8 IU/L	Standard Deviation 12.15
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Baseline (Day 1)	23.3 IU/L	Standard Deviation 7.45
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 35	47.7 IU/L	Standard Deviation 12.71
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 7	17.3 IU/L	Standard Deviation 1.71
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 5	52.5 IU/L	Standard Deviation 10.34
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 21	16.5 IU/L	Standard Deviation 2.08
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 42	52.2 IU/L	Standard Deviation 12.64
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 35	22.0 IU/L	Standard Deviation 11.76
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 5	18.0 IU/L	Standard Deviation 2.83
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 15	20.0 IU/L	Standard Deviation 9.9
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Baseline (Day 1)	23.6 IU/L	Standard Deviation 8.3
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 2	19.6 IU/L	Standard Deviation 2.61
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 7	16.3 IU/L	Standard Deviation 2.25
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 28	16.7 IU/L	Standard Deviation 6.02
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 35	28.0 IU/L	Standard Deviation 27.79
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 42	14.8 IU/L	Standard Deviation 3.66
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 5	16.8 IU/L	Standard Deviation 2.04
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Baseline (Day 1)	17.3 IU/L	Standard Deviation 3.44
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 11	54.0 IU/L	Standard Deviation 18.07
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 2	16.5 IU/L	Standard Deviation 3.02
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 28	17.5 IU/L	Standard Deviation 3.73
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 2	58.3 IU/L	Standard Deviation 20.97
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 14	61.0 IU/L	Standard Deviation 19.78
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 21	51.8 IU/L	Standard Deviation 14.3
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 28	60.0 IU/L	Standard Deviation 14.85
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Baseline (Day 1)	59.5 IU/L	Standard Deviation 19.69
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 21	15.7 IU/L	Standard Deviation 2.73
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 35	63.0 IU/L	Standard Deviation 34.89
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 42	60.3 IU/L	Standard Deviation 18.6
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 5	62.2 IU/L	Standard Deviation 23.59
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Baseline (Day 1)	15.8 IU/L	Standard Deviation 4.62
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 35	26.3 IU/L	Standard Deviation 19.34
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 14	16.7 IU/L	Standard Deviation 3.5
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 2	16.0 IU/L	Standard Deviation 4.9
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 5	16.0 IU/L	Standard Deviation 4.65
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 42	16.3 IU/L	Standard Deviation 1.75
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 7	14.5 IU/L	Standard Deviation 3.62
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 11	15.8 IU/L	Standard Deviation 3.54
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 11	12.5 IU/L	Standard Deviation 3.73
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 7	59.3 IU/L	Standard Deviation 20.65
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 14	12.2 IU/L	Standard Deviation 3.19
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 21	12.3 IU/L	Standard Deviation 3.33
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 35	18.4 IU/L	Standard Deviation 5.93
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Baseline (Day 1)	69.0 IU/L	Standard Deviation 22.43
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 3	68.6 IU/L	Standard Deviation 22.56
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 6	69.3 IU/L	Standard Deviation 21.99
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 8	71.9 IU/L	Standard Deviation 24.31
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 12	64.0 IU/L	Standard Deviation 19.95
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 15	66.5 IU/L	Standard Deviation 22.6
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 22	63.8 IU/L	Standard Deviation 18.72
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 28	62.6 IU/L	Standard Deviation 19.26
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 35	65.5 IU/L	Standard Deviation 17.88
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 42	66.5 IU/L	Standard Deviation 22.53
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Baseline (Day 1)	19.5 IU/L	Standard Deviation 5.71
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 3	16.6 IU/L	Standard Deviation 4.47
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 6	15.6 IU/L	Standard Deviation 5.48
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 8	18.1 IU/L	Standard Deviation 7.86
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 12	14.8 IU/L	Standard Deviation 5.85
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 15	18.1 IU/L	Standard Deviation 7.75
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 22	17.0 IU/L	Standard Deviation 8.72
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 28	20.9 IU/L	Standard Deviation 7.59
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 42	20.5 IU/L	Standard Deviation 5.93
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Baseline (Day 1)	18.9 IU/L	Standard Deviation 2.7
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 3	17.0 IU/L	Standard Deviation 2.98
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 6	16.0 IU/L	Standard Deviation 3.07
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 8	18.0 IU/L	Standard Deviation 4.69
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 12	15.9 IU/L	Standard Deviation 2.7
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 15	17.6 IU/L	Standard Deviation 4.17
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 22	16.6 IU/L	Standard Deviation 3.16
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 28	22.6 IU/L	Standard Deviation 8.19
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 35	20.5 IU/L	Standard Deviation 3.55
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 42	19.8 IU/L	Standard Deviation 4.2
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 7	14.7 IU/L	Standard Deviation 1.63
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 14	18.7 IU/L	Standard Deviation 7.31
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 5	54.3 IU/L	Standard Deviation 11.04
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 11	19.5 IU/L	Standard Deviation 8.76
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 7	18.8 IU/L	Standard Deviation 7.47
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 11	13.3 IU/L	Standard Deviation 2.5
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 5	17.3 IU/L	Standard Deviation 6.31
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 42	20.7 IU/L	Standard Deviation 3.27
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 2	19.0 IU/L	Standard Deviation 6.03
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Baseline (Day 1)	19.8 IU/L	Standard Deviation 6.24
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 14	13.8 IU/L	Standard Deviation 2.14
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 42	53.5 IU/L	Standard Deviation 10.65
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 35	20.2 IU/L	Standard Deviation 7.91
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 35	49.0 IU/L	Standard Deviation 11.37
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 28	51.3 IU/L	Standard Deviation 10.67
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 21	15.0 IU/L	Standard Deviation 3.16
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 21	50.8 IU/L	Standard Deviation 10.53
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 2	53.2 IU/L	Standard Deviation 10.91
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 14	49.7 IU/L	Standard Deviation 9.2
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 11	51.2 IU/L	Standard Deviation 9.77
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Baseline (Day 1)	53.8 IU/L	Standard Deviation 10.55
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 2	15.3 IU/L	Standard Deviation 3.08
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 28	20.7 IU/L	Standard Deviation 7.84
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Baseline (Day 1)	17.7 IU/L	Standard Deviation 3.27
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 42	21.8 IU/L	Standard Deviation 4.45
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 5	14.0 IU/L	Standard Deviation 2.1
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 35	18.3 IU/L	Standard Deviation 4.13
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 7	54.2 IU/L	Standard Deviation 10.46
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 28	22.3 IU/L	Standard Deviation 11.41
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 21	18.3 IU/L	Standard Deviation 8.19

Primary

Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin

Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of bilirubin.

Time frame: Up to Day 42

Arm	Measure	Group	Value (MEAN)	Dispersion
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 22	1.7955 μmol/L	Standard Deviation 0.36275
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 3	12.1410 μmol/L	Standard Deviation 1.69281
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 28	1.5048 μmol/L	Standard Deviation 0.38994
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Baseline (Day 1)	1.6856 μmol/L	Standard Deviation 0.34805
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 2	12.1752 μmol/L	Standard Deviation 1.75806
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Baseline (Day 1)	10.5776 μmol/L	Standard Deviation 2.98545
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 35	1.4250 μmol/L	Standard Deviation 0.33625
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 22	11.2005 μmol/L	Standard Deviation 2.29739
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 42	1.5105 μmol/L	Standard Deviation 0.36542
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 5	1.9238 μmol/L	Standard Deviation 0.64551
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 35	9.1770 μmol/L	Standard Deviation 2.04534
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 21	12.5258 μmol/L	Standard Deviation 0.21517
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 6	1.8810 μmol/L	Standard Deviation 0.24183
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 15	11.7990 μmol/L	Standard Deviation 2.66014
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 7	2.1375 μmol/L	Standard Deviation 0.40706
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 2	1.8126 μmol/L	Standard Deviation 0.35459
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 14	11.7563 μmol/L	Standard Deviation 2.12378
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 8	1.6245 μmol/L	Standard Deviation 0.36275
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 12	10.6875 μmol/L	Standard Deviation 0.36275
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 11	2.1803 μmol/L	Standard Deviation 0.56499
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 42	9.7755 μmol/L	Standard Deviation 3.14643
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 11	12.7395 μmol/L	Standard Deviation 2.48392
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 12	1.3680 μmol/L	Standard Deviation 0.24183
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 8	9.9180 μmol/L	Standard Deviation 1.69281
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 14	2.1375 μmol/L	Standard Deviation 0.45242
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 28	8.5842 μmol/L	Standard Deviation 2.34276
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 7	12.8250 μmol/L	Standard Deviation 2.43837
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 15	1.9665 μmol/L	Standard Deviation 0.12092
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 6	10.0890 μmol/L	Standard Deviation 1.93464
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 21	1.9665 μmol/L	Standard Deviation 0.35596
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 3	1.8810 μmol/L	Standard Deviation 0.24183
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 5	12.0128 μmol/L	Standard Deviation 2.81458
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 28	1.3965 μmol/L	Standard Deviation 0.58657
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Baseline (Day 1)	1.7670 μmol/L	Standard Deviation 0.88304
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 2	1.9665 μmol/L	Standard Deviation 0.66448
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 5	2.3370 μmol/L	Standard Deviation 0.71466
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 7	2.0805 μmol/L	Standard Deviation 0.81949
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 11	2.1660 μmol/L	Standard Deviation 0.62752
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 14	2.1660 μmol/L	Standard Deviation 0.61813
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 21	1.9950 μmol/L	Standard Deviation 0.61813
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 35	1.4535 μmol/L	Standard Deviation 0.49265
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 42	1.1115 μmol/L	Standard Deviation 0.50438
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Baseline (Day 1)	10.0890 μmol/L	Standard Deviation 5.9078
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 2	13.6800 μmol/L	Standard Deviation 6.64924
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 5	13.7370 μmol/L	Standard Deviation 5.74282
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 7	13.2240 μmol/L	Standard Deviation 6.58176
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 11	13.8510 μmol/L	Standard Deviation 5.61547
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 14	13.4235 μmol/L	Standard Deviation 4.72994
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 21	11.9700 μmol/L	Standard Deviation 4.2907
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 28	8.1225 μmol/L	Standard Deviation 4.03031
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 35	8.2365 μmol/L	Standard Deviation 2.28761
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 42	7.4385 μmol/L	Standard Deviation 2.67712
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 22	2.0734 μmol/L	Standard Deviation 0.58838
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 6	2.4795 μmol/L	Standard Deviation 0.6063
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 15	13.9793 μmol/L	Standard Deviation 3.8927
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 12	2.2871 μmol/L	Standard Deviation 0.48312
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Baseline (Day 1)	1.6031 μmol/L	Standard Deviation 0.74782
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 8	13.1456 μmol/L	Standard Deviation 2.44141
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 3	2.1161 μmol/L	Standard Deviation 0.56298
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 22	12.2479 μmol/L	Standard Deviation 3.78959
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 15	2.2444 μmol/L	Standard Deviation 0.37058
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 35	7.5454 μmol/L	Standard Deviation 2.29136
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 35	1.3253 μmol/L	Standard Deviation 0.27037
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 6	12.7181 μmol/L	Standard Deviation 3.00651
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 42	1.7100 μmol/L	Standard Deviation 0.342
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 8	2.2444 μmol/L	Standard Deviation 0.43296
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 12	13.8724 μmol/L	Standard Deviation 4.15402
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 28	6.6904 μmol/L	Standard Deviation 2.71983
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Baseline (Day 1)	9.5760 μmol/L	Standard Deviation 4.36923
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 3	12.5044 μmol/L	Standard Deviation 4.14193
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 28	1.2825 μmol/L	Standard Deviation 0.44778
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 42	8.6141 μmol/L	Standard Deviation 2.36934
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 28	8.3220 μmol/L	Standard Deviation 3.44499
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 21	2.8785 μmol/L	Standard Deviation 1.1719
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Baseline (Day 1)	2.5365 μmol/L	Standard Deviation 1.12089
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 5	15.7320 μmol/L	Standard Deviation 4.92171
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 14	3.0495 μmol/L	Standard Deviation 1.15683
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 7	16.4445 μmol/L	Standard Deviation 6.72047
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 11	3.1065 μmol/L	Standard Deviation 1.18678
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 11	16.4445 μmol/L	Standard Deviation 6.63464
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 7	3.2490 μmol/L	Standard Deviation 1.2331
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 35	15.0195 μmol/L	Standard Deviation 10.2214
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 14	15.6465 μmol/L	Standard Deviation 6.66132
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 5	2.4510 μmol/L	Standard Deviation 0.75447
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 21	16.9575 μmol/L	Standard Deviation 7.40445
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 2	2.8785 μmol/L	Standard Deviation 1.15177
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 35	2.8500 μmol/L	Standard Deviation 1.72927
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 42	13.0530 μmol/L	Standard Deviation 11.74742
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 42	2.5650 μmol/L	Standard Deviation 1.97947
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 28	1.8525 μmol/L	Standard Deviation 0.76026
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Baseline (Day 1)	12.8250 μmol/L	Standard Deviation 6.63163
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 2	16.8720 μmol/L	Standard Deviation 7.08416

Primary

Part 2: AUC Over a Dosing Interval From Time of Dosing to the Time of the Subsequent Dose (0-t) Following Repeat Dose Administration of VH4011499

Blood samples were collected as assessed by protocol, at specific time points for PK analysis to determine AUC(0-t). For AUC, a linear trapezoidal method was employed for all incremental trapezoids arising from increasing concentrations and the logarithmic trapezoidal method was used for those arising from decreasing concentrations.

Time frame: At Days 1 and 14 for Part 2 (MAD): VH4011499 200 mg PiB and Part 2 (MAD): VH4011499 400 mg PiB groups, and at Days 2 and 15 for Part 2 (MAD): VH4011499 300 mg + Midazolam PiB group

Population: The analysis was performed on the VH4011499 PK Set which included all participants in the Part 2 (MAD) Safety Set who received at least 1 full dose of study treatment with at least one non-missing PK assessment. The participants were analyzed according to the treatment they received.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: AUC Over a Dosing Interval From Time of Dosing to the Time of the Subsequent Dose (0-t) Following Repeat Dose Administration of VH4011499	Day 1/2	4211.67 h*ng/mL	Geometric Coefficient of Variation 15.36
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: AUC Over a Dosing Interval From Time of Dosing to the Time of the Subsequent Dose (0-t) Following Repeat Dose Administration of VH4011499	Day 14/15	95735.06 h*ng/mL	Geometric Coefficient of Variation 56.77
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: AUC Over a Dosing Interval From Time of Dosing to the Time of the Subsequent Dose (0-t) Following Repeat Dose Administration of VH4011499	Day 1/2	5385.19 h*ng/mL	Geometric Coefficient of Variation 21.74
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: AUC Over a Dosing Interval From Time of Dosing to the Time of the Subsequent Dose (0-t) Following Repeat Dose Administration of VH4011499	Day 14/15	168459.8 h*ng/mL	Geometric Coefficient of Variation 54.17
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: AUC Over a Dosing Interval From Time of Dosing to the Time of the Subsequent Dose (0-t) Following Repeat Dose Administration of VH4011499	Day 1/2	4879.14 h*ng/mL	Geometric Coefficient of Variation 36
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: AUC Over a Dosing Interval From Time of Dosing to the Time of the Subsequent Dose (0-t) Following Repeat Dose Administration of VH4011499	Day 14/15	139259.6 h*ng/mL	Geometric Coefficient of Variation 24.66

Primary

Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST

Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of ALT, ALP and AST. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value. SD=0.00 is defined as following: if all participants analyzed for a specific parameter at a specific time point have the same value, then SD is equal with 0.00.

Time frame: From Baseline (Day 1) and up to Day 42

Arm	Measure	Group	Value (MEAN)	Dispersion
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 21	-5.5 IU/L	Standard Deviation 4.65
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 7	-9.0 IU/L	Standard Deviation 14.31
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 6	-5.5 IU/L	Standard Deviation 0.71
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 22	-7.0 IU/L	Standard Deviation 0
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 5	-2.5 IU/L	Standard Deviation 1
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 28	-3.4 IU/L	Standard Deviation 7.09
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 35	-7.5 IU/L	Standard Deviation 7.79
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 3	-2.5 IU/L	Standard Deviation 0.71
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 2	-4.4 IU/L	Standard Deviation 5.81
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 35	-1.2 IU/L	Standard Deviation 8.47
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 14	-7.5 IU/L	Standard Deviation 15.15
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Baseline (Day 1)	23.3 IU/L	Standard Deviation 7.45
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 42	1.0 IU/L	Standard Deviation 8.39
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 6	0.0 IU/L	Standard Deviation 1.41
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 5	-6.8 IU/L	Standard Deviation 14.31
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 42	-3.0 IU/L	Standard Deviation 7.48
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 12	0.0 IU/L	Standard Deviation 1.41
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 3	0.0 IU/L	Standard Deviation 1.41
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 2	-5.8 IU/L	Standard Deviation 12.48
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Baseline (Day 1)	23.6 IU/L	Standard Deviation 8.3
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 22	0.0 IU/L	Standard Deviation 1.41
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Baseline (Day 1)	56.0 IU/L	Standard Deviation 16.78
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 42	0.8 IU/L	Standard Deviation 5.34
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 2	-2.6 IU/L	Standard Deviation 2.41
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 11	-9.0 IU/L	Standard Deviation 16.02
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 35	-0.8 IU/L	Standard Deviation 4.54
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 3	-3.0 IU/L	Standard Deviation 1.41
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 28	-1.6 IU/L	Standard Deviation 3.13
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 5	-4.5 IU/L	Standard Deviation 4.2
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 28	-6.2 IU/L	Standard Deviation 11.23
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 22	-3.5 IU/L	Standard Deviation 3.54
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 6	-7.0 IU/L	Standard Deviation 1.41
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 21	-4.0 IU/L	Standard Deviation 1.83
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 7	-5.5 IU/L	Standard Deviation 5.74
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 15	3.5 IU/L	Standard Deviation 3.54
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 15	-1.5 IU/L	Standard Deviation 2.12
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 8	-6.0 IU/L	Standard Deviation 2.83
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 14	-3.3 IU/L	Standard Deviation 2.22
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 11	-6.3 IU/L	Standard Deviation 6.02
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 21	-9.8 IU/L	Standard Deviation 15.59
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 12	-5.0 IU/L	Standard Deviation 2.83
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 12	-8.5 IU/L	Standard Deviation 2.12
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 11	-5.0 IU/L	Standard Deviation 3.16
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 14	-4.8 IU/L	Standard Deviation 5.85
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 8	0.0 IU/L	Standard Deviation 1.41
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 8	-4.5 IU/L	Standard Deviation 2.12
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 15	-0.5 IU/L	Standard Deviation 6.36
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 7	-3.3 IU/L	Standard Deviation 1.89
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 7	-1.3 IU/L	Standard Deviation 2.07
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 21	-7.7 IU/L	Standard Deviation 6.44
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 28	0.5 IU/L	Standard Deviation 9.52
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 35	3.5 IU/L	Standard Deviation 17.16
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 42	0.8 IU/L	Standard Deviation 8.08
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Baseline (Day 1)	15.8 IU/L	Standard Deviation 4.62
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 2	0.2 IU/L	Standard Deviation 1.72
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 5	0.2 IU/L	Standard Deviation 2.64
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 11	-3.3 IU/L	Standard Deviation 3.67
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 14	-3.7 IU/L	Standard Deviation 4.46
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 21	-3.5 IU/L	Standard Deviation 4.04
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 28	0.8 IU/L	Standard Deviation 3.66
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 35	12.2 IU/L	Standard Deviation 25.97
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 42	-1.0 IU/L	Standard Deviation 4.29
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Baseline (Day 1)	17.3 IU/L	Standard Deviation 3.44
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 2	-0.8 IU/L	Standard Deviation 1.47
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 5	-0.5 IU/L	Standard Deviation 1.87
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 7	-1.0 IU/L	Standard Deviation 2.1
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 11	-1.5 IU/L	Standard Deviation 1.64
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 14	-0.7 IU/L	Standard Deviation 2.73
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 21	-1.7 IU/L	Standard Deviation 2.25
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 28	0.2 IU/L	Standard Deviation 2.56
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 35	9.0 IU/L	Standard Deviation 19.07
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 42	-1.0 IU/L	Standard Deviation 2.61
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Baseline (Day 1)	59.5 IU/L	Standard Deviation 19.69
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 2	-1.2 IU/L	Standard Deviation 3.92
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 5	2.7 IU/L	Standard Deviation 5.09
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 7	-0.2 IU/L	Standard Deviation 3.66
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 11	-5.5 IU/L	Standard Deviation 3.89
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 14	1.5 IU/L	Standard Deviation 3.56
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 6	-2.9 IU/L	Standard Deviation 3.14
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 15	-1.4 IU/L	Standard Deviation 8.85
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 8	-0.9 IU/L	Standard Deviation 4.29
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 12	-4.8 IU/L	Standard Deviation 7.19
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 15	-2.5 IU/L	Standard Deviation 3.7
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 12	-3.0 IU/L	Standard Deviation 2.45
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 8	-1.4 IU/L	Standard Deviation 8.58
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 15	-1.3 IU/L	Standard Deviation 3.81
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 6	-3.9 IU/L	Standard Deviation 5.82
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 28	-6.4 IU/L	Standard Deviation 4.96
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 22	-2.3 IU/L	Standard Deviation 3.2
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 3	-2.9 IU/L	Standard Deviation 3.56
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 8	2.9 IU/L	Standard Deviation 7.32
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 28	3.8 IU/L	Standard Deviation 9.08
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 22	-5.3 IU/L	Standard Deviation 5.63
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 35	1.6 IU/L	Standard Deviation 3.81
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 42	0.9 IU/L	Standard Deviation 3.44
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Baseline (Day 1)	19.5 IU/L	Standard Deviation 5.71
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Baseline (Day 1)	69.0 IU/L	Standard Deviation 22.43
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 42	-2.5 IU/L	Standard Deviation 3.63
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 3	-0.4 IU/L	Standard Deviation 2.2
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 12	-5.0 IU/L	Standard Deviation 3.34
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 42	1.0 IU/L	Standard Deviation 2.45
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 35	-1.1 IU/L	Standard Deviation 4.26
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Baseline (Day 1)	18.9 IU/L	Standard Deviation 2.7
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 35	-3.5 IU/L	Standard Deviation 6.21
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 28	1.4 IU/L	Standard Deviation 5.78
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 3	-1.9 IU/L	Standard Deviation 2.23
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 22	-2.5 IU/L	Standard Deviation 9.43
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 6	0.3 IU/L	Standard Deviation 3.41
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 14	-4.2 IU/L	Standard Deviation 3.6
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 42	2.0 IU/L	Standard Deviation 4.1
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 28	-2.5 IU/L	Standard Deviation 3.15
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 7	-3.0 IU/L	Standard Deviation 2.45
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 14	-1.2 IU/L	Standard Deviation 3.66
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 42	3.0 IU/L	Standard Deviation 5.33
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 2	-2.3 IU/L	Standard Deviation 2.25
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 11	-2.7 IU/L	Standard Deviation 4.08
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 11	-4.3 IU/L	Standard Deviation 3.01
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 11	-0.3 IU/L	Standard Deviation 5.47
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 5	0.5 IU/L	Standard Deviation 2.59
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Baseline (Day 1)	53.8 IU/L	Standard Deviation 10.55
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 7	0.3 IU/L	Standard Deviation 3.33
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 14	-3.8 IU/L	Standard Deviation 2.32
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 7	-1.0 IU/L	Standard Deviation 2.97
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 42	-0.3 IU/L	Standard Deviation 3.72
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 21	-3.0 IU/L	Standard Deviation 4.82
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 2	-0.7 IU/L	Standard Deviation 3.5
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 21	-2.7 IU/L	Standard Deviation 3.83
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 5	-2.5 IU/L	Standard Deviation 2.74
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 5	-3.7 IU/L	Standard Deviation 2.73
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Baseline (Day 1)	17.7 IU/L	Standard Deviation 3.27
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 35	-4.8 IU/L	Standard Deviation 1.83
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 35	-1.5 IU/L	Standard Deviation 4.51
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 28	3.0 IU/L	Standard Deviation 5.73
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 2	-0.8 IU/L	Standard Deviation 2.32
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 28	2.5 IU/L	Standard Deviation 8.46
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 21	-1.5 IU/L	Standard Deviation 5.47
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 35	2.5 IU/L	Standard Deviation 5.96
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Baseline (Day 1)	19.8 IU/L	Standard Deviation 6.24

Primary

Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin

Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of bilirubin. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value. Standard Deviation (SD)=0.0000 is defined as following: if all participants analyzed for a specific parameter at a specific time point have the same value, then SD is equal with 0.0000.

Time frame: From Baseline (Day 1) and up to Day 42

Arm	Measure	Group	Value (MEAN)	Dispersion
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 22	0.0855 μmol/L	Standard Deviation 0.12092
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 3	0.4275 μmol/L	Standard Deviation 0.12092
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 28	-0.2052 μmol/L	Standard Deviation 0.778
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Baseline (Day 1)	1.6856 μmol/L	Standard Deviation 0.34805
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 2	2.0520 μmol/L	Standard Deviation 4.88623
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Baseline (Day 1)	10.5776 μmol/L	Standard Deviation 2.98545
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 35	-0.2565 μmol/L	Standard Deviation 0.44262
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 22	-0.5130 μmol/L	Standard Deviation 0.72549
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 42	-0.1710 μmol/L	Standard Deviation 0.37464
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 5	0.2565 μmol/L	Standard Deviation 1.04948
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 35	-1.8525 μmol/L	Standard Deviation 3.35337
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 21	1.8383 μmol/L	Standard Deviation 3.83481
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 6	0.1710 μmol/L	Standard Deviation 0
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 15	0.0855 μmol/L	Standard Deviation 1.08824
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 7	0.4703 μmol/L	Standard Deviation 0.7695
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 2	0.1368 μmol/L	Standard Deviation 0.67756
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 14	1.0688 μmol/L	Standard Deviation 4.14271
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 8	-0.0855 μmol/L	Standard Deviation 0.12092
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 12	-1.0260 μmol/L	Standard Deviation 1.20915
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 11	0.5130 μmol/L	Standard Deviation 0.91556
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 42	-1.2540 μmol/L	Standard Deviation 2.32376
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 11	2.0520 μmol/L	Standard Deviation 5.83575
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 12	-0.3420 μmol/L	Standard Deviation 0
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 8	-1.7955 μmol/L	Standard Deviation 0.12092
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 14	0.4703 μmol/L	Standard Deviation 0.66044
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 28	-2.5308 μmol/L	Standard Deviation 5.31257
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 7	2.1375 μmol/L	Standard Deviation 5.96052
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 15	0.2565 μmol/L	Standard Deviation 0.12092
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 6	-1.6245 μmol/L	Standard Deviation 0.36275
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 21	0.2993 μmol/L	Standard Deviation 0.78206
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 3	0.1710 μmol/L	Standard Deviation 0
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 5	1.3253 μmol/L	Standard Deviation 6.24774
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 28	-0.3705 μmol/L	Standard Deviation 0.52335
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Baseline (Day 1)	1.7670 μmol/L	Standard Deviation 0.88304
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 2	0.1995 μmol/L	Standard Deviation 0.4382
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 5	0.5700 μmol/L	Standard Deviation 0.42807
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 7	0.3135 μmol/L	Standard Deviation 0.36542
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 11	0.3990 μmol/L	Standard Deviation 0.31838
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 14	0.3990 μmol/L	Standard Deviation 0.3694
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 21	0.2280 μmol/L	Standard Deviation 0.46726
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 35	-0.3135 μmol/L	Standard Deviation 0.61576
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 42	-0.6555 μmol/L	Standard Deviation 0.46412
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Baseline (Day 1)	10.0890 μmol/L	Standard Deviation 5.9078
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 2	3.5910 μmol/L	Standard Deviation 1.49466
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 5	3.6480 μmol/L	Standard Deviation 1.09582
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 7	3.1350 μmol/L	Standard Deviation 2.20495
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 11	3.7620 μmol/L	Standard Deviation 2.69508
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 14	3.3345 μmol/L	Standard Deviation 1.83138
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 21	1.8810 μmol/L	Standard Deviation 3.11577
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 28	-1.9665 μmol/L	Standard Deviation 3.28525
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 35	-1.8525 μmol/L	Standard Deviation 4.50534
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 42	-2.6505 μmol/L	Standard Deviation 4.28354
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 22	0.4703 μmol/L	Standard Deviation 0.53881
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 6	0.8764 μmol/L	Standard Deviation 0.54412
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 15	4.4033 μmol/L	Standard Deviation 2.53263
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 12	0.6840 μmol/L	Standard Deviation 0.48366
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Baseline (Day 1)	1.6031 μmol/L	Standard Deviation 0.74782
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 8	3.5696 μmol/L	Standard Deviation 3.25149
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 3	0.5130 μmol/L	Standard Deviation 0.354
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 22	2.6719 μmol/L	Standard Deviation 3.49125
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 15	0.6413 μmol/L	Standard Deviation 0.42628
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 35	-2.0306 μmol/L	Standard Deviation 2.42251
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 35	-0.2779 μmol/L	Standard Deviation 0.56298
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 6	3.1421 μmol/L	Standard Deviation 2.90044
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 42	0.1069 μmol/L	Standard Deviation 0.63942
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 8	0.6413 μmol/L	Standard Deviation 0.60458
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 12	4.2964 μmol/L	Standard Deviation 2.74733
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 28	-2.8856 μmol/L	Standard Deviation 2.53212
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Baseline (Day 1)	9.5760 μmol/L	Standard Deviation 4.36923
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 3	2.9284 μmol/L	Standard Deviation 1.86301
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 28	-0.3206 μmol/L	Standard Deviation 0.57401
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 42	-0.9619 μmol/L	Standard Deviation 3.56231
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 28	-4.5030 μmol/L	Standard Deviation 4.18257
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 21	0.3420 μmol/L	Standard Deviation 0.35869
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Baseline (Day 1)	2.5365 μmol/L	Standard Deviation 1.12089
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 5	2.9070 μmol/L	Standard Deviation 2.52478
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 14	0.5130 μmol/L	Standard Deviation 0.30589
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 7	3.6195 μmol/L	Standard Deviation 1.75529
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 11	0.5700 μmol/L	Standard Deviation 0.46726
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 11	3.6195 μmol/L	Standard Deviation 1.29517
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 7	0.7125 μmol/L	Standard Deviation 0.36542
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 35	2.1945 μmol/L	Standard Deviation 4.64845
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 14	2.8215 μmol/L	Standard Deviation 1.26932
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 5	-0.0855 μmol/L	Standard Deviation 0.44262
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 21	4.1325 μmol/L	Standard Deviation 2.32816
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 2	0.3420 μmol/L	Standard Deviation 0.32445
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 35	0.3135 μmol/L	Standard Deviation 0.75253
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 42	0.2280 μmol/L	Standard Deviation 5.78644
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 42	0.0285 μmol/L	Standard Deviation 0.89456
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 28	-0.6840 μmol/L	Standard Deviation 0.71739
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Baseline (Day 1)	12.8250 μmol/L	Standard Deviation 6.63163
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 2	4.0470 μmol/L	Standard Deviation 1.90622

Primary

Part 2: Cmax Following Repeat Dose Administration of VH4011499

Blood samples were collected as assessed by protocol, at specific time points for PK analysis to determine Cmax.

Time frame: At Days 1 and 14 for Part 2 (MAD): VH4011499 200 mg PiB and Part 2 (MAD): VH4011499 400 mg PiB groups, and at Days 2 and 15 for Part 2 (MAD): VH4011499 300 mg + Midazolam PiB group

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Cmax Following Repeat Dose Administration of VH4011499	Day 14	1272.25 ng/mL	Geometric Coefficient of Variation 42.47
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Cmax Following Repeat Dose Administration of VH4011499	Day 1	260.89 ng/mL	Geometric Coefficient of Variation 19.62
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Cmax Following Repeat Dose Administration of VH4011499	Day 2	348.24 ng/mL	Geometric Coefficient of Variation 20.46
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Cmax Following Repeat Dose Administration of VH4011499	Day 15	1913.76 ng/mL	Geometric Coefficient of Variation 22.93
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Cmax Following Repeat Dose Administration of VH4011499	Day 1	321.37 ng/mL	Geometric Coefficient of Variation 53.14
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Cmax Following Repeat Dose Administration of VH4011499	Day 14	1509.90 ng/mL	Geometric Coefficient of Variation 22.56

Primary

Part 2: Number of Participants Discontinuing Treatment Due to AEs

Number of participants who discontinued treatment due to AEs are presented.

Time frame: Up to Day 42

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Number of Participants Discontinuing Treatment Due to AEs	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Number of Participants Discontinuing Treatment Due to AEs	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Number of Participants Discontinuing Treatment Due to AEs	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Number of Participants Discontinuing Treatment Due to AEs	0 Participants

Primary

Part 2: Number of Participants With AEs

An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a study intervention whether or not considered related to the study intervention.

Time frame: Up to Day 42

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Number of Participants With AEs	2 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Number of Participants With AEs	3 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Number of Participants With AEs	3 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Number of Participants With AEs	2 Participants

Primary

Part 2: Number of Participants With AEs by Severity

Time frame: Up to Day 42

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Number of Participants With AEs by Severity	Grade 3	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Number of Participants With AEs by Severity	Grade 4	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Number of Participants With AEs by Severity	Grade 1	2 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Number of Participants With AEs by Severity	Grade 2	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Number of Participants With AEs by Severity	Grade 5	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Number of Participants With AEs by Severity	Grade 3	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Number of Participants With AEs by Severity	Grade 4	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Number of Participants With AEs by Severity	Grade 2	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Number of Participants With AEs by Severity	Grade 1	3 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Number of Participants With AEs by Severity	Grade 5	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Number of Participants With AEs by Severity	Grade 3	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Number of Participants With AEs by Severity	Grade 1	3 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Number of Participants With AEs by Severity	Grade 2	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Number of Participants With AEs by Severity	Grade 4	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Number of Participants With AEs by Severity	Grade 5	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Number of Participants With AEs by Severity	Grade 4	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Number of Participants With AEs by Severity	Grade 2	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Number of Participants With AEs by Severity	Grade 1	2 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Number of Participants With AEs by Severity	Grade 3	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Number of Participants With AEs by Severity	Grade 5	0 Participants

Primary

Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters

Time frame: Up to Day 42

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 4	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 4	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 4	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 3	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 1	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 1	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 2	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 2	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 3	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 1	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 2	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 2	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 3	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 4	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 4	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 3	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 1	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 1	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 2	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 4	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 2	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 4	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 1	1 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 4	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 2	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 1	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 2	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 1	1 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 4	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 1	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 4	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 1	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 2	0 Participants
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 2	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 1	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 1	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 2	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 4	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 1	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 2	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 4	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 1	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 2	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 4	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 2	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 4	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 1	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 2	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 4	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 2	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 1	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 4	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 4	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 2	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 1	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 2	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 1	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 1	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 2	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 4	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 1	1 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 2	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 4	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 3	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 4	0 Participants
Part 1 (SAD): VH4011499 200 mg PiB	Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 3	0 Participants

Primary

Part 2: T1/2 Following Repeat Dose Administration of VH4011499

Blood samples were collected as assessed by protocol, at specific time points for PK analysis to determine T1/2.

Time frame: At Day 14 for Part 2 (MAD): VH4011499 200 mg PiB and Part 2 (MAD): VH4011499 400 mg PiB groups, and at Day 15 for Part 2 (MAD): VH4011499 300 mg + Midazolam PiB group

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: T1/2 Following Repeat Dose Administration of VH4011499	Day 14	51.17 hours	Geometric Coefficient of Variation 16.68
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: T1/2 Following Repeat Dose Administration of VH4011499	Day 15	66.47 hours	Geometric Coefficient of Variation 19.1
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: T1/2 Following Repeat Dose Administration of VH4011499	Day 14	60.36 hours	Geometric Coefficient of Variation 21.81

Primary

Part 2: Tmax Following Repeat Dose Administration of VH4011499

Blood samples were collected as assessed by protocol, at specific time points for PK analysis to determine Tmax.

Time frame: At Days 1 and 14 for Part 2 (MAD): VH4011499 200 mg PiB and Part 2 (MAD): VH4011499 400 mg PiB groups, and at Days 2 and 15 for Part 2 (MAD): VH4011499 300 mg + Midazolam PiB group

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Tmax Following Repeat Dose Administration of VH4011499	Day 1	10.71 hours	Geometric Coefficient of Variation 41.53
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 2: Tmax Following Repeat Dose Administration of VH4011499	Day 14	4.80 hours	Geometric Coefficient of Variation 30.46
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Tmax Following Repeat Dose Administration of VH4011499	Day 2	8.11 hours	Geometric Coefficient of Variation 22.96
Part 1 (SAD): VH4011499 25 mg PiB	Part 2: Tmax Following Repeat Dose Administration of VH4011499	Day 15	5.27 hours	Geometric Coefficient of Variation 32.11
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Tmax Following Repeat Dose Administration of VH4011499	Day 1	9.50 hours	Geometric Coefficient of Variation 51
Part 1 (SAD): VH4011499 125 mg PiB	Part 2: Tmax Following Repeat Dose Administration of VH4011499	Day 14	5.99 hours	Geometric Coefficient of Variation 42.79

Primary

Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST

Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of ALT, ALP and AST

Time frame: Up to Day 28

Population: The analysis was performed on the Safety Set which included all enrolled participants in Part 3 (Single Dose) who received 1 single dose of study treatment. The participants were analyzed according to the treatment they received.

Arm	Measure	Group	Value (MEAN)	Dispersion
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 7	15.0 μmol/L	Standard Deviation 5.87
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Baseline (Day 1)	52.0 μmol/L	Standard Deviation 8.12
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 2	50.7 μmol/L	Standard Deviation 7.99
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 3	51.0 μmol/L	Standard Deviation 8.2
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 4	54.3 μmol/L	Standard Deviation 7.39
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 5	56.6 μmol/L	Standard Deviation 7.73
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 6	54.2 μmol/L	Standard Deviation 6.62
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 7	54.7 μmol/L	Standard Deviation 6.12
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 14	54.7 μmol/L	Standard Deviation 10.39
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 21	52.7 μmol/L	Standard Deviation 7.61
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALP, Day 28	56.3 μmol/L	Standard Deviation 8.52
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Baseline (Day 1)	12.7 μmol/L	Standard Deviation 4.03
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 2	15.2 μmol/L	Standard Deviation 6.74
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 3	15.0 μmol/L	Standard Deviation 6.6
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 4	15.0 μmol/L	Standard Deviation 8.32
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 5	13.0 μmol/L	Standard Deviation 4.42
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 6	15.2 μmol/L	Standard Deviation 6.85
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 14	17.5 μmol/L	Standard Deviation 8.96
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 21	19.2 μmol/L	Standard Deviation 10.26
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	ALT, Day 28	15.0 μmol/L	Standard Deviation 4.38
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Baseline	16.7 μmol/L	Standard Deviation 1.63
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 2	17.3 μmol/L	Standard Deviation 3.2
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 3	16.3 μmol/L	Standard Deviation 2.34
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 4	16.5 μmol/L	Standard Deviation 2.26
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 5	16.6 μmol/L	Standard Deviation 1.14
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 6	17.2 μmol/L	Standard Deviation 1.83
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 7	16.3 μmol/L	Standard Deviation 1.63
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 14	19.3 μmol/L	Standard Deviation 3.44
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 21	21.0 μmol/L	Standard Deviation 9.03
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST	AST, Day 28	18.5 μmol/L	Standard Deviation 3.27

Primary

Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin

Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of bilirubin.

Time frame: Up to Day 28

Arm	Measure	Group	Value (MEAN)	Dispersion
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Baseline (Day 1)	1.4250 IU/L	Standard Deviation 0.6981
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 2	2.1375 IU/L	Standard Deviation 0.97784
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 3	2.2515 IU/L	Standard Deviation 1.05642
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 4	1.9665 IU/L	Standard Deviation 0.94747
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 5	1.7784 IU/L	Standard Deviation 0.44591
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 6	2.3085 IU/L	Standard Deviation 1.11216
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 7	1.9950 IU/L	Standard Deviation 0.89619
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 14	1.9665 IU/L	Standard Deviation 0.69038
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 21	1.8525 IU/L	Standard Deviation 0.69601
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 28	2.6790 IU/L	Standard Deviation 2.39074
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Baseline (Day 1)	7.6950 IU/L	Standard Deviation 3.19912
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 2	14.2500 IU/L	Standard Deviation 7.57873
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 3	13.8225 IU/L	Standard Deviation 7.43283
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 4	12.2550 IU/L	Standard Deviation 6.56575
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 5	10.8756 IU/L	Standard Deviation 2.84755
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 6	14.5920 IU/L	Standard Deviation 8.80586
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 7	11.2290 IU/L	Standard Deviation 5.55123
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 14	11.7705 IU/L	Standard Deviation 6.12879
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 21	8.2365 IU/L	Standard Deviation 3.08827
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 28	14.4495 IU/L	Standard Deviation 15.05412

Primary

Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST

Time frame: From Baseline (Day 1) and up to Day 28

Arm	Measure	Group	Value (MEAN)	Dispersion
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Baseline (Day 1)	52.0 IU/L	Standard Deviation 8.12
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 2	-1.3 IU/L	Standard Deviation 6.02
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 3	-1.0 IU/L	Standard Deviation 6.29
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 4	2.3 IU/L	Standard Deviation 6.31
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 5	5.4 IU/L	Standard Deviation 5.73
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 6	2.2 IU/L	Standard Deviation 6.52
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 7	2.7 IU/L	Standard Deviation 6.47
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 14	2.7 IU/L	Standard Deviation 7.17
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 21	0.7 IU/L	Standard Deviation 6.02
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALP, Day 28	4.3 IU/L	Standard Deviation 5.5
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Baseline (Day 1)	12.7 IU/L	Standard Deviation 4.03
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 2	2.5 IU/L	Standard Deviation 5.17
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 3	2.3 IU/L	Standard Deviation 5.57
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 4	2.3 IU/L	Standard Deviation 6.98
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 5	0.8 IU/L	Standard Deviation 1.64
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 6	2.5 IU/L	Standard Deviation 4.42
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 7	2.3 IU/L	Standard Deviation 3.39
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 14	4.8 IU/L	Standard Deviation 5.6
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 21	6.5 IU/L	Standard Deviation 6.66
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	ALT, Day 28	2.3 IU/L	Standard Deviation 1.03
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Baseline (Day 1)	16.7 IU/L	Standard Deviation 1.63
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 2	0.7 IU/L	Standard Deviation 3.5
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 3	-0.3 IU/L	Standard Deviation 2.34
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 4	-0.2 IU/L	Standard Deviation 2.64
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 5	-0.4 IU/L	Standard Deviation 1.52
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 6	0.5 IU/L	Standard Deviation 1.87
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 7	-0.3 IU/L	Standard Deviation 1.86
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 14	2.7 IU/L	Standard Deviation 3.27
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 21	4.3 IU/L	Standard Deviation 7.79
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST	AST, Day 28	1.8 IU/L	Standard Deviation 2.56

Primary

Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin

Time frame: From Baseline (Day 1) and up to Day 28

Arm	Measure	Group	Value (MEAN)	Dispersion
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Baseline (Day 1)	1.4250 IU/L	Standard Deviation 0.6981
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 2	0.7125 IU/L	Standard Deviation 0.89456
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 3	0.8265 IU/L	Standard Deviation 0.9392
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 4	0.5415 IU/L	Standard Deviation 0.92667
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 5	0.4104 IU/L	Standard Deviation 0.53531
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 6	0.8835 IU/L	Standard Deviation 0.98182
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 7	0.5700 IU/L	Standard Deviation 0.79228
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 14	0.5415 IU/L	Standard Deviation 0.66154
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 21	0.4275 IU/L	Standard Deviation 0.41536
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Direct Bilirubin, Day 28	1.2540 IU/L	Standard Deviation 2.25219
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Baseline (Day 1)	7.6950 IU/L	Standard Deviation 3.19912
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 2	6.5550 IU/L	Standard Deviation 6.58354
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 3	6.1275 IU/L	Standard Deviation 6.16873
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 4	4.5600 IU/L	Standard Deviation 5.75401
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 5	3.6936 IU/L	Standard Deviation 3.29058
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 6	6.8970 IU/L	Standard Deviation 7.58181
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 7	3.5340 IU/L	Standard Deviation 5.11821
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 14	4.0755 IU/L	Standard Deviation 4.44786
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 21	0.5415 IU/L	Standard Deviation 2.47901
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin	Total Bilirubin, Day 28	6.7545 IU/L	Standard Deviation 13.42355

Primary

Part 3: Number of Participants With AEs

An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a study intervention whether or not considered related to the study intervention.

Time frame: Up to Day 28

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Number of Participants With AEs	1 Participants

Primary

Part 3: Number of Participants With AEs by Severity

Time frame: Up to Day 28

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Number of Participants With AEs by Severity	Grade 1	1 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Number of Participants With AEs by Severity	Grade 2	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Number of Participants With AEs by Severity	Grade 3	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Number of Participants With AEs by Severity	Grade 4	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Number of Participants With AEs by Severity	Grade 5	0 Participants

Primary

Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters

Time frame: Up to Day 28

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 1	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 2	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 3	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALT, Increase to Grade 4	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 1	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 2	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 3	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	ALP, Increase to Grade 4	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 1	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 2	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 3	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	AST, Increase to Grade 4	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 1	1 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 2	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 3	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Total Bilirubin, Increase to Grade 4	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 1	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 2	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 3	0 Participants
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)	Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters	Direct Bilirubin, Increase to Grade 4	0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4011499 in Healthy Participants

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Masking description

Intervention model description

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)

Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin

Part 1: Apparent Terminal Half-life (T1/2) Following Single Dose Administration of VH4011499

Part 1: Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to Infinity (0-inf) Following Single Dose Administration of VH4011499

Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST

Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin

Part 1: Maximum Observed Plasma Concentration (Cmax) Following Single Dose Administration of VH4011499.

Part 1: Number of Participants With Adverse Events (AEs)

Part 1: Number of Participants With AEs by Severity

Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters

Part 1: Time to Maximum Observed Plasma Concentration (Tmax) Following Single Dose Administration of VH4011499

Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST

Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin

Part 2: AUC Over a Dosing Interval From Time of Dosing to the Time of the Subsequent Dose (0-t) Following Repeat Dose Administration of VH4011499

Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST

Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin

Part 2: Cmax Following Repeat Dose Administration of VH4011499

Part 2: Number of Participants Discontinuing Treatment Due to AEs

Part 2: Number of Participants With AEs

Part 2: Number of Participants With AEs by Severity

Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters

Part 2: T1/2 Following Repeat Dose Administration of VH4011499

Part 2: Tmax Following Repeat Dose Administration of VH4011499

Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST

Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin

Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST

Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin

Part 3: Number of Participants With AEs

Part 3: Number of Participants With AEs by Severity

Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters