Trial Outcomes & Findings for Phase I, KM-819 in Healthy Subjects for Parkinson's Disease (NCT NCT03022799)
NCT ID: NCT03022799
Last Updated: 2020-04-13
Results Overview
All AEs will be coded using the latest available version 19.1 of the Medical Dictionary for Regulatory Activities (MedDRA). A treatment-emergent adverse event (TEAE) is defined as an AE that begins or that worsens in severity after at least one dose of the study drug has been administered.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
88 participants
Primary outcome timeframe
From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
Results posted on
2020-04-13
Participant Flow
A first in human, single center, randomized, placebo controlled, double blind, sequential group Phase 1 study in healthy subjects recruited from Nov 2016 to Sep 2017. Participants who met all the inclusion and none of the exclusion criteria were enrolled.
All subjects underwent a Screening period of up to 28 days and a 3 day Confinement period when they were hospitalized for study activities (Day -1 to Day 3) for Part A (Single Ascending Doses) and an 8 day Confinement period when they were hospitalized for study activities (Day -1 to Day 8) for Part B (Multiple Ascending Doses)
Participant milestones
| Measure |
KM-819 - 10 mg (Part A)
6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 30 mg (Part A)
6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 100mg (Part A)
6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part A)
6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 400mg (Part A)
6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part A)
6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part A)
12 subjects received placebo orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 30 mg (Part B)
6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 100 mg (Part B)
6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part B)
6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 400mg (Part B)
6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part B)
6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part B)
10 subjects received placebo of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
6
|
12
|
6
|
6
|
6
|
6
|
6
|
10
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
6
|
12
|
6
|
6
|
5
|
5
|
6
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
KM-819 - 10 mg (Part A)
6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 30 mg (Part A)
6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 100mg (Part A)
6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part A)
6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 400mg (Part A)
6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part A)
6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part A)
12 subjects received placebo orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 30 mg (Part B)
6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 100 mg (Part B)
6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part B)
6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 400mg (Part B)
6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part B)
6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part B)
10 subjects received placebo of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Phase I, KM-819 in Healthy Subjects for Parkinson's Disease
Baseline characteristics by cohort
| Measure |
KM-819 - 10 mg (Part A)
n=6 Participants
6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 30 mg (Part A)
n=6 Participants
6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 100mg (Part A)
n=6 Participants
6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part A)
n=6 Participants
6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 400mg (Part A)
n=6 Participants
6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part A)
n=6 Participants
6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part A)
n=12 Participants
12 subjects received placebo orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 30 mg (Part B)
n=6 Participants
6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 100 mg (Part B)
n=6 Participants
6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part B)
n=6 Participants
6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 400mg (Part B)
n=6 Participants
6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part B)
n=6 Participants
6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part B)
n=10 Participants
10 subjects received placebo of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
23.7 Years
STANDARD_DEVIATION 6.28 • n=5 Participants
|
25.2 Years
STANDARD_DEVIATION 7.57 • n=7 Participants
|
26.2 Years
STANDARD_DEVIATION 5.04 • n=5 Participants
|
27.5 Years
STANDARD_DEVIATION 6.38 • n=4 Participants
|
26.3 Years
STANDARD_DEVIATION 4.13 • n=21 Participants
|
75.0 Years
STANDARD_DEVIATION 5.76 • n=10 Participants
|
35.6 Years
STANDARD_DEVIATION 19.76 • n=115 Participants
|
27.5 Years
STANDARD_DEVIATION 7.56 • n=6 Participants
|
30.2 Years
STANDARD_DEVIATION 6.85 • n=6 Participants
|
28.7 Years
STANDARD_DEVIATION 5.65 • n=64 Participants
|
22.5 Years
STANDARD_DEVIATION 1.38 • n=17 Participants
|
72.8 Years
STANDARD_DEVIATION 6.59 • n=21 Participants
|
38.5 Years
STANDARD_DEVIATION 19.73 • n=22 Participants
|
35.3 Years
STANDARD_DEVIATION 7.8 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=64 Participants
|
6 Participants
n=17 Participants
|
6 Participants
n=21 Participants
|
10 Participants
n=22 Participants
|
88 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=64 Participants
|
6 Participants
n=17 Participants
|
6 Participants
n=21 Participants
|
10 Participants
n=22 Participants
|
87 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.Population: All subjects who received at least one dose.
All AEs will be coded using the latest available version 19.1 of the Medical Dictionary for Regulatory Activities (MedDRA). A treatment-emergent adverse event (TEAE) is defined as an AE that begins or that worsens in severity after at least one dose of the study drug has been administered.
Outcome measures
| Measure |
KM-819 - 400mg (Part A)
n=6 Participants
6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part A)
n=6 Participants
6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 10 mg (Part A)
n=6 Participants
6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 30 mg (Part A)
n=6 Participants
6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 100mg (Part A)
n=6 Participants
6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part A)
n=6 Participants
6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part A)
n=12 Participants
12 subjects received placebo orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 30 mg (Part B)
n=6 Participants
6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 100 mg (Part B)
n=6 Participants
6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part B)
n=6 Participants
6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours
|
KM-819 400mg (Part B)
n=6 Participants
6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part B)
n=6 Participants
6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part B)
n=10 Participants
10 subjects received placebo of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
TEAEs leading to death
|
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
|
|
Number of Participants With Adverse Events
TEAEs
|
0 participants
|
2 participants
|
2 participants
|
2 participants
|
2 participants
|
1 participants
|
3 participants
|
2 participants
|
4 participants
|
5 participants
|
5 participants
|
3 participants
|
5 participants
|
|
Number of Participants With Adverse Events
Serious TEAEs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events
Severe TEAEs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events
Related TEAEs
|
0 participants
|
2 participants
|
2 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
2 participants
|
2 participants
|
5 participants
|
4 participants
|
3 participants
|
5 participants
|
|
Number of Participants With Adverse Events
TEAEs leading to withdrawal
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Part A: Day1 to Day 4. Part B: Day-1 to Day 8Population: All subjects who received at least one dose.
To evaluate Cmax of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.
Outcome measures
| Measure |
KM-819 - 400mg (Part A)
n=6 Participants
6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part A)
n=6 Participants
6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 10 mg (Part A)
n=6 Participants
6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 30 mg (Part A)
n=6 Participants
6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 100mg (Part A)
n=6 Participants
6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part A)
n=6 Participants
6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part A)
n=6 Participants
12 subjects received placebo orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 30 mg (Part B)
n=6 Participants
6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 100 mg (Part B)
n=6 Participants
6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part B)
n=6 Participants
6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours
|
KM-819 400mg (Part B)
n=6 Participants
6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part B)
6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part B)
10 subjects received placebo of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax (Maximum Plasma Concentration Determined Directly From the Concentration-time Profile)
|
2767 ng/mL
Geometric Coefficient of Variation 43.4
|
1766 ng/mL
Geometric Coefficient of Variation 26.0
|
244.1 ng/mL
Geometric Coefficient of Variation 31.4
|
503.6 ng/mL
Geometric Coefficient of Variation 28.0
|
1152 ng/mL
Geometric Coefficient of Variation 36.7
|
1879 ng/mL
Geometric Coefficient of Variation 55.3
|
512.0 ng/mL
Geometric Coefficient of Variation 30.9
|
1009 ng/mL
Geometric Coefficient of Variation 33.0
|
1465 ng/mL
Geometric Coefficient of Variation 77.2
|
3163 ng/mL
Geometric Coefficient of Variation 50.7
|
3542 ng/mL
Geometric Coefficient of Variation 76.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Part A:Day 1 to 4; Part B: Day 1 to Day 8Population: All subjects who received at least one dose.
To evaluate the pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.
Outcome measures
| Measure |
KM-819 - 400mg (Part A)
n=6 Participants
6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part A)
n=6 Participants
6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 10 mg (Part A)
n=6 Participants
6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 30 mg (Part A)
n=6 Participants
6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 100mg (Part A)
n=6 Participants
6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part A)
n=6 Participants
6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part A)
n=6 Participants
12 subjects received placebo orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 30 mg (Part B)
n=6 Participants
6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 100 mg (Part B)
n=6 Participants
6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part B)
n=6 Participants
6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours
|
KM-819 400mg (Part B)
n=6 Participants
6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part B)
6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part B)
10 subjects received placebo of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax (Time to Achieve Maximum Observed Plasma Concentration Determined Directly From the Concentration-time Profile)
Part A
|
4.000 hours
Interval 2.0 to 4.0
|
2.000 hours
Interval 1.0 to 4.0
|
1.500 hours
Interval 0.5 to 2.0
|
1.000 hours
Interval 0.5 to 2.0
|
2.000 hours
Interval 1.0 to 4.0
|
2.008 hours
Interval 1.0 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tmax (Time to Achieve Maximum Observed Plasma Concentration Determined Directly From the Concentration-time Profile)
Part B-Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
2.000 hours
Interval 1.0 to 6.0
|
2.000 hours
Interval 1.0 to 4.0
|
3.000 hours
Interval 2.0 to 6.0
|
2.008 hours
Interval 1.0 to 6.0
|
2.000 hours
Interval 1.0 to 6.0
|
—
|
—
|
|
Tmax (Time to Achieve Maximum Observed Plasma Concentration Determined Directly From the Concentration-time Profile)
Part B-Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
2.000 hours
Interval 0.97 to 6.0
|
3.000 hours
Interval 1.0 to 4.0
|
4.000 hours
Interval 3.92 to 4.03
|
2.000 hours
Interval 0.5 to 4.0
|
2.017 hours
Interval 1.0 to 4.02
|
—
|
—
|
SECONDARY outcome
Timeframe: Part A: Day 1 to Day 4. Part B: Day1 to Day 8Population: All subjects who received at least one dose
To evaluate the pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects. To evaluate the PK and PD of single and multiple oral doses of KM-819 in elderly male subjects.
Outcome measures
| Measure |
KM-819 - 400mg (Part A)
n=6 Participants
6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part A)
n=6 Participants
6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 10 mg (Part A)
n=6 Participants
6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 30 mg (Part A)
n=6 Participants
6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 100mg (Part A)
n=6 Participants
6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part A)
n=6 Participants
6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part A)
n=6 Participants
12 subjects received placebo orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 30 mg (Part B)
n=6 Participants
6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 100 mg (Part B)
n=6 Participants
6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part B)
n=6 Participants
6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours
|
KM-819 400mg (Part B)
n=6 Participants
6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part B)
6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part B)
10 subjects received placebo of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
t½ (Apparent Terminal Elimination Half Life)
Part A
|
8.527 Hours
Geometric Coefficient of Variation 63.2
|
10.55 Hours
Geometric Coefficient of Variation 28.5
|
1.786 Hours
Geometric Coefficient of Variation 28.3
|
4.791 Hours
Geometric Coefficient of Variation 25.0
|
9.159 Hours
Geometric Coefficient of Variation 41.2
|
9.010 Hours
Geometric Coefficient of Variation 71.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
t½ (Apparent Terminal Elimination Half Life)
Part B
|
—
|
—
|
—
|
—
|
—
|
—
|
3.075 Hours
Geometric Coefficient of Variation 46.9
|
5.417 Hours
Geometric Coefficient of Variation 15.1
|
5.785 Hours
Geometric Coefficient of Variation 24.1
|
—
|
4.389 Hours
Geometric Coefficient of Variation 13.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Part A: Day1 to Day 4. Part B: Day 1 to Day 8Population: All subjects who received at least one dose.
To evaluate the T lag of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.
Outcome measures
| Measure |
KM-819 - 400mg (Part A)
n=6 Participants
6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part A)
n=6 Participants
6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 10 mg (Part A)
n=6 Participants
6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 30 mg (Part A)
n=6 Participants
6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 100mg (Part A)
n=6 Participants
6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part A)
n=6 Participants
6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part A)
n=6 Participants
12 subjects received placebo orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 30 mg (Part B)
n=6 Participants
6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 100 mg (Part B)
n=6 Participants
6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part B)
n=6 Participants
6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours
|
KM-819 400mg (Part B)
n=6 Participants
6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part B)
6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part B)
10 subjects received placebo of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tlag (Lag Time)
Part A
|
0 Hours
Standard Deviation 0
|
0 Hours
Standard Deviation 0
|
0.08333 Hours
Standard Deviation 0.1291
|
0 Hours
Standard Deviation 0
|
0 Hours
Standard Deviation 0
|
0.04167 Hours
Standard Deviation 0.1021
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tlag (Lag Time)
Part B-Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
0.04167 Hours
Standard Deviation 0.1021
|
0.08333 Hours
Standard Deviation 0.1291
|
0 Hours
Standard Deviation 0
|
0 Hours
Standard Deviation 0
|
0 Hours
Standard Deviation 0
|
—
|
—
|
|
Tlag (Lag Time)
Part B-Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Hours
Standard Deviation 0
|
0 Hours
Standard Deviation 0
|
0 Hours
Standard Deviation 0
|
0 Hours
Standard Deviation 0
|
0 Hours
Standard Deviation 0
|
—
|
—
|
SECONDARY outcome
Timeframe: Part A: Day 1 to 4; Part B: Day 1 to Day 8Population: All subjects who received at least one dose.
To evaluate AUClast of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.
Outcome measures
| Measure |
KM-819 - 400mg (Part A)
n=6 Participants
6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part A)
n=6 Participants
6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 10 mg (Part A)
n=6 Participants
6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 30 mg (Part A)
n=6 Participants
6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 100mg (Part A)
n=6 Participants
6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part A)
n=6 Participants
6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part A)
n=6 Participants
12 subjects received placebo orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 30 mg (Part B)
n=6 Participants
6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 100 mg (Part B)
n=6 Participants
6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part B)
n=6 Participants
6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours
|
KM-819 400mg (Part B)
n=6 Participants
6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part B)
6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part B)
10 subjects received placebo of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUClast (Area Under the Plasma Concentration-time From Predose (Time 0) to the Last Quantifiable Concentration)
Part A
|
12770 h*ng/mL
Standard Deviation 4321
|
10880 h*ng/mL
Standard Deviation 1108
|
597.5 h*ng/mL
Standard Deviation 140.5
|
1726 h*ng/mL
Standard Deviation 289.7
|
4479 h*ng/mL
Standard Deviation 1423
|
8210 h*ng/mL
Standard Deviation 2912
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUClast (Area Under the Plasma Concentration-time From Predose (Time 0) to the Last Quantifiable Concentration)
Part B-Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
1786 h*ng/mL
Standard Deviation 379.4
|
3944 h*ng/mL
Standard Deviation 1453
|
7340 h*ng/mL
Standard Deviation 3890
|
11880 h*ng/mL
Standard Deviation 4525
|
19660 h*ng/mL
Standard Deviation 11160
|
—
|
—
|
|
AUClast (Area Under the Plasma Concentration-time From Predose (Time 0) to the Last Quantifiable Concentration)
Part B-Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
1608 h*ng/mL
Standard Deviation 414.2
|
3688 h*ng/mL
Standard Deviation 686.0
|
6333 h*ng/mL
Standard Deviation 2402
|
17330 h*ng/mL
Standard Deviation 10900
|
17020 h*ng/mL
Standard Deviation 5676
|
—
|
—
|
SECONDARY outcome
Timeframe: Part A: Day 1 to 4; Part B: Day 1 to Day 8Population: All subjects who received at least one dose.
To evaluate AUCinf of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male-subjects.
Outcome measures
| Measure |
KM-819 - 400mg (Part A)
n=6 Participants
6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part A)
n=6 Participants
6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 10 mg (Part A)
n=6 Participants
6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 30 mg (Part A)
n=6 Participants
6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 100mg (Part A)
n=6 Participants
6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part A)
n=6 Participants
6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part A)
n=6 Participants
12 subjects received placebo orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 30 mg (Part B)
n=6 Participants
6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 100 mg (Part B)
n=6 Participants
6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part B)
n=6 Participants
6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours
|
KM-819 400mg (Part B)
n=6 Participants
6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part B)
6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part B)
10 subjects received placebo of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUCinf (Area Under the Plasma Concentration-time Curve From Predose (Time 0) Extrapolated to Infinity)
Part A
|
12640 h*ng/mL
Geometric Coefficient of Variation 36.1
|
10970 h*ng/mL
Geometric Coefficient of Variation 9.8
|
594.2 h*ng/mL
Geometric Coefficient of Variation 24.4
|
1731 h*ng/mL
Geometric Coefficient of Variation 17.3
|
4872 h*ng/mL
Geometric Coefficient of Variation 30.8
|
7338 h*ng/mL
Geometric Coefficient of Variation 51.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUCinf (Area Under the Plasma Concentration-time Curve From Predose (Time 0) Extrapolated to Infinity)
Part B-Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
1713 h*ng/mL
Geometric Coefficient of Variation 22.4
|
3884 h*ng/mL
Geometric Coefficient of Variation 41.5
|
10070 h*ng/mL
Geometric Coefficient of Variation 30.8
|
—
|
18550 h*ng/mL
Geometric Coefficient of Variation 57.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Part A: Day 1 to 4; Part B: Day 1 to Day 8Population: All subjects who received at least one dose.
To evaluate %AUCex of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.
Outcome measures
| Measure |
KM-819 - 400mg (Part A)
n=6 Participants
6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part A)
n=6 Participants
6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 10 mg (Part A)
n=6 Participants
6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 30 mg (Part A)
n=6 Participants
6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 100mg (Part A)
n=6 Participants
6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part A)
n=6 Participants
6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part A)
n=6 Participants
12 subjects received placebo orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 30 mg (Part B)
n=6 Participants
6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 100 mg (Part B)
n=6 Participants
6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part B)
n=6 Participants
6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours
|
KM-819 400mg (Part B)
n=6 Participants
6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part B)
6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part B)
10 subjects received placebo of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
%AUCex (Percentage of AUCinf That is Due to Extrapolation Beyond Tlast)
Part A
|
0.4833 percentage of AUC
Geometric Coefficient of Variation 164.4
|
0.9795 percentage of AUC
Geometric Coefficient of Variation 77.9
|
1.664 percentage of AUC
Geometric Coefficient of Variation 50.5
|
1.331 percentage of AUC
Geometric Coefficient of Variation 51.2
|
1.338 percentage of AUC
Geometric Coefficient of Variation 19.0
|
0.7787 percentage of AUC
Geometric Coefficient of Variation 65.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
%AUCex (Percentage of AUCinf That is Due to Extrapolation Beyond Tlast)
Part B
|
—
|
—
|
—
|
—
|
—
|
—
|
1.273 percentage of AUC
Geometric Coefficient of Variation 43.9
|
3.075 percentage of AUC
Geometric Coefficient of Variation 63.3
|
2.263 percentage of AUC
Geometric Coefficient of Variation 84.8
|
—
|
1.982 percentage of AUC
Geometric Coefficient of Variation 112.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Part A: Day 1 to 4; Part B: Day 1 to Day 8Population: All subjects who received at least one dose.
To evaluate the CL/F of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.
Outcome measures
| Measure |
KM-819 - 400mg (Part A)
n=6 Participants
6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part A)
n=6 Participants
6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 10 mg (Part A)
n=6 Participants
6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 30 mg (Part A)
n=6 Participants
6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 100mg (Part A)
n=6 Participants
6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part A)
n=6 Participants
6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part A)
n=6 Participants
12 subjects received placebo orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 30 mg (Part B)
n=6 Participants
6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 100 mg (Part B)
n=6 Participants
6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part B)
n=6 Participants
6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours
|
KM-819 400mg (Part B)
n=6 Participants
6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part B)
6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part B)
10 subjects received placebo of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
CL/F (Apparent Oral Clearance)
Part A
|
31650 mL/h
Geometric Coefficient of Variation 36.1
|
18230 mL/h
Geometric Coefficient of Variation 9.8
|
16830 mL/h
Geometric Coefficient of Variation 24.4
|
17340 mL/h
Geometric Coefficient of Variation 17.3
|
20530 mL/h
Geometric Coefficient of Variation 30.8
|
27260 mL/h
Geometric Coefficient of Variation 51.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
CL/F (Apparent Oral Clearance)
Part B-Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
17520 mL/h
Geometric Coefficient of Variation 22.4
|
25740 mL/h
Geometric Coefficient of Variation 41.5
|
19860 mL/h
Geometric Coefficient of Variation 30.8
|
—
|
10780 mL/h
Geometric Coefficient of Variation 57.8
|
—
|
—
|
|
CL/F (Apparent Oral Clearance)
Part B-Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
19090 mL/h
Geometric Coefficient of Variation 24.8
|
28760 mL/h
Geometric Coefficient of Variation 17.9
|
24930 mL/h
Geometric Coefficient of Variation 7.7
|
20480 mL/h
Geometric Coefficient of Variation 96.4
|
12300 mL/h
Geometric Coefficient of Variation 34.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Part A: Day 1 to 4; Part B: Day 1 to Day 8Population: All subjects who received at least one dose.
To evaluate Vz/F of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects multiple oral doses of KM-819 in elderly male subjects.
Outcome measures
| Measure |
KM-819 - 400mg (Part A)
n=6 Participants
6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part A)
n=6 Participants
6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 10 mg (Part A)
n=6 Participants
6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 30 mg (Part A)
n=6 Participants
6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 100mg (Part A)
n=6 Participants
6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part A)
n=6 Participants
6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part A)
n=6 Participants
12 subjects received placebo orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 30 mg (Part B)
n=6 Participants
6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 100 mg (Part B)
n=6 Participants
6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part B)
n=6 Participants
6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours
|
KM-819 400mg (Part B)
n=6 Participants
6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part B)
6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part B)
10 subjects received placebo of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Vz/F (Apparent Volume of Distribution)
Part A
|
389300 mL
Geometric Coefficient of Variation 49.5
|
277500 mL
Geometric Coefficient of Variation 27.3
|
43370 mL
Geometric Coefficient of Variation 18.8
|
119800 mL
Geometric Coefficient of Variation 23.5
|
271200 mL
Geometric Coefficient of Variation 56.6
|
354300 mL
Geometric Coefficient of Variation 114.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Vz/F (Apparent Volume of Distribution)
Part B-Day1
|
—
|
—
|
—
|
—
|
—
|
—
|
77710 mL
Geometric Coefficient of Variation 32.9
|
201200 mL
Geometric Coefficient of Variation 57.6
|
165700 mL
Geometric Coefficient of Variation 58.1
|
—
|
68250 mL
Geometric Coefficient of Variation 72.8
|
—
|
—
|
|
Vz/F (Apparent Volume of Distribution)
Part B-Day7
|
—
|
—
|
—
|
—
|
—
|
—
|
143400 mL
Geometric Coefficient of Variation 33.5
|
241300 mL
Geometric Coefficient of Variation 23.6
|
171400 mL
Geometric Coefficient of Variation 7.4
|
187100 mL
Geometric Coefficient of Variation 151.8
|
88200 mL
Geometric Coefficient of Variation 64.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Part B: Day 1 predose (within 30 minutes prior to study drug administration) and 0.25, 0.5, 1, 2, 4, 6, 8, and 12 hours postdose, predose on Days 2, 3, 4, 5, 6, and on Day 7 predose (within 30 minutes prior to study drug administration) and 0.25, 0.5, 1,Population: All subjects who received at least one dose in Part B
To evaluate the pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects multiple oral doses of KM-819 in elderly male subjects.
Outcome measures
| Measure |
KM-819 - 400mg (Part A)
n=6 Participants
6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part A)
6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 10 mg (Part A)
n=6 Participants
6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 30 mg (Part A)
n=6 Participants
6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 100mg (Part A)
n=6 Participants
6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part A)
n=6 Participants
6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part A)
12 subjects received placebo orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 30 mg (Part B)
6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 100 mg (Part B)
6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part B)
6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours
|
KM-819 400mg (Part B)
6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part B)
6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part B)
10 subjects received placebo of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUCtau (Area Under the Plasma Concentration-time Curve for a Dosing Interval) (Part B)
|
17020 h*ng/mL
Interval 11000.0 to 25800.0
|
—
|
1612 h*ng/mL
Interval 1130.0 to 2320.0
|
3521 h*ng/mL
Interval 2760.0 to 4290.0
|
8039 h*ng/mL
Interval 7670.0 to 8770.0
|
22830 h*ng/mL
Interval 11000.0 to 34700.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part B: Day 1 predose (within 30 minutes prior to study drug administration) and 0.25, 0.5, 1, 2, 4, 6, 8, and 12 hours postdose, predose on Days 2, 3, 4, 5, 6, and on Day 7 predose (within 30 minutes prior to study drug administration) and 0.25, 0.5, 1,Population: All subjects who received at least one dose in Part B
To evaluate the pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects multiple oral doses of KM-819 in elderly male subjects.
Outcome measures
| Measure |
KM-819 - 400mg (Part A)
n=6 Participants
6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part A)
6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 10 mg (Part A)
n=6 Participants
6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 30 mg (Part A)
n=6 Participants
6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 100mg (Part A)
n=6 Participants
6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part A)
n=6 Participants
6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part A)
12 subjects received placebo orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 30 mg (Part B)
6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 100 mg (Part B)
6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part B)
6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours
|
KM-819 400mg (Part B)
6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part B)
6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part B)
10 subjects received placebo of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Rac(AUC) (Observed Accumulation by AUC) (Part B)
|
0.9241 ratio
Interval 0.67 to 1.28
|
—
|
0.8926 ratio
Interval 0.7 to 1.13
|
0.9727 ratio
Interval 0.69 to 1.37
|
0.7568 ratio
Interval 0.57 to 1.0
|
1.485 ratio
Interval 0.86 to 2.56
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part B: Day 1 predose (within 30 minutes prior to study drug administration) and 0.25, 0.5, 1, 2, 4, 6, 8, and 12 hours postdose, predose on Days 2, 3, 4, 5, 6, and on Day 7 predose (within 30 minutes prior to study drug administration) and 0.25, 0.5, 1,Population: All subjects who received at least one dose in Part B
To evaluate the pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.
Outcome measures
| Measure |
KM-819 - 400mg (Part A)
n=6 Participants
6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part A)
6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 10 mg (Part A)
n=6 Participants
6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 30 mg (Part A)
n=6 Participants
6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 100mg (Part A)
n=6 Participants
6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part A)
n=6 Participants
6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part A)
12 subjects received placebo orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 30 mg (Part B)
6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 100 mg (Part B)
6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part B)
6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours
|
KM-819 400mg (Part B)
6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part B)
6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part B)
10 subjects received placebo of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Rac (Cmax) (Observed Accumulation by Cmax) (Part B)
|
0.9122 ratio
Interval 0.53 to 1.58
|
—
|
0.8173 ratio
Interval 0.53 to 1.26
|
1.003 ratio
Interval 0.73 to 1.39
|
0.6227 ratio
Interval 0.55 to 0.71
|
1.117 ratio
Interval 1.0 to 1.25
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part B: Day 1 predose (within 30 minutes prior to study drug administration) and 0.25, 0.5, 1, 2, 4, 6, 8, and 12 hours postdose, predose on Days 2, 3, 4, 5, 6, and on Day 7 predose (within 30 minutes prior to study drug administration) and 0.25, 0.5, 1,Population: All subjects who received at least one dose in Part B
To evaluate the pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.
Outcome measures
| Measure |
KM-819 - 400mg (Part A)
n=6 Participants
6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part A)
6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 10 mg (Part A)
n=6 Participants
6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 30 mg (Part A)
n=6 Participants
6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 100mg (Part A)
n=6 Participants
6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part A)
n=6 Participants
6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part A)
12 subjects received placebo orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 30 mg (Part B)
6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 100 mg (Part B)
6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part B)
6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours
|
KM-819 400mg (Part B)
6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part B)
6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part B)
10 subjects received placebo of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUCtau_D (AUCtau Divided by Dose) (Part B)
|
85.09 (h*ng/mL)/mg
Interval 55.1 to 129.0
|
—
|
53.74 (h*ng/mL)/mg
Interval 37.7 to 77.4
|
35.21 (h*ng/mL)/mg
Interval 27.6 to 42.9
|
40.19 (h*ng/mL)/mg
Interval 38.3 to 43.6
|
57.08 (h*ng/mL)/mg
Interval 27.5 to 86.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 1 (3 hours post dose), Day2, Day 3, Day 4, and Day 8.Population: All subjects who received at least one dose.
The Bond-Lader Visual Analogue Scales (VAS) will be analyzed using 3 factor scores: alertness, contentedness, and calmness. Participants were asked to indicate on the VAS scale ranging from 0 to 100 mm about how they felt at the moment the scale was administered. Baseline is defined as the last available recording prior to dosing on Day 1. 1. Alertness (Range 0 to 100, the higher scores indicated more alertness) 2. Mood (Range 0 to 100, where higher scores indicated elevated mood) 3. Calmness (Range 0 to 100, where higher scores indicated more calmness).
Outcome measures
| Measure |
KM-819 - 400mg (Part A)
n=6 Participants
6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part A)
n=6 Participants
6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 10 mg (Part A)
n=6 Participants
6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 30 mg (Part A)
n=6 Participants
6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 100mg (Part A)
n=6 Participants
6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part A)
n=6 Participants
6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part A)
n=12 Participants
12 subjects received placebo orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 30 mg (Part B)
n=6 Participants
6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 100 mg (Part B)
n=6 Participants
6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part B)
n=5 Participants
6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours
|
KM-819 400mg (Part B)
n=5 Participants
6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part B)
n=6 Participants
6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part B)
n=10 Participants
10 subjects received placebo of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline for Bond and Lader Visual Analogue Scale (VAS)
Alertness-Day 2, 24 hours postdose
|
-2.427 units on a scale
Standard Deviation 5.7016
|
2.315 units on a scale
Standard Deviation 4.8479
|
-3.202 units on a scale
Standard Deviation 5.4359
|
-0.465 units on a scale
Standard Deviation 11.1985
|
-2.333 units on a scale
Standard Deviation 3.4326
|
-0.148 units on a scale
Standard Deviation 7.5707
|
-0.171 units on a scale
Standard Deviation 6.8216
|
0.093 units on a scale
Standard Deviation 6.0070
|
-5.687 units on a scale
Standard Deviation 9.4737
|
-0.222 units on a scale
Standard Deviation 10.7325
|
-0.976 units on a scale
Standard Deviation 6.2563
|
-3.760 units on a scale
Standard Deviation 6.2182
|
0.566 units on a scale
Standard Deviation 8.2926
|
|
Change From Baseline for Bond and Lader Visual Analogue Scale (VAS)
Alertness-Day 4, 72 hours postdose
|
-3.368 units on a scale
Standard Deviation 9.2123
|
3.222 units on a scale
Standard Deviation 3.4213
|
-6.665 units on a scale
Standard Deviation 5.8359
|
-3.372 units on a scale
Standard Deviation 8.8024
|
-6.352 units on a scale
Standard Deviation 11.6716
|
-6.372 units on a scale
Standard Deviation 6.0623
|
-7.814 units on a scale
Standard Deviation 7.5635
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline for Bond and Lader Visual Analogue Scale (VAS)
Calmness-Day 1, 3 hours postdose
|
0.25 units on a scale
Standard Deviation 4.709
|
1.67 units on a scale
Standard Deviation 5.279
|
0.42 units on a scale
Standard Deviation 8.417
|
-3.08 units on a scale
Standard Deviation 6.888
|
1.75 units on a scale
Standard Deviation 9.832
|
-1.17 units on a scale
Standard Deviation 9.852
|
-1.04 units on a scale
Standard Deviation 6.580
|
-10.92 units on a scale
Standard Deviation 18.400
|
1.33 units on a scale
Standard Deviation 5.654
|
-1.00 units on a scale
Standard Deviation 36.447
|
-12.30 units on a scale
Standard Deviation 16.010
|
4.00 units on a scale
Standard Deviation 17.593
|
1.40 units on a scale
Standard Deviation 6.728
|
|
Change From Baseline for Bond and Lader Visual Analogue Scale (VAS)
Calmness-Day 2, 24 hours postdose
|
3.92 units on a scale
Standard Deviation 3.513
|
0.83 units on a scale
Standard Deviation 8.430
|
-1.42 units on a scale
Standard Deviation 9.952
|
1.00 units on a scale
Standard Deviation 9.290
|
-3.75 units on a scale
Standard Deviation 13.080
|
3.42 units on a scale
Standard Deviation 12.064
|
-0.63 units on a scale
Standard Deviation 9.033
|
-7.33 units on a scale
Standard Deviation 18.384
|
0.25 units on a scale
Standard Deviation 3.504
|
-8.40 units on a scale
Standard Deviation 13.093
|
-7.70 units on a scale
Standard Deviation 20.092
|
8.25 units on a scale
Standard Deviation 16.121
|
1.25 units on a scale
Standard Deviation 6.233
|
|
Change From Baseline for Bond and Lader Visual Analogue Scale (VAS)
Contentedness-Day 1, 3 hours postdose
|
-1.93 units on a scale
Standard Deviation 6.822
|
-3.10 units on a scale
Standard Deviation 13.121
|
-1.83 units on a scale
Standard Deviation 6.770
|
-2.67 units on a scale
Standard Deviation 3.355
|
-2.37 units on a scale
Standard Deviation 3.194
|
-1.33 units on a scale
Standard Deviation 1.473
|
0.90 units on a scale
Standard Deviation 6.872
|
-1.80 units on a scale
Standard Deviation 4.818
|
3.23 units on a scale
Standard Deviation 5.251
|
2.52 units on a scale
Standard Deviation 18.349
|
0.96 units on a scale
Standard Deviation 3.542
|
-7.13 units on a scale
Standard Deviation 6.565
|
-0.42 units on a scale
Standard Deviation 3.294
|
|
Change From Baseline for Bond and Lader Visual Analogue Scale (VAS)
Contentedness-Day 3, 48 hours postdose
|
-1.30 units on a scale
Standard Deviation 6.549
|
0.37 units on a scale
Standard Deviation 7.337
|
-7.37 units on a scale
Standard Deviation 13.125
|
-2.83 units on a scale
Standard Deviation 5.159
|
-3.80 units on a scale
Standard Deviation 5.374
|
-1.07 units on a scale
Standard Deviation 3.840
|
-2.30 units on a scale
Standard Deviation 9.936
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline for Bond and Lader Visual Analogue Scale (VAS)
Contentedness-Day 4, 72 hours postdose
|
-3.93 units on a scale
Standard Deviation 5.504
|
-1.60 units on a scale
Standard Deviation 7.201
|
-7.00 units on a scale
Standard Deviation 11.021
|
-0.80 units on a scale
Standard Deviation 2.086
|
-3.13 units on a scale
Standard Deviation 8.256
|
-3.23 units on a scale
Standard Deviation 3.024
|
-4.83 units on a scale
Standard Deviation 6.200
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline for Bond and Lader Visual Analogue Scale (VAS)
Alertness-Day 8, 24 hours postdose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-2.282 units on a scale
Standard Deviation 3.6448
|
-8.835 units on a scale
Standard Deviation 8.3161
|
3.842 units on a scale
Standard Deviation 9.4304
|
-7.358 units on a scale
Standard Deviation 4.7420
|
-6.683 units on a scale
Standard Deviation 15.6554
|
-2.834 units on a scale
Standard Deviation 6.5374
|
|
Change From Baseline for Bond and Lader Visual Analogue Scale (VAS)
Calmness-Day 8, 24 hours postdose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-7.75 units on a scale
Standard Deviation 19.263
|
6.75 units on a scale
Standard Deviation 14.754
|
1.90 units on a scale
Standard Deviation 7.171
|
-6.10 units on a scale
Standard Deviation 18.301
|
10.25 units on a scale
Standard Deviation 16.825
|
1.40 units on a scale
Standard Deviation 10.538
|
|
Change From Baseline for Bond and Lader Visual Analogue Scale (VAS)
Contentedness-Day 8, 24 hours postdose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-2.87 units on a scale
Standard Deviation 5.731
|
-3.27 units on a scale
Standard Deviation 2.738
|
-0.40 units on a scale
Standard Deviation 2.429
|
-1.44 units on a scale
Standard Deviation 7.249
|
-8.27 units on a scale
Standard Deviation 8.068
|
-1.76 units on a scale
Standard Deviation 6.983
|
|
Change From Baseline for Bond and Lader Visual Analogue Scale (VAS)
Alertness- Day 1, 3 hours postdose
|
-2.333 units on a scale
Standard Deviation 6.4200
|
3.093 units on a scale
Standard Deviation 3.7733
|
-0.482 units on a scale
Standard Deviation 3.6349
|
-4.315 units on a scale
Standard Deviation 8.8671
|
0.720 units on a scale
Standard Deviation 7.2589
|
-3.610 units on a scale
Standard Deviation 9.4171
|
-2.926 units on a scale
Standard Deviation 11.4835
|
7.058 units on a scale
Standard Deviation 12.2168
|
3.445 units on a scale
Standard Deviation 11.1990
|
9.264 units on a scale
Standard Deviation 21.4350
|
-4.668 units on a scale
Standard Deviation 4.6964
|
-0.128 units on a scale
Standard Deviation 8.7694
|
2.088 units on a scale
Standard Deviation 8.4283
|
|
Change From Baseline for Bond and Lader Visual Analogue Scale (VAS)
Contentedness-Day 2, 24 hours postdose
|
-0.73 units on a scale
Standard Deviation 8.911
|
-0.53 units on a scale
Standard Deviation 9.226
|
-7.13 units on a scale
Standard Deviation 12.139
|
1.30 units on a scale
Standard Deviation 5.383
|
-3.53 units on a scale
Standard Deviation 3.384
|
1.03 units on a scale
Standard Deviation 3.674
|
-1.43 units on a scale
Standard Deviation 5.775
|
-3.63 units on a scale
Standard Deviation 5.126
|
-2.23 units on a scale
Standard Deviation 5.076
|
-5.12 units on a scale
Standard Deviation 2.674
|
2.16 units on a scale
Standard Deviation 9.459
|
-4.43 units on a scale
Standard Deviation 5.321
|
-1.58 units on a scale
Standard Deviation 2.978
|
|
Change From Baseline for Bond and Lader Visual Analogue Scale (VAS)
Alertness-Day 3, 48 hours postdose
|
-4.110 units on a scale
Standard Deviation 8.6208
|
5.500 units on a scale
Standard Deviation 5.2313
|
-4.500 units on a scale
Standard Deviation 6.2535
|
-2.278 units on a scale
Standard Deviation 11.9110
|
-8.073 units on a scale
Standard Deviation 8.6618
|
-3.128 units on a scale
Standard Deviation 6.5867
|
-4.572 units on a scale
Standard Deviation 9.7416
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline for Bond and Lader Visual Analogue Scale (VAS)
Calmness-Day 3, 48 hours postdose
|
3.58 units on a scale
Standard Deviation 4.188
|
1.00 units on a scale
Standard Deviation 5.138
|
-5.42 units on a scale
Standard Deviation 10.542
|
0.42 units on a scale
Standard Deviation 7.651
|
-9.92 units on a scale
Standard Deviation 9.388
|
-2.33 units on a scale
Standard Deviation 4.502
|
-3.21 units on a scale
Standard Deviation 10.310
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline for Bond and Lader Visual Analogue Scale (VAS)
Calmness-Day 4, 72 hours postdose
|
6.58 units on a scale
Standard Deviation 7.249
|
0.42 units on a scale
Standard Deviation 4.443
|
-3.42 units on a scale
Standard Deviation 11.160
|
3.33 units on a scale
Standard Deviation 10.567
|
-8.50 units on a scale
Standard Deviation 11.908
|
1.42 units on a scale
Standard Deviation 7.807
|
-2.67 units on a scale
Standard Deviation 8.446
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part A: Day 1; Part B: Day 7Population: All subjects who received at least one dose
The K-WAIS-IV consists of an assessment of the cognitive ability using a core battery of 10 unique subtests (Block Design, Similarities, Digit Span, Matrix Reasoning, Vocabulary, Arithmetic, Symbol Search, Visual Puzzles, Information, and Coding) that focus on four specific domains of intelligence: verbal comprehension, perceptual reasoning, working memory, and processing speed. The Verbal Comprehension Index, Perceptual Reasoning Index, Working Memory Index, and Processing Speed Index (standard scores: mean=100, standard deviation=15) that are all based on a number of core and supplemental subtests (scaled scores: mean=15, standard deviation=3) that provide pertinent clinical information and flexibility in implementation. The higher values represent a better outcome.
Outcome measures
| Measure |
KM-819 - 400mg (Part A)
n=6 Participants
6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part A)
n=6 Participants
6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 10 mg (Part A)
n=6 Participants
6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 30 mg (Part A)
n=6 Participants
6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 100mg (Part A)
n=6 Participants
6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part A)
n=6 Participants
6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part A)
n=12 Participants
12 subjects received placebo orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 30 mg (Part B)
n=6 Participants
6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 100 mg (Part B)
n=6 Participants
6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part B)
n=6 Participants
6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours
|
KM-819 400mg (Part B)
n=6 Participants
6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part B)
n=6 Participants
6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part B)
n=10 Participants
10 subjects received placebo of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Korean Wechsler Adult Intelligence Scale-IV (K-WAIS-IV)
Day 1, 6 hours postdose
|
6.0 Intelligence quotient (IQ)
Standard Deviation 8.88
|
3.3 Intelligence quotient (IQ)
Standard Deviation 7.50
|
6.5 Intelligence quotient (IQ)
Standard Deviation 14.53
|
-1.7 Intelligence quotient (IQ)
Standard Deviation 8.07
|
2.7 Intelligence quotient (IQ)
Standard Deviation 8.43
|
8.7 Intelligence quotient (IQ)
Standard Deviation 9.79
|
3.3 Intelligence quotient (IQ)
Standard Deviation 7.97
|
3.7 Intelligence quotient (IQ)
Standard Deviation 6.50
|
4.7 Intelligence quotient (IQ)
Standard Deviation 3.72
|
2.2 Intelligence quotient (IQ)
Standard Deviation 7.22
|
0.0 Intelligence quotient (IQ)
Standard Deviation 16.69
|
5.5 Intelligence quotient (IQ)
Standard Deviation 4.97
|
2.9 Intelligence quotient (IQ)
Standard Deviation 13.62
|
|
Korean Wechsler Adult Intelligence Scale-IV (K-WAIS-IV)
Day 7, 12 hours postdose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
17.8 Intelligence quotient (IQ)
Standard Deviation 20.94
|
30.3 Intelligence quotient (IQ)
Standard Deviation 12.48
|
24.4 Intelligence quotient (IQ)
Standard Deviation 9.29
|
18.8 Intelligence quotient (IQ)
Standard Deviation 8.26
|
11.7 Intelligence quotient (IQ)
Standard Deviation 3.78
|
12.8 Intelligence quotient (IQ)
Standard Deviation 20.87
|
|
Korean Wechsler Adult Intelligence Scale-IV (K-WAIS-IV)
Day 7, pre-dose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
10.5 Intelligence quotient (IQ)
Standard Deviation 10.33
|
22.2 Intelligence quotient (IQ)
Standard Deviation 13.29
|
17.6 Intelligence quotient (IQ)
Standard Deviation 6.77
|
11.0 Intelligence quotient (IQ)
Standard Deviation 8.72
|
10.3 Intelligence quotient (IQ)
Standard Deviation 5.57
|
7.3 Intelligence quotient (IQ)
Standard Deviation 19.80
|
|
Korean Wechsler Adult Intelligence Scale-IV (K-WAIS-IV)
Day 1, 3 hours postdose
|
4.8 Intelligence quotient (IQ)
Standard Deviation 6.94
|
3.3 Intelligence quotient (IQ)
Standard Deviation 5.24
|
6.2 Intelligence quotient (IQ)
Standard Deviation 10.05
|
-0.3 Intelligence quotient (IQ)
Standard Deviation 8.73
|
-3.8 Intelligence quotient (IQ)
Standard Deviation 16.18
|
2.2 Intelligence quotient (IQ)
Standard Deviation 8.04
|
2.5 Intelligence quotient (IQ)
Standard Deviation 8.87
|
1.7 Intelligence quotient (IQ)
Standard Deviation 5.50
|
4.3 Intelligence quotient (IQ)
Standard Deviation 6.41
|
2.0 Intelligence quotient (IQ)
Standard Deviation 15.12
|
1.2 Intelligence quotient (IQ)
Standard Deviation 4.09
|
1.2 Intelligence quotient (IQ)
Standard Deviation 4.45
|
-1.6 Intelligence quotient (IQ)
Standard Deviation 16.19
|
|
Korean Wechsler Adult Intelligence Scale-IV (K-WAIS-IV)
Day 1, 12 hours postdose
|
9.5 Intelligence quotient (IQ)
Standard Deviation 7.66
|
7.3 Intelligence quotient (IQ)
Standard Deviation 5.82
|
12.8 Intelligence quotient (IQ)
Standard Deviation 14.95
|
4.5 Intelligence quotient (IQ)
Standard Deviation 7.82
|
3.0 Intelligence quotient (IQ)
Standard Deviation 14.99
|
10.2 Intelligence quotient (IQ)
Standard Deviation 10.34
|
4.4 Intelligence quotient (IQ)
Standard Deviation 12.62
|
12.7 Intelligence quotient (IQ)
Standard Deviation 10.39
|
13.2 Intelligence quotient (IQ)
Standard Deviation 4.26
|
11.2 Intelligence quotient (IQ)
Standard Deviation 7.66
|
-1.4 Intelligence quotient (IQ)
Standard Deviation 10.21
|
7.0 Intelligence quotient (IQ)
Standard Deviation 5.33
|
6.2 Intelligence quotient (IQ)
Standard Deviation 19.52
|
|
Korean Wechsler Adult Intelligence Scale-IV (K-WAIS-IV)
Day 7, 3 hours postdose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
15.8 Intelligence quotient (IQ)
Standard Deviation 13.88
|
19.7 Intelligence quotient (IQ)
Standard Deviation 6.74
|
24.6 Intelligence quotient (IQ)
Standard Deviation 10.41
|
12.2 Intelligence quotient (IQ)
Standard Deviation 9.76
|
10.2 Intelligence quotient (IQ)
Standard Deviation 5.12
|
6.6 Intelligence quotient (IQ)
Standard Deviation 21.76
|
|
Korean Wechsler Adult Intelligence Scale-IV (K-WAIS-IV)
Day 7, 6 hours postdose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
13.7 Intelligence quotient (IQ)
Standard Deviation 21.16
|
27.2 Intelligence quotient (IQ)
Standard Deviation 6.21
|
22.0 Intelligence quotient (IQ)
Standard Deviation 16.32
|
14.8 Intelligence quotient (IQ)
Standard Deviation 12.03
|
12.3 Intelligence quotient (IQ)
Standard Deviation 5.39
|
13.6 Intelligence quotient (IQ)
Standard Deviation 22.47
|
SECONDARY outcome
Timeframe: Plasma - Part B: Day 7 (at 1 hour after last dosing) / CSF - Part B: Day 7 (at 1 hour after last dosing)Population: All subjects who received at least one dose in Part B
To evaluate Alpha synuclein oligomer in plasma and CSF of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.
Outcome measures
| Measure |
KM-819 - 400mg (Part A)
n=6 Participants
6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part A)
n=10 Participants
6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 10 mg (Part A)
n=6 Participants
6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 30 mg (Part A)
n=6 Participants
6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 100mg (Part A)
n=5 Participants
6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part A)
n=5 Participants
6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part A)
12 subjects received placebo orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 30 mg (Part B)
6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 100 mg (Part B)
6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part B)
6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours
|
KM-819 400mg (Part B)
6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part B)
6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part B)
10 subjects received placebo of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Alpha Synuclein Oligomer in Plasma and CSF (Part B)
CSF, Day 7, 1 hour postdose
|
34.8672 pg/mL
Interval -22.683 to 95.017
|
20.3025 pg/mL
Interval -82.488 to 145.654
|
49.9424 pg/mL
Interval 1.118 to 188.833
|
-252.5578 pg/mL
Interval -1565.068 to 47.61
|
0.6012 pg/mL
Interval -25.141 to 24.998
|
18.2112 pg/mL
Interval -121.943 to 163.679
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Alpha Synuclein Oligomer in Plasma and CSF (Part B)
Plasma, Day 7, 1 hour postdose
|
-11712.090 pg/mL
Interval -45482.537 to 880.845
|
-4464.9082 pg/mL
Interval -24410.549 to 23915.23
|
3884.4127 pg/mL
Interval -40474.448 to 47672.249
|
575.4570 pg/mL
Interval -29995.002 to 27948.723
|
3809.5090 pg/mL
Interval -16201.393 to 18993.995
|
-64843.287 pg/mL
Interval -297443.64 to 4664.264
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: CSF - Part B: Day 1 (at -120 minutes to 0 minute prior to the first dosing) and on Day 7 (at 1 hour after last dosing)Population: All subjects who received at least one dose in Part B
To evaluate Total Tau in CSF of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.
Outcome measures
| Measure |
KM-819 - 400mg (Part A)
n=6 Participants
6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part A)
n=10 Participants
6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 10 mg (Part A)
n=6 Participants
6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 30 mg (Part A)
n=6 Participants
6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 100mg (Part A)
n=5 Participants
6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part A)
n=5 Participants
6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part A)
12 subjects received placebo orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 30 mg (Part B)
6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 100 mg (Part B)
6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part B)
6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours
|
KM-819 400mg (Part B)
6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part B)
6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part B)
10 subjects received placebo of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline Total Tau in CSF (Part B)
|
29.2961 pg/mL
Interval -52.079 to 203.508
|
20.8198 pg/mL
Interval -13.358 to 82.099
|
60.3043 pg/mL
Interval -23.213 to 145.209
|
9.2313 pg/mL
Interval -9.048 to 33.901
|
-3.1593 pg/mL
Interval -15.058 to 22.546
|
27.8648 pg/mL
Interval -32.813 to 134.771
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: CSF - Part B: Day 1 (at -120 minutes to 0 minute prior to the first dosing) and on Day 7 (at 1 hour after last dosing)Population: All subjects who received at least one dose in Part B
To evaluate Phospho-Tau of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.
Outcome measures
| Measure |
KM-819 - 400mg (Part A)
n=6 Participants
6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part A)
n=10 Participants
6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 10 mg (Part A)
n=6 Participants
6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 30 mg (Part A)
n=6 Participants
6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 100mg (Part A)
n=5 Participants
6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part A)
n=5 Participants
6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part A)
12 subjects received placebo orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 30 mg (Part B)
6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 100 mg (Part B)
6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part B)
6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours
|
KM-819 400mg (Part B)
6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part B)
6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part B)
10 subjects received placebo of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline Phospho-Tau in CSF (Part B)
|
5.1606 pg/mL
Interval -5.717 to 23.325
|
5.3123 pg/mL
Interval -3.592 to 23.931
|
6.4132 pg/mL
Interval -13.59 to 42.811
|
0.2072 pg/mL
Interval -1.154 to 2.231
|
4.4672 pg/mL
Interval -1.534 to 18.292
|
6.7032 pg/mL
Interval -2.773 to 19.666
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Plasma - Part B: Day 7 (at 1 hour after last dosing) / CSF - Part B: on Day 7 (at 1 hour after last dosing)Population: All subjects who received at least one dose in Part B
Ratio of CSF concentration/Plasma Cmax
Outcome measures
| Measure |
KM-819 - 400mg (Part A)
6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part A)
6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 10 mg (Part A)
n=3 Participants
6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 30 mg (Part A)
n=3 Participants
6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 100mg (Part A)
n=4 Participants
6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part A)
n=5 Participants
6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part A)
12 subjects received placebo orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 30 mg (Part B)
6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 100 mg (Part B)
6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part B)
6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours
|
KM-819 400mg (Part B)
6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part B)
6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part B)
10 subjects received placebo of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Ratio of CSF Concentration/Plasma Cmax (Part B)
|
—
|
—
|
0.00067004 Ratio
Interval 0.00040485 to 0.00085699
|
0.00074179 Ratio
Interval 0.00047881 to 0.00090404
|
0.00048832 Ratio
Interval 0.00011022 to 0.0013316
|
0.00031749 Ratio
Interval 0.00018612 to 0.00045
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Placebo (Part A)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
KM-819 - 10 mg (Part A)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
KM-819 - 30 mg (Part A)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
KM-819 - 100mg (Part A)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
KM-819 200mg (Part A)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
KM-819 - 400mg (Part A)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
KM-819 200mg (Elderly Male Subjects) (Part A)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo (Part B)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
KM-819 30 mg (Part B)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
KM-819 100 mg (Part B)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
KM-819 200mg (Part B)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
KM-819 400mg (Part B)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
KM-819 200mg (Elderly Male Subjects) (Part B)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (Part A)
n=12 participants at risk
12 subjects received placebo orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 10 mg (Part A)
n=6 participants at risk
6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 30 mg (Part A)
n=6 participants at risk
6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 100mg (Part A)
n=6 participants at risk
6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part A)
n=6 participants at risk
6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 400mg (Part A)
n=6 participants at risk
6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part A)
n=6 participants at risk
6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part B)
n=10 participants at risk
10 subjects received placebo of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 30 mg (Part B)
n=6 participants at risk
6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 100 mg (Part B)
n=6 participants at risk
6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part B)
n=6 participants at risk
6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 400mg (Part B)
n=6 participants at risk
6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part B)
n=6 participants at risk
6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/12 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/10 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
16.7%
1/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
Other adverse events
| Measure |
Placebo (Part A)
n=12 participants at risk
12 subjects received placebo orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 10 mg (Part A)
n=6 participants at risk
6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 30 mg (Part A)
n=6 participants at risk
6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 100mg (Part A)
n=6 participants at risk
6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part A)
n=6 participants at risk
6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 - 400mg (Part A)
n=6 participants at risk
6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part A)
n=6 participants at risk
6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
Placebo (Part B)
n=10 participants at risk
10 subjects received placebo of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 30 mg (Part B)
n=6 participants at risk
6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 100 mg (Part B)
n=6 participants at risk
6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Part B)
n=6 participants at risk
6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 400mg (Part B)
n=6 participants at risk
6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
KM-819 200mg (Elderly Male Subjects) (Part B)
n=6 participants at risk
6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/12 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
16.7%
1/6 • Number of events 1 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
10.0%
1/10 • Number of events 1 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
16.7%
1/6 • Number of events 1 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
|
Eye disorders
Eye swelling
|
8.3%
1/12 • Number of events 1 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/10 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/12 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
33.3%
2/6 • Number of events 2 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
16.7%
1/6 • Number of events 1 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
10.0%
1/10 • Number of events 1 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
16.7%
1/6 • Number of events 1 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
|
Infections and infestations
Influenza
|
8.3%
1/12 • Number of events 1 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/10 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/12 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
16.7%
1/6 • Number of events 1 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/10 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/12 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
16.7%
1/6 • Number of events 1 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/10 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 1 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
33.3%
2/6 • Number of events 2 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
20.0%
2/10 • Number of events 4 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
33.3%
2/6 • Number of events 3 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
16.7%
1/6 • Number of events 2 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
83.3%
5/6 • Number of events 11 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
66.7%
4/6 • Number of events 7 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/12 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
16.7%
1/6 • Number of events 1 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
10.0%
1/10 • Number of events 1 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
33.3%
2/6 • Number of events 2 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/12 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
16.7%
1/6 • Number of events 1 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/10 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/12 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
16.7%
1/6 • Number of events 1 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/10 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Number of events 2 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/10 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
|
Vascular disorders
Hot flush
|
0.00%
0/12 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
16.7%
1/6 • Number of events 1 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/10 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
|
Eye disorders
Erythema of eyelid
|
0.00%
0/12 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/10 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
16.7%
1/6 • Number of events 1 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/12 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/10 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
16.7%
1/6 • Number of events 1 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
10.0%
1/10 • Number of events 1 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
16.7%
1/6 • Number of events 1 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/10 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
33.3%
2/6 • Number of events 2 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
16.7%
1/6 • Number of events 1 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
66.7%
4/6 • Number of events 5 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/10 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
33.3%
2/6 • Number of events 2 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
66.7%
4/6 • Number of events 4 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
30.0%
3/10 • Number of events 3 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
33.3%
2/6 • Number of events 2 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
16.7%
1/6 • Number of events 1 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
16.7%
1/6 • Number of events 2 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
33.3%
2/6 • Number of events 3 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/12 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/10 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
16.7%
1/6 • Number of events 1 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/12 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/10 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
16.7%
1/6 • Number of events 1 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
16.7%
1/6 • Number of events 2 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/12 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/10 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
16.7%
1/6 • Number of events 1 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
20.0%
2/10 • Number of events 2 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
16.7%
1/6 • Number of events 1 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
16.7%
1/6 • Number of events 1 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
33.3%
2/6 • Number of events 2 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/12 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
10.0%
1/10 • Number of events 1 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/12 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/10 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
16.7%
1/6 • Number of events 1 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/12 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/10 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
16.7%
1/6 • Number of events 1 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/12 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/10 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
16.7%
1/6 • Number of events 1 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/12 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
10.0%
1/10 • Number of events 1 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/12 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
10.0%
1/10 • Number of events 1 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
16.7%
1/6 • Number of events 1 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/6 • From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place