Trial Outcomes & Findings for Safety and Biological Activity of Vesatolimod in HIV-1 Infected, Virologically Suppressed Adults (NCT NCT02858401)
NCT ID: NCT02858401
Last Updated: 2020-02-21
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
Results posted on
2020-02-21
Participant Flow
Participants were enrolled at study sites in United States. The first participant was screened on 29 January 2015. The last study visit occurred on 14 February 2019.
58 participants were screened.
Participant milestones
| Measure |
Vesatolimod 1 mg (Cohort 1)
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing antiretroviral (ARV) regimen in accordance with their prescribing information (the following agents were allowed: nucleoside/nucleotide reverse transcriptase inhibitors \[NRTIs\], raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to Day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
6
|
12
|
|
Overall Study
COMPLETED
|
6
|
5
|
6
|
6
|
6
|
5
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Vesatolimod 1 mg (Cohort 1)
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing antiretroviral (ARV) regimen in accordance with their prescribing information (the following agents were allowed: nucleoside/nucleotide reverse transcriptase inhibitors \[NRTIs\], raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to Day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrew Consent
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Biological Activity of Vesatolimod in HIV-1 Infected, Virologically Suppressed Adults
Baseline characteristics by cohort
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=6 Participants
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=6 Participants
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=6 Participants
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=6 Participants
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=12 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
44 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
45 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
52 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
44 years
STANDARD_DEVIATION 9.3 • n=4 Participants
|
45 years
STANDARD_DEVIATION 9.9 • n=21 Participants
|
47 years
STANDARD_DEVIATION 17.5 • n=10 Participants
|
45 years
STANDARD_DEVIATION 11.9 • n=115 Participants
|
46 years
STANDARD_DEVIATION 10.9 • n=24 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
5 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
43 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
5 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
43 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
46 Participants
n=24 Participants
|
|
HIV-1 RNA
|
1.28 log10 copies/mL
STANDARD_DEVIATION 0.000 • n=5 Participants
|
1.28 log10 copies/mL
STANDARD_DEVIATION 0.000 • n=7 Participants
|
1.30 log10 copies/mL
STANDARD_DEVIATION 0.062 • n=5 Participants
|
1.28 log10 copies/mL
STANDARD_DEVIATION 0.000 • n=4 Participants
|
1.28 log10 copies/mL
STANDARD_DEVIATION 0.000 • n=21 Participants
|
1.28 log10 copies/mL
STANDARD_DEVIATION 0.000 • n=10 Participants
|
1.28 log10 copies/mL
STANDARD_DEVIATION 0.000 • n=115 Participants
|
1.28 log10 copies/mL
STANDARD_DEVIATION 0.022 • n=24 Participants
|
|
HIV-1 RNA Category
< 50 copies/ mL
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
48 Participants
n=24 Participants
|
|
HIV-1 RNA Category
≥ 50 copies/ mL
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 daysPopulation: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=6 Participants
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=6 Participants
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=6 Participants
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=6 Participants
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=12 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) and Any Treatment-Emergent Adverse Events (AEs).
AEs
|
66.7 percentage of participants
|
66.7 percentage of participants
|
33.3 percentage of participants
|
66.7 percentage of participants
|
83.3 percentage of participants
|
66.7 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) and Any Treatment-Emergent Adverse Events (AEs).
SAEs
|
0.0 percentage of participants
|
16.7 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
PRIMARY outcome
Timeframe: For Cohorts 1 to 3: Baseline to Day 81; For Cohorts 4 to 6: Baseline to Day 134; For placebo: Baseline to Day 81 or Baseline to Day 134Population: The Full Analysis Set included participants who were randomized and received at least 1 dose of study drug.
The maximum change from baseline in plasma Log10 HIV-1 RNA refers to the maximum change at any postdose timepoint up to Day 81 or Day 134 for placebo, Day 81 for Cohorts 1 to 3, and Day 134 for Cohorts 4 to 6.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=6 Participants
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=6 Participants
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=6 Participants
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=6 Participants
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=12 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Maximum Change From Baseline in Plasma Log10 HIV-1 RNA at Any Postdose Timepoint
|
0.06 Log10 copies/mL
Standard Error 0.141
|
0.01 Log10 copies/mL
Standard Error 0.018
|
0.10 Log10 copies/mL
Standard Error 0.252
|
0.04 Log10 copies/mL
Standard Error 0.092
|
0.00 Log10 copies/mL
Standard Error 0.000
|
0.07 Log10 copies/mL
Standard Error 0.073
|
0.42 Log10 copies/mL
Standard Error 0.729
|
SECONDARY outcome
Timeframe: Baseline; Day 2Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 2.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=6 Participants
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=5 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 2
|
—
|
—
|
—
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
SECONDARY outcome
Timeframe: Baseline; Day 3Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 3.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=6 Participants
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=6 Participants
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=6 Participants
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=6 Participants
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=5 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=12 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 3
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.091
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.01 Log10 copies/mL
Standard Deviation 0.034
|
SECONDARY outcome
Timeframe: Baseline; Day 5Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 5.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=6 Participants
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=6 Participants
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=6 Participants
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=6 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 5
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
-0.03 Log10 copies/mL
Standard Deviation 0.062
|
—
|
—
|
—
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
SECONDARY outcome
Timeframe: Baseline; Day 8Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 8.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=6 Participants
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=6 Participants
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=5 Participants
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=6 Participants
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=12 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 8
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
-0.03 Log10 copies/mL
Standard Deviation 0.068
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
SECONDARY outcome
Timeframe: Baseline; Day 11Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 11.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=6 Participants
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=6 Participants
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=5 Participants
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=6 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 11
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
-0.03 Log10 copies/mL
Standard Deviation 0.068
|
—
|
—
|
—
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
SECONDARY outcome
Timeframe: Baseline; Day 15Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 15.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=5 Participants
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=6 Participants
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=6 Participants
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=6 Participants
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=12 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 15
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
-0.03 Log10 copies/mL
Standard Deviation 0.062
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
SECONDARY outcome
Timeframe: Baseline; Day 17Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 17.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=6 Participants
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=6 Participants
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=6 Participants
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=6 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 17
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.01 Log10 copies/mL
Standard Deviation 0.117
|
—
|
—
|
—
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
SECONDARY outcome
Timeframe: Baseline; Day 19Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 19.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=6 Participants
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=6 Participants
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=6 Participants
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=6 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 19
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
-0.03 Log10 copies/mL
Standard Deviation 0.062
|
—
|
—
|
—
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
SECONDARY outcome
Timeframe: Baseline; Day 22Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 22.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=6 Participants
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=6 Participants
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=5 Participants
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=6 Participants
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=12 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 22
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.02 Log10 copies/mL
Standard Deviation 0.037
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
SECONDARY outcome
Timeframe: Baseline; Day 25Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 25.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=6 Participants
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=6 Participants
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=6 Participants
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=6 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 25
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
-0.03 Log10 copies/mL
Standard Deviation 0.062
|
—
|
—
|
—
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
SECONDARY outcome
Timeframe: Baseline; Day 29Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 29.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=6 Participants
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=5 Participants
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=6 Participants
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=6 Participants
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=12 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 29
|
0.01 Log10 copies/mL
Standard Deviation 0.018
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.02 Log10 copies/mL
Standard Deviation 0.112
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
SECONDARY outcome
Timeframe: Baseline; Day 31Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 31.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=6 Participants
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=5 Participants
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=6 Participants
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=10 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 31
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
-0.03 Log10 copies/mL
Standard Deviation 0.062
|
—
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.014
|
SECONDARY outcome
Timeframe: Baseline; Day 33Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 33.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=6 Participants
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=5 Participants
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=6 Participants
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=5 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 33
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
-0.03 Log10 copies/mL
Standard Deviation 0.062
|
—
|
—
|
—
|
0.01 Log10 copies/mL
Standard Deviation 0.028
|
SECONDARY outcome
Timeframe: Baseline; Day 36Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 36
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=6 Participants
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=5 Participants
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=6 Participants
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=6 Participants
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=12 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 36
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
-0.03 Log10 copies/mL
Standard Deviation 0.062
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.16 Log10 copies/mL
Standard Deviation 0.500
|
SECONDARY outcome
Timeframe: Baseline; Day 39Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 39
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=6 Participants
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=5 Participants
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=6 Participants
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=6 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 39
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.04 Log10 copies/mL
Standard Deviation 0.190
|
—
|
—
|
—
|
0.25 Log10 copies/mL
Standard Deviation 0.620
|
SECONDARY outcome
Timeframe: Baseline; Day 43Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 43
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=6 Participants
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=5 Participants
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=6 Participants
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=6 Participants
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=12 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 43
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
-0.03 Log10 copies/mL
Standard Deviation 0.062
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
SECONDARY outcome
Timeframe: Baseline; Day 45Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit pn Day 45
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=6 Participants
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=5 Participants
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=6 Participants
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=9 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 45
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
-0.03 Log10 copies/mL
Standard Deviation 0.062
|
—
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
SECONDARY outcome
Timeframe: Baseline; Day 47Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 47
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=6 Participants
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=5 Participants
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=5 Participants
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=6 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 47
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.07 Log10 copies/mL
Standard Deviation 0.249
|
—
|
—
|
—
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
SECONDARY outcome
Timeframe: Baseline; Day 50Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 50.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=6 Participants
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=5 Participants
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=6 Participants
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=6 Participants
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=12 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 50
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
-0.03 Log10 copies/mL
Standard Deviation 0.062
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
SECONDARY outcome
Timeframe: Baseline; Day 53Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 53
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=6 Participants
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=5 Participants
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=6 Participants
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=6 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 53
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.01 Log10 copies/mL
Standard Deviation 0.126
|
—
|
—
|
—
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
SECONDARY outcome
Timeframe: Baseline; Day 57Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 57.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=6 Participants
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=5 Participants
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=6 Participants
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=6 Participants
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=11 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 57
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.03 Log10 copies/mL
Standard Deviation 0.165
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.03 Log10 copies/mL
Standard Deviation 0.097
|
SECONDARY outcome
Timeframe: Baseline; Day 58Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 58.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=6 Participants
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=5 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 58
|
—
|
—
|
—
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
SECONDARY outcome
Timeframe: Baseline; Day 59Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 59.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=6 Participants
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=5 Participants
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=6 Participants
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=6 Participants
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=11 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 59
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
-0.01 Log10 copies/mL
Standard Deviation 0.081
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.07 Log10 copies/mL
Standard Deviation 0.190
|
SECONDARY outcome
Timeframe: Baseline; Day 61Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 61.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=6 Participants
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=5 Participants
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=6 Participants
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=6 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 61
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.01 Log10 copies/mL
Standard Deviation 0.126
|
—
|
—
|
—
|
0.03 Log10 copies/mL
Standard Deviation 0.081
|
SECONDARY outcome
Timeframe: Baseline; Day 64Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 64.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=5 Participants
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=5 Participants
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=6 Participants
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=6 Participants
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=11 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 64
|
0.07 Log10 copies/mL
Standard Deviation 0.154
|
0.01 Log10 copies/mL
Standard Deviation 0.019
|
0.07 Log10 copies/mL
Standard Deviation 0.249
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.02 Log10 copies/mL
Standard Deviation 0.041
|
0.02 Log10 copies/mL
Standard Deviation 0.072
|
SECONDARY outcome
Timeframe: Baseline; Day 67Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 67.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=6 Participants
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=5 Participants
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=6 Participants
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=6 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 67
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.04 Log10 copies/mL
Standard Deviation 0.194
|
—
|
—
|
—
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
SECONDARY outcome
Timeframe: Baseline; Day 71Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 71.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=6 Participants
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=5 Participants
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=6 Participants
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=6 Participants
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=12 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 71
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.02 Log10 copies/mL
Standard Deviation 0.140
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.02 Log10 copies/mL
Standard Deviation 0.056
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
SECONDARY outcome
Timeframe: Baseline; Day 73Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 73.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=6 Participants
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=5 Participants
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=6 Participants
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=10 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 73
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.01 Log10 copies/mL
Standard Deviation 0.112
|
—
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.04 Log10 copies/mL
Standard Deviation 0.136
|
SECONDARY outcome
Timeframe: Baseline; Day 75Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 75.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=6 Participants
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=5 Participants
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=6 Participants
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=6 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 75
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
-0.03 Log10 copies/mL
Standard Deviation 0.062
|
—
|
—
|
—
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
SECONDARY outcome
Timeframe: Baseline; Day 78Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 78.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=6 Participants
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=5 Participants
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=6 Participants
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=6 Participants
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=11 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 78
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
-0.03 Log10 copies/mL
Standard Deviation 0.062
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.19 Log10 copies/mL
Standard Deviation 0.635
|
SECONDARY outcome
Timeframe: Baseline; Day 81Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 81.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=6 Participants
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=5 Participants
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=5 Participants
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=6 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 81
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
-0.03 Log10 copies/mL
Standard Deviation 0.071
|
—
|
—
|
—
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
SECONDARY outcome
Timeframe: Baseline; Day 85Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 85.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=6 Participants
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=6 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 85
|
—
|
—
|
—
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.03 Log10 copies/mL
Standard Deviation 0.075
|
SECONDARY outcome
Timeframe: Baseline; Day 87Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 87.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=4 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 87
|
—
|
—
|
—
|
—
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.19 Log10 copies/mL
Standard Deviation 0.385
|
SECONDARY outcome
Timeframe: Baseline; Day 92Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 92.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=6 Participants
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=6 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 92
|
—
|
—
|
—
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.11 Log10 copies/mL
Standard Deviation 0.261
|
SECONDARY outcome
Timeframe: Baseline; Day 99Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 99.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=6 Participants
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=6 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 99
|
—
|
—
|
—
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.03 Log10 copies/mL
Standard Deviation 0.062
|
0.07 Log10 copies/mL
Standard Deviation 0.142
|
SECONDARY outcome
Timeframe: Baseline; Day 101Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 101.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=6 Participants
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=5 Participants
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=6 Participants
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=10 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 101
|
0.02 Log10 copies/mL
Standard Deviation 0.049
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.102
|
—
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.05 Log10 copies/mL
Standard Deviation 0.173
|
SECONDARY outcome
Timeframe: Baseline; Day 106Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 106.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=6 Participants
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=6 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 106
|
—
|
—
|
—
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.10 Log10 copies/mL
Standard Deviation 0.250
|
SECONDARY outcome
Timeframe: Baseline; Day 113Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 113.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=6 Participants
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=6 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 113
|
—
|
—
|
—
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.09 Log10 copies/mL
Standard Deviation 0.218
|
SECONDARY outcome
Timeframe: Baseline; Day 115Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 115.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=4 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 115
|
—
|
—
|
—
|
—
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.08 Log10 copies/mL
Standard Deviation 0.156
|
SECONDARY outcome
Timeframe: Baseline; Day 120Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 120.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=6 Participants
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=6 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 120
|
—
|
—
|
—
|
0.04 Log10 copies/mL
Standard Deviation 0.092
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.01 Log10 copies/mL
Standard Deviation 0.018
|
SECONDARY outcome
Timeframe: Baseline; Day 127Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 127.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=6 Participants
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=5 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=6 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 127
|
—
|
—
|
—
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
SECONDARY outcome
Timeframe: Baseline; Day 128Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 128.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=6 Participants
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=5 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=6 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 128
|
—
|
—
|
—
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.06 Log10 copies/mL
Standard Deviation 0.129
|
SECONDARY outcome
Timeframe: Baseline; Day 129Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 129.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=6 Participants
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=5 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=6 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 129
|
—
|
—
|
—
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.03 Log10 copies/mL
Standard Deviation 0.062
|
SECONDARY outcome
Timeframe: Baseline; Day 134Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 134.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=6 Participants
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=5 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=6 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 134
|
—
|
—
|
—
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.09 Log10 copies/mL
Standard Deviation 0.215
|
SECONDARY outcome
Timeframe: Baseline; Day 157Population: Participants in the Full Analysis Set with available data were analyzed.
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 157.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=6 Participants
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=5 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=6 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 157
|
—
|
—
|
—
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.00 Log10 copies/mL
Standard Deviation 0.000
|
0.13 Log10 copies/mL
Standard Deviation 0.254
|
SECONDARY outcome
Timeframe: Postdose 1 on Day 1Population: Participants in the Full Analysis Set were analyzed.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=6 Participants
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=6 Participants
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=6 Participants
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=6 Participants
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=12 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at Postdose 1 on Day 1
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: PostDose 2 on Day 15Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=6 Participants
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=6 Participants
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=6 Participants
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=5 Participants
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=12 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 2 on Day 15
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: PostDose 3 on Day 29Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=6 Participants
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=5 Participants
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=6 Participants
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=6 Participants
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=12 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 3 on Day 29
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
8.3 percentage of participants
|
SECONDARY outcome
Timeframe: PostDose 4 on Day 43Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=6 Participants
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=5 Participants
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=6 Participants
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=6 Participants
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=12 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 4 on Day 43
|
0.0 percentage of participants
|
0.0 percentage of participants
|
16.7 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: PostDose 5 on Day 57Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=6 Participants
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=5 Participants
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=6 Participants
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=6 Participants
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=11 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 5 on Day 57
|
0.0 percentage of participants
|
0.0 percentage of participants
|
16.7 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
9.1 percentage of participants
|
SECONDARY outcome
Timeframe: PostDose 6 on Day 71Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=6 Participants
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=5 Participants
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=6 Participants
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=5 Participants
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=11 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 6 on Day 71
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
9.1 percentage of participants
|
SECONDARY outcome
Timeframe: PostDose 7 on Day 85Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=6 Participants
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=6 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 7 on Day 85
|
—
|
—
|
—
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
16.7 percentage of participants
|
SECONDARY outcome
Timeframe: PostDose 8 on Day 99Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=4 Participants
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=6 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 8 on Day 99
|
—
|
—
|
—
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
16.7 percentage of participants
|
SECONDARY outcome
Timeframe: PostDose 9 on Day 113Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=4 Participants
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=6 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 9 on Day 113
|
—
|
—
|
—
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: PostDose 10 on Day 127Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Vesatolimod 1 mg (Cohort 1)
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=6 Participants
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 Participants
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=5 Participants
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=6 Participants
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 10 on Day 127
|
—
|
—
|
—
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
16.7 percentage of participants
|
Adverse Events
Vesatolimod 1 mg (Cohort 1)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Vesatolimod 2 mg (Cohort 2)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Vesatolimod 4 mg (Cohort 3)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Vesatolimod 6 mg (Cohort 4)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Vesatolimod 8 mg (Cohort 5)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Vesatolimod 10 or 12 mg (Cohort 6)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=6 participants at risk
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=6 participants at risk
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=6 participants at risk
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=6 participants at risk
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 participants at risk
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 participants at risk
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=12 participants at risk
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Diverticulitis
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Vesatolimod 1 mg (Cohort 1)
n=6 participants at risk
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 2 mg (Cohort 2)
n=6 participants at risk
Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 4 mg (Cohort 3)
n=6 participants at risk
Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 6 mg (Cohort 4)
n=6 participants at risk
Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 8 mg (Cohort 5)
n=6 participants at risk
Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Vesatolimod 10 or 12 mg (Cohort 6)
n=6 participants at risk
Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
Placebo
n=12 participants at risk
Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
33.3%
2/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
8.3%
1/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Ear pain
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
8.3%
1/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
8.3%
1/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Eye disorders
Erythema of eyelid
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Eye disorders
Scleral hyperaemia
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
8.3%
1/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
8.3%
1/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
8.3%
1/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Sensitivity of teeth
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
8.3%
1/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Chills
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Early satiety
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
33.3%
2/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
50.0%
3/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
25.0%
3/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Feeling cold
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Malaise
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
8.3%
1/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Sluggishness
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
8.3%
1/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Bone abscess
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Conjunctivitis
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
8.3%
1/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
8.3%
1/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Proctitis gonococcal
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Syphilis
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
8.3%
1/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
8.3%
1/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Exposure to communicable disease
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
8.3%
1/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Eyelid contusion
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
8.3%
1/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
8.3%
1/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
33.3%
2/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
8.3%
1/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
8.3%
1/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
8.3%
1/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
2/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
8.3%
1/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Slow speech
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
8.3%
1/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depressed mood
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Proteinuria
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Genital lesion
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
8.3%
1/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Penile pain
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
8.3%
1/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
25.0%
3/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
33.3%
2/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
8.3%
1/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal oedema
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
8.3%
1/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
2/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
8.3%
1/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
8.3%
1/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pseudofolliculitis
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
8.3%
1/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Vascular disorders
Hot flush
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/12 • For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER