Trial Outcomes & Findings for A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Oral ARN-75039 in Healthy Adult Subjects (NCT NCT05735249)
NCT ID: NCT05735249
Last Updated: 2026-05-01
Results Overview
A treatment-emergent adverse event (TEAE) was defined as any adverse event that began or worsened after administration of the study drug (ARN-75039 or placebo) through the End-of-Study visit.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
94 participants
Primary outcome timeframe
From first dose through the End-of-Study (EOS) visit: Part 1 (SAD), through Day 15/EOS; Food-effect cohort, through the second treatment period and Day 29/EOS; Part 2 (MAD), from Day 1 through Day 39/EOS.
Results posted on
2026-05-01
Participant Flow
This study was conducted at a single site in the United States from January 23, 2023 (first participant visit) to March 28, 2025 (last participant visit). The study included Screening, Treatment, and Follow-up periods.
This first-in-human, Phase 1, randomized, double-blind, placebo-controlled study evaluated the safety, tolerability, and pharmacokinetics (PK) of oral ARN-75039 in healthy adults, including the effect of food on PK. The study comprised single-ascending-dose (SAD) and multiple-ascending-dose (MAD) parts. Six SAD cohorts (including one food-effect cohort) and five MAD cohorts were conducted. A total of 94 participants were enrolled, and 90 completed the study.
Participant milestones
| Measure |
Part 1- SAD: Cohort 1 (30mg, Fed)
Participants received a single 30 mg oral dose of ARN-75039 capsules under fed conditions
|
Part 1- SAD: Cohort 2 (100mg, Fed)
Participants received a single 100 mg oral dose of ARN-75039 capsules under fed conditions
|
Part 1- SAD: Cohort 3 (300mg, Fed and Fasted for FE)
Cohort 3 (food effect cohort) received a single oral dose of ARN 75039 or placebo under fasted conditions no less than 14 days after receiving the first dose under fed conditions
|
Part 1- SAD: Cohort 4 (600mg, Fed)
Participants received a single 600mg oral dose of ARN-75039 capsules under fed conditions.
|
Part 1- SAD: Cohort 5 (1200mg, Fed)
Participants received a single 1200mg oral dose of ARN-75039 capsules under fed conditions.
|
Part 1- SAD: Cohort 6 (2000mg, Fed)
Participants received a single 2000mg oral dose of ARN-75039 capsules under fed conditions.
|
Part 1- SAD: Placebo (Fed and Fasted)
Participants received matching placebo capsules containing microcrystalline cellulose administered orally according to the corresponding cohort dosing schedule.
|
Part 2- MAD: Cohort 7 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 36 and 24 mg doses, Day 2: 24 mg BID, Days 3-10: 12 mg BID
|
Part 2- MAD: Cohort 8 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 75 and 50 mg doses, Day 2: 50 mg BID, Days 3-10: 25 mg BID
|
Part 2- MAD: Cohort 9 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 150 and 100 mg doses, Day 2: 100 mg BID, Days 3-10: 50 mg BID
|
Part 2- MAD: Cohort 10 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 240 and 160 mg doses, Day 2: 160 mg BID, Days 3-10: 80 mg BID
|
Part 2- MAD: Cohort 11 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 360 and 240 mg doses, Day 2: 240 mg BID, Days 3-10: 120 mg BID
|
Part 2- MAD: Placebo (Fed)
Participants received matching placebo capsules containing microcrystalline cellulose administered orally according to the corresponding cohort dosing schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
8
|
6
|
6
|
6
|
12
|
6
|
6
|
6
|
7
|
7
|
12
|
|
Overall Study
COMPLETED
|
6
|
6
|
8
|
6
|
6
|
5
|
11
|
6
|
6
|
5
|
6
|
6
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
1
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
Part 1- SAD: Cohort 1 (30mg, Fed)
Participants received a single 30 mg oral dose of ARN-75039 capsules under fed conditions
|
Part 1- SAD: Cohort 2 (100mg, Fed)
Participants received a single 100 mg oral dose of ARN-75039 capsules under fed conditions
|
Part 1- SAD: Cohort 3 (300mg, Fed and Fasted for FE)
Cohort 3 (food effect cohort) received a single oral dose of ARN 75039 or placebo under fasted conditions no less than 14 days after receiving the first dose under fed conditions
|
Part 1- SAD: Cohort 4 (600mg, Fed)
Participants received a single 600mg oral dose of ARN-75039 capsules under fed conditions.
|
Part 1- SAD: Cohort 5 (1200mg, Fed)
Participants received a single 1200mg oral dose of ARN-75039 capsules under fed conditions.
|
Part 1- SAD: Cohort 6 (2000mg, Fed)
Participants received a single 2000mg oral dose of ARN-75039 capsules under fed conditions.
|
Part 1- SAD: Placebo (Fed and Fasted)
Participants received matching placebo capsules containing microcrystalline cellulose administered orally according to the corresponding cohort dosing schedule.
|
Part 2- MAD: Cohort 7 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 36 and 24 mg doses, Day 2: 24 mg BID, Days 3-10: 12 mg BID
|
Part 2- MAD: Cohort 8 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 75 and 50 mg doses, Day 2: 50 mg BID, Days 3-10: 25 mg BID
|
Part 2- MAD: Cohort 9 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 150 and 100 mg doses, Day 2: 100 mg BID, Days 3-10: 50 mg BID
|
Part 2- MAD: Cohort 10 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 240 and 160 mg doses, Day 2: 160 mg BID, Days 3-10: 80 mg BID
|
Part 2- MAD: Cohort 11 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 360 and 240 mg doses, Day 2: 240 mg BID, Days 3-10: 120 mg BID
|
Part 2- MAD: Placebo (Fed)
Participants received matching placebo capsules containing microcrystalline cellulose administered orally according to the corresponding cohort dosing schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Oral ARN-75039 in Healthy Adult Subjects
Baseline characteristics by cohort
| Measure |
Part 2-MAD: Cohort 9 (Fed)
n=6 Participants
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 150 and 100 mg doses, Day 2: 100 mg BID, Days 3-10: 50 mg BID.
|
Part 2-MAD: Cohort 10 (Fed)
n=7 Participants
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 240 and 160 mg doses, Day 2: 160 mg BID, Days 3-10: 80 mg BID.
|
Part 2-MAD: Cohort 11 (Fed)
n=7 Participants
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 360 and 240 mg doses, Day 2: 240 mg BID, Days 3-10: 120 mg BID.
|
Part 2-MAD: Placebo (Fed)
n=12 Participants
Participants received matching placebo capsules containing microcrystalline cellulose administered orally according to the corresponding cohort dosing schedule.
|
Total
n=94 Participants
Total of all reporting groups
|
Part 1-SAD: Cohort 1 (30mg, Fed)
n=6 Participants
Participants received a single 30 mg oral dose of ARN-75039 capsules under fed conditions.
|
Part 1-SAD: Cohort 2 (100mg, Fed)
n=6 Participants
Participants received a single 100 mg oral dose of ARN-75039 capsules under fed conditions.
|
Part 1-SAD: Cohort 3 (300mg, Fed and Fasted for Food Effect)
n=8 Participants
Participants received a single 300 mg oral dose of ARN-75039 under fed conditions on Day 1 and a second 300 mg oral dose under fasted conditions on Day 15 or later after an appropriate washout period to assess the food effect
|
Part 1-SAD: Cohort 4 (600mg, Fed)
n=6 Participants
Participants received a single 600mg oral dose of ARN-75039 capsules under fed conditions.
|
Part 1-SAD: Cohort 5 (1200mg, Fed)
n=6 Participants
Participants received a single 1200mg oral dose of ARN-75039 capsules under fed conditions.
|
Part 1-SAD: Cohort 6 (2000mg, Fed)
n=6 Participants
Participants received a single 2000mg oral dose of ARN-75039 capsules under fed conditions.
|
Part 1-SAD: Placebo (Fed and Fasted for Food Effect)
n=12 Participants
Participants received matching placebo capsules administered according to the corresponding cohort dosing schedule; in the food-effect cohort, placebo was administered under fed conditions on Day 1 and under fasted conditions on Day 15 or later after washout
|
Part 2-MAD: Cohort 7 (Fed)
n=6 Participants
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 36 and 24 mg doses, Day 2: 24 mg BID, Days 3-10: 12 mg BID.
|
Part 2: MAD: Cohort 8 (Fed)
n=6 Participants
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 75 and 50 mg doses, Day 2: 50 mg BID, Days 3-10: 25 mg BID.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
41.5 Years
STANDARD_DEVIATION 11.41 • n=30 Participants
|
34.9 Years
STANDARD_DEVIATION 7.38 • n=8 Participants
|
36.4 Years
STANDARD_DEVIATION 7.14 • n=3 Participants
|
33.0 Years
STANDARD_DEVIATION 8.83 • n=3 Participants
|
37.3 Years
STANDARD_DEVIATION 9.7 • n=1 Participants
|
43.7 Years
STANDARD_DEVIATION 10.98 • n=14 Participants
|
33.2 Years
STANDARD_DEVIATION 12.09 • n=34 Participants
|
39.6 Years
STANDARD_DEVIATION 8.63 • n=69 Participants
|
45.5 Years
STANDARD_DEVIATION 10.39 • n=140 Participants
|
29.5 Years
STANDARD_DEVIATION 6.83 • n=451 Participants
|
30.0 Years
STANDARD_DEVIATION 7.77 • n=27 Participants
|
37.3 Years
STANDARD_DEVIATION 10.09 • n=162 Participants
|
42.5 Years
STANDARD_DEVIATION 7.71 • n=19729 Participants
|
41.2 Years
STANDARD_DEVIATION 5.64 • n=221228 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=30 Participants
|
6 Participants
n=8 Participants
|
4 Participants
n=3 Participants
|
5 Participants
n=3 Participants
|
46 Participants
n=1 Participants
|
3 Participants
n=14 Participants
|
3 Participants
n=34 Participants
|
4 Participants
n=69 Participants
|
3 Participants
n=140 Participants
|
1 Participants
n=451 Participants
|
3 Participants
n=27 Participants
|
6 Participants
n=162 Participants
|
2 Participants
n=19729 Participants
|
1 Participants
n=221228 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=30 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=3 Participants
|
7 Participants
n=3 Participants
|
48 Participants
n=1 Participants
|
3 Participants
n=14 Participants
|
3 Participants
n=34 Participants
|
4 Participants
n=69 Participants
|
3 Participants
n=140 Participants
|
5 Participants
n=451 Participants
|
3 Participants
n=27 Participants
|
6 Participants
n=162 Participants
|
4 Participants
n=19729 Participants
|
5 Participants
n=221228 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=162 Participants
|
0 Participants
n=19729 Participants
|
0 Participants
n=221228 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=30 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
4 Participants
n=1 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=162 Participants
|
0 Participants
n=19729 Participants
|
0 Participants
n=221228 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=162 Participants
|
0 Participants
n=19729 Participants
|
0 Participants
n=221228 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=30 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=3 Participants
|
6 Participants
n=3 Participants
|
42 Participants
n=1 Participants
|
2 Participants
n=14 Participants
|
2 Participants
n=34 Participants
|
2 Participants
n=69 Participants
|
3 Participants
n=140 Participants
|
3 Participants
n=451 Participants
|
2 Participants
n=27 Participants
|
6 Participants
n=162 Participants
|
3 Participants
n=19729 Participants
|
4 Participants
n=221228 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=30 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
43 Participants
n=1 Participants
|
4 Participants
n=14 Participants
|
3 Participants
n=34 Participants
|
6 Participants
n=69 Participants
|
3 Participants
n=140 Participants
|
3 Participants
n=451 Participants
|
3 Participants
n=27 Participants
|
6 Participants
n=162 Participants
|
3 Participants
n=19729 Participants
|
2 Participants
n=221228 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=30 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=1 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=162 Participants
|
0 Participants
n=19729 Participants
|
0 Participants
n=221228 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=1 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=162 Participants
|
0 Participants
n=19729 Participants
|
0 Participants
n=221228 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=30 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
12 Participants
n=1 Participants
|
1 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
1 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=162 Participants
|
2 Participants
n=19729 Participants
|
0 Participants
n=221228 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=30 Participants
|
5 Participants
n=8 Participants
|
6 Participants
n=3 Participants
|
9 Participants
n=3 Participants
|
82 Participants
n=1 Participants
|
5 Participants
n=14 Participants
|
6 Participants
n=34 Participants
|
8 Participants
n=69 Participants
|
5 Participants
n=140 Participants
|
6 Participants
n=451 Participants
|
6 Participants
n=27 Participants
|
10 Participants
n=162 Participants
|
4 Participants
n=19729 Participants
|
6 Participants
n=221228 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=162 Participants
|
0 Participants
n=19729 Participants
|
0 Participants
n=221228 Participants
|
|
Body Mass Index (BMI)
|
26.75 Kg/m^2
STANDARD_DEVIATION 2.25 • n=30 Participants
|
30.67 Kg/m^2
STANDARD_DEVIATION 2.29 • n=8 Participants
|
27.49 Kg/m^2
STANDARD_DEVIATION 1.98 • n=3 Participants
|
26.90 Kg/m^2
STANDARD_DEVIATION 3.02 • n=3 Participants
|
27.2 Kg/m^2
STANDARD_DEVIATION 3.19 • n=1 Participants
|
27.18 Kg/m^2
STANDARD_DEVIATION 2.93 • n=14 Participants
|
26.23 Kg/m^2
STANDARD_DEVIATION 3.57 • n=34 Participants
|
29.13 Kg/m^2
STANDARD_DEVIATION 3.88 • n=69 Participants
|
27.47 Kg/m^2
STANDARD_DEVIATION 3.39 • n=140 Participants
|
26.68 Kg/m^2
STANDARD_DEVIATION 1.62 • n=451 Participants
|
25.10 Kg/m^2
STANDARD_DEVIATION 5.41 • n=27 Participants
|
26.18 Kg/m^2
STANDARD_DEVIATION 3.258 • n=162 Participants
|
26.27 Kg/m^2
STANDARD_DEVIATION 2.67 • n=19729 Participants
|
27.63 Kg/m^2
STANDARD_DEVIATION 1.81 • n=221228 Participants
|
|
Weight
|
77.17 kg
STANDARD_DEVIATION 4.53 • n=30 Participants
|
86.69 kg
STANDARD_DEVIATION 11.77 • n=8 Participants
|
77.40 kg
STANDARD_DEVIATION 12.672 • n=3 Participants
|
79.35 kg
STANDARD_DEVIATION 15.161 • n=3 Participants
|
79.6 kg
STANDARD_DEVIATION 12.82 • n=1 Participants
|
75.77 kg
STANDARD_DEVIATION 11.31 • n=14 Participants
|
76.47 kg
STANDARD_DEVIATION 20.44 • n=34 Participants
|
82.50 kg
STANDARD_DEVIATION 12.27 • n=69 Participants
|
77.90 kg
STANDARD_DEVIATION 6.66 • n=140 Participants
|
82.43 kg
STANDARD_DEVIATION 13.84 • n=451 Participants
|
79.80 kg
STANDARD_DEVIATION 19.90 • n=27 Participants
|
78.15 kg
STANDARD_DEVIATION 14.20 • n=162 Participants
|
76.03 kg
STANDARD_DEVIATION 11.61 • n=19729 Participants
|
85.07 kg
STANDARD_DEVIATION 3.00 • n=221228 Participants
|
|
Height
|
170.02 cm
STANDARD_DEVIATION 7.20 • n=30 Participants
|
167.79 cm
STANDARD_DEVIATION 8.24 • n=8 Participants
|
167.40 cm
STANDARD_DEVIATION 12.12 • n=3 Participants
|
171.30 cm
STANDARD_DEVIATION 13.04 • n=3 Participants
|
170.89 cm
STANDARD_DEVIATION 11.04 • n=1 Participants
|
167.05 cm
STANDARD_DEVIATION 13.24 • n=14 Participants
|
169.42 cm
STANDARD_DEVIATION 14.11 • n=34 Participants
|
168.51 cm
STANDARD_DEVIATION 9.73 • n=69 Participants
|
168.95 cm
STANDARD_DEVIATION 10.22 • n=140 Participants
|
175.05 cm
STANDARD_DEVIATION 10.73 • n=451 Participants
|
177.93 cm
STANDARD_DEVIATION 13.08 • n=27 Participants
|
172.54 cm
STANDARD_DEVIATION 13.05 • n=162 Participants
|
169.78 cm
STANDARD_DEVIATION 9.16 • n=19729 Participants
|
175.68 cm
STANDARD_DEVIATION 6.90 • n=221228 Participants
|
PRIMARY outcome
Timeframe: From first dose through the End-of-Study (EOS) visit: Part 1 (SAD), through Day 15/EOS; Food-effect cohort, through the second treatment period and Day 29/EOS; Part 2 (MAD), from Day 1 through Day 39/EOS.Population: PK population per SAP; All participants who received ≥ 1 dose of study drug or placebo.
A treatment-emergent adverse event (TEAE) was defined as any adverse event that began or worsened after administration of the study drug (ARN-75039 or placebo) through the End-of-Study visit.
Outcome measures
| Measure |
Cohort 3 (300mg, Fed)
n=8 Participants
Participants received a single 300mg oral dose of ARN-75039 under fed conditions, followed by a second dose under fasted conditions after an appropriate washout period to assess the food effect (fed/fasted cross-over). 9 participants completed the fasted period; 8 were included in the PK analysis per SAP (1 excluded due to pre-specified criteria)
|
Cohort 1 (30mg, Fed)
n=6 Participants
Participants received a single 30 mg oral dose of ARN-75039 capsules under fed conditions
|
Cohort 2 (100mg, Fed)
n=6 Participants
Participants received a single 100 mg oral dose of ARN-75039 capsules under fed conditions
|
Cohort 3 (300mg, Fasted)
n=8 Participants
Participants received a single 300mg oral dose of ARN-75039 under fed conditions, followed by a second dose under fasted conditions after an appropriate washout period to assess the food effect (fed/fasted cross-over). 9 participants completed the fasted period; 8 were included in the PK analysis per SAP (1 excluded due to pre-specified criteria)
|
Cohort 4 (600mg, Fed)
n=6 Participants
Participants received a single 600mg oral dose of ARN-75039 capsules under fed conditions.
|
Cohort 5 (1200mg, Fed)
n=6 Participants
Participants received a single 1200mg oral dose of ARN-75039 capsules under fed conditions.
|
Cohort 6 (2000mg, Fed)
n=6 Participants
Participants received a single 2000mg oral dose of ARN-75039 capsules under fed conditions.
|
Part 1-SAD: Placebo (Fed)
n=12 Participants
Participants received matching placebo capsules containing microcrystalline cellulose administered orally according to the corresponding cohort dosing schedule.
|
Part 1-SAD: Placebo (Fasted)
n=1 Participants
The onsite pharmacist dispensed the placebo (microcrystalline cellulose) weight corresponding to the drug dose within the same cohort and encapsulated it in an HPMC capsule prior to dosing.
|
Part 2-MAD: Cohort 7 (Fed)
n=6 Participants
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 36 and 24 mg doses, Day 2: 24 mg BID, Days 3-10: 12 mg BID
|
Part 2: MAD: Cohort 8 (Fed)
n=6 Participants
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 75 and 50 mg doses, Day 2: 50 mg BID, Days 3-10: 25 mg BID
|
Part 2-MAD: Cohort 9 (Fed)
n=6 Participants
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 150 and 100 mg doses, Day 2: 100 mg BID, Days 3-10: 50 mg BID
|
Part 2-MAD: Cohort 10 (Fed)
n=7 Participants
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 240 and 160 mg doses, Day 2: 160 mg BID, Days 3-10: 80 mg BID
|
Part 2-MAD: Cohort 11 (Fed)
n=7 Participants
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 360 and 240 mg doses, Day 2: 240 mg BID, Days 3-10: 120 mg BID
|
Part 2-MAD: Placebo (Fed)
n=12 Participants
Participants received matching placebo capsules containing microcrystalline cellulose administered orally according to the corresponding cohort dosing schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events (TEAEs)
|
5 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
6 Participants
|
5 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: From first dose through the End-of-Study (EOS) visit: Part 1 (SAD), through Day 15/EOS; Food-effect cohort, through the second treatment period and Day 29/EOS; Part 2 (MAD), from Day 1 through Day 39/EOS.Population: The Safety Population included all subjects who received at least one dose of study drug (ARN-75039 or placebo).
Number of participants with at least one treatment-emergent Serious adverse event (TESAE). A TESAE is any adverse event that starts or worsens after administration of study drug (ARN-75039 or placebo).
Outcome measures
| Measure |
Cohort 3 (300mg, Fed)
n=8 Participants
Participants received a single 300mg oral dose of ARN-75039 under fed conditions, followed by a second dose under fasted conditions after an appropriate washout period to assess the food effect (fed/fasted cross-over). 9 participants completed the fasted period; 8 were included in the PK analysis per SAP (1 excluded due to pre-specified criteria)
|
Cohort 1 (30mg, Fed)
n=6 Participants
Participants received a single 30 mg oral dose of ARN-75039 capsules under fed conditions
|
Cohort 2 (100mg, Fed)
n=6 Participants
Participants received a single 100 mg oral dose of ARN-75039 capsules under fed conditions
|
Cohort 3 (300mg, Fasted)
n=8 Participants
Participants received a single 300mg oral dose of ARN-75039 under fed conditions, followed by a second dose under fasted conditions after an appropriate washout period to assess the food effect (fed/fasted cross-over). 9 participants completed the fasted period; 8 were included in the PK analysis per SAP (1 excluded due to pre-specified criteria)
|
Cohort 4 (600mg, Fed)
n=6 Participants
Participants received a single 600mg oral dose of ARN-75039 capsules under fed conditions.
|
Cohort 5 (1200mg, Fed)
n=6 Participants
Participants received a single 1200mg oral dose of ARN-75039 capsules under fed conditions.
|
Cohort 6 (2000mg, Fed)
n=6 Participants
Participants received a single 2000mg oral dose of ARN-75039 capsules under fed conditions.
|
Part 1-SAD: Placebo (Fed)
n=12 Participants
Participants received matching placebo capsules containing microcrystalline cellulose administered orally according to the corresponding cohort dosing schedule.
|
Part 1-SAD: Placebo (Fasted)
n=1 Participants
The onsite pharmacist dispensed the placebo (microcrystalline cellulose) weight corresponding to the drug dose within the same cohort and encapsulated it in an HPMC capsule prior to dosing.
|
Part 2-MAD: Cohort 7 (Fed)
n=6 Participants
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 36 and 24 mg doses, Day 2: 24 mg BID, Days 3-10: 12 mg BID
|
Part 2: MAD: Cohort 8 (Fed)
n=6 Participants
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 75 and 50 mg doses, Day 2: 50 mg BID, Days 3-10: 25 mg BID
|
Part 2-MAD: Cohort 9 (Fed)
n=6 Participants
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 150 and 100 mg doses, Day 2: 100 mg BID, Days 3-10: 50 mg BID
|
Part 2-MAD: Cohort 10 (Fed)
n=7 Participants
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 240 and 160 mg doses, Day 2: 160 mg BID, Days 3-10: 80 mg BID
|
Part 2-MAD: Cohort 11 (Fed)
n=7 Participants
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 360 and 240 mg doses, Day 2: 240 mg BID, Days 3-10: 120 mg BID
|
Part 2-MAD: Placebo (Fed)
n=12 Participants
Participants received matching placebo capsules containing microcrystalline cellulose administered orally according to the corresponding cohort dosing schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Incidence of Treatment-Emergent Serious Adverse Events (TESAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 predose and at 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 12, 24 (Day 2), 48 (Day 3), 72 (Day 4), 168 (Day 8), and 336 (Day 15/EOS) hours postdose.Population: All participants with sufficient post-dose concentrations per SAP.
Maximum Observed Plasma Concentrations of ARN-75039 (Cmax); Pharmacokinetic endpoints included standard noncompartmental parameters following single and multiple ascending oral doses of ARN-75039. The effect of food on ARN-75039 pharmacokinetics was evaluated following administration under fed and fasted conditions. Integrated safety and PK data were used to determine the recommended Phase 2 dose (RP2D) and dosing regimen.
Outcome measures
| Measure |
Cohort 3 (300mg, Fed)
n=8 Participants
Participants received a single 300mg oral dose of ARN-75039 under fed conditions, followed by a second dose under fasted conditions after an appropriate washout period to assess the food effect (fed/fasted cross-over). 9 participants completed the fasted period; 8 were included in the PK analysis per SAP (1 excluded due to pre-specified criteria)
|
Cohort 1 (30mg, Fed)
n=6 Participants
Participants received a single 30 mg oral dose of ARN-75039 capsules under fed conditions
|
Cohort 2 (100mg, Fed)
n=6 Participants
Participants received a single 100 mg oral dose of ARN-75039 capsules under fed conditions
|
Cohort 3 (300mg, Fasted)
n=8 Participants
Participants received a single 300mg oral dose of ARN-75039 under fed conditions, followed by a second dose under fasted conditions after an appropriate washout period to assess the food effect (fed/fasted cross-over). 9 participants completed the fasted period; 8 were included in the PK analysis per SAP (1 excluded due to pre-specified criteria)
|
Cohort 4 (600mg, Fed)
n=6 Participants
Participants received a single 600mg oral dose of ARN-75039 capsules under fed conditions.
|
Cohort 5 (1200mg, Fed)
n=6 Participants
Participants received a single 1200mg oral dose of ARN-75039 capsules under fed conditions.
|
Cohort 6 (2000mg, Fed)
n=6 Participants
Participants received a single 2000mg oral dose of ARN-75039 capsules under fed conditions.
|
Part 1-SAD: Placebo (Fed)
Participants received matching placebo capsules containing microcrystalline cellulose administered orally according to the corresponding cohort dosing schedule.
|
Part 1-SAD: Placebo (Fasted)
The onsite pharmacist dispensed the placebo (microcrystalline cellulose) weight corresponding to the drug dose within the same cohort and encapsulated it in an HPMC capsule prior to dosing.
|
Part 2-MAD: Cohort 7 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 36 and 24 mg doses, Day 2: 24 mg BID, Days 3-10: 12 mg BID
|
Part 2: MAD: Cohort 8 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 75 and 50 mg doses, Day 2: 50 mg BID, Days 3-10: 25 mg BID
|
Part 2-MAD: Cohort 9 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 150 and 100 mg doses, Day 2: 100 mg BID, Days 3-10: 50 mg BID
|
Part 2-MAD: Cohort 10 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 240 and 160 mg doses, Day 2: 160 mg BID, Days 3-10: 80 mg BID
|
Part 2-MAD: Cohort 11 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 360 and 240 mg doses, Day 2: 240 mg BID, Days 3-10: 120 mg BID
|
Part 2-MAD: Placebo (Fed)
Participants received matching placebo capsules containing microcrystalline cellulose administered orally according to the corresponding cohort dosing schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1-SAD: Cmax
|
1281 ng/mL
Standard Deviation 445.04
|
141.3 ng/mL
Standard Deviation 48.359
|
442.0 ng/mL
Standard Deviation 134.76
|
722.1 ng/mL
Standard Deviation 281.30
|
1962 ng/mL
Standard Deviation 762.01
|
2687 ng/mL
Standard Deviation 1252.2
|
2933 ng/mL
Standard Deviation 554.24
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 predose and at 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 12, 24 (Day 2), 48 (Day 3), 72 (Day 4), 168 (Day 8), and 336 (Day 15/EOS) hours postdose.Population: All participants with sufficient post-dose concentrations per SAP.
PK of ARN-75039 in healthy subjects as assessed by time to reach Cmax (Tmax) towards the determination of the optimal PK dose
Outcome measures
| Measure |
Cohort 3 (300mg, Fed)
n=8 Participants
Participants received a single 300mg oral dose of ARN-75039 under fed conditions, followed by a second dose under fasted conditions after an appropriate washout period to assess the food effect (fed/fasted cross-over). 9 participants completed the fasted period; 8 were included in the PK analysis per SAP (1 excluded due to pre-specified criteria)
|
Cohort 1 (30mg, Fed)
n=6 Participants
Participants received a single 30 mg oral dose of ARN-75039 capsules under fed conditions
|
Cohort 2 (100mg, Fed)
n=6 Participants
Participants received a single 100 mg oral dose of ARN-75039 capsules under fed conditions
|
Cohort 3 (300mg, Fasted)
n=8 Participants
Participants received a single 300mg oral dose of ARN-75039 under fed conditions, followed by a second dose under fasted conditions after an appropriate washout period to assess the food effect (fed/fasted cross-over). 9 participants completed the fasted period; 8 were included in the PK analysis per SAP (1 excluded due to pre-specified criteria)
|
Cohort 4 (600mg, Fed)
n=6 Participants
Participants received a single 600mg oral dose of ARN-75039 capsules under fed conditions.
|
Cohort 5 (1200mg, Fed)
n=6 Participants
Participants received a single 1200mg oral dose of ARN-75039 capsules under fed conditions.
|
Cohort 6 (2000mg, Fed)
n=6 Participants
Participants received a single 2000mg oral dose of ARN-75039 capsules under fed conditions.
|
Part 1-SAD: Placebo (Fed)
Participants received matching placebo capsules containing microcrystalline cellulose administered orally according to the corresponding cohort dosing schedule.
|
Part 1-SAD: Placebo (Fasted)
The onsite pharmacist dispensed the placebo (microcrystalline cellulose) weight corresponding to the drug dose within the same cohort and encapsulated it in an HPMC capsule prior to dosing.
|
Part 2-MAD: Cohort 7 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 36 and 24 mg doses, Day 2: 24 mg BID, Days 3-10: 12 mg BID
|
Part 2: MAD: Cohort 8 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 75 and 50 mg doses, Day 2: 50 mg BID, Days 3-10: 25 mg BID
|
Part 2-MAD: Cohort 9 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 150 and 100 mg doses, Day 2: 100 mg BID, Days 3-10: 50 mg BID
|
Part 2-MAD: Cohort 10 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 240 and 160 mg doses, Day 2: 160 mg BID, Days 3-10: 80 mg BID
|
Part 2-MAD: Cohort 11 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 360 and 240 mg doses, Day 2: 240 mg BID, Days 3-10: 120 mg BID
|
Part 2-MAD: Placebo (Fed)
Participants received matching placebo capsules containing microcrystalline cellulose administered orally according to the corresponding cohort dosing schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1-SAD: Tmax
|
5.51 h
Standard Deviation 0.93
|
5.67 h
Standard Deviation 0.81
|
6.03 h
Standard Deviation 0.07
|
4.27 h
Standard Deviation 1.65
|
6.01 h
Standard Deviation 3.33
|
5.67 h
Standard Deviation 0.82
|
6.67 h
Standard Deviation 2.74
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Derived from plasma samples collected from Day 1 predose through 336 hours (Day 15/EOS) postdose.Population: All participants with sufficient post-dose concentrations per SAP.
PK of ARN-75039 in healthy subjects as assessed by terminal elimination half-life (T1/2)
Outcome measures
| Measure |
Cohort 3 (300mg, Fed)
n=8 Participants
Participants received a single 300mg oral dose of ARN-75039 under fed conditions, followed by a second dose under fasted conditions after an appropriate washout period to assess the food effect (fed/fasted cross-over). 9 participants completed the fasted period; 8 were included in the PK analysis per SAP (1 excluded due to pre-specified criteria)
|
Cohort 1 (30mg, Fed)
n=6 Participants
Participants received a single 30 mg oral dose of ARN-75039 capsules under fed conditions
|
Cohort 2 (100mg, Fed)
n=6 Participants
Participants received a single 100 mg oral dose of ARN-75039 capsules under fed conditions
|
Cohort 3 (300mg, Fasted)
n=8 Participants
Participants received a single 300mg oral dose of ARN-75039 under fed conditions, followed by a second dose under fasted conditions after an appropriate washout period to assess the food effect (fed/fasted cross-over). 9 participants completed the fasted period; 8 were included in the PK analysis per SAP (1 excluded due to pre-specified criteria)
|
Cohort 4 (600mg, Fed)
n=6 Participants
Participants received a single 600mg oral dose of ARN-75039 capsules under fed conditions.
|
Cohort 5 (1200mg, Fed)
n=6 Participants
Participants received a single 1200mg oral dose of ARN-75039 capsules under fed conditions.
|
Cohort 6 (2000mg, Fed)
n=6 Participants
Participants received a single 2000mg oral dose of ARN-75039 capsules under fed conditions.
|
Part 1-SAD: Placebo (Fed)
Participants received matching placebo capsules containing microcrystalline cellulose administered orally according to the corresponding cohort dosing schedule.
|
Part 1-SAD: Placebo (Fasted)
The onsite pharmacist dispensed the placebo (microcrystalline cellulose) weight corresponding to the drug dose within the same cohort and encapsulated it in an HPMC capsule prior to dosing.
|
Part 2-MAD: Cohort 7 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 36 and 24 mg doses, Day 2: 24 mg BID, Days 3-10: 12 mg BID
|
Part 2: MAD: Cohort 8 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 75 and 50 mg doses, Day 2: 50 mg BID, Days 3-10: 25 mg BID
|
Part 2-MAD: Cohort 9 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 150 and 100 mg doses, Day 2: 100 mg BID, Days 3-10: 50 mg BID
|
Part 2-MAD: Cohort 10 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 240 and 160 mg doses, Day 2: 160 mg BID, Days 3-10: 80 mg BID
|
Part 2-MAD: Cohort 11 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 360 and 240 mg doses, Day 2: 240 mg BID, Days 3-10: 120 mg BID
|
Part 2-MAD: Placebo (Fed)
Participants received matching placebo capsules containing microcrystalline cellulose administered orally according to the corresponding cohort dosing schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1-SAD: Terminal Half-life
|
15.43 h
Standard Deviation 10.45
|
4.27 h
Standard Deviation 0
|
6.24 h
Standard Deviation 1.97
|
10.13 h
Standard Deviation 9.66
|
137.3 h
Standard Deviation 62.67
|
98 h
Standard Deviation 39.82
|
90.34 h
Standard Deviation 46.94
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 predose and at 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 12, 24 (Day 2), 48 (Day 3), 72 (Day 4), 168 (Day 8), and 336 (Day 15/EOS) hours postdose.Population: All participants with sufficient post-dose concentrations per SAP.
PK of ARN-75039 in healthy subjects as assessed by plasma exposure (AUC), determination of the optimal PK dose
Outcome measures
| Measure |
Cohort 3 (300mg, Fed)
n=8 Participants
Participants received a single 300mg oral dose of ARN-75039 under fed conditions, followed by a second dose under fasted conditions after an appropriate washout period to assess the food effect (fed/fasted cross-over). 9 participants completed the fasted period; 8 were included in the PK analysis per SAP (1 excluded due to pre-specified criteria)
|
Cohort 1 (30mg, Fed)
n=6 Participants
Participants received a single 30 mg oral dose of ARN-75039 capsules under fed conditions
|
Cohort 2 (100mg, Fed)
n=6 Participants
Participants received a single 100 mg oral dose of ARN-75039 capsules under fed conditions
|
Cohort 3 (300mg, Fasted)
n=6 Participants
Participants received a single 300mg oral dose of ARN-75039 under fed conditions, followed by a second dose under fasted conditions after an appropriate washout period to assess the food effect (fed/fasted cross-over). 9 participants completed the fasted period; 8 were included in the PK analysis per SAP (1 excluded due to pre-specified criteria)
|
Cohort 4 (600mg, Fed)
n=6 Participants
Participants received a single 600mg oral dose of ARN-75039 capsules under fed conditions.
|
Cohort 5 (1200mg, Fed)
n=6 Participants
Participants received a single 1200mg oral dose of ARN-75039 capsules under fed conditions.
|
Cohort 6 (2000mg, Fed)
n=6 Participants
Participants received a single 2000mg oral dose of ARN-75039 capsules under fed conditions.
|
Part 1-SAD: Placebo (Fed)
Participants received matching placebo capsules containing microcrystalline cellulose administered orally according to the corresponding cohort dosing schedule.
|
Part 1-SAD: Placebo (Fasted)
The onsite pharmacist dispensed the placebo (microcrystalline cellulose) weight corresponding to the drug dose within the same cohort and encapsulated it in an HPMC capsule prior to dosing.
|
Part 2-MAD: Cohort 7 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 36 and 24 mg doses, Day 2: 24 mg BID, Days 3-10: 12 mg BID
|
Part 2: MAD: Cohort 8 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 75 and 50 mg doses, Day 2: 50 mg BID, Days 3-10: 25 mg BID
|
Part 2-MAD: Cohort 9 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 150 and 100 mg doses, Day 2: 100 mg BID, Days 3-10: 50 mg BID
|
Part 2-MAD: Cohort 10 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 240 and 160 mg doses, Day 2: 160 mg BID, Days 3-10: 80 mg BID
|
Part 2-MAD: Cohort 11 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 360 and 240 mg doses, Day 2: 240 mg BID, Days 3-10: 120 mg BID
|
Part 2-MAD: Placebo (Fed)
Participants received matching placebo capsules containing microcrystalline cellulose administered orally according to the corresponding cohort dosing schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1-SAD: AUC
AUC 0-∞
|
15830 h*ng/mL
Standard Deviation 4982.7
|
1448 h*ng/mL
Standard Deviation 0
|
5004 h*ng/mL
Standard Deviation 1266.7
|
8083 h*ng/mL
Standard Deviation 4132.0
|
38740 h*ng/mL
Standard Deviation 8194.1
|
48860 h*ng/mL
Standard Deviation 23704
|
62860 h*ng/mL
Standard Deviation 16776
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1-SAD: AUC
AUC 0-t
|
15170 h*ng/mL
Standard Deviation 4816.3
|
952.3 h*ng/mL
Standard Deviation 313.61
|
4184 h*ng/mL
Standard Deviation 1276.9
|
7593 h*ng/mL
Standard Deviation 3833.8
|
32710 h*ng/mL
Standard Deviation 6233.1
|
43650 h*ng/mL
Standard Deviation 22149
|
56780 h*ng/mL
Standard Deviation 14333
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 10: predose and at 0.5, 1, 2, 4, 6, 8, and 10 hours after the morning dose.Population: All participants with sufficient post-dose concentrations per SAP.
Maximum Plasma Concentrations of ARN-75039 at 1 and 10 days. Pharmacokinetic endpoints included standard noncompartmental parameters following single and multiple ascending oral doses of ARN-75039. The effect of food on ARN-75039 pharmacokinetics was evaluated following administration under fed and fasted conditions. Integrated safety and PK data were used to determine the recommended Phase 2 dose (RP2D) and dosing regimen
Outcome measures
| Measure |
Cohort 3 (300mg, Fed)
n=5 Participants
Participants received a single 300mg oral dose of ARN-75039 under fed conditions, followed by a second dose under fasted conditions after an appropriate washout period to assess the food effect (fed/fasted cross-over). 9 participants completed the fasted period; 8 were included in the PK analysis per SAP (1 excluded due to pre-specified criteria)
|
Cohort 1 (30mg, Fed)
n=6 Participants
Participants received a single 30 mg oral dose of ARN-75039 capsules under fed conditions
|
Cohort 2 (100mg, Fed)
n=6 Participants
Participants received a single 100 mg oral dose of ARN-75039 capsules under fed conditions
|
Cohort 3 (300mg, Fasted)
n=7 Participants
Participants received a single 300mg oral dose of ARN-75039 under fed conditions, followed by a second dose under fasted conditions after an appropriate washout period to assess the food effect (fed/fasted cross-over). 9 participants completed the fasted period; 8 were included in the PK analysis per SAP (1 excluded due to pre-specified criteria)
|
Cohort 4 (600mg, Fed)
n=7 Participants
Participants received a single 600mg oral dose of ARN-75039 capsules under fed conditions.
|
Cohort 5 (1200mg, Fed)
Participants received a single 1200mg oral dose of ARN-75039 capsules under fed conditions.
|
Cohort 6 (2000mg, Fed)
Participants received a single 2000mg oral dose of ARN-75039 capsules under fed conditions.
|
Part 1-SAD: Placebo (Fed)
Participants received matching placebo capsules containing microcrystalline cellulose administered orally according to the corresponding cohort dosing schedule.
|
Part 1-SAD: Placebo (Fasted)
The onsite pharmacist dispensed the placebo (microcrystalline cellulose) weight corresponding to the drug dose within the same cohort and encapsulated it in an HPMC capsule prior to dosing.
|
Part 2-MAD: Cohort 7 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 36 and 24 mg doses, Day 2: 24 mg BID, Days 3-10: 12 mg BID
|
Part 2: MAD: Cohort 8 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 75 and 50 mg doses, Day 2: 50 mg BID, Days 3-10: 25 mg BID
|
Part 2-MAD: Cohort 9 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 150 and 100 mg doses, Day 2: 100 mg BID, Days 3-10: 50 mg BID
|
Part 2-MAD: Cohort 10 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 240 and 160 mg doses, Day 2: 160 mg BID, Days 3-10: 80 mg BID
|
Part 2-MAD: Cohort 11 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 360 and 240 mg doses, Day 2: 240 mg BID, Days 3-10: 120 mg BID
|
Part 2-MAD: Placebo (Fed)
Participants received matching placebo capsules containing microcrystalline cellulose administered orally according to the corresponding cohort dosing schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2-MAD: Cmax0-10h
Cmax (day 1)
|
678.8 ng/mL
Standard Deviation 296.86
|
144.7 ng/mL
Standard Deviation 34.82
|
304.8 ng/mL
Standard Deviation 45.86
|
723.7 ng/mL
Standard Deviation 139.6
|
1639 ng/mL
Standard Deviation 615.63
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2-MAD: Cmax0-10h
Cmax (day 10)
|
346.3 ng/mL
Standard Deviation 129.40
|
76.42 ng/mL
Standard Deviation 16.94
|
159.5 ng/mL
Standard Deviation 27.60
|
333.0 ng/mL
Standard Deviation 73.54
|
800.0 ng/mL
Standard Deviation 270.33
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 10: predose and at 0.5, 1, 2, 4, 6, 8, and 10 hours after the morning dose.Population: All participants with sufficient post-dose concentrations per SAP.
Time to maximum ARN-75039 concentration. Pharmacokinetic endpoints included standard noncompartmental parameters following single and multiple ascending oral doses of ARN-75039. The effect of food on ARN-75039 pharmacokinetics was evaluated following administration under fed and fasted conditions. Integrated safety and PK data were used to determine the recommended Phase 2 dose (RP2D) and dosing regimen.
Outcome measures
| Measure |
Cohort 3 (300mg, Fed)
n=5 Participants
Participants received a single 300mg oral dose of ARN-75039 under fed conditions, followed by a second dose under fasted conditions after an appropriate washout period to assess the food effect (fed/fasted cross-over). 9 participants completed the fasted period; 8 were included in the PK analysis per SAP (1 excluded due to pre-specified criteria)
|
Cohort 1 (30mg, Fed)
n=6 Participants
Participants received a single 30 mg oral dose of ARN-75039 capsules under fed conditions
|
Cohort 2 (100mg, Fed)
n=6 Participants
Participants received a single 100 mg oral dose of ARN-75039 capsules under fed conditions
|
Cohort 3 (300mg, Fasted)
n=7 Participants
Participants received a single 300mg oral dose of ARN-75039 under fed conditions, followed by a second dose under fasted conditions after an appropriate washout period to assess the food effect (fed/fasted cross-over). 9 participants completed the fasted period; 8 were included in the PK analysis per SAP (1 excluded due to pre-specified criteria)
|
Cohort 4 (600mg, Fed)
n=7 Participants
Participants received a single 600mg oral dose of ARN-75039 capsules under fed conditions.
|
Cohort 5 (1200mg, Fed)
Participants received a single 1200mg oral dose of ARN-75039 capsules under fed conditions.
|
Cohort 6 (2000mg, Fed)
Participants received a single 2000mg oral dose of ARN-75039 capsules under fed conditions.
|
Part 1-SAD: Placebo (Fed)
Participants received matching placebo capsules containing microcrystalline cellulose administered orally according to the corresponding cohort dosing schedule.
|
Part 1-SAD: Placebo (Fasted)
The onsite pharmacist dispensed the placebo (microcrystalline cellulose) weight corresponding to the drug dose within the same cohort and encapsulated it in an HPMC capsule prior to dosing.
|
Part 2-MAD: Cohort 7 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 36 and 24 mg doses, Day 2: 24 mg BID, Days 3-10: 12 mg BID
|
Part 2: MAD: Cohort 8 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 75 and 50 mg doses, Day 2: 50 mg BID, Days 3-10: 25 mg BID
|
Part 2-MAD: Cohort 9 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 150 and 100 mg doses, Day 2: 100 mg BID, Days 3-10: 50 mg BID
|
Part 2-MAD: Cohort 10 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 240 and 160 mg doses, Day 2: 160 mg BID, Days 3-10: 80 mg BID
|
Part 2-MAD: Cohort 11 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 360 and 240 mg doses, Day 2: 240 mg BID, Days 3-10: 120 mg BID
|
Part 2-MAD: Placebo (Fed)
Participants received matching placebo capsules containing microcrystalline cellulose administered orally according to the corresponding cohort dosing schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2-MAD: Tmax0-10h.
Tmax0-10h (day 1)
|
3.20 h
Standard Deviation 1.10
|
4.7 h
Standard Deviation 1.64
|
3.67 h
Standard Deviation 1.51
|
4.30 h
Standard Deviation 0.75
|
4.00 h
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2-MAD: Tmax0-10h.
Tmax0-10h (day 10)
|
5.01 h
Standard Deviation 1.16
|
5.01 h
Standard Deviation 1.10
|
5.35 h
Standard Deviation 1.04
|
4.67 h
Standard Deviation 1.04
|
5.01 h
Standard Deviation 1.10
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 10: predose and at 0.5, 1, 2, 4, 6, 8, and 10 hours after the morning dose.Population: All participants with sufficient post-dose concentrations per SAP.
Area Under the Concentration Time Profile. Pharmacokinetic endpoints included standard noncompartmental parameters following single and multiple ascending oral doses of ARN-75039. The effect of food on ARN-75039 pharmacokinetics was evaluated following administration under fed and fasted conditions. Integrated safety and PK data were used to determine the recommended Phase 2 dose (RP2D) and dosing regimen.
Outcome measures
| Measure |
Cohort 3 (300mg, Fed)
n=5 Participants
Participants received a single 300mg oral dose of ARN-75039 under fed conditions, followed by a second dose under fasted conditions after an appropriate washout period to assess the food effect (fed/fasted cross-over). 9 participants completed the fasted period; 8 were included in the PK analysis per SAP (1 excluded due to pre-specified criteria)
|
Cohort 1 (30mg, Fed)
n=6 Participants
Participants received a single 30 mg oral dose of ARN-75039 capsules under fed conditions
|
Cohort 2 (100mg, Fed)
n=6 Participants
Participants received a single 100 mg oral dose of ARN-75039 capsules under fed conditions
|
Cohort 3 (300mg, Fasted)
n=7 Participants
Participants received a single 300mg oral dose of ARN-75039 under fed conditions, followed by a second dose under fasted conditions after an appropriate washout period to assess the food effect (fed/fasted cross-over). 9 participants completed the fasted period; 8 were included in the PK analysis per SAP (1 excluded due to pre-specified criteria)
|
Cohort 4 (600mg, Fed)
n=7 Participants
Participants received a single 600mg oral dose of ARN-75039 capsules under fed conditions.
|
Cohort 5 (1200mg, Fed)
Participants received a single 1200mg oral dose of ARN-75039 capsules under fed conditions.
|
Cohort 6 (2000mg, Fed)
Participants received a single 2000mg oral dose of ARN-75039 capsules under fed conditions.
|
Part 1-SAD: Placebo (Fed)
Participants received matching placebo capsules containing microcrystalline cellulose administered orally according to the corresponding cohort dosing schedule.
|
Part 1-SAD: Placebo (Fasted)
The onsite pharmacist dispensed the placebo (microcrystalline cellulose) weight corresponding to the drug dose within the same cohort and encapsulated it in an HPMC capsule prior to dosing.
|
Part 2-MAD: Cohort 7 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 36 and 24 mg doses, Day 2: 24 mg BID, Days 3-10: 12 mg BID
|
Part 2: MAD: Cohort 8 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 75 and 50 mg doses, Day 2: 50 mg BID, Days 3-10: 25 mg BID
|
Part 2-MAD: Cohort 9 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 150 and 100 mg doses, Day 2: 100 mg BID, Days 3-10: 50 mg BID
|
Part 2-MAD: Cohort 10 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 240 and 160 mg doses, Day 2: 160 mg BID, Days 3-10: 80 mg BID
|
Part 2-MAD: Cohort 11 (Fed)
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 360 and 240 mg doses, Day 2: 240 mg BID, Days 3-10: 120 mg BID
|
Part 2-MAD: Placebo (Fed)
Participants received matching placebo capsules containing microcrystalline cellulose administered orally according to the corresponding cohort dosing schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2-MAD: AUC0-10h
AUC0-10h (day 1)
|
3805 h*ng/mL
Standard Deviation 1439.5
|
821.8 h*ng/mL
Standard Deviation 145.64
|
1651 h*ng/mL
Standard Deviation 228.57
|
4042 h*ng/mL
Standard Deviation 876.96
|
9039 h*ng/mL
Standard Deviation 2833.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2-MAD: AUC0-10h
AUC0-10h (day 10)
|
2322 h*ng/mL
Standard Deviation 815.21
|
548.7 h*ng/mL
Standard Deviation 78.321
|
1197 h*ng/mL
Standard Deviation 183.86
|
2433 h*ng/mL
Standard Deviation 461.71
|
6270 h*ng/mL
Standard Deviation 2264.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part 1-SAD: Cohort 3 (300mg, Fed)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 1-SAD: Cohort 3 (300mg, Fasted)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1-SAD: Cohort 4 (600mg, Fed)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1-SAD: Cohort 5 (1200mg, Fed)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1-SAD: Cohort 6 (2000mg, Fed)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 1-SAD: Placebo (Fed)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 1-SAD: Placebo (Fasted)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1-SAD: Cohort 1 (30mg, Fed)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1-SAD: Cohort 2 (100mg, Fed)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 2-MAD: Cohort 7 (Fed)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 2: MAD: Cohort 8 (Fed)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 2-MAD: Cohort 9 (Fed)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 2-MAD: Cohort 10 (Fed)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 2-MAD: Cohort 11 (Fed)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 2-MAD: Placebo (Fed)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1-SAD: Cohort 3 (300mg, Fed)
n=8 participants at risk
Participants received a single 300mg oral dose of ARN-75039 under fed conditions, followed by a second dose under fasted conditions after an appropriate washout period to assess the food effect (fed/fasted cross-over). 9 participants completed the fasted period; 8 were included in the PK analysis per SAP (1 excluded due to pre-specified criteria).
|
Part 1-SAD: Cohort 3 (300mg, Fasted)
n=8 participants at risk
Participants received a single 300mg oral dose of ARN-75039 under fed conditions, followed by a second dose under fasted conditions after an appropriate washout period to assess the food effect (fed/fasted cross-over). 9 participants completed the fasted period; 8 were included in the PK analysis per SAP (1 excluded due to pre-specified criteria).
|
Part 1-SAD: Cohort 4 (600mg, Fed)
n=6 participants at risk
Participants received a single 600mg oral dose of ARN-75039 capsules under fed conditions.
|
Part 1-SAD: Cohort 5 (1200mg, Fed)
n=6 participants at risk
Participants received a single 1200mg oral dose of ARN-75039 capsules under fed conditions.
|
Part 1-SAD: Cohort 6 (2000mg, Fed)
n=6 participants at risk
Participants received a single 2000mg oral dose of ARN-75039 capsules under fed conditions.
|
Part 1-SAD: Placebo (Fed)
n=12 participants at risk
Participants received matching placebo capsules containing microcrystalline cellulose administered orally according to the corresponding cohort dosing schedule.
|
Part 1-SAD: Placebo (Fasted)
n=1 participants at risk
The onsite pharmacist dispensed the weight of placebo (microcrystalline cellulose) corresponding to the dose drug within the same cohort and encapsulated it in an HPMC capsule prior to dosing.
|
Part 1-SAD: Cohort 1 (30mg, Fed)
n=6 participants at risk
Participants received a single 30 mg oral dose of ARN-75039 capsules under fed conditions.
|
Part 1-SAD: Cohort 2 (100mg, Fed)
n=6 participants at risk
Participants received a single 100 mg oral dose of ARN-75039 capsules under fed conditions
|
Part 2-MAD: Cohort 7 (Fed)
n=6 participants at risk
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 36 and 24 mg doses, Day 2: 24 mg BID, Days 3-10: 12 mg BID
|
Part 2: MAD: Cohort 8 (Fed)
n=6 participants at risk
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 75 and 50 mg doses, Day 2: 50 mg BID, Days 3-10: 25 mg BID
|
Part 2-MAD: Cohort 9 (Fed)
n=6 participants at risk
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 150 and 100 mg doses, Day 2: 100 mg BID, Days 3-10: 50 mg BID
|
Part 2-MAD: Cohort 10 (Fed)
n=7 participants at risk
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 240 and 160 mg doses, Day 2: 160 mg BID, Days 3-10: 80 mg BID
|
Part 2-MAD: Cohort 11 (Fed)
n=7 participants at risk
Participants received multiple oral doses of ARN-75039 administered twice daily (approximately 10 hours apart) for 10 days following a loading dose regimen on Days 1 and 2.
Day 1: 360 and 240 mg doses, Day 2: 240 mg BID, Days 3-10: 120 mg BID
|
Part 2-MAD: Placebo (Fed)
n=12 participants at risk
Participants received matching placebo capsules containing microcrystalline cellulose administered orally according to the corresponding cohort dosing schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Medical device site reaction
|
12.5%
1/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
16.7%
1/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/1 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
16.7%
1/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
50.0%
3/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
71.4%
5/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
42.9%
3/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
25.0%
3/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
|
General disorders
Feeling hot
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
16.7%
1/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/1 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
8.3%
1/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
|
General disorders
Swelling face
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/1 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
16.7%
1/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
|
General disorders
Vessel puncture site bruise
|
12.5%
1/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/1 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
16.7%
1/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/1 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
16.7%
1/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
|
Gastrointestinal disorders
Abnormal faeces
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/1 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
16.7%
1/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
14.3%
1/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
|
Gastrointestinal disorders
Bowel movement irregularity
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/1 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
16.7%
1/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
8.3%
1/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
1/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/1 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
16.7%
1/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
14.3%
1/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
16.7%
1/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
16.7%
1/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/1 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
16.7%
1/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
16.7%
1/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/1 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
16.7%
1/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/1 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
16.7%
1/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
50.0%
3/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/1 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
16.7%
1/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
33.3%
2/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/1 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
14.3%
1/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
16.7%
1/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
16.7%
1/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/1 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
16.7%
1/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/1 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
|
Cardiac disorders
Dizziness postural
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/1 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
16.7%
1/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
8.3%
1/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/1 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
8.3%
1/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
|
Cardiac disorders
Postural orthostatic tachycardia syndrome
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/1 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
8.3%
1/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/1 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
14.3%
1/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
8.3%
1/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
8.3%
1/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/1 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
25.0%
2/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/1 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
16.7%
1/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/1 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
16.7%
1/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/1 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
16.7%
1/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
16.7%
1/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/1 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/1 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
14.3%
1/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/1 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
14.3%
1/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
16.7%
1/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/1 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/1 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
14.3%
1/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/1 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
14.3%
1/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
14.3%
1/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
33.3%
2/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/1 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
14.3%
1/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
8.3%
1/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
16.7%
1/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/1 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/1 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
16.7%
1/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
14.3%
1/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
16.7%
1/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/1 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
8.3%
1/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/1 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
16.7%
1/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
8.3%
1/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/1 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
12.5%
1/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/1 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
|
Eye disorders
Chalazion
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/1 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
16.7%
1/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
|
Eye disorders
Photophobia
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/1 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
16.7%
1/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
|
Infections and infestations
COVID-19
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/1 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
16.7%
1/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
|
Infections and infestations
Viral infection
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/8 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
8.3%
1/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/1 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/6 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/7 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
0.00%
0/12 • From first dose through the End-of-Study visit: Part 1 (SAD), through Day 15/EOS (14 days after dosing); Food-effect cohort, through Day 29/EOS; Part 2 (MAD), through Day 39/EOS (28 days after the last dose on Day 10).
Adverse events were collected from the first dose through the end-of-study visit. Frequency Threshold set to "zero" due to a small participant pool.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place