Trial Outcomes & Findings for A Study of LY3484356 in Healthy Female Participants (NCT NCT04840888)
NCT ID: NCT04840888
Last Updated: 2025-12-11
Results Overview
Cmax of LY3484356
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
82 participants
Primary outcome timeframe
Period 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 h postdose; Period 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 and 96 h postdose
Results posted on
2025-12-11
Participant Flow
Participant milestones
| Measure |
Cohort 1 Sequence 1: 400 mg LY3484356 Fasted/ 400 mg LY3484356 Fed
Participants were randomized (1:1) to 1 of 2 treatment sequences; LY3484356 received as single dose with (fed) or without food (fasted) administered orally as below:
Period 1: Single dose of 400 mg LY3484356 in the fasted state.
Period 2: Single dose of 400 mg LY3484356 in the fed state.
There was a washout period of 4 days between doses of LY3484356
|
Cohort 1 Sequence 2: 400 mg LY3484356 Fed/ 400 mg LY3484356 Fasted
Participants were randomized (1:1) to 1 of 2 treatment sequences; LY3484356 received as single dose with (fed) or without food (fasted) administered orally as below:
Period 1: Single dose of 400 mg LY3484356 in the fed state.
Period 2: Single dose of 400 mg LY3484356 in the fasted state.
There was a washout period of 4 days between doses of LY3484356.
|
Cohort 2: LY3484356 + Omeprazole
Participants received single dose of LY3484356 and a single oral dose of omeprazole alone and in combination administered orally as below:
Day 1: 400 mg LY3484356 alone
Days 5 to 8: 40 mg omeprazole alone once daily
Day 9: 400 mg LY3484356 + 40 mg omeprazole once
There was a washout period of 8 days between doses of LY3484356.
|
Cohort 3: LY3484356 + Itraconazole
Participants received single dose of LY3484356 and a single oral dose of Itraconazole alone and in combination administered orally as below:
Day 1: 200 mg LY3484356 alone
Days 5 to 9: 200 mg itraconazole alone (twice on Day 5 \[dose separated by approximately 12 hours\], then once daily on Days 6 through 9)
Day 10: 200 mg LY3484356 + 200 mg itraconazole once (coadministered with the morning dose)
Days 11 to 16: 200 mg itraconazole alone once daily.
There was a washout period of 9 days between doses of LY3484356.
|
Cohort 4: LY3484356 + Carbamazepine
Participants received single dose of LY3484356 and a single oral dose of carbamazepine alone and in combination administered orally as below:
Day 1: 400 mg LY3484356 alone
Days 6 to 8: 100 mg carbamazepine twice daily (BID) alone
Days 9 to 11: 200 mg carbamazepine BID alone
Days 12 to 17: 300 mg carbamazepine BID alone
Day 18: 300 mg carbamazepine BID + 400 mg LY3484356 (coadministered with morning dose)
Days 19 to 22: 300 mg carbamazepine BID alone
Day 23: 300 mg carbamazepine alone (morning dose only).
There was a washout period of 17 days between doses of LY3484356.
|
Cohort 5: Carbamazepine + Midazolam
Participants received single dose of Carbamazepine and a single oral dose of midazolam alone and in combination administered orally as below:
Day 1: 1.2 mg midazolam alone
Days 2 to 4: 100 mg carbamazepine BID alone
Days 5 to 7: 200 mg carbamazepine BID alone
Days 8 to 10: 300 mg carbamazepine BID alone
Day 11: 300 mg carbamazepine BID + 1.2 mg midazolam (coadministered with morning dose)
Days 12 to 13: 300 mg carbamazepine BID alone
Day 14: 300 mg carbamazepine BID + 1.2 mg midazolam (coadministered with morning dose).
|
|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
5
|
3
|
10
|
20
|
29
|
15
|
|
Period 1
Received at Least One Dose of Study Drug
|
5
|
3
|
10
|
20
|
29
|
15
|
|
Period 1
COMPLETED
|
5
|
3
|
9
|
19
|
18
|
14
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
1
|
1
|
11
|
1
|
|
Period 2
STARTED
|
5
|
3
|
0
|
0
|
0
|
0
|
|
Period 2
Received at Least One Dose of Study Drug
|
5
|
3
|
0
|
0
|
0
|
0
|
|
Period 2
COMPLETED
|
5
|
3
|
0
|
0
|
0
|
0
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1 Sequence 1: 400 mg LY3484356 Fasted/ 400 mg LY3484356 Fed
Participants were randomized (1:1) to 1 of 2 treatment sequences; LY3484356 received as single dose with (fed) or without food (fasted) administered orally as below:
Period 1: Single dose of 400 mg LY3484356 in the fasted state.
Period 2: Single dose of 400 mg LY3484356 in the fed state.
There was a washout period of 4 days between doses of LY3484356
|
Cohort 1 Sequence 2: 400 mg LY3484356 Fed/ 400 mg LY3484356 Fasted
Participants were randomized (1:1) to 1 of 2 treatment sequences; LY3484356 received as single dose with (fed) or without food (fasted) administered orally as below:
Period 1: Single dose of 400 mg LY3484356 in the fed state.
Period 2: Single dose of 400 mg LY3484356 in the fasted state.
There was a washout period of 4 days between doses of LY3484356.
|
Cohort 2: LY3484356 + Omeprazole
Participants received single dose of LY3484356 and a single oral dose of omeprazole alone and in combination administered orally as below:
Day 1: 400 mg LY3484356 alone
Days 5 to 8: 40 mg omeprazole alone once daily
Day 9: 400 mg LY3484356 + 40 mg omeprazole once
There was a washout period of 8 days between doses of LY3484356.
|
Cohort 3: LY3484356 + Itraconazole
Participants received single dose of LY3484356 and a single oral dose of Itraconazole alone and in combination administered orally as below:
Day 1: 200 mg LY3484356 alone
Days 5 to 9: 200 mg itraconazole alone (twice on Day 5 \[dose separated by approximately 12 hours\], then once daily on Days 6 through 9)
Day 10: 200 mg LY3484356 + 200 mg itraconazole once (coadministered with the morning dose)
Days 11 to 16: 200 mg itraconazole alone once daily.
There was a washout period of 9 days between doses of LY3484356.
|
Cohort 4: LY3484356 + Carbamazepine
Participants received single dose of LY3484356 and a single oral dose of carbamazepine alone and in combination administered orally as below:
Day 1: 400 mg LY3484356 alone
Days 6 to 8: 100 mg carbamazepine twice daily (BID) alone
Days 9 to 11: 200 mg carbamazepine BID alone
Days 12 to 17: 300 mg carbamazepine BID alone
Day 18: 300 mg carbamazepine BID + 400 mg LY3484356 (coadministered with morning dose)
Days 19 to 22: 300 mg carbamazepine BID alone
Day 23: 300 mg carbamazepine alone (morning dose only).
There was a washout period of 17 days between doses of LY3484356.
|
Cohort 5: Carbamazepine + Midazolam
Participants received single dose of Carbamazepine and a single oral dose of midazolam alone and in combination administered orally as below:
Day 1: 1.2 mg midazolam alone
Days 2 to 4: 100 mg carbamazepine BID alone
Days 5 to 7: 200 mg carbamazepine BID alone
Days 8 to 10: 300 mg carbamazepine BID alone
Day 11: 300 mg carbamazepine BID + 1.2 mg midazolam (coadministered with morning dose)
Days 12 to 13: 300 mg carbamazepine BID alone
Day 14: 300 mg carbamazepine BID + 1.2 mg midazolam (coadministered with morning dose).
|
|---|---|---|---|---|---|---|
|
Period 1
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Period 1
Adverse Event
|
0
|
0
|
1
|
1
|
10
|
1
|
Baseline Characteristics
A Study of LY3484356 in Healthy Female Participants
Baseline characteristics by cohort
| Measure |
Cohort 1: Sequence 1/Sequence 2
n=8 Participants
Participants were randomized (1:1) to 1 of 2 treatment sequences; LY3484356 received as single dose with (fed) or without food (fasted) administered orally as below:
Cohort 1 Sequence 1:
Period 1: Single dose of 400 mg LY3484356 in the fed state.
Period 2: Single dose of 400 mg LY3484356 in the fasted state.
Cohort 1 Sequence 2:
Period 1: Single dose of 400 mg LY3484356 in the fasted state.
Period 2: Single dose of 400 mg LY3484356 in the fed state.
There was a washout period of 4 days between doses of LY3484356
|
Cohort 2: LY3484356 + Omeprazole
n=10 Participants
Participants received single dose of LY3484356 and a single dose of omeprazole alone and in combination administered orally as below:
Day 1: 400 mg LY3484356 alone
Days 5 to 8: 40 mg omeprazole alone once daily
Day 9: 400 mg LY3484356 + 40 mg omeprazole once
There was a washout period of 8 days between doses of LY3484356.
|
Cohort 3: LY3484356 + Itraconazole
n=20 Participants
Participants received single dose of LY3484356 and a single dose of Itraconazole alone and in combination administered orally as below:
Day 1: 200 mg LY3484356 alone
Days 5 to 9: 200 mg itraconazole alone (twice on Day 5 \[dose separated by approximately 12 hours\], then once daily on Days 6 through 9)
Day 10: 200 mg LY3484356 + 200 mg itraconazole once (coadministered with the morning dose)
Days 11 to 16: 200 mg itraconazole alone once daily.
There was a washout period of 9 days between doses of LY3484356
|
Cohort 4: LY3484356 + Carbamazepine
n=29 Participants
Participants received single dose of LY3484356 and a single dose of carbamazepine alone and in combination administered orally as below:
Day 1: 400 mg LY3484356 alone
Days 6 to 8: 100 mg carbamazepine BID alone
Days 9 to 11: 200 mg carbamazepine BID alone
Days 12 to 17: 300 mg carbamazepine BID alone
Day 18: 300 mg carbamazepine BID + 400 mg LY3484356 (coadministered with morning dose)
Days 19 to 22: 300 mg carbamazepine BID alone Day 23: 300 mg carbamazepine alone (morning dose only).
There was a washout period of 17 days between doses of LY3484356.
|
Cohort 5: Carbamazepine + Midazolam
n=15 Participants
Participants received single dose of Carbamazepine and a single dose of midazolam alone and in combination administered orally as below:
Day 1: 1.2 mg midazolam alone
Days 2 to 4: 100 mg carbamazepine BID alone
Days 5 to 7: 200 mg carbamazepine BID alone
Days 8 to 10: 300 mg carbamazepine BID alone
Day 11: 300 mg carbamazepine BID + 1.2 mg midazolam (coadministered with morning dose)
Days 12 to 13: 300 mg carbamazepine BID alone
Day 14: 300 mg carbamazepine BID + 1.2 mg midazolam (coadministered with morning dose)
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
51.8 years
STANDARD_DEVIATION 6.9 • n=237 Participants
|
58.6 years
STANDARD_DEVIATION 6.9 • n=243 Participants
|
52.5 years
STANDARD_DEVIATION 9.2 • n=480 Participants
|
49.8 years
STANDARD_DEVIATION 10.1 • n=639 Participants
|
46.4 years
STANDARD_DEVIATION 10.4 • n=277 Participants
|
51.1 years
STANDARD_DEVIATION 9.8 • n=294 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=237 Participants
|
10 Participants
n=243 Participants
|
20 Participants
n=480 Participants
|
29 Participants
n=639 Participants
|
3 Participants
n=277 Participants
|
70 Participants
n=294 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
0 Participants
n=639 Participants
|
12 Participants
n=277 Participants
|
12 Participants
n=294 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=237 Participants
|
5 Participants
n=243 Participants
|
11 Participants
n=480 Participants
|
18 Participants
n=639 Participants
|
8 Participants
n=277 Participants
|
45 Participants
n=294 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=237 Participants
|
5 Participants
n=243 Participants
|
9 Participants
n=480 Participants
|
11 Participants
n=639 Participants
|
7 Participants
n=277 Participants
|
37 Participants
n=294 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
0 Participants
n=639 Participants
|
0 Participants
n=277 Participants
|
0 Participants
n=294 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
0 Participants
n=639 Participants
|
0 Participants
n=277 Participants
|
1 Participants
n=294 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
0 Participants
n=639 Participants
|
0 Participants
n=277 Participants
|
0 Participants
n=294 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
0 Participants
n=639 Participants
|
0 Participants
n=277 Participants
|
0 Participants
n=294 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=237 Participants
|
3 Participants
n=243 Participants
|
2 Participants
n=480 Participants
|
8 Participants
n=639 Participants
|
2 Participants
n=277 Participants
|
18 Participants
n=294 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=237 Participants
|
7 Participants
n=243 Participants
|
18 Participants
n=480 Participants
|
21 Participants
n=639 Participants
|
13 Participants
n=277 Participants
|
63 Participants
n=294 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
0 Participants
n=639 Participants
|
0 Participants
n=277 Participants
|
0 Participants
n=294 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
0 Participants
n=639 Participants
|
0 Participants
n=277 Participants
|
0 Participants
n=294 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=237 Participants
|
10 Participants
n=243 Participants
|
20 Participants
n=480 Participants
|
29 Participants
n=639 Participants
|
15 Participants
n=277 Participants
|
82 Participants
n=294 Participants
|
PRIMARY outcome
Timeframe: Period 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours (h) postdose; Period 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 and 96 h postdosePopulation: All enrolled participants in cohort 1 who received at least one dose of study drug and had evaluable PK data.
PK: AUC\[0-∞\] of LY3484356
Outcome measures
| Measure |
Cohort 1: 400 mg LY3484356 Fasted
n=4 Participants
Participants received single oral dose of 400 mg LY3484356 in the fasted state.
|
Cohort 1: 400 mg LY3484356 Fed
n=6 Participants
Participants received single oral dose of 400 mg LY3484356 in the fed state.
|
|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3484356 (Cohort 1)
|
1810 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 59
|
4350 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 39
|
PRIMARY outcome
Timeframe: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 9: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdosePopulation: All enrolled participants in cohort 2 who received at least one dose of study drug and had evaluable PK data.
PK: AUC\[0-∞\] of LY3484356
Outcome measures
| Measure |
Cohort 1: 400 mg LY3484356 Fasted
n=4 Participants
Participants received single oral dose of 400 mg LY3484356 in the fasted state.
|
Cohort 1: 400 mg LY3484356 Fed
Participants received single oral dose of 400 mg LY3484356 in the fed state.
|
|---|---|---|
|
PK: AUC[0-∞] of LY3484356 (Cohort 2)
Day 1
|
2270 ng*hr/mL
Geometric Coefficient of Variation 93
|
—
|
|
PK: AUC[0-∞] of LY3484356 (Cohort 2)
Day 9
|
1960 ng*hr/mL
Geometric Coefficient of Variation 46
|
—
|
PRIMARY outcome
Timeframe: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 10: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdosePopulation: All enrolled participants in cohort 3 who received at least one dose of study drug and had evaluable PK data.
PK: AUC\[0-∞\] of LY3484356
Outcome measures
| Measure |
Cohort 1: 400 mg LY3484356 Fasted
n=19 Participants
Participants received single oral dose of 400 mg LY3484356 in the fasted state.
|
Cohort 1: 400 mg LY3484356 Fed
Participants received single oral dose of 400 mg LY3484356 in the fed state.
|
|---|---|---|
|
PK: AUC[0-∞] of LY3484356 (Cohort 3)
Day 1
|
1430 ng*hr/mL
Geometric Coefficient of Variation 58
|
—
|
|
PK: AUC[0-∞] of LY3484356 (Cohort 3)
Day 10
|
3120 ng*hr/mL
Geometric Coefficient of Variation 41
|
—
|
PRIMARY outcome
Timeframe: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 18: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdosePopulation: All enrolled participants in cohort 4 who received at least one dose of study drug and had evaluable PK data.
AUC\[0-∞\] of LY3484356
Outcome measures
| Measure |
Cohort 1: 400 mg LY3484356 Fasted
n=26 Participants
Participants received single oral dose of 400 mg LY3484356 in the fasted state.
|
Cohort 1: 400 mg LY3484356 Fed
Participants received single oral dose of 400 mg LY3484356 in the fed state.
|
|---|---|---|
|
PK: AUC[0-∞] of LY3484356 (Cohort 4)
Day 1
|
1950 ng*hr/mL
Geometric Coefficient of Variation 67
|
—
|
|
PK: AUC[0-∞] of LY3484356 (Cohort 4)
Day 18
|
1090 ng*hr/mL
Geometric Coefficient of Variation 32
|
—
|
PRIMARY outcome
Timeframe: Period 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 h postdose; Period 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 and 96 h postdosePopulation: All enrolled participants in cohort 1 who received at least one dose of study drug and had evaluable PK data.
PK: Tmax of LY3484356
Outcome measures
| Measure |
Cohort 1: 400 mg LY3484356 Fasted
n=8 Participants
Participants received single oral dose of 400 mg LY3484356 in the fasted state.
|
Cohort 1: 400 mg LY3484356 Fed
n=8 Participants
Participants received single oral dose of 400 mg LY3484356 in the fed state.
|
|---|---|---|
|
PK: Time of Maximum Observed Concentration (Tmax) of LY3484356 (Cohort 1)
|
8.00 hours
Interval 3.0 to 35.8
|
3.02 hours
Interval 2.0 to 8.0
|
PRIMARY outcome
Timeframe: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 9: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdosePopulation: All enrolled participants in cohort 2 who received at least one dose of study drug and had evaluable PK data.
PK: Tmax of LY3484356
Outcome measures
| Measure |
Cohort 1: 400 mg LY3484356 Fasted
n=10 Participants
Participants received single oral dose of 400 mg LY3484356 in the fasted state.
|
Cohort 1: 400 mg LY3484356 Fed
Participants received single oral dose of 400 mg LY3484356 in the fed state.
|
|---|---|---|
|
PK: Tmax of LY3484356 (Cohort 2)
Day 9
|
6.00 hours
Interval 4.0 to 36.0
|
—
|
|
PK: Tmax of LY3484356 (Cohort 2)
Day 1
|
6.02 hours
Interval 1.0 to 10.0
|
—
|
PRIMARY outcome
Timeframe: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 10: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdosePopulation: All enrolled participants in cohort 3 who received at least one dose of study drug and had evaluable PK data.
PK: Tmax of LY3484356
Outcome measures
| Measure |
Cohort 1: 400 mg LY3484356 Fasted
n=20 Participants
Participants received single oral dose of 400 mg LY3484356 in the fasted state.
|
Cohort 1: 400 mg LY3484356 Fed
Participants received single oral dose of 400 mg LY3484356 in the fed state.
|
|---|---|---|
|
PK: Tmax of LY3484356 (Cohort 3)
Day 1
|
6.00 hours
Interval 2.0 to 36.0
|
—
|
|
PK: Tmax of LY3484356 (Cohort 3)
Day 10
|
6.00 hours
Interval 1.0 to 12.0
|
—
|
PRIMARY outcome
Timeframe: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 18: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdosePopulation: All enrolled participants in cohort 4 who received at least one dose of study drug and had evaluable PK data.
Tmax of LY3484356
Outcome measures
| Measure |
Cohort 1: 400 mg LY3484356 Fasted
n=29 Participants
Participants received single oral dose of 400 mg LY3484356 in the fasted state.
|
Cohort 1: 400 mg LY3484356 Fed
Participants received single oral dose of 400 mg LY3484356 in the fed state.
|
|---|---|---|
|
PK: Tmax of LY3484356 (Cohort 4)
Day 1
|
4.00 hours
Interval 2.0 to 36.0
|
—
|
|
PK: Tmax of LY3484356 (Cohort 4)
Day 18
|
3.87 hours
Interval 1.0 to 8.0
|
—
|
PRIMARY outcome
Timeframe: Period 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 h postdose; Period 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 and 96 h postdosePopulation: All enrolled participants in cohort 1 who received at least one dose of study drug and had evaluable PK data.
Cmax of LY3484356
Outcome measures
| Measure |
Cohort 1: 400 mg LY3484356 Fasted
n=8 Participants
Participants received single oral dose of 400 mg LY3484356 in the fasted state.
|
Cohort 1: 400 mg LY3484356 Fed
n=8 Participants
Participants received single oral dose of 400 mg LY3484356 in the fed state.
|
|---|---|---|
|
PK: Maximum Observed Concentration (Cmax) of LY3484356 (Cohort 1)
|
37.2 nanogram per millilitre (ng/mL)
Geometric Coefficient of Variation 51
|
143 nanogram per millilitre (ng/mL)
Geometric Coefficient of Variation 28
|
PRIMARY outcome
Timeframe: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 9: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdosePopulation: All enrolled participants in cohort 2 who received at least one dose of study drug and had evaluable PK data.
Cmax of LY3484356
Outcome measures
| Measure |
Cohort 1: 400 mg LY3484356 Fasted
n=10 Participants
Participants received single oral dose of 400 mg LY3484356 in the fasted state.
|
Cohort 1: 400 mg LY3484356 Fed
Participants received single oral dose of 400 mg LY3484356 in the fed state.
|
|---|---|---|
|
PK: Cmax of LY3484356 (Cohort 2)
Day 1
|
49.1 ng/mL
Geometric Coefficient of Variation 61
|
—
|
|
PK: Cmax of LY3484356 (Cohort 2)
Day 9
|
39.6 ng/mL
Geometric Coefficient of Variation 47
|
—
|
PRIMARY outcome
Timeframe: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 10: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdosePopulation: All enrolled participants in cohort 3 who received at least one dose of study drug and had evaluable PK data.
Cmax of LY3484356
Outcome measures
| Measure |
Cohort 1: 400 mg LY3484356 Fasted
n=20 Participants
Participants received single oral dose of 400 mg LY3484356 in the fasted state.
|
Cohort 1: 400 mg LY3484356 Fed
Participants received single oral dose of 400 mg LY3484356 in the fed state.
|
|---|---|---|
|
PK: Cmax of LY3484356 (Cohort 3)
Day 1
|
30.3 ng/mL
Geometric Coefficient of Variation 57
|
—
|
|
PK: Cmax of LY3484356 (Cohort 3)
Day 10
|
56.7 ng/mL
Geometric Coefficient of Variation 47
|
—
|
PRIMARY outcome
Timeframe: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 18: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdosePopulation: All enrolled participants in cohort 4 who received at least one dose of study drug and had evaluable PK data.
Cmax of LY3484356
Outcome measures
| Measure |
Cohort 1: 400 mg LY3484356 Fasted
n=29 Participants
Participants received single oral dose of 400 mg LY3484356 in the fasted state.
|
Cohort 1: 400 mg LY3484356 Fed
Participants received single oral dose of 400 mg LY3484356 in the fed state.
|
|---|---|---|
|
PK: Cmax of LY3484356 (Cohort 4)
Day 1
|
49.6 ng/mL
Geometric Coefficient of Variation 76
|
—
|
|
PK: Cmax of LY3484356 (Cohort 4)
Day 18
|
33.3 ng/mL
Geometric Coefficient of Variation 41
|
—
|
Adverse Events
Cohort 5: 300 mg Carbamazepine + 1.2 mg Midazolam (Day 14)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 4: 300 mg Carbamazepine + 400 mg LY3484356 (Days 12 to 22)
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Cohort 4: 300 mg Carbamazepine (Day 23)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 5: 1.2 mg Midazolam (Day 1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 5: 100 mg Carbamazepine (Days 2 to 4)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 5: 200 mg Carbamazepine (Days 5 to 7)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 5: 300 mg Carbamazepine (Days 8 to 10)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 5: 300 mg Carbamazepine + 1.2 mg Midazolam (Day 11)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 5: 300 mg Carbamazepine (Days 12 to 13)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 1: 400 mg LY3484356 Fasted
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 1: 400 mg LY3484356 Fed
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2: 400 mg LY3484356 (Day 1)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 2: 40 mg Omeprazole (Days 5 to 8)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 2: 400 mg LY3484356 + 40 mg Omeprazole (Day 9)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3: 200 mg LY3484356 (Day 1)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 3: 200 mg Itraconazole (Days 5 to 9)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 3: 200 mg LY3484356 + 200 mg Itraconazole (Days 10 to 16)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 4: 400 mg LY3484356 (Day 1)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 4: 100 mg Carbamazepine (Days 6 to 8)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 4: 200 mg Carbamazepine (Days 9 to 11)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 5: 300 mg Carbamazepine + 1.2 mg Midazolam (Day 14)
n=14 participants at risk
Participants received 300 mg carbamazepine BID + 1.2 mg midazolam (co-administered with morning dose) administered orally (Day 14).
|
Cohort 4: 300 mg Carbamazepine + 400 mg LY3484356 (Days 12 to 22)
n=28 participants at risk
Participants received 300 mg carbamazepine administered orally BID (Days 12 to 17), then 300 mg carbamazepine BID + 400 mg LY3484356 (co-administered with morning dose) administered orally (Day 18) followed by 300 mg carbamazepine administered orally BID (Day 19 to 22).
|
Cohort 4: 300 mg Carbamazepine (Day 23)
n=20 participants at risk
Participants received 300 mg carbamazepine (morning dose only) administered orally (Day 23).
|
Cohort 5: 1.2 mg Midazolam (Day 1)
n=15 participants at risk
Participants received 1.2 mg midazolam administered orally (Day 1).
|
Cohort 5: 100 mg Carbamazepine (Days 2 to 4)
n=15 participants at risk
Participants received 100 mg carbamazepine administered orally BID (Days 2 to 4).
|
Cohort 5: 200 mg Carbamazepine (Days 5 to 7)
n=15 participants at risk
Participants received 200 mg carbamazepine administered orally BID (Days 5 to 7).
|
Cohort 5: 300 mg Carbamazepine (Days 8 to 10)
n=15 participants at risk
Participants received 300 mg carbamazepine administered orally BID (Days 8 to 10).
|
Cohort 5: 300 mg Carbamazepine + 1.2 mg Midazolam (Day 11)
n=15 participants at risk
Participants received 300 mg carbamazepine BID + 1.2 mg midazolam (co-administered with morning dose) administered orally (Day 11)
|
Cohort 5: 300 mg Carbamazepine (Days 12 to 13)
n=15 participants at risk
Participants received 300 mg carbamazepine administered orally BID (Days 12 to 13)
|
Cohort 1: 400 mg LY3484356 Fasted
n=8 participants at risk
Participants received single oral dose of 400 mg LY3484356 in the fasted state.
|
Cohort 1: 400 mg LY3484356 Fed
n=8 participants at risk
Participants received single oral dose of 400 mg LY3484356 in the fed state.
|
Cohort 2: 400 mg LY3484356 (Day 1)
n=10 participants at risk
Participants received 400 mg LY3484356 alone administered orally (Day 1).
|
Cohort 2: 40 mg Omeprazole (Days 5 to 8)
n=10 participants at risk
Participants received 40 mg omeprazole administered orally once daily (Days 5 to 8).
|
Cohort 2: 400 mg LY3484356 + 40 mg Omeprazole (Day 9)
n=9 participants at risk
Participants received 400 mg LY3484356 + 40 mg omeprazole administered orally (Day 9).
|
Cohort 3: 200 mg LY3484356 (Day 1)
n=20 participants at risk
Participants received 200 mg LY3484356 administered orally (Day 1)
|
Cohort 3: 200 mg Itraconazole (Days 5 to 9)
n=20 participants at risk
Participants received 200 mg itraconazole administered orally alone (twice on Day 5 \[dose separated by approximately 12 hours\], then once daily on Days 6 through 9)
|
Cohort 3: 200 mg LY3484356 + 200 mg Itraconazole (Days 10 to 16)
n=20 participants at risk
Participants received 200 mg LY3484356 + 200 mg itraconazole administered orally once (co-administered with the morning dose) (Day 10), then 200 mg itraconazole administered orally alone once daily (Days 11 to 16).
|
Cohort 4: 400 mg LY3484356 (Day 1)
n=29 participants at risk
Participants received 400 mg LY3484356 administered orally (Day 1)
|
Cohort 4: 100 mg Carbamazepine (Days 6 to 8)
n=28 participants at risk
Participants received 100 mg carbamazepine administered orally BID (Days 6 to 8).
|
Cohort 4: 200 mg Carbamazepine (Days 9 to 11)
n=28 participants at risk
Participants received 200 mg carbamazepine administered orally BID (Days 9 to 11).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Hepatitis e
|
0.00%
0/14 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
3.6%
1/28 • Number of events 1 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/8 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/8 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/10 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/10 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/9 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/29 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/28 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/28 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
Other adverse events
| Measure |
Cohort 5: 300 mg Carbamazepine + 1.2 mg Midazolam (Day 14)
n=14 participants at risk
Participants received 300 mg carbamazepine BID + 1.2 mg midazolam (co-administered with morning dose) administered orally (Day 14).
|
Cohort 4: 300 mg Carbamazepine + 400 mg LY3484356 (Days 12 to 22)
n=28 participants at risk
Participants received 300 mg carbamazepine administered orally BID (Days 12 to 17), then 300 mg carbamazepine BID + 400 mg LY3484356 (co-administered with morning dose) administered orally (Day 18) followed by 300 mg carbamazepine administered orally BID (Day 19 to 22).
|
Cohort 4: 300 mg Carbamazepine (Day 23)
n=20 participants at risk
Participants received 300 mg carbamazepine (morning dose only) administered orally (Day 23).
|
Cohort 5: 1.2 mg Midazolam (Day 1)
n=15 participants at risk
Participants received 1.2 mg midazolam administered orally (Day 1).
|
Cohort 5: 100 mg Carbamazepine (Days 2 to 4)
n=15 participants at risk
Participants received 100 mg carbamazepine administered orally BID (Days 2 to 4).
|
Cohort 5: 200 mg Carbamazepine (Days 5 to 7)
n=15 participants at risk
Participants received 200 mg carbamazepine administered orally BID (Days 5 to 7).
|
Cohort 5: 300 mg Carbamazepine (Days 8 to 10)
n=15 participants at risk
Participants received 300 mg carbamazepine administered orally BID (Days 8 to 10).
|
Cohort 5: 300 mg Carbamazepine + 1.2 mg Midazolam (Day 11)
n=15 participants at risk
Participants received 300 mg carbamazepine BID + 1.2 mg midazolam (co-administered with morning dose) administered orally (Day 11)
|
Cohort 5: 300 mg Carbamazepine (Days 12 to 13)
n=15 participants at risk
Participants received 300 mg carbamazepine administered orally BID (Days 12 to 13)
|
Cohort 1: 400 mg LY3484356 Fasted
n=8 participants at risk
Participants received single oral dose of 400 mg LY3484356 in the fasted state.
|
Cohort 1: 400 mg LY3484356 Fed
n=8 participants at risk
Participants received single oral dose of 400 mg LY3484356 in the fed state.
|
Cohort 2: 400 mg LY3484356 (Day 1)
n=10 participants at risk
Participants received 400 mg LY3484356 alone administered orally (Day 1).
|
Cohort 2: 40 mg Omeprazole (Days 5 to 8)
n=10 participants at risk
Participants received 40 mg omeprazole administered orally once daily (Days 5 to 8).
|
Cohort 2: 400 mg LY3484356 + 40 mg Omeprazole (Day 9)
n=9 participants at risk
Participants received 400 mg LY3484356 + 40 mg omeprazole administered orally (Day 9).
|
Cohort 3: 200 mg LY3484356 (Day 1)
n=20 participants at risk
Participants received 200 mg LY3484356 administered orally (Day 1)
|
Cohort 3: 200 mg Itraconazole (Days 5 to 9)
n=20 participants at risk
Participants received 200 mg itraconazole administered orally alone (twice on Day 5 \[dose separated by approximately 12 hours\], then once daily on Days 6 through 9)
|
Cohort 3: 200 mg LY3484356 + 200 mg Itraconazole (Days 10 to 16)
n=20 participants at risk
Participants received 200 mg LY3484356 + 200 mg itraconazole administered orally once (co-administered with the morning dose) (Day 10), then 200 mg itraconazole administered orally alone once daily (Days 11 to 16).
|
Cohort 4: 400 mg LY3484356 (Day 1)
n=29 participants at risk
Participants received 400 mg LY3484356 administered orally (Day 1)
|
Cohort 4: 100 mg Carbamazepine (Days 6 to 8)
n=28 participants at risk
Participants received 100 mg carbamazepine administered orally BID (Days 6 to 8).
|
Cohort 4: 200 mg Carbamazepine (Days 9 to 11)
n=28 participants at risk
Participants received 200 mg carbamazepine administered orally BID (Days 9 to 11).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/14 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/28 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
12.5%
1/8 • Number of events 1 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/8 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/10 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
10.0%
1/10 • Number of events 1 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/9 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
5.0%
1/20 • Number of events 1 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
3.4%
1/29 • Number of events 1 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/28 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/28 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/14 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
10.7%
3/28 • Number of events 3 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
6.7%
1/15 • Number of events 1 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/8 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
12.5%
1/8 • Number of events 1 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
10.0%
1/10 • Number of events 1 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/10 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/9 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
5.0%
1/20 • Number of events 1 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
3.4%
1/29 • Number of events 1 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
3.6%
1/28 • Number of events 1 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
10.7%
3/28 • Number of events 4 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/14 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/28 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/8 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/8 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
10.0%
1/10 • Number of events 1 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
10.0%
1/10 • Number of events 1 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/9 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
5.0%
1/20 • Number of events 1 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
30.0%
6/20 • Number of events 6 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/29 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/28 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/28 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/14 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/28 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
6.7%
1/15 • Number of events 1 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/8 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/8 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/10 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/10 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/9 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
5.0%
1/20 • Number of events 1 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
5.0%
1/20 • Number of events 1 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/29 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/28 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/28 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/14 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
14.3%
4/28 • Number of events 4 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/8 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/8 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/10 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/10 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/9 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
5.0%
1/20 • Number of events 1 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/29 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/28 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/28 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
|
Infections and infestations
Covid-19
|
0.00%
0/14 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
7.1%
2/28 • Number of events 2 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
15.0%
3/20 • Number of events 3 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/8 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/8 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/10 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/10 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/9 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/29 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/28 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/28 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
|
Investigations
Amylase increased
|
0.00%
0/14 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/28 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/8 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/8 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/10 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
10.0%
1/10 • Number of events 1 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/9 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/29 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/28 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/28 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/14 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/28 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
6.7%
1/15 • Number of events 1 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/8 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/8 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/10 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/10 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/9 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/29 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/28 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/28 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
|
Nervous system disorders
Dizziness
|
0.00%
0/14 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
32.1%
9/28 • Number of events 9 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/8 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/8 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/10 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/10 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/9 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
5.0%
1/20 • Number of events 1 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/29 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/28 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
7.1%
2/28 • Number of events 3 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
|
Nervous system disorders
Headache
|
0.00%
0/14 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
25.0%
7/28 • Number of events 7 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/8 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/8 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/10 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
10.0%
1/10 • Number of events 1 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/9 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
10.0%
2/20 • Number of events 2 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
5.0%
1/20 • Number of events 1 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/29 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/28 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
3.6%
1/28 • Number of events 1 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
|
Nervous system disorders
Somnolence
|
0.00%
0/14 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/28 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
13.3%
2/15 • Number of events 2 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/8 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/8 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/10 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/10 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/9 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/29 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/28 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
7.1%
2/28 • Number of events 2 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/14 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/28 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/8 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/8 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/10 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/10 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
11.1%
1/9 • Number of events 1 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/29 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/28 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/28 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal hypoaesthesia
|
0.00%
0/14 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/28 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
6.7%
1/15 • Number of events 1 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/8 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/8 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/10 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/10 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/9 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/29 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/28 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/28 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/14 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
7.1%
2/28 • Number of events 2 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/15 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
6.7%
1/15 • Number of events 1 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/8 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/8 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/10 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/10 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/9 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/20 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/29 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/28 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
0.00%
0/28 • Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each dose level of treatment regimen
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60