Trial Outcomes & Findings for A Study of LY3009104(Baricitinib) for Healthy Subjects (NCT NCT01247350)
NCT ID: NCT01247350
Last Updated: 2018-04-13
Results Overview
Adverse events were considered clinically significant effects. A summary of serious adverse events and other nonserious adverse events are located in the Reported Adverse Event section.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
34 participants
Primary outcome timeframe
Days 1-10 for Cohorts 1 & 2, Days 1-7 for single dose of Cohorts 3 & 4, Days 8-31 for multiple doses
Results posted on
2018-04-13
Participant Flow
Participant milestones
| Measure |
2 mg LY3009104 (Baricitinib)
2 mg administered orally once on Day 1 (single dose)
|
5 mg LY3009104
5 mg administered orally once on Day 1 (single dose)
|
10 mg LY3009104
10 mg administered orally on Day 1 (single dose) and following a 7-day washout period, administered once daily for 10 days ((multiple dose)
|
14 mg LY3009104
14 mg administered orally on Day 1 (single dose) and following a 7-day washout period, administered once daily for 10 days (multiple dose)
|
Placebo
administered orally on Day 1 (single dose) and following a 7-day washout period, administered once daily for 10 days (multiple dose)
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
7
|
9
|
|
Overall Study
Received Multiple Doses of Study Drug
|
0
|
0
|
6
|
6
|
5
|
|
Overall Study
COMPLETED
|
6
|
6
|
5
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
2 mg LY3009104 (Baricitinib)
2 mg administered orally once on Day 1 (single dose)
|
5 mg LY3009104
5 mg administered orally once on Day 1 (single dose)
|
10 mg LY3009104
10 mg administered orally on Day 1 (single dose) and following a 7-day washout period, administered once daily for 10 days ((multiple dose)
|
14 mg LY3009104
14 mg administered orally on Day 1 (single dose) and following a 7-day washout period, administered once daily for 10 days (multiple dose)
|
Placebo
administered orally on Day 1 (single dose) and following a 7-day washout period, administered once daily for 10 days (multiple dose)
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Entry criteria not met
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of LY3009104(Baricitinib) for Healthy Subjects
Baseline characteristics by cohort
| Measure |
2 mg LY3009104
n=6 Participants
2 mg administered orally once on Day 1 (single dose)
|
5 mg LY3009104
n=6 Participants
5 mg administered orally once on Day 1 (single dose)
|
10 mg LY3009104
n=6 Participants
10 mg administered orally on Day 1 (single dose) and following a 7-day washout period, administered once daily for 10 days ((multiple dose)
|
14 mg LY3009104
n=7 Participants
14 mg administered orally on Day 1 (single dose) and following a 7-day washout period, administered once daily for 10 days (multiple dose)
|
Placebo
n=9 Participants
administered orally on Day 1 (single dose) and following a 7-day washout period, administered once daily for 10 days (multiple dose)
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
46.3 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
48.0 years
STANDARD_DEVIATION 15.0 • n=7 Participants
|
46.7 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
51.1 years
STANDARD_DEVIATION 6.3 • n=4 Participants
|
45.1 years
STANDARD_DEVIATION 10.7 • n=21 Participants
|
47.4 years
STANDARD_DEVIATION 10.2 • n=10 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
22 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
34 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
34 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Days 1-10 for Cohorts 1 & 2, Days 1-7 for single dose of Cohorts 3 & 4, Days 8-31 for multiple dosesPopulation: Participants who were administered study drug.
Adverse events were considered clinically significant effects. A summary of serious adverse events and other nonserious adverse events are located in the Reported Adverse Event section.
Outcome measures
| Measure |
2 mg LY3009104 Single Dose
n=6 Participants
2 mg administered orally once on Day 1
|
5 mg LY3009104 Single Dose
n=6 Participants
5 mg administered orally once on Day 1
|
10 mg LY3009104 Single Dose
n=6 Participants
10 mg administered orally once on Day 1
|
14 mg LY3009104 Single Dose
n=7 Participants
14 mg administered orally once on Day 1
|
Placebo Single Dose
n=9 Participants
administered orally once on Day 1
|
10 mg LY3009104 Multiple Dose
n=6 Participants
Following a 7-day washout period, participants in the 10 mg LY3009104 single-dose group received 10 mg LY3009104 once daily for 10 days
|
14 mg LY3009104 Multiple Dose
n=6 Participants
Following a 7-day washout period, participants in the 14 mg LY3009104 single-dose group received 14 mg LY3009104 once daily for 10 days
|
Placebo Multiple Dose
n=5 Participants
Following a 7-day washout period, participants in the placebo single-dose group received placebo once daily for 10 days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Effects
Serious Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Effects
Nonserious Adverse Events
|
1 Participants
|
1 Participants
|
2 Participants
|
7 Participants
|
6 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdosePopulation: Participants who were administered study drug and had pharmacokinetics (PK) samples for the analyses.
Cmax of Day 1 is Cmax after single dose, and Cmax of Day 17 is Cmax at steady-state.
Outcome measures
| Measure |
2 mg LY3009104 Single Dose
n=6 Participants
2 mg administered orally once on Day 1
|
5 mg LY3009104 Single Dose
n=6 Participants
5 mg administered orally once on Day 1
|
10 mg LY3009104 Single Dose
n=6 Participants
10 mg administered orally once on Day 1
|
14 mg LY3009104 Single Dose
n=7 Participants
14 mg administered orally once on Day 1
|
Placebo Single Dose
n=5 Participants
administered orally once on Day 1
|
10 mg LY3009104 Multiple Dose
n=6 Participants
Following a 7-day washout period, participants in the 10 mg LY3009104 single-dose group received 10 mg LY3009104 once daily for 10 days
|
14 mg LY3009104 Multiple Dose
Following a 7-day washout period, participants in the 14 mg LY3009104 single-dose group received 14 mg LY3009104 once daily for 10 days
|
Placebo Multiple Dose
Following a 7-day washout period, participants in the placebo single-dose group received placebo once daily for 10 days.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) of LY3009104
|
76.1 nanomoles/Liter (nmol/L)
Geometric Coefficient of Variation 29
|
220 nanomoles/Liter (nmol/L)
Geometric Coefficient of Variation 35
|
327 nanomoles/Liter (nmol/L)
Geometric Coefficient of Variation 43
|
410 nanomoles/Liter (nmol/L)
Geometric Coefficient of Variation 19
|
319 nanomoles/Liter (nmol/L)
Geometric Coefficient of Variation 30
|
439 nanomoles/Liter (nmol/L)
Geometric Coefficient of Variation 9
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdosePopulation: Participants who were administered study drug and had pharmacokinetics (PK) samples for the analyses.
AUC is the measure of total plasma exposure of a drug over a given time period. AUC of Day 1 is AUC from 0 to 24 hours. AUC of Day 17 is AUC during one dosing interval at steady-state.
Outcome measures
| Measure |
2 mg LY3009104 Single Dose
n=6 Participants
2 mg administered orally once on Day 1
|
5 mg LY3009104 Single Dose
n=6 Participants
5 mg administered orally once on Day 1
|
10 mg LY3009104 Single Dose
n=6 Participants
10 mg administered orally once on Day 1
|
14 mg LY3009104 Single Dose
n=7 Participants
14 mg administered orally once on Day 1
|
Placebo Single Dose
n=5 Participants
administered orally once on Day 1
|
10 mg LY3009104 Multiple Dose
n=6 Participants
Following a 7-day washout period, participants in the 10 mg LY3009104 single-dose group received 10 mg LY3009104 once daily for 10 days
|
14 mg LY3009104 Multiple Dose
Following a 7-day washout period, participants in the 14 mg LY3009104 single-dose group received 14 mg LY3009104 once daily for 10 days
|
Placebo Multiple Dose
Following a 7-day washout period, participants in the placebo single-dose group received placebo once daily for 10 days.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY3009104
|
403 nanomoles*hour/Liter (nmol*h/L)
Geometric Coefficient of Variation 10
|
1240 nanomoles*hour/Liter (nmol*h/L)
Geometric Coefficient of Variation 23
|
1730 nanomoles*hour/Liter (nmol*h/L)
Geometric Coefficient of Variation 21
|
2790 nanomoles*hour/Liter (nmol*h/L)
Geometric Coefficient of Variation 14
|
1970 nanomoles*hour/Liter (nmol*h/L)
Geometric Coefficient of Variation 18
|
3060 nanomoles*hour/Liter (nmol*h/L)
Geometric Coefficient of Variation 17
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdosePopulation: Participants who were administered study drug and had pharmacokinetics (PK) samples for the analyses.
Half life (t1/2) is the time measured for the plasma concentration of LY3009104 to decrease by one half.
Outcome measures
| Measure |
2 mg LY3009104 Single Dose
n=6 Participants
2 mg administered orally once on Day 1
|
5 mg LY3009104 Single Dose
n=6 Participants
5 mg administered orally once on Day 1
|
10 mg LY3009104 Single Dose
n=6 Participants
10 mg administered orally once on Day 1
|
14 mg LY3009104 Single Dose
n=7 Participants
14 mg administered orally once on Day 1
|
Placebo Single Dose
n=5 Participants
administered orally once on Day 1
|
10 mg LY3009104 Multiple Dose
n=6 Participants
Following a 7-day washout period, participants in the 10 mg LY3009104 single-dose group received 10 mg LY3009104 once daily for 10 days
|
14 mg LY3009104 Multiple Dose
Following a 7-day washout period, participants in the 14 mg LY3009104 single-dose group received 14 mg LY3009104 once daily for 10 days
|
Placebo Multiple Dose
Following a 7-day washout period, participants in the placebo single-dose group received placebo once daily for 10 days.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Half-Life(t1/2) of LY3009104
|
5.19 hour (h)
Interval 3.88 to 6.31
|
6.82 hour (h)
Interval 5.7 to 7.79
|
6.43 hour (h)
Interval 4.37 to 9.9
|
8.48 hour (h)
Interval 6.95 to 10.8
|
8.57 hour (h)
Interval 7.43 to 9.3
|
9.41 hour (h)
Interval 7.24 to 13.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdosePopulation: Participants who were administered study drug and had pharmacokinetics (PK) samples for the analyses.
Apparent volume of distribution is used to quantify the distribution of a drug between plasma and the rest of the body after dosing. It is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Day 1, it is apparent volume of distribution during the terminal phase after single dose. Day 17, it is apparent volume of distribution during the terminal phase at steady-state.
Outcome measures
| Measure |
2 mg LY3009104 Single Dose
n=6 Participants
2 mg administered orally once on Day 1
|
5 mg LY3009104 Single Dose
n=6 Participants
5 mg administered orally once on Day 1
|
10 mg LY3009104 Single Dose
n=6 Participants
10 mg administered orally once on Day 1
|
14 mg LY3009104 Single Dose
n=7 Participants
14 mg administered orally once on Day 1
|
Placebo Single Dose
n=5 Participants
administered orally once on Day 1
|
10 mg LY3009104 Multiple Dose
n=6 Participants
Following a 7-day washout period, participants in the 10 mg LY3009104 single-dose group received 10 mg LY3009104 once daily for 10 days
|
14 mg LY3009104 Multiple Dose
Following a 7-day washout period, participants in the 14 mg LY3009104 single-dose group received 14 mg LY3009104 once daily for 10 days
|
Placebo Multiple Dose
Following a 7-day washout period, participants in the placebo single-dose group received placebo once daily for 10 days.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Apparent Volume of Distribution of LY3009104
|
96.3 Liter (L)
Geometric Coefficient of Variation 18
|
99.4 Liter (L)
Geometric Coefficient of Variation 29
|
138 Liter (L)
Geometric Coefficient of Variation 41
|
150 Liter (L)
Geometric Coefficient of Variation 19
|
169 Liter (L)
Geometric Coefficient of Variation 24
|
167 Liter (L)
Geometric Coefficient of Variation 23
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 38 and 48 hours postdosePopulation: Participants who were administered study drug and had pharmacokinetics (PK) samples for the analyses.
Apparent total body clearance is the volume of plasma from which the drug is completely removed in a given time period. For Day 1, it is apparent total body clearance of drug after single dose. For Day 17, it is apparent total body clearance of drug at steady-state.
Outcome measures
| Measure |
2 mg LY3009104 Single Dose
n=6 Participants
2 mg administered orally once on Day 1
|
5 mg LY3009104 Single Dose
n=6 Participants
5 mg administered orally once on Day 1
|
10 mg LY3009104 Single Dose
n=6 Participants
10 mg administered orally once on Day 1
|
14 mg LY3009104 Single Dose
n=7 Participants
14 mg administered orally once on Day 1
|
Placebo Single Dose
n=5 Participants
administered orally once on Day 1
|
10 mg LY3009104 Multiple Dose
n=6 Participants
Following a 7-day washout period, participants in the 10 mg LY3009104 single-dose group received 10 mg LY3009104 once daily for 10 days
|
14 mg LY3009104 Multiple Dose
Following a 7-day washout period, participants in the 14 mg LY3009104 single-dose group received 14 mg LY3009104 once daily for 10 days
|
Placebo Multiple Dose
Following a 7-day washout period, participants in the placebo single-dose group received placebo once daily for 10 days.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Apparent Total Body Clearance of LY3009104
|
12.9 Liter/hour (L/h)
Geometric Coefficient of Variation 11
|
10.1 Liter/hour (L/h)
Geometric Coefficient of Variation 22
|
14.8 Liter/hour (L/h)
Geometric Coefficient of Variation 20
|
12.2 Liter/hour (L/h)
Geometric Coefficient of Variation 17
|
13.7 Liter/hour (L/h)
Geometric Coefficient of Variation 18
|
12.3 Liter/hour (L/h)
Geometric Coefficient of Variation 17
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 38 and 48 hours postdosePopulation: Participants who were administered study drug and had pharmacokinetics (PK) samples for the analyses.
Tmax is time to reach maximum observed drug concentration. For Day 1, it is tmax after single dose. For Day 17, it is tmax at steady-state.
Outcome measures
| Measure |
2 mg LY3009104 Single Dose
n=6 Participants
2 mg administered orally once on Day 1
|
5 mg LY3009104 Single Dose
n=6 Participants
5 mg administered orally once on Day 1
|
10 mg LY3009104 Single Dose
n=6 Participants
10 mg administered orally once on Day 1
|
14 mg LY3009104 Single Dose
n=7 Participants
14 mg administered orally once on Day 1
|
Placebo Single Dose
n=5 Participants
administered orally once on Day 1
|
10 mg LY3009104 Multiple Dose
n=6 Participants
Following a 7-day washout period, participants in the 10 mg LY3009104 single-dose group received 10 mg LY3009104 once daily for 10 days
|
14 mg LY3009104 Multiple Dose
Following a 7-day washout period, participants in the 14 mg LY3009104 single-dose group received 14 mg LY3009104 once daily for 10 days
|
Placebo Multiple Dose
Following a 7-day washout period, participants in the placebo single-dose group received placebo once daily for 10 days.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Time of Maximum Observed LY3009104 Concentration (Tmax)
|
1.00 hour (h)
Interval 0.5 to 2.0
|
1.00 hour (h)
Interval 0.5 to 1.0
|
1.25 hour (h)
Interval 0.5 to 2.0
|
1.00 hour (h)
Interval 0.5 to 2.1
|
1.00 hour (h)
Interval 0.5 to 2.0
|
1.00 hour (h)
Interval 1.0 to 1.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: continuous for 24 hoursPopulation: Participants who were administered study drug (10 mg and 14 mg LY3009104 per protocol) and had pharmacokinetics (PK) samples for the analyses.
Percentage of LY3009104 excreted in urine from zero to 24 hours.
Outcome measures
| Measure |
2 mg LY3009104 Single Dose
n=6 Participants
2 mg administered orally once on Day 1
|
5 mg LY3009104 Single Dose
n=7 Participants
5 mg administered orally once on Day 1
|
10 mg LY3009104 Single Dose
10 mg administered orally once on Day 1
|
14 mg LY3009104 Single Dose
14 mg administered orally once on Day 1
|
Placebo Single Dose
administered orally once on Day 1
|
10 mg LY3009104 Multiple Dose
Following a 7-day washout period, participants in the 10 mg LY3009104 single-dose group received 10 mg LY3009104 once daily for 10 days
|
14 mg LY3009104 Multiple Dose
Following a 7-day washout period, participants in the 14 mg LY3009104 single-dose group received 14 mg LY3009104 once daily for 10 days
|
Placebo Multiple Dose
Following a 7-day washout period, participants in the placebo single-dose group received placebo once daily for 10 days.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Renal Excretion of LY3009104
|
75.8 percentage of drug
Geometric Coefficient of Variation 7
|
63.6 percentage of drug
Geometric Coefficient of Variation 13
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
2 mg LY3009104 - Single Dose
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
5 mg LY3009104 - Single Dose
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
10 mg LY3009104 - Single Dose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
14 mg LY3009104 - Single Dose
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo - Single Dose
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
10 mg LY3009104 - Multiple Dose
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
14 mg LY3009104 - Multiple Dose
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo - Multiple Dose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
2 mg LY3009104 - Single Dose
n=6 participants at risk
2 mg administered orally once on Day 1
|
5 mg LY3009104 - Single Dose
n=6 participants at risk
5 mg administered orally once on Day 1
|
10 mg LY3009104 - Single Dose
n=6 participants at risk
10 mg administered orally on Day 1
|
14 mg LY3009104 - Single Dose
n=7 participants at risk
14 mg administered orally on Day 1
|
Placebo - Single Dose
n=9 participants at risk
administered orally on Day 1
|
10 mg LY3009104 - Multiple Dose
n=6 participants at risk
Following a 7-day washout period, participants in the 10 mg LY3009104 single-dose group received 10 mg LY3009104 once daily for 10 days
|
14 mg LY3009104 - Multiple Dose
n=6 participants at risk
Following a 7-day washout period, participants in the 14 mg LY3009104 single-dose group received 14 mg LY3009104 once daily for 10 days
|
Placebo - Multiple Dose
n=5 participants at risk
Following a 7-day washout period, participants in the placebo single-dose group received placebo once daily for 10 days.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/7 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/9 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
16.7%
1/6 • Number of events 1 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/5 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/7 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/9 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
16.7%
1/6 • Number of events 1 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/5 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
16.7%
1/6 • Number of events 1 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/7 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/9 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/5 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
14.3%
1/7 • Number of events 1 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/9 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
16.7%
1/6 • Number of events 1 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
16.7%
1/6 • Number of events 1 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
20.0%
1/5 • Number of events 1 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/7 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/9 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
16.7%
1/6 • Number of events 2 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/5 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/7 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/9 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
16.7%
1/6 • Number of events 1 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
20.0%
1/5 • Number of events 1 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/7 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
11.1%
1/9 • Number of events 1 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/5 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
|
General disorders
Application Site Reaction
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/7 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
11.1%
1/9 • Number of events 1 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/5 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
|
General disorders
Chest Discomfort
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/7 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
11.1%
1/9 • Number of events 1 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/5 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
|
General disorders
Discomfort
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
14.3%
1/7 • Number of events 1 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/9 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/5 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
|
General disorders
Fatigue
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/7 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/9 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
33.3%
2/6 • Number of events 2 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/5 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
|
General disorders
Vessel Puncture Site Haematoma
|
16.7%
1/6 • Number of events 1 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
16.7%
1/6 • Number of events 1 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
42.9%
3/7 • Number of events 6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
11.1%
1/9 • Number of events 1 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
16.7%
1/6 • Number of events 1 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/5 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
16.7%
1/6 • Number of events 1 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/7 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
11.1%
1/9 • Number of events 1 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/5 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/7 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
22.2%
2/9 • Number of events 4 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/5 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/7 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/9 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
20.0%
1/5 • Number of events 1 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
71.4%
5/7 • Number of events 6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/9 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
16.7%
1/6 • Number of events 1 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
50.0%
3/6 • Number of events 3 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/5 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
|
Investigations
Reticulocyte Count Decreased
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/7 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/9 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
16.7%
1/6 • Number of events 1 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/5 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/7 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/9 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
16.7%
1/6 • Number of events 2 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/5 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
|
Nervous system disorders
Dizziness Postural
|
16.7%
1/6 • Number of events 1 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/7 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/9 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/5 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
16.7%
1/6 • Number of events 1 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/7 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
33.3%
3/9 • Number of events 3 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
33.3%
2/6 • Number of events 2 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
16.7%
1/6 • Number of events 1 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/5 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/7 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/9 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
16.7%
1/6 • Number of events 1 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/5 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/7 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/9 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
16.7%
1/6 • Number of events 1 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
20.0%
1/5 • Number of events 1 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
16.7%
1/6 • Number of events 1 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/7 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/9 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/5 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
16.7%
1/6 • Number of events 1 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
14.3%
1/7 • Number of events 1 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/9 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
0.00%
0/6 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
20.0%
1/5 • Number of events 1 • From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60