Trial Outcomes & Findings for A Study to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of VH3739937 in in Treatment-Naive Adults Living With HIV-1 (NCT NCT06061081)
NCT ID: NCT06061081
Last Updated: 2025-10-20
Results Overview
Plasma samples were collected for the quantitative analysis of plasma HIV-1 RNA. The maximum change from baseline was calculated by determining the largest change from baseline value across all assessment timepoints. This is identified by subtracting the lowest post-dose visit value up to Day 8 (inclusive) from the baseline value. The baseline was defined as the most recent pre-dose assessment with a valid, non-missing value, including measurements from any unscheduled visits.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
From Day 1 to Day 8
Results posted on
2025-10-20
Participant Flow
This study was terminated due to Sponsor decision.
Participant milestones
| Measure |
VH3739937 Low Dose Group
Participants received a low dose of VH3739937 as loading Dose 1 (LD1) on Day 1, followed by a once-daily (QD) dose of VH3739937 as maintenance Dose 1 (MD1) from Days 2 through 7, where MD1 was lower than LD1. On Day 8, all participants transitioned to standard-of-care (SOC) combination antiretroviral therapy (cART) and continued study assessments through Day 25.
|
VH3739937 Medium Dose Group
Participants received a medium dose of VH3739937 as loading Dose 2 (LD2) on Day 1, followed by a QD dose of VH3739937 as maintenance Dose 2 (MD2) from Days 2 through 7, where MD2 was lower than LD2. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
VH3739937 High Dose Group
Participants received a single high dose (Dose 3) of VH3739937 on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Once Daily (QD)
Participants received Placebo QD from Day 1 through Day 7. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Single Dose (SD)
Participants received Placebo SD on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
6
|
1
|
1
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
VH3739937 Low Dose Group
Participants received a low dose of VH3739937 as loading Dose 1 (LD1) on Day 1, followed by a once-daily (QD) dose of VH3739937 as maintenance Dose 1 (MD1) from Days 2 through 7, where MD1 was lower than LD1. On Day 8, all participants transitioned to standard-of-care (SOC) combination antiretroviral therapy (cART) and continued study assessments through Day 25.
|
VH3739937 Medium Dose Group
Participants received a medium dose of VH3739937 as loading Dose 2 (LD2) on Day 1, followed by a QD dose of VH3739937 as maintenance Dose 2 (MD2) from Days 2 through 7, where MD2 was lower than LD2. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
VH3739937 High Dose Group
Participants received a single high dose (Dose 3) of VH3739937 on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Once Daily (QD)
Participants received Placebo QD from Day 1 through Day 7. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Single Dose (SD)
Participants received Placebo SD on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of VH3739937 in in Treatment-Naive Adults Living With HIV-1
Baseline characteristics by cohort
| Measure |
VH3739937 Low Dose Group
n=7 Participants
Participants received a low dose of VH3739937 as loading Dose 1 (LD1) on Day 1, followed by a once-daily (QD) dose of VH3739937 as maintenance Dose 1 (MD1) from Days 2 through 7, where MD1 was lower than LD1. On Day 8, all participants transitioned to standard-of-care (SOC) combination antiretroviral therapy (cART) and continued study assessments through Day 25.
|
VH3739937 Medium Dose Group
n=6 Participants
Participants received a medium dose of VH3739937 as loading Dose 2 (LD2) on Day 1, followed by a QD dose of VH3739937 as maintenance Dose 2 (MD2) from Days 2 through 7, where MD2 was lower than LD2. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
VH3739937 High Dose Group
n=6 Participants
Participants received a single high dose (Dose 3) of VH3739937 on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Once Daily (QD)
n=1 Participants
Participants received Placebo QD from Day 1 through Day 7. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Single Dose (SD)
n=1 Participants
Participants received Placebo SD on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
30.1 Years
STANDARD_DEVIATION 5.52 • n=5 Participants
|
38.2 Years
STANDARD_DEVIATION 9.68 • n=7 Participants
|
35.7 Years
STANDARD_DEVIATION 14.32 • n=5 Participants
|
48.0 Years
STANDARD_DEVIATION NA • n=4 Participants
|
19.0 Years
STANDARD_DEVIATION NA • n=21 Participants
|
34.3 Years
STANDARD_DEVIATION 10.77 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 8Population: The analysis was performed on the full analysis set (FAS) which included all randomized participants who received at least one full dose of study treatment. Only participants with data available at the specified timepoints were included in this analysis.
Plasma samples were collected for the quantitative analysis of plasma HIV-1 RNA. The maximum change from baseline was calculated by determining the largest change from baseline value across all assessment timepoints. This is identified by subtracting the lowest post-dose visit value up to Day 8 (inclusive) from the baseline value. The baseline was defined as the most recent pre-dose assessment with a valid, non-missing value, including measurements from any unscheduled visits.
Outcome measures
| Measure |
VH3739937 Low Dose Group
n=7 Participants
Participants received a low dose of VH3739937 as loading Dose 1 (LD1) on Day 1, followed by a once-daily (QD) dose of VH3739937 as maintenance Dose 1 (MD1) from Days 2 through 7, where MD1 was lower than LD1. On Day 8, all participants transitioned to standard-of-care (SOC) combination antiretroviral therapy (cART) and continued study assessments through Day 25.
|
VH3739937 Medium Dose Group
n=6 Participants
Participants received a medium dose of VH3739937 as loading Dose 2 (LD2) on Day 1, followed by a QD dose of VH3739937 as maintenance Dose 2 (MD2) from Days 2 through 7, where MD2 was lower than LD2. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
VH3739937 High Dose Group
n=6 Participants
Participants received a single high dose (Dose 3) of VH3739937 on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Once Daily (QD)
n=1 Participants
Participants received Placebo QD from Day 1 through Day 7. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Single Dose (SD)
n=1 Participants
Participants received Placebo SD on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
|---|---|---|---|---|---|
|
Maximum Change From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA).
|
-116909.43 copies/milliliter (c/mL)
Standard Deviation 187489.611
|
-130461.67 copies/milliliter (c/mL)
Standard Deviation 106486.489
|
-126026.67 copies/milliliter (c/mL)
Standard Deviation 190725.475
|
-428000.00 copies/milliliter (c/mL)
Standard Deviation NA
Standard deviation could not be calculated for a single participant.
|
-14200.00 copies/milliliter (c/mL)
Standard Deviation NA
Standard deviation could not be calculated for a single participant.
|
SECONDARY outcome
Timeframe: From Day 1 to Day 8Population: The analysis was performed on the safety set which included all randomized participants who took at least 1 partial or full dose of study treatment. Only participants with data available at the specified timepoints were included in this analysis.
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement.
Outcome measures
| Measure |
VH3739937 Low Dose Group
n=7 Participants
Participants received a low dose of VH3739937 as loading Dose 1 (LD1) on Day 1, followed by a once-daily (QD) dose of VH3739937 as maintenance Dose 1 (MD1) from Days 2 through 7, where MD1 was lower than LD1. On Day 8, all participants transitioned to standard-of-care (SOC) combination antiretroviral therapy (cART) and continued study assessments through Day 25.
|
VH3739937 Medium Dose Group
n=6 Participants
Participants received a medium dose of VH3739937 as loading Dose 2 (LD2) on Day 1, followed by a QD dose of VH3739937 as maintenance Dose 2 (MD2) from Days 2 through 7, where MD2 was lower than LD2. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
VH3739937 High Dose Group
n=6 Participants
Participants received a single high dose (Dose 3) of VH3739937 on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Once Daily (QD)
n=1 Participants
Participants received Placebo QD from Day 1 through Day 7. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Single Dose (SD)
n=1 Participants
Participants received Placebo SD on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) During Study Intervention Period
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 1 to Day 8Population: The analysis was performed on the safety set. Only participants with data available at the specified timepoints were included in this analysis.
Outcome measures
| Measure |
VH3739937 Low Dose Group
n=7 Participants
Participants received a low dose of VH3739937 as loading Dose 1 (LD1) on Day 1, followed by a once-daily (QD) dose of VH3739937 as maintenance Dose 1 (MD1) from Days 2 through 7, where MD1 was lower than LD1. On Day 8, all participants transitioned to standard-of-care (SOC) combination antiretroviral therapy (cART) and continued study assessments through Day 25.
|
VH3739937 Medium Dose Group
n=6 Participants
Participants received a medium dose of VH3739937 as loading Dose 2 (LD2) on Day 1, followed by a QD dose of VH3739937 as maintenance Dose 2 (MD2) from Days 2 through 7, where MD2 was lower than LD2. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
VH3739937 High Dose Group
n=6 Participants
Participants received a single high dose (Dose 3) of VH3739937 on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Once Daily (QD)
n=1 Participants
Participants received Placebo QD from Day 1 through Day 7. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Single Dose (SD)
n=1 Participants
Participants received Placebo SD on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
|---|---|---|---|---|---|
|
Number of Reported Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 1 to Day 8Population: The analysis was performed on the safety set. Only participants with data available at the specified timepoints were included in this analysis.
An AE is any untoward medical occurrence (an unfavourable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention. The AE may or may not be considered related to the study intervention. A participant is considered to have discontinued from the study if no new study procedure has been performed or no new information has been collected for him/her since the date of last contact.
Outcome measures
| Measure |
VH3739937 Low Dose Group
n=7 Participants
Participants received a low dose of VH3739937 as loading Dose 1 (LD1) on Day 1, followed by a once-daily (QD) dose of VH3739937 as maintenance Dose 1 (MD1) from Days 2 through 7, where MD1 was lower than LD1. On Day 8, all participants transitioned to standard-of-care (SOC) combination antiretroviral therapy (cART) and continued study assessments through Day 25.
|
VH3739937 Medium Dose Group
n=6 Participants
Participants received a medium dose of VH3739937 as loading Dose 2 (LD2) on Day 1, followed by a QD dose of VH3739937 as maintenance Dose 2 (MD2) from Days 2 through 7, where MD2 was lower than LD2. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
VH3739937 High Dose Group
n=6 Participants
Participants received a single high dose (Dose 3) of VH3739937 on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Once Daily (QD)
n=1 Participants
Participants received Placebo QD from Day 1 through Day 7. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Single Dose (SD)
n=1 Participants
Participants received Placebo SD on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) Leading to Discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h post-dose on Day 1Population: The analysis was performed on the Pharmacokinetic (PK) set which included all participants in the Safety analysis set who had at least 1 PK assessment. Only participants with data available at the mentioned timepoints were included in this analysis.
Blood samples were collected at indicated timepoints for PK analysis.
Outcome measures
| Measure |
VH3739937 Low Dose Group
n=7 Participants
Participants received a low dose of VH3739937 as loading Dose 1 (LD1) on Day 1, followed by a once-daily (QD) dose of VH3739937 as maintenance Dose 1 (MD1) from Days 2 through 7, where MD1 was lower than LD1. On Day 8, all participants transitioned to standard-of-care (SOC) combination antiretroviral therapy (cART) and continued study assessments through Day 25.
|
VH3739937 Medium Dose Group
n=6 Participants
Participants received a medium dose of VH3739937 as loading Dose 2 (LD2) on Day 1, followed by a QD dose of VH3739937 as maintenance Dose 2 (MD2) from Days 2 through 7, where MD2 was lower than LD2. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
VH3739937 High Dose Group
Participants received a single high dose (Dose 3) of VH3739937 on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Once Daily (QD)
Participants received Placebo QD from Day 1 through Day 7. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Single Dose (SD)
Participants received Placebo SD on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of VH3739937 on QD Dosing
|
397.62 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 28.42
|
1225.91 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 34.36
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h post-dose on Day 1Population: The analysis was performed on the PK set. Only participants with data available at the mentioned timepoints were included in this analysis.
Blood samples were collected at indicated timepoints for PK analysis. Tmax is defined as the time to reach maximum observed plasma concentration (Cmax).
Outcome measures
| Measure |
VH3739937 Low Dose Group
n=7 Participants
Participants received a low dose of VH3739937 as loading Dose 1 (LD1) on Day 1, followed by a once-daily (QD) dose of VH3739937 as maintenance Dose 1 (MD1) from Days 2 through 7, where MD1 was lower than LD1. On Day 8, all participants transitioned to standard-of-care (SOC) combination antiretroviral therapy (cART) and continued study assessments through Day 25.
|
VH3739937 Medium Dose Group
n=6 Participants
Participants received a medium dose of VH3739937 as loading Dose 2 (LD2) on Day 1, followed by a QD dose of VH3739937 as maintenance Dose 2 (MD2) from Days 2 through 7, where MD2 was lower than LD2. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
VH3739937 High Dose Group
Participants received a single high dose (Dose 3) of VH3739937 on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Once Daily (QD)
Participants received Placebo QD from Day 1 through Day 7. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Single Dose (SD)
Participants received Placebo SD on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
|---|---|---|---|---|---|
|
Time to Maximum Concentration (Tmax) of VH3739937 on QD Dosing
|
6.00 hour (h)
Interval 4.0 to 10.0
|
7.56 hour (h)
Interval 4.9 to 10.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 24h post-dose on Day 1Population: The analysis was performed on the PK set. Only participants with data available at the mentioned timepoints were included in this analysis.
C24 is defined as concentration at nominal time of 24 hours after dosing. Blood samples were collected at indicated timepoints for PK analysis.
Outcome measures
| Measure |
VH3739937 Low Dose Group
n=7 Participants
Participants received a low dose of VH3739937 as loading Dose 1 (LD1) on Day 1, followed by a once-daily (QD) dose of VH3739937 as maintenance Dose 1 (MD1) from Days 2 through 7, where MD1 was lower than LD1. On Day 8, all participants transitioned to standard-of-care (SOC) combination antiretroviral therapy (cART) and continued study assessments through Day 25.
|
VH3739937 Medium Dose Group
n=6 Participants
Participants received a medium dose of VH3739937 as loading Dose 2 (LD2) on Day 1, followed by a QD dose of VH3739937 as maintenance Dose 2 (MD2) from Days 2 through 7, where MD2 was lower than LD2. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
VH3739937 High Dose Group
Participants received a single high dose (Dose 3) of VH3739937 on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Once Daily (QD)
Participants received Placebo QD from Day 1 through Day 7. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Single Dose (SD)
Participants received Placebo SD on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
|---|---|---|---|---|---|
|
Concentration at 24 Hours (C24) Post Dose of VH3739937 on QD Dosing
|
276.29 ng/mL
Standard Deviation 102.761
|
860.17 ng/mL
Standard Deviation 321.210
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h post-dose on Day 1Population: The analysis was performed on the PK set. Only participants with data available at the mentioned timepoints were included in this analysis.
Blood samples were collected at indicated timepoints for PK analysis.
Outcome measures
| Measure |
VH3739937 Low Dose Group
n=7 Participants
Participants received a low dose of VH3739937 as loading Dose 1 (LD1) on Day 1, followed by a once-daily (QD) dose of VH3739937 as maintenance Dose 1 (MD1) from Days 2 through 7, where MD1 was lower than LD1. On Day 8, all participants transitioned to standard-of-care (SOC) combination antiretroviral therapy (cART) and continued study assessments through Day 25.
|
VH3739937 Medium Dose Group
n=6 Participants
Participants received a medium dose of VH3739937 as loading Dose 2 (LD2) on Day 1, followed by a QD dose of VH3739937 as maintenance Dose 2 (MD2) from Days 2 through 7, where MD2 was lower than LD2. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
VH3739937 High Dose Group
Participants received a single high dose (Dose 3) of VH3739937 on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Once Daily (QD)
Participants received Placebo QD from Day 1 through Day 7. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Single Dose (SD)
Participants received Placebo SD on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Zero to 24h (AUC[0-24]) of VH3739937 on QD Dosing.
|
6573.08 Hour nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 27.55
|
20679.28 Hour nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 36.73
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h post-dose on Day 7Population: The analysis was performed on the PK set. Only participants with data available at the mentioned timepoints were included in this analysis.
Blood samples were collected at indicated timepoints for PK analysis.
Outcome measures
| Measure |
VH3739937 Low Dose Group
n=6 Participants
Participants received a low dose of VH3739937 as loading Dose 1 (LD1) on Day 1, followed by a once-daily (QD) dose of VH3739937 as maintenance Dose 1 (MD1) from Days 2 through 7, where MD1 was lower than LD1. On Day 8, all participants transitioned to standard-of-care (SOC) combination antiretroviral therapy (cART) and continued study assessments through Day 25.
|
VH3739937 Medium Dose Group
n=6 Participants
Participants received a medium dose of VH3739937 as loading Dose 2 (LD2) on Day 1, followed by a QD dose of VH3739937 as maintenance Dose 2 (MD2) from Days 2 through 7, where MD2 was lower than LD2. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
VH3739937 High Dose Group
Participants received a single high dose (Dose 3) of VH3739937 on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Once Daily (QD)
Participants received Placebo QD from Day 1 through Day 7. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Single Dose (SD)
Participants received Placebo SD on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
|---|---|---|---|---|---|
|
Cmax of VH3739937 at Steady State (Cmax, ss) on QD Dosing
|
327.09 ng/mL
Geometric Coefficient of Variation 10.31
|
1221.20 ng/mL
Geometric Coefficient of Variation 27.79
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h post-dose on Day 7Population: The analysis was performed on the PK set. Only participants with data available at the mentioned timepoints were included in this analysis.
Blood samples were collected at indicated timepoints for PK analysis. Tmax is defined as the time to reach the maximum observed plasma concentration (Cmax).
Outcome measures
| Measure |
VH3739937 Low Dose Group
n=6 Participants
Participants received a low dose of VH3739937 as loading Dose 1 (LD1) on Day 1, followed by a once-daily (QD) dose of VH3739937 as maintenance Dose 1 (MD1) from Days 2 through 7, where MD1 was lower than LD1. On Day 8, all participants transitioned to standard-of-care (SOC) combination antiretroviral therapy (cART) and continued study assessments through Day 25.
|
VH3739937 Medium Dose Group
n=6 Participants
Participants received a medium dose of VH3739937 as loading Dose 2 (LD2) on Day 1, followed by a QD dose of VH3739937 as maintenance Dose 2 (MD2) from Days 2 through 7, where MD2 was lower than LD2. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
VH3739937 High Dose Group
Participants received a single high dose (Dose 3) of VH3739937 on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Once Daily (QD)
Participants received Placebo QD from Day 1 through Day 7. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Single Dose (SD)
Participants received Placebo SD on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
|---|---|---|---|---|---|
|
Tmax of VH3739937 at Steady State (Tmax, ss) on QD Dosing
|
5.07 hour (h)
Interval 2.0 to 8.0
|
7.48 hour (h)
Interval 5.0 to 10.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 24h post-dose on Day 7Population: The analysis was performed on the PK set. Only participants with data available at the mentioned timepoints were included in this analysis.
Blood samples were collected at indicated timepoints for PK analysis.
Outcome measures
| Measure |
VH3739937 Low Dose Group
n=6 Participants
Participants received a low dose of VH3739937 as loading Dose 1 (LD1) on Day 1, followed by a once-daily (QD) dose of VH3739937 as maintenance Dose 1 (MD1) from Days 2 through 7, where MD1 was lower than LD1. On Day 8, all participants transitioned to standard-of-care (SOC) combination antiretroviral therapy (cART) and continued study assessments through Day 25.
|
VH3739937 Medium Dose Group
n=6 Participants
Participants received a medium dose of VH3739937 as loading Dose 2 (LD2) on Day 1, followed by a QD dose of VH3739937 as maintenance Dose 2 (MD2) from Days 2 through 7, where MD2 was lower than LD2. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
VH3739937 High Dose Group
Participants received a single high dose (Dose 3) of VH3739937 on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Once Daily (QD)
Participants received Placebo QD from Day 1 through Day 7. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Single Dose (SD)
Participants received Placebo SD on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
|---|---|---|---|---|---|
|
C24 of VH3739937 at Steady State (C24, ss) on QD Dosing
|
263.67 ng/mL
Standard Deviation 26.493
|
937.50 ng/mL
Standard Deviation 344.099
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h post-dose on Day 7Population: The analysis was performed on the PK set. Only participants with data available at the mentioned timepoints were included in this analysis.
Blood samples were collected at indicated timepoints for PK analysis.
Outcome measures
| Measure |
VH3739937 Low Dose Group
n=6 Participants
Participants received a low dose of VH3739937 as loading Dose 1 (LD1) on Day 1, followed by a once-daily (QD) dose of VH3739937 as maintenance Dose 1 (MD1) from Days 2 through 7, where MD1 was lower than LD1. On Day 8, all participants transitioned to standard-of-care (SOC) combination antiretroviral therapy (cART) and continued study assessments through Day 25.
|
VH3739937 Medium Dose Group
n=6 Participants
Participants received a medium dose of VH3739937 as loading Dose 2 (LD2) on Day 1, followed by a QD dose of VH3739937 as maintenance Dose 2 (MD2) from Days 2 through 7, where MD2 was lower than LD2. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
VH3739937 High Dose Group
Participants received a single high dose (Dose 3) of VH3739937 on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Once Daily (QD)
Participants received Placebo QD from Day 1 through Day 7. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Single Dose (SD)
Participants received Placebo SD on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
|---|---|---|---|---|---|
|
AUC(0-24) of VH3739937 at Steady State (AUC[0-24], ss) on QD Dosing
|
6610.59 h*ng/mL
Geometric Coefficient of Variation 16.57
|
23871.02 h*ng/mL
Geometric Coefficient of Variation 30.24
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h post-dose (single dose administered on Day 1)Population: The analysis was performed on the PK set. Only participants with data available at the mentioned timepoints were included in this analysis.
Blood samples were collected at indicated timepoints for PK analysis.
Outcome measures
| Measure |
VH3739937 Low Dose Group
n=6 Participants
Participants received a low dose of VH3739937 as loading Dose 1 (LD1) on Day 1, followed by a once-daily (QD) dose of VH3739937 as maintenance Dose 1 (MD1) from Days 2 through 7, where MD1 was lower than LD1. On Day 8, all participants transitioned to standard-of-care (SOC) combination antiretroviral therapy (cART) and continued study assessments through Day 25.
|
VH3739937 Medium Dose Group
Participants received a medium dose of VH3739937 as loading Dose 2 (LD2) on Day 1, followed by a QD dose of VH3739937 as maintenance Dose 2 (MD2) from Days 2 through 7, where MD2 was lower than LD2. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
VH3739937 High Dose Group
Participants received a single high dose (Dose 3) of VH3739937 on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Once Daily (QD)
Participants received Placebo QD from Day 1 through Day 7. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Single Dose (SD)
Participants received Placebo SD on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
|---|---|---|---|---|---|
|
Cmax Post Single Dose of VH3739937
|
2058.35 ng/mL
Geometric Coefficient of Variation 35.50
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h post-dose (single dose administered on Day 1)Population: The analysis was performed on the PK set. Only participants with data available at the mentioned timepoints were included in this analysis.
Blood samples were collected at indicated timepoints for PK analysis.
Outcome measures
| Measure |
VH3739937 Low Dose Group
n=6 Participants
Participants received a low dose of VH3739937 as loading Dose 1 (LD1) on Day 1, followed by a once-daily (QD) dose of VH3739937 as maintenance Dose 1 (MD1) from Days 2 through 7, where MD1 was lower than LD1. On Day 8, all participants transitioned to standard-of-care (SOC) combination antiretroviral therapy (cART) and continued study assessments through Day 25.
|
VH3739937 Medium Dose Group
Participants received a medium dose of VH3739937 as loading Dose 2 (LD2) on Day 1, followed by a QD dose of VH3739937 as maintenance Dose 2 (MD2) from Days 2 through 7, where MD2 was lower than LD2. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
VH3739937 High Dose Group
Participants received a single high dose (Dose 3) of VH3739937 on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Once Daily (QD)
Participants received Placebo QD from Day 1 through Day 7. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Single Dose (SD)
Participants received Placebo SD on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
|---|---|---|---|---|---|
|
Tmax Post Single Dose of VH3739937
|
8.08 hour (h)
Interval 6.0 to 12.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 168 hours post-dose (single dose administered on Day 1)Population: The analysis was performed on the PK set. Only participants with data available at the mentioned timepoints were included in this analysis.
C168 is defined as concentration of VH3739937 at a nominal time of 168 hours after dosing. Blood samples were collected at indicated timepoints for PK analysis.
Outcome measures
| Measure |
VH3739937 Low Dose Group
n=6 Participants
Participants received a low dose of VH3739937 as loading Dose 1 (LD1) on Day 1, followed by a once-daily (QD) dose of VH3739937 as maintenance Dose 1 (MD1) from Days 2 through 7, where MD1 was lower than LD1. On Day 8, all participants transitioned to standard-of-care (SOC) combination antiretroviral therapy (cART) and continued study assessments through Day 25.
|
VH3739937 Medium Dose Group
Participants received a medium dose of VH3739937 as loading Dose 2 (LD2) on Day 1, followed by a QD dose of VH3739937 as maintenance Dose 2 (MD2) from Days 2 through 7, where MD2 was lower than LD2. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
VH3739937 High Dose Group
Participants received a single high dose (Dose 3) of VH3739937 on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Once Daily (QD)
Participants received Placebo QD from Day 1 through Day 7. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Single Dose (SD)
Participants received Placebo SD on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
|---|---|---|---|---|---|
|
Concentration at 168 Hours (C168) Post Single Dose of VH3739937
|
297.25 ng/mL
Geometric Coefficient of Variation 35.19
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h post-dose (single dose administered on Day 1)Population: The analysis was performed on the PK set. Only participants with data available at the mentioned timepoints were included in this analysis.
Blood samples were collected at indicated timepoints for analysis.
Outcome measures
| Measure |
VH3739937 Low Dose Group
n=6 Participants
Participants received a low dose of VH3739937 as loading Dose 1 (LD1) on Day 1, followed by a once-daily (QD) dose of VH3739937 as maintenance Dose 1 (MD1) from Days 2 through 7, where MD1 was lower than LD1. On Day 8, all participants transitioned to standard-of-care (SOC) combination antiretroviral therapy (cART) and continued study assessments through Day 25.
|
VH3739937 Medium Dose Group
Participants received a medium dose of VH3739937 as loading Dose 2 (LD2) on Day 1, followed by a QD dose of VH3739937 as maintenance Dose 2 (MD2) from Days 2 through 7, where MD2 was lower than LD2. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
VH3739937 High Dose Group
Participants received a single high dose (Dose 3) of VH3739937 on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Once Daily (QD)
Participants received Placebo QD from Day 1 through Day 7. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Single Dose (SD)
Participants received Placebo SD on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Zero to 168h [AUC(0-168)] Post Single Dose of VH3739937
|
144443.90 h*ng/mL
Geometric Coefficient of Variation 39.51
|
—
|
—
|
—
|
—
|
Adverse Events
VH3739937 Low Dose Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
VH3739937 Medium Dose Group
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
VH3739937 High Dose Group
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo Once Daily (QD)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Single Dose (SD)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VH3739937 Low Dose Group
n=7 participants at risk
Participants received a low dose of VH3739937 as loading Dose 1 (LD1) on Day 1, followed by a once-daily (QD) dose of VH3739937 as maintenance Dose 1 (MD1) from Days 2 through 7, where MD1 was lower than LD1. On Day 8, all participants transitioned to standard-of-care (SOC) combination antiretroviral therapy (cART) and continued study assessments through Day 25.
|
VH3739937 Medium Dose Group
n=6 participants at risk
Participants received a medium dose of VH3739937 as loading Dose 2 (LD2) on Day 1, followed by a QD dose of VH3739937 as maintenance Dose 2 (MD2) from Days 2 through 7, where MD2 was lower than LD2. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
VH3739937 High Dose Group
n=6 participants at risk
Participants received a single high dose (Dose 3) of VH3739937 on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Once Daily (QD)
n=1 participants at risk
Participants received Placebo QD from Day 1 through Day 7. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Single Dose (SD)
n=1 participants at risk
Participants received Placebo SD on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection
|
0.00%
0/7 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
16.7%
1/6 • Number of events 1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/6 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
Other adverse events
| Measure |
VH3739937 Low Dose Group
n=7 participants at risk
Participants received a low dose of VH3739937 as loading Dose 1 (LD1) on Day 1, followed by a once-daily (QD) dose of VH3739937 as maintenance Dose 1 (MD1) from Days 2 through 7, where MD1 was lower than LD1. On Day 8, all participants transitioned to standard-of-care (SOC) combination antiretroviral therapy (cART) and continued study assessments through Day 25.
|
VH3739937 Medium Dose Group
n=6 participants at risk
Participants received a medium dose of VH3739937 as loading Dose 2 (LD2) on Day 1, followed by a QD dose of VH3739937 as maintenance Dose 2 (MD2) from Days 2 through 7, where MD2 was lower than LD2. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
VH3739937 High Dose Group
n=6 participants at risk
Participants received a single high dose (Dose 3) of VH3739937 on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Once Daily (QD)
n=1 participants at risk
Participants received Placebo QD from Day 1 through Day 7. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
Placebo Single Dose (SD)
n=1 participants at risk
Participants received Placebo SD on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.
|
|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/7 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/6 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
16.7%
1/6 • Number of events 1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Number of events 1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/6 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
16.7%
1/6 • Number of events 1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/7 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/6 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
16.7%
1/6 • Number of events 1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/6 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
16.7%
1/6 • Number of events 1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
14.3%
1/7 • Number of events 1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/6 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/6 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
14.3%
1/7 • Number of events 1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/6 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/6 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
14.3%
1/7 • Number of events 1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/6 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
16.7%
1/6 • Number of events 1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/7 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/6 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
16.7%
1/6 • Number of events 1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/7 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
16.7%
1/6 • Number of events 1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
16.7%
1/6 • Number of events 1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/7 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/6 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
16.7%
1/6 • Number of events 1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/7 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/6 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
16.7%
1/6 • Number of events 1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/7 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
16.7%
1/6 • Number of events 1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
33.3%
2/6 • Number of events 2 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
|
Gastrointestinal disorders
Faeces soft
|
14.3%
1/7 • Number of events 1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/6 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/6 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Number of events 1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/6 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
16.7%
1/6 • Number of events 1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
|
General disorders
Energy increased
|
0.00%
0/7 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/6 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
16.7%
1/6 • Number of events 1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
|
Infections and infestations
Gonococcal infection
|
14.3%
1/7 • Number of events 1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/6 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/6 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
|
Infections and infestations
Herpes simplex
|
14.3%
1/7 • Number of events 1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/6 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/6 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/7 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/6 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
16.7%
1/6 • Number of events 1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
|
Investigations
Heart rate increased
|
0.00%
0/7 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/6 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
16.7%
1/6 • Number of events 1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.3%
1/7 • Number of events 1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/6 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/6 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
14.3%
1/7 • Number of events 1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/6 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/6 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
0.00%
0/1 • AEs were reported from Day 1 to Day 25. SAEs and All-cause mortality were reported from the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) to Day 25.
SAEs and AEs were reported for the Safety set. Safety set included all randomized participants who took at least 1 partial or full dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER