Trial Outcomes & Findings for A Study to Assess the Safety and Tolerability of Single and Multiple Ascending Doses of Oral RO7020531 in Chinese Healthy Participants. (NCT NCT03530917)
NCT ID: NCT03530917
Last Updated: 2020-07-13
Results Overview
An Adverse Event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, any deterioration in a laboratory value or other clinical test or adverse events that are related to a protocol-mandated intervention, including those that occur prior to assignment of study treatment.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
70 participants
Primary outcome timeframe
Screening up until 28 days after the last dose of study drug (up to 1 year).
Results posted on
2020-07-13
Participant Flow
The study was conducted at 1 Center in China.
A total of 70 Healthy Male and Female Chinese Participants were enrolled.
Participant milestones
| Measure |
Single Ascending Dose (SAD): Placebo
In SAD Cohorts 1-4, there will be eight participants in total receiving placebo, two in each cohort.
|
SAD: Cohort 1
Eight participants will be administered 40mg RO7020531 orally on Day 1.
|
SAD: Cohort 2
Eight participants will be administered 100mg RO7020531 orally on Day 1.
|
SAD: Cohort 3
Eight participants will be administered 140mg RO7020531 orally on Day 1.
|
SAD: Cohort 4
Eight participants will be administered 170mg RO7020531 orally on Day 1.
|
Multiple Ascending Dose (MAD): Placebo
In MAD Cohorts 1-3, there will be six participants in total receiving placebo, two in each cohort.
|
MAD: Cohort 1
Eight participants will be administered 100mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
|
MAD: Cohorts 2 and 3
Sixteen participants will be administered 150mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
8
|
6
|
8
|
16
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
8
|
8
|
6
|
8
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess the Safety and Tolerability of Single and Multiple Ascending Doses of Oral RO7020531 in Chinese Healthy Participants.
Baseline characteristics by cohort
| Measure |
Single Ascending Dose (SAD): Placebo
n=8 Participants
In SAD Cohorts 1-4, there will be eight participants in total receiving placebo, two in each cohort.
|
SAD: Cohort 1
n=8 Participants
Eight participants will be administered 40mg RO7020531 orally on Day 1.
|
SAD: Cohort 2
n=8 Participants
Eight participants will be administered 100mg RO7020531 orally on Day 1.
|
SAD: Cohort 3
n=8 Participants
Eight participants will be administered 140mg RO7020531 orally on Day 1.
|
SAD: Cohort 4
n=8 Participants
Eight participants will be administered 170mg RO7020531 orally on Day 1.
|
Multiple Ascending Dose (MAD): Placebo
n=6 Participants
In MAD Cohorts 1-3, there will be six participants in total receiving placebo, two in each cohort.
|
MAD: Cohort 1
n=8 Participants
Eight participants will be administered 100mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
|
MAD: Cohorts 2 and 3
n=16 Participants
Sixteen participants will be administered 150mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
26.25 Years
STANDARD_DEVIATION 6.65 • n=93 Participants
|
25.25 Years
STANDARD_DEVIATION 7.67 • n=4 Participants
|
24.13 Years
STANDARD_DEVIATION 8.58 • n=27 Participants
|
23.00 Years
STANDARD_DEVIATION 3.66 • n=483 Participants
|
26.75 Years
STANDARD_DEVIATION 9.44 • n=36 Participants
|
22.50 Years
STANDARD_DEVIATION 3.02 • n=10 Participants
|
25.75 Years
STANDARD_DEVIATION 8.24 • n=115 Participants
|
23.19 Years
STANDARD_DEVIATION 3.37 • n=40 Participants
|
24.50 Years
STANDARD_DEVIATION 6.37 • n=8 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
25 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
13 Participants
n=40 Participants
|
45 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
16 Participants
n=40 Participants
|
70 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Screening up until 28 days after the last dose of study drug (up to 1 year).Population: The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not.
An Adverse Event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, any deterioration in a laboratory value or other clinical test or adverse events that are related to a protocol-mandated intervention, including those that occur prior to assignment of study treatment.
Outcome measures
| Measure |
Single Ascending Dose (SAD): Placebo
n=8 Participants
In SAD Cohorts 1-4, there will be eight participants in total receiving placebo, two in each cohort.
|
SAD: Cohort 1
n=8 Participants
Eight participants will be administered 40mg RO7020531 orally on Day 1.
|
SAD: Cohort 2
n=8 Participants
Eight participants will be administered 100mg RO7020531 orally on Day 1.
|
SAD: Cohort 3
n=8 Participants
Eight participants will be administered 140mg RO7020531 orally on Day 1.
|
SAD: Cohort 4
n=8 Participants
Eight participants will be administered 170mg RO7020531 orally on Day 1.
|
Multiple Ascending Dose (MAD): Placebo
n=6 Participants
In MAD Cohorts 1-3, there will be six participants in total receiving placebo, two in each cohort.
|
MAD: Cohort 1
n=8 Participants
Eight participants will be administered 100mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
|
MAD: Cohorts 2 and 3
n=16 Participants
Sixteen participants will be administered 150mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs)
|
37.5 Percentage of Participants
|
37.5 Percentage of Participants
|
25.0 Percentage of Participants
|
50.0 Percentage of Participants
|
100 Percentage of Participants
|
100 Percentage of Participants
|
100 Percentage of Participants
|
93.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: SAD: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48 hours (h) Post-dose Days 1, 2; MAD: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24h Post-dose Days 1, 2 and Days 13, 14; Pre-dose, 2, 6, 24hr Post-dose Days 3, 5, 7, 9 and 11.Population: The PK analysis population included all healthy volunteers randomised and adherent to the protocol. Participants were excluded if they significantly violated the inclusion/exclusion criteria, deviated significantly from the protocol or if data were unavailable or incomplete. Data presented is only for participants included in the actual analysis.
Non-compartmental analysis using WinNonlin software was used to calculate PK parameters where appropriate. Summary descriptive statistics (Arithmetic Mean and Standard Deviation) for Cmax will be presented by treatment arm. Where appropriate, data maybe pooled and analyzed. Please note that this Outcome Measure was not measured for the Placebo Cohorts and SAD Cohorts (1-4) (on Day 13).
Outcome measures
| Measure |
Single Ascending Dose (SAD): Placebo
n=8 Participants
In SAD Cohorts 1-4, there will be eight participants in total receiving placebo, two in each cohort.
|
SAD: Cohort 1
n=8 Participants
Eight participants will be administered 40mg RO7020531 orally on Day 1.
|
SAD: Cohort 2
n=8 Participants
Eight participants will be administered 100mg RO7020531 orally on Day 1.
|
SAD: Cohort 3
n=8 Participants
Eight participants will be administered 140mg RO7020531 orally on Day 1.
|
SAD: Cohort 4
n=8 Participants
Eight participants will be administered 170mg RO7020531 orally on Day 1.
|
Multiple Ascending Dose (MAD): Placebo
n=16 Participants
In MAD Cohorts 1-3, there will be six participants in total receiving placebo, two in each cohort.
|
MAD: Cohort 1
Eight participants will be administered 100mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
|
MAD: Cohorts 2 and 3
Sixteen participants will be administered 150mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) for RO7020531, Main Active Metabolite (RO7011785) and Prodrug Metabolites (RO7018822 and RO7033805)
Day 1 (RO7033805)
|
NA ng/ml
Standard Deviation NA
Values were below the lower limit of quantification.
|
NA ng/ml
Standard Deviation NA
Values were below the lower limit of quantification.
|
0.14 ng/ml
Standard Deviation 0.39
|
NA ng/ml
Standard Deviation NA
Values were below the lower limit of quantification.
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) for RO7020531, Main Active Metabolite (RO7011785) and Prodrug Metabolites (RO7018822 and RO7033805)
Day 1 (RO7020531)
|
NA ng/ml
Standard Deviation NA
Values were below the lower limit of quantification.
|
NA ng/ml
Standard Deviation NA
Values were below the lower limit of quantification.
|
0.14 ng/ml
Standard Deviation 0.39
|
NA ng/ml
Standard Deviation NA
Values were below the lower limit of quantification.
|
—
|
1.08 ng/ml
Standard Deviation NA
Values were below the lower limit of quantification.
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) for RO7020531, Main Active Metabolite (RO7011785) and Prodrug Metabolites (RO7018822 and RO7033805)
Day 13 (RO7020531)
|
—
|
—
|
—
|
—
|
—
|
1.56 ng/ml
Standard Deviation NA
Values were below the lower limit of quantification.
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) for RO7020531, Main Active Metabolite (RO7011785) and Prodrug Metabolites (RO7018822 and RO7033805)
Day 1 (RO7011785)
|
640 ng/ml
Standard Deviation 227
|
1380 ng/ml
Standard Deviation 461
|
1940 ng/ml
Standard Deviation 516
|
2180 ng/ml
Standard Deviation 841
|
1290 ng/ml
Standard Deviation 414
|
1900 ng/ml
Standard Deviation 501
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) for RO7020531, Main Active Metabolite (RO7011785) and Prodrug Metabolites (RO7018822 and RO7033805)
Day 13 (RO7011785)
|
—
|
—
|
—
|
—
|
1110 ng/ml
Standard Deviation 480
|
1530 ng/ml
Standard Deviation 382
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) for RO7020531, Main Active Metabolite (RO7011785) and Prodrug Metabolites (RO7018822 and RO7033805)
Day 1 (RO7018822)
|
78.6 ng/ml
Standard Deviation 32.9
|
125 ng/ml
Standard Deviation 56.7
|
200 ng/ml
Standard Deviation 70.4
|
247 ng/ml
Standard Deviation 112
|
249 ng/ml
Standard Deviation 217
|
231 ng/ml
Standard Deviation 98.5
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) for RO7020531, Main Active Metabolite (RO7011785) and Prodrug Metabolites (RO7018822 and RO7033805)
Day 13 (RO7018822)
|
—
|
—
|
—
|
—
|
116 ng/ml
Standard Deviation 55.2
|
155 ng/ml
Standard Deviation 50.6
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) for RO7020531, Main Active Metabolite (RO7011785) and Prodrug Metabolites (RO7018822 and RO7033805)
Day 13 (RO7033805)
|
—
|
—
|
—
|
—
|
—
|
1.08 ng/ml
Standard Deviation NA
Values were below the lower limit of quantification.
|
—
|
—
|
SECONDARY outcome
Timeframe: SAD: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48 hours (h) Post-dose Days 1, 2; MAD: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24h Post-dose Days 1, 2 and Days 13, 14; Pre-dose, 2, 6, 24hr Post-dose Days 3, 5, 7, 9 and 11.Population: The PK analysis population included all healthy volunteers randomised and adherent to the protocol. Participants were excluded if they significantly violated the inclusion/exclusion criteria, deviated significantly from the protocol or if data were unavailable or incomplete. Data presented is only for participants included in the actual analysis.
Non-compartmental analysis using WinNonlin software was used to calculate PK parameters where appropriate. Summary descriptive statistics (Arithmetic Mean and Standard Deviation) for AUClast will be presented by treatment arm. Where appropriate, data maybe pooled and analyzed. Please note that this Outcome Measure was not measured for the Placebo Cohorts and SAD Cohorts (1-4) (on Day 13).
Outcome measures
| Measure |
Single Ascending Dose (SAD): Placebo
n=8 Participants
In SAD Cohorts 1-4, there will be eight participants in total receiving placebo, two in each cohort.
|
SAD: Cohort 1
n=8 Participants
Eight participants will be administered 40mg RO7020531 orally on Day 1.
|
SAD: Cohort 2
n=8 Participants
Eight participants will be administered 100mg RO7020531 orally on Day 1.
|
SAD: Cohort 3
n=8 Participants
Eight participants will be administered 140mg RO7020531 orally on Day 1.
|
SAD: Cohort 4
n=8 Participants
Eight participants will be administered 170mg RO7020531 orally on Day 1.
|
Multiple Ascending Dose (MAD): Placebo
n=16 Participants
In MAD Cohorts 1-3, there will be six participants in total receiving placebo, two in each cohort.
|
MAD: Cohort 1
Eight participants will be administered 100mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
|
MAD: Cohorts 2 and 3
Sixteen participants will be administered 150mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) for RO7020531, Main Active Metabolite (RO7011785) and Prodrug Metabolites (RO7018822 and RO7033805)
Day 1 (RO7020531)
|
0.00 hr*ng/ml
Standard Deviation 0.00
|
0.00 hr*ng/ml
Standard Deviation 0.00
|
0.02 hr*ng/ml
Standard Deviation 0.05
|
0.00 hr*ng/ml
Standard Deviation 0.00
|
—
|
0.14 hr*ng/ml
Standard Deviation NA
Values were below the lower limit of quantification.
|
—
|
—
|
|
Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) for RO7020531, Main Active Metabolite (RO7011785) and Prodrug Metabolites (RO7018822 and RO7033805)
Day 13 (RO7020531)
|
—
|
—
|
—
|
—
|
—
|
0.92 hr*ng/ml
Standard Deviation NA
Values were below the lower limit of quantification.
|
—
|
—
|
|
Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) for RO7020531, Main Active Metabolite (RO7011785) and Prodrug Metabolites (RO7018822 and RO7033805)
Day 1 (RO7011785)
|
707 hr*ng/ml
Standard Deviation 155
|
1660 hr*ng/ml
Standard Deviation 229
|
2500 hr*ng/ml
Standard Deviation 550
|
2700 hr*ng/ml
Standard Deviation 467
|
1870 hr*ng/ml
Standard Deviation 333
|
2650 hr*ng/ml
Standard Deviation 389
|
—
|
—
|
|
Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) for RO7020531, Main Active Metabolite (RO7011785) and Prodrug Metabolites (RO7018822 and RO7033805)
Day 13 (RO7011785)
|
—
|
—
|
—
|
—
|
1650 hr*ng/ml
Standard Deviation 313
|
2550 hr*ng/ml
Standard Deviation 521
|
—
|
—
|
|
Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) for RO7020531, Main Active Metabolite (RO7011785) and Prodrug Metabolites (RO7018822 and RO7033805)
Day 1 (RO7018822)
|
57.9 hr*ng/ml
Standard Deviation 22.8
|
109 hr*ng/ml
Standard Deviation 29.7
|
199 hr*ng/ml
Standard Deviation 78.9
|
250 hr*ng/ml
Standard Deviation 125
|
235 hr*ng/ml
Standard Deviation 125
|
211 hr*ng/ml
Standard Deviation 58.5
|
—
|
—
|
|
Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) for RO7020531, Main Active Metabolite (RO7011785) and Prodrug Metabolites (RO7018822 and RO7033805)
Day 13 (RO7018822)
|
—
|
—
|
—
|
—
|
169 hr*ng/ml
Standard Deviation 98.8
|
184 hr*ng/ml
Standard Deviation 51.0
|
—
|
—
|
|
Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) for RO7020531, Main Active Metabolite (RO7011785) and Prodrug Metabolites (RO7018822 and RO7033805)
Day 1 (RO7033805)
|
0.00 hr*ng/ml
Standard Deviation 0.00
|
0.00 hr*ng/ml
Standard Deviation 0.00
|
0.02 hr*ng/ml
Standard Deviation 0.05
|
0.00 hr*ng/ml
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) for RO7020531, Main Active Metabolite (RO7011785) and Prodrug Metabolites (RO7018822 and RO7033805)
Day 13 (RO7033805)
|
—
|
—
|
—
|
—
|
—
|
0.14 hr*ng/ml
Standard Deviation NA
Values were below the lower limit of quantification.
|
—
|
—
|
SECONDARY outcome
Timeframe: SAD: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48 hours (h) Post-dose Days 1, 2; MAD: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24h Post-dose Days 1, 2 and Days 13, 14; Pre-dose, 2, 6, 24hr Post-dose Days 3, 5, 7, 9 and 11.Population: The PK analysis population included all healthy volunteers randomised and adherent to the protocol. Participants were excluded if they significantly violated the inclusion/exclusion criteria, deviated significantly from the protocol or if data were unavailable or incomplete. Data presented is only for participants included in the actual analysis.
Non-compartmental analysis using WinNonlin software was used to calculate PK parameters where appropriate. Summary descriptive statistics (Arithmetic Mean and Standard Deviation) for AUCinf will be presented by treatment arm. Where appropriate, data maybe pooled and analyzed. Please note that this Outcome Measure was not measured for the Placebo Cohorts and SAD Cohorts (1-4) (on Day 13). Due to insufficient plasma concentration data for RO7020531 and RO7033805, AUCinf for these 2 compounds could not be estimated.
Outcome measures
| Measure |
Single Ascending Dose (SAD): Placebo
n=8 Participants
In SAD Cohorts 1-4, there will be eight participants in total receiving placebo, two in each cohort.
|
SAD: Cohort 1
n=8 Participants
Eight participants will be administered 40mg RO7020531 orally on Day 1.
|
SAD: Cohort 2
n=8 Participants
Eight participants will be administered 100mg RO7020531 orally on Day 1.
|
SAD: Cohort 3
n=8 Participants
Eight participants will be administered 140mg RO7020531 orally on Day 1.
|
SAD: Cohort 4
n=8 Participants
Eight participants will be administered 170mg RO7020531 orally on Day 1.
|
Multiple Ascending Dose (MAD): Placebo
n=16 Participants
In MAD Cohorts 1-3, there will be six participants in total receiving placebo, two in each cohort.
|
MAD: Cohort 1
Eight participants will be administered 100mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
|
MAD: Cohorts 2 and 3
Sixteen participants will be administered 150mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) for RO7020531, Main Active Metabolite (RO7011785) and Prodrug Metabolites (RO7018822 and RO7033805)
Day 1 (RO7011785)
|
714 hr*ng/ml
Standard Deviation 154
|
1670 hr*ng/ml
Standard Deviation 229
|
2510 hr*ng/ml
Standard Deviation 549
|
2720 hr*ng/ml
Standard Deviation 467
|
1880 hr*ng/ml
Standard Deviation 333
|
2660 hr*ng/ml
Standard Deviation 389
|
—
|
—
|
|
Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) for RO7020531, Main Active Metabolite (RO7011785) and Prodrug Metabolites (RO7018822 and RO7033805)
Day 13 (RO7011785)
|
—
|
—
|
—
|
—
|
1660 hr*ng/ml
Standard Deviation 311
|
2510 hr*ng/ml
Standard Deviation 523
|
—
|
—
|
|
Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) for RO7020531, Main Active Metabolite (RO7011785) and Prodrug Metabolites (RO7018822 and RO7033805)
Day 1 (RO7018822)
|
58.5 hr*ng/ml
Standard Deviation 22.8
|
111 hr*ng/ml
Standard Deviation 29.6
|
204 hr*ng/ml
Standard Deviation 80.6
|
245 hr*ng/ml
Standard Deviation 133
|
241 hr*ng/ml
Standard Deviation 135
|
214 hr*ng/ml
Standard Deviation 58.7
|
—
|
—
|
|
Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) for RO7020531, Main Active Metabolite (RO7011785) and Prodrug Metabolites (RO7018822 and RO7033805)
Day 13 (RO7018822)
|
—
|
—
|
—
|
—
|
177 hr*ng/ml
Standard Deviation 115
|
189 hr*ng/ml
Standard Deviation 52.4
|
—
|
—
|
SECONDARY outcome
Timeframe: SAD: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48 hours (h) Post-dose Days 1, 2; MAD: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24h Post-dose Days 1, 2 and Days 13, 14; Pre-dose, 2, 6, 24hr Post-dose Days 3, 5, 7, 9 and 11.Population: The PK analysis population included all healthy volunteers randomised and adherent to the protocol. Participants were excluded if they significantly violated the inclusion/exclusion criteria, deviated significantly from the protocol or if data were unavailable or incomplete. Data presented is only for participants included in the actual analysis.
Non-compartmental analysis using WinNonlin software was used to calculate PK parameters where appropriate. Summary descriptive statistics (Median and Full Range) for Tmax will be presented by treatment arm. Where appropriate, data maybe pooled and analyzed. Please note that this Outcome Measure was not measured for the Placebo Cohorts and SAD Cohorts (1-4) (on Day 13).
Outcome measures
| Measure |
Single Ascending Dose (SAD): Placebo
n=8 Participants
In SAD Cohorts 1-4, there will be eight participants in total receiving placebo, two in each cohort.
|
SAD: Cohort 1
n=8 Participants
Eight participants will be administered 40mg RO7020531 orally on Day 1.
|
SAD: Cohort 2
n=8 Participants
Eight participants will be administered 100mg RO7020531 orally on Day 1.
|
SAD: Cohort 3
n=8 Participants
Eight participants will be administered 140mg RO7020531 orally on Day 1.
|
SAD: Cohort 4
n=8 Participants
Eight participants will be administered 170mg RO7020531 orally on Day 1.
|
Multiple Ascending Dose (MAD): Placebo
n=16 Participants
In MAD Cohorts 1-3, there will be six participants in total receiving placebo, two in each cohort.
|
MAD: Cohort 1
Eight participants will be administered 100mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
|
MAD: Cohorts 2 and 3
Sixteen participants will be administered 150mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Observed Plasma Concentration (Tmax) for RO7020531, Main Active Metabolite (RO7011785) and Prodrug Metabolites (RO7018822 and RO7033805)
Day 1 (RO7020531)
|
—
|
—
|
0.50 hr
Interval 0.5 to 0.5
|
—
|
—
|
0.25 hr
Interval 0.25 to 0.25
|
—
|
—
|
|
Time to Maximum Observed Plasma Concentration (Tmax) for RO7020531, Main Active Metabolite (RO7011785) and Prodrug Metabolites (RO7018822 and RO7033805)
Day 13 (RO7020531)
|
—
|
—
|
—
|
—
|
—
|
0.50 hr
Interval 0.5 to 0.5
|
—
|
—
|
|
Time to Maximum Observed Plasma Concentration (Tmax) for RO7020531, Main Active Metabolite (RO7011785) and Prodrug Metabolites (RO7018822 and RO7033805)
Day 1 (RO7011785)
|
0.50 hr
Interval 0.5 to 1.0
|
0.75 hr
Interval 0.5 to 1.5
|
0.50 hr
Interval 0.5 to 1.5
|
0.50 hr
Interval 0.5 to 1.5
|
1.50 hr
Interval 0.5 to 2.0
|
0.52 hr
Interval 0.5 to 1.5
|
—
|
—
|
|
Time to Maximum Observed Plasma Concentration (Tmax) for RO7020531, Main Active Metabolite (RO7011785) and Prodrug Metabolites (RO7018822 and RO7033805)
Day 13 (RO7011785)
|
—
|
—
|
—
|
—
|
1.00 hr
Interval 0.53 to 3.0
|
1.00 hr
Interval 0.5 to 1.5
|
—
|
—
|
|
Time to Maximum Observed Plasma Concentration (Tmax) for RO7020531, Main Active Metabolite (RO7011785) and Prodrug Metabolites (RO7018822 and RO7033805)
Day 1 (RO7018822)
|
0.50 hr
Interval 0.5 to 1.0
|
0.50 hr
Interval 0.25 to 1.5
|
0.50 hr
Interval 0.25 to 1.5
|
0.50 hr
Interval 0.5 to 2.0
|
0.50 hr
Interval 0.25 to 2.0
|
0.50 hr
Interval 0.25 to 1.5
|
—
|
—
|
|
Time to Maximum Observed Plasma Concentration (Tmax) for RO7020531, Main Active Metabolite (RO7011785) and Prodrug Metabolites (RO7018822 and RO7033805)
Day 13 (RO7018822)
|
—
|
—
|
—
|
—
|
1.00 hr
Interval 0.25 to 3.0
|
0.50 hr
Interval 0.5 to 1.5
|
—
|
—
|
|
Time to Maximum Observed Plasma Concentration (Tmax) for RO7020531, Main Active Metabolite (RO7011785) and Prodrug Metabolites (RO7018822 and RO7033805)
Day 1 (RO7033805)
|
—
|
—
|
0.50 hr
Interval 0.5 to 0.5
|
—
|
—
|
—
|
—
|
—
|
|
Time to Maximum Observed Plasma Concentration (Tmax) for RO7020531, Main Active Metabolite (RO7011785) and Prodrug Metabolites (RO7018822 and RO7033805)
Day 13 (RO7033805)
|
—
|
—
|
—
|
—
|
—
|
0.50 hr
Interval 0.5 to 0.5
|
—
|
—
|
SECONDARY outcome
Timeframe: SAD: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48 hours (h) Post-dose Days 1, 2; MAD: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24h Post-dose Days 1, 2 and Days 13, 14; Pre-dose, 2, 6, 24hr Post-dose Days 3, 5, 7, 9 and 11.Population: The PK analysis population included all healthy volunteers randomised and adherent to the protocol. Participants were excluded if they significantly violated the inclusion/exclusion criteria, deviated significantly from the protocol or if data were unavailable or incomplete. Data presented is only for participants included in the actual analysis.
Non-compartmental analysis using WinNonlin software was used to calculate PK parameters where appropriate. Summary descriptive statistics (Arithmetic Mean and Standard Deviation) for t1/2 will be presented by treatment arm. Where appropriate, data maybe pooled and analyzed. Please note that this Outcome Measure was not measured for the Placebo Cohorts and SAD Cohorts (1-4) (on Day 13). Due to insufficient plasma concentration data for RO7020531 and RO7033805, t1/2 for these 2 compounds could not be estimated.
Outcome measures
| Measure |
Single Ascending Dose (SAD): Placebo
n=8 Participants
In SAD Cohorts 1-4, there will be eight participants in total receiving placebo, two in each cohort.
|
SAD: Cohort 1
n=8 Participants
Eight participants will be administered 40mg RO7020531 orally on Day 1.
|
SAD: Cohort 2
n=8 Participants
Eight participants will be administered 100mg RO7020531 orally on Day 1.
|
SAD: Cohort 3
n=8 Participants
Eight participants will be administered 140mg RO7020531 orally on Day 1.
|
SAD: Cohort 4
n=8 Participants
Eight participants will be administered 170mg RO7020531 orally on Day 1.
|
Multiple Ascending Dose (MAD): Placebo
n=16 Participants
In MAD Cohorts 1-3, there will be six participants in total receiving placebo, two in each cohort.
|
MAD: Cohort 1
Eight participants will be administered 100mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
|
MAD: Cohorts 2 and 3
Sixteen participants will be administered 150mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
|
|---|---|---|---|---|---|---|---|---|
|
Half-Life (t1/2) for RO7020531, Main Active Metabolite (RO7011785) and Prodrug Metabolites (RO7018822 and RO7033805)
Day 1 (RO7011785)
|
2.92 hr
Standard Deviation 0.787
|
3.38 hr
Standard Deviation 0.499
|
3.96 hr
Standard Deviation 0.761
|
4.24 hr
Standard Deviation 0.667
|
3.38 hr
Standard Deviation 0.976
|
4.39 hr
Standard Deviation 0.918
|
—
|
—
|
|
Half-Life (t1/2) for RO7020531, Main Active Metabolite (RO7011785) and Prodrug Metabolites (RO7018822 and RO7033805)
Day 13 (RO7011785)
|
—
|
—
|
—
|
—
|
3.52 hr
Standard Deviation 0.813
|
3.85 hr
Standard Deviation 0.807
|
—
|
—
|
|
Half-Life (t1/2) for RO7020531, Main Active Metabolite (RO7011785) and Prodrug Metabolites (RO7018822 and RO7033805)
Day 1 (RO7018822)
|
0.519 hr
Standard Deviation 0.124
|
0.606 hr
Standard Deviation 0.0932
|
0.642 hr
Standard Deviation 0.160
|
0.612 hr
Standard Deviation 0.172
|
0.605 hr
Standard Deviation 0.0920
|
0.611 hr
Standard Deviation 0.0935
|
—
|
—
|
|
Half-Life (t1/2) for RO7020531, Main Active Metabolite (RO7011785) and Prodrug Metabolites (RO7018822 and RO7033805)
Day 13 (RO7018822)
|
—
|
—
|
—
|
—
|
0.753 hr
Standard Deviation 0.189
|
0.706 hr
Standard Deviation 0.315
|
—
|
—
|
SECONDARY outcome
Timeframe: SAD: Pre-dose, 0-4, 4-8, 8-12, 12-24h Day 1Population: The PK analysis population included all healthy volunteers randomised and adherent to the protocol. Participants were excluded if they significantly violated the inclusion/exclusion criteria, deviated significantly from the protocol or if data were unavailable or incomplete. Data presented is only for participants included in the actual analysis.
Non-compartmental analysis using WinNonlin software was used to calculate PK parameters where appropriate. Summary descriptive statistics (Arithmetic Mean and Standard Deviation) for Total Amount Excreted, will be presented by treatment arm. Where appropriate, data maybe pooled and analyzed. Please note that this Outcome Measure was not measured for the Placebo Cohorts and MAD Cohorts (1-4).
Outcome measures
| Measure |
Single Ascending Dose (SAD): Placebo
n=8 Participants
In SAD Cohorts 1-4, there will be eight participants in total receiving placebo, two in each cohort.
|
SAD: Cohort 1
n=8 Participants
Eight participants will be administered 40mg RO7020531 orally on Day 1.
|
SAD: Cohort 2
n=8 Participants
Eight participants will be administered 100mg RO7020531 orally on Day 1.
|
SAD: Cohort 3
n=8 Participants
Eight participants will be administered 140mg RO7020531 orally on Day 1.
|
SAD: Cohort 4
Eight participants will be administered 170mg RO7020531 orally on Day 1.
|
Multiple Ascending Dose (MAD): Placebo
In MAD Cohorts 1-3, there will be six participants in total receiving placebo, two in each cohort.
|
MAD: Cohort 1
Eight participants will be administered 100mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
|
MAD: Cohorts 2 and 3
Sixteen participants will be administered 150mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
|
|---|---|---|---|---|---|---|---|---|
|
Total Amount Excreted as RO7020531, RO7011785, RO7018822 and RO7033805
RO7020531
|
0.00 mg
Standard Deviation 0.00
|
0.00 mg
Standard Deviation 0.00
|
0.00 mg
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
—
|
|
Total Amount Excreted as RO7020531, RO7011785, RO7018822 and RO7033805
RO7011785
|
22.2 mg
Standard Deviation 1.96
|
58.3 mg
Standard Deviation 6.27
|
87.0 mg
Standard Deviation 10.1
|
104 mg
Standard Deviation 14.9
|
—
|
—
|
—
|
—
|
|
Total Amount Excreted as RO7020531, RO7011785, RO7018822 and RO7033805
RO7018822
|
0.39 mg
Standard Deviation 0.14
|
0.74 mg
Standard Deviation 0.16
|
1.31 mg
Standard Deviation 0.40
|
1.63 mg
Standard Deviation 0.51
|
—
|
—
|
—
|
—
|
|
Total Amount Excreted as RO7020531, RO7011785, RO7018822 and RO7033805
RO7033805
|
0.00 mg
Standard Deviation 0.00
|
0.00 mg
Standard Deviation 0.00
|
0.00 mg
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: SAD: Pre-dose, 0-4, 4-8, 8-12, 12-24h Day 1Population: The PK analysis population included all healthy volunteers randomised and adherent to the protocol. Participants were excluded if they significantly violated the inclusion/exclusion criteria, deviated significantly from the protocol or if data were unavailable or incomplete. Data presented is only for participants included in the actual analysis.
Non-compartmental analysis using WinNonlin software was used to calculate PK parameters where appropriate. Summary descriptive statistics (Arithmetic Mean and Standard Deviation) for Fraction Excreted (Molecular Weight corrected) will be presented by treatment arm. Where appropriate, data maybe pooled and analyzed. Please note that this Outcome Measure was not measured for the Placebo Cohorts and MAD Cohorts (1-4).
Outcome measures
| Measure |
Single Ascending Dose (SAD): Placebo
n=8 Participants
In SAD Cohorts 1-4, there will be eight participants in total receiving placebo, two in each cohort.
|
SAD: Cohort 1
n=8 Participants
Eight participants will be administered 40mg RO7020531 orally on Day 1.
|
SAD: Cohort 2
n=8 Participants
Eight participants will be administered 100mg RO7020531 orally on Day 1.
|
SAD: Cohort 3
n=8 Participants
Eight participants will be administered 140mg RO7020531 orally on Day 1.
|
SAD: Cohort 4
Eight participants will be administered 170mg RO7020531 orally on Day 1.
|
Multiple Ascending Dose (MAD): Placebo
In MAD Cohorts 1-3, there will be six participants in total receiving placebo, two in each cohort.
|
MAD: Cohort 1
Eight participants will be administered 100mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
|
MAD: Cohorts 2 and 3
Sixteen participants will be administered 150mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
|
|---|---|---|---|---|---|---|---|---|
|
Fraction Excreted as RO7020531, RO7011785, RO7018822 and RO7033805
RO7020531
|
0.00 Percentage
Standard Deviation 0.00
|
0.00 Percentage
Standard Deviation 0.00
|
0.00 Percentage
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
—
|
|
Fraction Excreted as RO7020531, RO7011785, RO7018822 and RO7033805
RO7011785
|
59.9 Percentage
Standard Deviation 5.30
|
62.9 Percentage
Standard Deviation 6.77
|
67.1 Percentage
Standard Deviation 7.78
|
66.2 Percentage
Standard Deviation 9.47
|
—
|
—
|
—
|
—
|
|
Fraction Excreted as RO7020531, RO7011785, RO7018822 and RO7033805
RO7018822
|
1.10 Percentage
Standard Deviation 0.40
|
0.84 Percentage
Standard Deviation 0.18
|
1.06 Percentage
Standard Deviation 0.33
|
1.09 Percentage
Standard Deviation 0.34
|
—
|
—
|
—
|
—
|
|
Fraction Excreted as RO7020531, RO7011785, RO7018822 and RO7033805
RO7033805
|
0.00 Percentage
Standard Deviation 0.00
|
0.00 Percentage
Standard Deviation 0.00
|
0.00 Percentage
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: SAD: Pre-dose, 0-4, 4-8, 8-12, 12-24h Day 1Population: The PK analysis population included all healthy volunteers randomised and adherent to the protocol. Participants were excluded if they significantly violated the inclusion/exclusion criteria, deviated significantly from the protocol or if data were unavailable or incomplete. Data presented is only for participants included in the actual analysis.
Non-compartmental analysis using WinNonlin software was used to calculate PK parameters where appropriate. Summary descriptive statistics (Arithmetic Mean and Standard Deviation) for Renal Clearance will be presented by treatment arm. Where appropriate, data maybe pooled and analyzed. Please note that this Outcome Measure was not measured for the Placebo Cohorts and MAD Cohorts (1-4). Due to insufficient urine concentration data for RO7020531 and RO7033805, Renal Clearance for these 2 compounds could not be estimated.
Outcome measures
| Measure |
Single Ascending Dose (SAD): Placebo
n=8 Participants
In SAD Cohorts 1-4, there will be eight participants in total receiving placebo, two in each cohort.
|
SAD: Cohort 1
n=8 Participants
Eight participants will be administered 40mg RO7020531 orally on Day 1.
|
SAD: Cohort 2
n=8 Participants
Eight participants will be administered 100mg RO7020531 orally on Day 1.
|
SAD: Cohort 3
n=8 Participants
Eight participants will be administered 140mg RO7020531 orally on Day 1.
|
SAD: Cohort 4
Eight participants will be administered 170mg RO7020531 orally on Day 1.
|
Multiple Ascending Dose (MAD): Placebo
In MAD Cohorts 1-3, there will be six participants in total receiving placebo, two in each cohort.
|
MAD: Cohort 1
Eight participants will be administered 100mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
|
MAD: Cohorts 2 and 3
Sixteen participants will be administered 150mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
|
|---|---|---|---|---|---|---|---|---|
|
Renal Clearance of RO7020531, RO7011785, RO7018822 and RO7033805
RO7011785
|
536 CLr (mL/min)
Standard Deviation 101
|
590 CLr (mL/min)
Standard Deviation 78.4
|
600 CLr (mL/min)
Standard Deviation 136
|
659 CLr (mL/min)
Standard Deviation 157
|
—
|
—
|
—
|
—
|
|
Renal Clearance of RO7020531, RO7011785, RO7018822 and RO7033805
RO7018822
|
115.31 CLr (mL/min)
Standard Deviation 48.54
|
116.30 CLr (mL/min)
Standard Deviation 36.41
|
117.80 CLr (mL/min)
Standard Deviation 42.15
|
119.99 CLr (mL/min)
Standard Deviation 36.54
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: SAD: Day -1, Pre-dose, 2, 6, 12, 24h Post-dose Day 1 to Day 2, 3, 5, 8; MAD: Day -1, Pre-dose 2, 6, 12, 24h Post-dose Day 1 to Day 2, Pre-dose, 2, 6, 24h Post-dose Days 3, 5, 7, 13 and 20Population: The Pharmacodynamic (PD) analysis population was defined as all participants who were randomized, received at least one dose of study medication (RO7020531 or placebo), and have PD data available.
Protein and metabolite markers of humoral response include interferon (IFN)-alfa, IP-10, Tumor Necrosis Factor (TNF)-alfa, interleukin (IL)-6, IL-10, IL-12p40 and Neopterin. Summary descriptive statistics will be presented for the induction of cytokines, chemokines and neopterin and of interferon-response genes separately by treatment arm. Only mean concentrations were collected for IFN-alfa and hence why this data is only presented below.
Outcome measures
| Measure |
Single Ascending Dose (SAD): Placebo
n=8 Participants
In SAD Cohorts 1-4, there will be eight participants in total receiving placebo, two in each cohort.
|
SAD: Cohort 1
n=8 Participants
Eight participants will be administered 40mg RO7020531 orally on Day 1.
|
SAD: Cohort 2
n=8 Participants
Eight participants will be administered 100mg RO7020531 orally on Day 1.
|
SAD: Cohort 3
n=8 Participants
Eight participants will be administered 140mg RO7020531 orally on Day 1.
|
SAD: Cohort 4
n=8 Participants
Eight participants will be administered 170mg RO7020531 orally on Day 1.
|
Multiple Ascending Dose (MAD): Placebo
n=6 Participants
In MAD Cohorts 1-3, there will be six participants in total receiving placebo, two in each cohort.
|
MAD: Cohort 1
n=8 Participants
Eight participants will be administered 100mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
|
MAD: Cohorts 2 and 3
n=16 Participants
Sixteen participants will be administered 150mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
|
|---|---|---|---|---|---|---|---|---|
|
Mean Concentrations of Protein and Metabolite Markers of Humoral Response
|
0.1232 ng/L
Standard Deviation 8.5366
|
0.0433 ng/L
Standard Deviation 1.0244
|
0.0707 ng/L
Standard Deviation 2.3422
|
0.1316 ng/L
Standard Deviation 3.6720
|
0.1156 ng/L
Standard Deviation 3.6654
|
0.0455 ng/L
Standard Deviation 1.2143
|
0.1339 ng/L
Standard Deviation 4.1386
|
0.3733 ng/L
Standard Deviation 6.4327
|
SECONDARY outcome
Timeframe: SAD: Day -1, Pre-dose, 2, 6, 12, 24, 48 (only Neopterin), 96h (only Neopterin), Post-dose Day 1 to Day 2, 3, 5, 8; MAD: Day -1, Pre-dose 2, 6, 12, 24h Post-dose Day 1 to Day 2, Pre-dose, 2, 6, 24h Post-dose Days 3, 5, 7, 13 and 20Population: The Pharmacodynamic (PD) analysis population was defined as all participants who were randomized, received at least one dose of study medication (RO7020531 or placebo), and have PD data available.
Protein and metabolite markers of humoral response include interferon (IFN)-alfa, IP-10, Tumor Necrosis Factor (TNF)-alfa, interleukin (IL)-6, IL-10, IL-12p40 and Neopterin. Summary descriptive statistics will be presented for the induction of cytokines, chemokines and neopterin and of interferon-response genes separately by treatment arm. Mean fold change data is presented below.
Outcome measures
| Measure |
Single Ascending Dose (SAD): Placebo
n=8 Participants
In SAD Cohorts 1-4, there will be eight participants in total receiving placebo, two in each cohort.
|
SAD: Cohort 1
n=8 Participants
Eight participants will be administered 40mg RO7020531 orally on Day 1.
|
SAD: Cohort 2
n=8 Participants
Eight participants will be administered 100mg RO7020531 orally on Day 1.
|
SAD: Cohort 3
n=8 Participants
Eight participants will be administered 140mg RO7020531 orally on Day 1.
|
SAD: Cohort 4
n=8 Participants
Eight participants will be administered 170mg RO7020531 orally on Day 1.
|
Multiple Ascending Dose (MAD): Placebo
n=6 Participants
In MAD Cohorts 1-3, there will be six participants in total receiving placebo, two in each cohort.
|
MAD: Cohort 1
n=8 Participants
Eight participants will be administered 100mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
|
MAD: Cohorts 2 and 3
n=16 Participants
Sixteen participants will be administered 150mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
|
|---|---|---|---|---|---|---|---|---|
|
Mean Fold Changes of Protein and Metabolite Markers of Humoral Response
IP-10
|
1.1108 Fold Change
Interval 0.589 to 2.088
|
0.9522 Fold Change
Interval 0.651 to 1.552
|
0.9987 Fold Change
Interval 0.265 to 4.637
|
1.5327 Fold Change
Interval 0.57 to 7.885
|
1.6229 Fold Change
Interval 0.607 to 25.958
|
0.8087 Fold Change
Interval 0.191 to 2.084
|
1.4014 Fold Change
Interval 0.545 to 21.149
|
2.1550 Fold Change
Interval 0.374 to 49.901
|
|
Mean Fold Changes of Protein and Metabolite Markers of Humoral Response
Neopterin
|
1.0757 Fold Change
Interval 0.741 to 1.766
|
1.0175 Fold Change
Interval 0.759 to 1.287
|
1.0408 Fold Change
Interval 0.621 to 1.783
|
1.1615 Fold Change
Interval 0.811 to 3.0
|
1.2142 Fold Change
Interval 0.824 to 3.561
|
0.9003 Fold Change
Interval 0.278 to 1.75
|
1.2012 Fold Change
Interval 0.754 to 3.071
|
1.6792 Fold Change
Interval 0.445 to 7.797
|
|
Mean Fold Changes of Protein and Metabolite Markers of Humoral Response
Tumor Necrosis Factor (TNF)-alfa
|
1.0233 Fold Change
Interval 0.664 to 2.027
|
0.9286 Fold Change
Interval 0.48 to 1.877
|
0.7816 Fold Change
Interval 0.054 to 2.153
|
1.2098 Fold Change
Interval 0.563 to 2.187
|
1.0947 Fold Change
Interval 0.507 to 3.196
|
0.7482 Fold Change
Interval 0.086 to 1.881
|
0.9661 Fold Change
Interval 0.064 to 2.375
|
0.9909 Fold Change
Interval 0.17 to 2.591
|
|
Mean Fold Changes of Protein and Metabolite Markers of Humoral Response
IL-6
|
1.0699 Fold Change
Interval 0.208 to 2.719
|
0.9374 Fold Change
Interval 0.223 to 2.676
|
1.0253 Fold Change
Interval 0.105 to 8.919
|
1.1300 Fold Change
Interval 0.483 to 2.975
|
1.0363 Fold Change
Interval 0.273 to 4.513
|
0.8815 Fold Change
Interval 0.059 to 8.506
|
1.0762 Fold Change
Interval 0.304 to 9.522
|
1.0702 Fold Change
Interval 0.081 to 10.878
|
|
Mean Fold Changes of Protein and Metabolite Markers of Humoral Response
IL-10
|
0.9410 Fold Change
Interval 0.39 to 1.757
|
0.8394 Fold Change
Interval 0.388 to 2.571
|
1.0561 Fold Change
Interval 0.317 to 4.244
|
1.0567 Fold Change
Interval 0.86 to 1.847
|
1.1666 Fold Change
Interval 0.679 to 3.834
|
0.8262 Fold Change
Interval 0.074 to 10.016
|
0.9641 Fold Change
Interval 0.083 to 3.116
|
0.9662 Fold Change
Interval 0.138 to 5.398
|
|
Mean Fold Changes of Protein and Metabolite Markers of Humoral Response
IL-12p40
|
0.9126 Fold Change
Interval 0.296 to 1.504
|
0.9872 Fold Change
Interval 0.749 to 2.252
|
0.9844 Fold Change
Interval 0.47 to 2.971
|
0.9811 Fold Change
Interval 0.863 to 1.289
|
0.9781 Fold Change
Interval 0.658 to 1.536
|
1.0260 Fold Change
Interval 1.0 to 1.792
|
0.9384 Fold Change
Interval 0.386 to 5.008
|
1.0331 Fold Change
Interval 1.0 to 2.311
|
SECONDARY outcome
Timeframe: SAD: Day -1, Pre-dose, 2, 6, 12, 24h Post-dose Day 1 to Day 2 and Day 8; MAD: Day -1, Pre-dose 2, 6, 12, 24h Post-dose Day 1 to Day 2, Pre-dose, 2, 6, 24h Post-dose Days 3, 5, 7, 13 and 20Population: The PD analysis population was defined as all participants who were randomized, received at least one dose of study medication (RO7020531 or placebo), and have PD data available.
Markers of transcriptional responses includes ISG15, OAS-1, MX1 and Toll-Like Receptor (TLR)7. Summary descriptive statistics will be presented for these markers separately by treatment arm.
Outcome measures
| Measure |
Single Ascending Dose (SAD): Placebo
n=8 Participants
In SAD Cohorts 1-4, there will be eight participants in total receiving placebo, two in each cohort.
|
SAD: Cohort 1
n=8 Participants
Eight participants will be administered 40mg RO7020531 orally on Day 1.
|
SAD: Cohort 2
n=8 Participants
Eight participants will be administered 100mg RO7020531 orally on Day 1.
|
SAD: Cohort 3
n=8 Participants
Eight participants will be administered 140mg RO7020531 orally on Day 1.
|
SAD: Cohort 4
n=8 Participants
Eight participants will be administered 170mg RO7020531 orally on Day 1.
|
Multiple Ascending Dose (MAD): Placebo
n=6 Participants
In MAD Cohorts 1-3, there will be six participants in total receiving placebo, two in each cohort.
|
MAD: Cohort 1
n=8 Participants
Eight participants will be administered 100mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
|
MAD: Cohorts 2 and 3
n=16 Participants
Sixteen participants will be administered 150mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
|
|---|---|---|---|---|---|---|---|---|
|
Mean Fold Changes of Markers of Transcriptional Responses
ISG15 mRNA
|
1.0538 Fold Change
Interval 0.097 to 2.471
|
1.0907 Fold Change
Interval 0.381 to 2.255
|
1.9190 Fold Change
Interval 0.404 to 16.973
|
4.0828 Fold Change
Interval 0.272 to 119.203
|
4.3223 Fold Change
Interval 0.522 to 49.787
|
0.6938 Fold Change
Interval 0.043 to 18.505
|
2.0720 Fold Change
Interval 0.284 to 66.544
|
4.2679 Fold Change
Interval 0.108 to 285.243
|
|
Mean Fold Changes of Markers of Transcriptional Responses
OAS-1 mRNA
|
1.0739 Fold Change
Interval 0.24 to 1.948
|
1.1256 Fold Change
Interval 0.689 to 1.723
|
1.6148 Fold Change
Interval 0.445 to 8.118
|
2.9338 Fold Change
Interval 0.273 to 18.984
|
3.0716 Fold Change
Interval 0.908 to 21.051
|
0.6315 Fold Change
Interval 0.065 to 3.918
|
1.9447 Fold Change
Interval 0.4 to 30.905
|
3.1327 Fold Change
Interval 0.242 to 84.463
|
|
Mean Fold Changes of Markers of Transcriptional Responses
MX1 mRNA
|
1.0562 Fold Change
Interval 0.158 to 2.544
|
1.1742 Fold Change
Interval 0.506 to 1.848
|
2.1984 Fold Change
Interval 0.536 to 12.948
|
3.8705 Fold Change
Interval 0.299 to 46.893
|
4.3748 Fold Change
Interval 0.784 to 46.515
|
0.7414 Fold Change
Interval 0.066 to 6.957
|
1.8317 Fold Change
Interval 0.312 to 30.016
|
3.0186 Fold Change
Interval 0.183 to 106.211
|
|
Mean Fold Changes of Markers of Transcriptional Responses
TLR7 mRNA
|
1.0883 Fold Change
Interval 0.258 to 2.595
|
1.1638 Fold Change
Interval 0.587 to 2.301
|
0.9921 Fold Change
Interval 0.471 to 3.214
|
2.0835 Fold Change
Interval 0.602 to 11.521
|
1.3872 Fold Change
Interval 0.299 to 4.584
|
0.8483 Fold Change
Interval 0.275 to 1.708
|
1.4923 Fold Change
Interval 0.442 to 6.572
|
1.5454 Fold Change
Interval 0.243 to 17.387
|
Adverse Events
Single Ascending Dose (SAD): Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
SAD: Cohort 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
SAD: Cohort 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
SAD: Cohort 3
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
SAD: Cohort 4
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Multiple Ascending Dose (MAD): Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
MAD: Cohort 1
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
MAD: Cohorts 2 and 3
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single Ascending Dose (SAD): Placebo
n=8 participants at risk
In SAD Cohorts 1-4, there will be eight participants in total receiving placebo, two in each cohort.
|
SAD: Cohort 1
n=8 participants at risk
Eight participants will be administered 40mg RO7020531 orally on Day 1.
|
SAD: Cohort 2
n=8 participants at risk
Eight participants will be administered 100mg RO7020531 orally on Day 1.
|
SAD: Cohort 3
n=8 participants at risk
Eight participants will be administered 140mg RO7020531 orally on Day 1.
|
SAD: Cohort 4
n=8 participants at risk
Eight participants will be administered 170mg RO7020531 orally on Day 1.
|
Multiple Ascending Dose (MAD): Placebo
n=6 participants at risk
In MAD Cohorts 1-3, there will be six participants in total receiving placebo, two in each cohort.
|
MAD: Cohort 1
n=8 participants at risk
Eight participants will be administered 100mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
|
MAD: Cohorts 2 and 3
n=16 participants at risk
Sixteen participants will be administered 150mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
|
|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/16 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
Other adverse events
| Measure |
Single Ascending Dose (SAD): Placebo
n=8 participants at risk
In SAD Cohorts 1-4, there will be eight participants in total receiving placebo, two in each cohort.
|
SAD: Cohort 1
n=8 participants at risk
Eight participants will be administered 40mg RO7020531 orally on Day 1.
|
SAD: Cohort 2
n=8 participants at risk
Eight participants will be administered 100mg RO7020531 orally on Day 1.
|
SAD: Cohort 3
n=8 participants at risk
Eight participants will be administered 140mg RO7020531 orally on Day 1.
|
SAD: Cohort 4
n=8 participants at risk
Eight participants will be administered 170mg RO7020531 orally on Day 1.
|
Multiple Ascending Dose (MAD): Placebo
n=6 participants at risk
In MAD Cohorts 1-3, there will be six participants in total receiving placebo, two in each cohort.
|
MAD: Cohort 1
n=8 participants at risk
Eight participants will be administered 100mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
|
MAD: Cohorts 2 and 3
n=16 participants at risk
Sixteen participants will be administered 150mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
|
|---|---|---|---|---|---|---|---|---|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/16 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
6.2%
1/16 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
16.7%
1/6 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/16 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
43.8%
7/16 • Number of events 7 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
16.7%
1/6 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
25.0%
2/8 • Number of events 2 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/16 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
6.2%
1/16 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
6.2%
1/16 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Eye disorders
Dry eye
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/16 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
6.2%
1/16 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
2/16 • Number of events 2 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
6.2%
1/16 • Number of events 2 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
16.7%
1/6 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
25.0%
2/8 • Number of events 2 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
2/16 • Number of events 2 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
16.7%
1/6 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
6.2%
1/16 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
16.7%
1/6 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
2/16 • Number of events 2 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
25.0%
2/8 • Number of events 2 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/16 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Gastrointestinal disorders
Gingival swelling
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/16 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
2/16 • Number of events 2 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
6.2%
1/16 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
6.2%
1/16 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
General disorders
Asthenia
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
2/16 • Number of events 2 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
General disorders
Catheter site bruise
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
25.0%
2/8 • Number of events 3 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
2/16 • Number of events 2 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
General disorders
Catheter site erythema
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/16 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
General disorders
Catheter site hypoaesthesia
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/16 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
General disorders
Catheter site pain
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
16.7%
1/6 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
25.0%
2/8 • Number of events 2 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
6.2%
1/16 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
General disorders
Catheter site pruritus
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/16 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
General disorders
Catheter site swelling
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
6.2%
1/16 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
General disorders
Chest pain
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
16.7%
1/6 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/16 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
General disorders
Chills
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
6.2%
1/16 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
General disorders
Fatigue
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
16.7%
1/6 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
25.0%
4/16 • Number of events 4 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
General disorders
Influenza like illness
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
6.2%
1/16 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
General disorders
Pyrexia
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
43.8%
7/16 • Number of events 7 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/16 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
25.0%
2/8 • Number of events 2 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
37.5%
3/8 • Number of events 3 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/16 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/16 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
16.7%
1/6 • Number of events 2 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
2/16 • Number of events 2 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
16.7%
1/6 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/16 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/16 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
6.2%
1/16 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
6.2%
1/16 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
16.7%
1/6 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
6.2%
1/16 • Number of events 2 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
16.7%
1/6 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
6.2%
1/16 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/16 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
18.8%
3/16 • Number of events 3 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
16.7%
1/6 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
25.0%
2/8 • Number of events 2 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
31.2%
5/16 • Number of events 5 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
6.2%
1/16 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Nervous system disorders
Presyncope
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/16 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
25.0%
2/8 • Number of events 2 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
18.8%
3/16 • Number of events 3 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/16 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
16.7%
1/6 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
37.5%
3/8 • Number of events 3 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/16 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
2/16 • Number of events 2 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
16.7%
1/6 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
37.5%
3/8 • Number of events 3 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
6.2%
1/16 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/16 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
12.5%
1/8 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/16 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
25.0%
2/8 • Number of events 2 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/16 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/6 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
0.00%
0/8 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
6.2%
1/16 • Number of events 1 • Screening up until 28 days after the last dose of study drug (up to 1 year).
The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. AEs that were entered into the database at the time of the database lock were included in the AE analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER