Trial Outcomes & Findings for Safety, PK and Efficacy Study of SJP-0132 in Subjects With Dry Eye Disease (NCT NCT04139122)
NCT ID: NCT04139122
Last Updated: 2023-04-20
Results Overview
Number of participants with adverse events by severity are summarize in each cohort. Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
89 participants
Primary outcome timeframe
Day 2 for cohort 1-4, Day 29 for cohort 5-6
Results posted on
2023-04-20
Participant Flow
Participant milestones
| Measure |
Single-dose (Cohort 1): 0.03% SJP-0132
Single dose of 0.03% SJP-0132 as Cohort 1
|
Single-dose (Cohort 2) : 0.1% SJP-0132
Single dose of 0.1% SJP-0132 as Cohort 2
|
Single-dose (Cohort 3) : 0.3% SJP-0132
Single dose of 0.3% SJP-0132 as Cohort 3
|
Single-dose (Cohort 4) : 1% SJP-0132
Single dose of 1% SJP-0132 as Cohort 4
|
Single-dose (Cohort 1-4) : Placebo
Single dose of placebo as Cohort 1 to 4
|
Multiple-dose (Cohort 5) : 0.3% SJP-0132
Multiple dose of 0.3% SJP-0132 for 4 weeks as Cohort 5
|
Multiple-dose (Cohort 6) : 1% SJP-0132
Multiple dose of 1% SJP-0132 for 4 weeks as Cohort 6
|
Multiple-dose (Cohort 5, 6) : Placebo
Multiple dose for 4 weeks as Cohort 5 and 6
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
5
|
4
|
8
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
5
|
6
|
5
|
4
|
8
|
20
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, PK and Efficacy Study of SJP-0132 in Subjects With Dry Eye Disease
Baseline characteristics by cohort
| Measure |
Single-dose (Cohort 1) : 0.03% SJP-0132
n=6 Participants
Single dose of 0.03% SJP-0132 as Cohort 1
|
Single-dose (Cohort 2) : 0.1% SJP-0132
n=6 Participants
Single dose of 0.1% SJP-0132 as Cohort 2
|
Single-dose (Cohort 3) : 0.3% SJP-0132
n=5 Participants
Single dose of 0.3% SJP-0132 as Cohort 3
|
Single-dose (Cohort 4) : 1% SJP-0132
n=4 Participants
Single dose of 1% SJP-0132 as Cohort 4
|
Single-dose (Cohort 1-4) : Placebo
n=8 Participants
Single dose of placebo as Cohort 1 to 4
|
Multiple-dose (Cohort 5) : 0.3% SJP-0132
n=20 Participants
Multiple dose of 0.3% SJP-0132 for 4 weeks as Cohort 5
|
Multiple-dose (Cohort 6) : 1% SJP-0132
n=20 Participants
Multiple dose of 1% SJP-0132 for 4 weeks as Cohort 6
|
Multiple-dose (Cohort 5, 6) : Placebo
n=20 Participants
Multiple dose for 4 weeks as Cohort 5 and 6
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
27.8 years
STANDARD_DEVIATION 5.64 • n=93 Participants
|
34.8 years
STANDARD_DEVIATION 7.78 • n=4 Participants
|
35.0 years
STANDARD_DEVIATION 6.82 • n=27 Participants
|
35.8 years
STANDARD_DEVIATION 11.87 • n=483 Participants
|
33.0 years
STANDARD_DEVIATION 6.72 • n=36 Participants
|
46.1 years
STANDARD_DEVIATION 14.34 • n=10 Participants
|
34.9 years
STANDARD_DEVIATION 8.07 • n=115 Participants
|
39.7 years
STANDARD_DEVIATION 11.74 • n=40 Participants
|
37.9 years
STANDARD_DEVIATION 11.51 • n=8 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
13 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
13 Participants
n=40 Participants
|
50 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
7 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
7 Participants
n=40 Participants
|
39 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
14 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
10 Participants
n=40 Participants
|
51 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
10 Participants
n=40 Participants
|
36 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=93 Participants
|
6 participants
n=4 Participants
|
5 participants
n=27 Participants
|
4 participants
n=483 Participants
|
8 participants
n=36 Participants
|
20 participants
n=10 Participants
|
20 participants
n=115 Participants
|
20 participants
n=40 Participants
|
89 participants
n=8 Participants
|
|
BMI
|
24.675 Kg/m^2
STANDARD_DEVIATION 3.8471 • n=93 Participants
|
23.882 Kg/m^2
STANDARD_DEVIATION 4.0167 • n=4 Participants
|
24.144 Kg/m^2
STANDARD_DEVIATION 3.6329 • n=27 Participants
|
24.593 Kg/m^2
STANDARD_DEVIATION 3.5238 • n=483 Participants
|
23.303 Kg/m^2
STANDARD_DEVIATION 3.1095 • n=36 Participants
|
23.596 Kg/m^2
STANDARD_DEVIATION 2.967 • n=10 Participants
|
25.513 Kg/m^2
STANDARD_DEVIATION 2.9228 • n=115 Participants
|
24.407 Kg/m^2
STANDARD_DEVIATION 2.7066 • n=40 Participants
|
24.35 Kg/m^2
STANDARD_DEVIATION 3.0727 • n=8 Participants
|
PRIMARY outcome
Timeframe: Day 2 for cohort 1-4, Day 29 for cohort 5-6Population: Safety set
Number of participants with adverse events by severity are summarize in each cohort. Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
Outcome measures
| Measure |
Single-dose (Cohort 1) : 0.03% SJP-0132
n=6 Participants
Single dose of 0.03% SJP-0132 as Cohort 1
|
Single-dose (Cohort 2) : 0.1% SJP-0132
n=6 Participants
Single dose of 0.1% SJP-0132 as Cohort 2
|
Single-dose (Cohort 3) : 0.3% SJP-0132
n=5 Participants
Single dose of 0.3% SJP-0132 as Cohort 3
|
Single-dose (Cohort 4) : 1% SJP-0132
n=4 Participants
Single dose of 1% SJP-0132 as Cohort 4
|
Single-dose (Cohort 1-4) : Placebo
n=8 Participants
Single dose of placebo as Cohort 1 to 4
|
Multiple-dose (Cohort 5) : 0.3% SJP-0132
n=20 Participants
Multiple dose of 0.3% SJP-0132 for 4 weeks as Cohort 5
|
Multiple-dose (Cohort 6) : 1% SJP-0132
n=20 Participants
Multiple dose of 1% SJP-0132 for 4 weeks as Cohort 6
|
Multiple-dose (Cohort 5, 6) : Placebo
n=20 Participants
Multiple dose of placebo for 4 weeks as Cohort 5 and 6
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events by Severity in Each Cohort
Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events by Severity in Each Cohort
Mild
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
7 Participants
|
|
Number of Participants With Adverse Events by Severity in Each Cohort
Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 2 for cohort 1-4, Day 29 for cohort 5-6Population: Safety Set
Clinical laboratory parameters include hematology, clinical chemistry, urinalysis, and serology. Vital signs include diastolic blood pressure, systolic blood pressure, heart rate, respiratory rate, and body temperature. Ophthalmologic observations include examination of visual acuity, slit lamp biomicroscopy, Schirmer I, intraocular pressure, and ophthalmoscopy.
Outcome measures
| Measure |
Single-dose (Cohort 1) : 0.03% SJP-0132
n=6 Participants
Single dose of 0.03% SJP-0132 as Cohort 1
|
Single-dose (Cohort 2) : 0.1% SJP-0132
n=6 Participants
Single dose of 0.1% SJP-0132 as Cohort 2
|
Single-dose (Cohort 3) : 0.3% SJP-0132
n=5 Participants
Single dose of 0.3% SJP-0132 as Cohort 3
|
Single-dose (Cohort 4) : 1% SJP-0132
n=4 Participants
Single dose of 1% SJP-0132 as Cohort 4
|
Single-dose (Cohort 1-4) : Placebo
n=8 Participants
Single dose of placebo as Cohort 1 to 4
|
Multiple-dose (Cohort 5) : 0.3% SJP-0132
n=20 Participants
Multiple dose of 0.3% SJP-0132 for 4 weeks as Cohort 5
|
Multiple-dose (Cohort 6) : 1% SJP-0132
n=20 Participants
Multiple dose of 1% SJP-0132 for 4 weeks as Cohort 6
|
Multiple-dose (Cohort 5, 6) : Placebo
n=20 Participants
Multiple dose of placebo for 4 weeks as Cohort 5 and 6
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort
Laboratory parameters
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort
Vital signs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort
Physical observations
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort
Ophthalmologic observations
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: Pharmacokinetic Set
The results are from the maximum plasma concentration (Cmax) on Day 1. The blood for pharmacokinetics assessment was collected at 0, 0.25, 0.5, 1, 2, 4, 8, and 12 hours after dosing on Day 1 for Cohorts 1 to 4. The blood for pharmacokinetics assessment was collected at 0, 0.25, 0.5, 1, 2, and 4 hours after dosing on Day 1 for Cohorts 5 and 6.
Outcome measures
| Measure |
Single-dose (Cohort 1) : 0.03% SJP-0132
n=6 Participants
Single dose of 0.03% SJP-0132 as Cohort 1
|
Single-dose (Cohort 2) : 0.1% SJP-0132
n=6 Participants
Single dose of 0.1% SJP-0132 as Cohort 2
|
Single-dose (Cohort 3) : 0.3% SJP-0132
n=5 Participants
Single dose of 0.3% SJP-0132 as Cohort 3
|
Single-dose (Cohort 4) : 1% SJP-0132
n=4 Participants
Single dose of 1% SJP-0132 as Cohort 4
|
Single-dose (Cohort 1-4) : Placebo
n=12 Participants
Single dose of placebo as Cohort 1 to 4
|
Multiple-dose (Cohort 5) : 0.3% SJP-0132
n=12 Participants
Multiple dose of 0.3% SJP-0132 for 4 weeks as Cohort 5
|
Multiple-dose (Cohort 6) : 1% SJP-0132
Multiple dose of 1% SJP-0132 for 4 weeks as Cohort 6
|
Multiple-dose (Cohort 5, 6) : Placebo
Multiple dose of placebo for 4 weeks as Cohort 5 and 6
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
0.03773 ng/mL
Standard Deviation 0.015911
|
0.12940 ng/mL
Standard Deviation 0.095403
|
0.10228 ng/mL
Standard Deviation 0.063893
|
0.69275 ng/mL
Standard Deviation 0.293932
|
0.14077 ng/mL
Standard Deviation 0.106705
|
0.63273 ng/mL
Standard Deviation 0.804411
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: Pharmacokinetic Set
Area under the plasma concentration-time curves (AUCs) for Cohorts 1 to 4 were calculated using the plasma collected at 0, 0.25, 0.5, 1, 2, 4, 8, and 12 hours after dosing on Day 1, and those for Cohorts 5 and 6 were calculated using the plasma collected at 0, 0.25, 0.5, 1, 2, and 4 hours after dosing on Day 1.
Outcome measures
| Measure |
Single-dose (Cohort 1) : 0.03% SJP-0132
n=6 Participants
Single dose of 0.03% SJP-0132 as Cohort 1
|
Single-dose (Cohort 2) : 0.1% SJP-0132
n=6 Participants
Single dose of 0.1% SJP-0132 as Cohort 2
|
Single-dose (Cohort 3) : 0.3% SJP-0132
n=5 Participants
Single dose of 0.3% SJP-0132 as Cohort 3
|
Single-dose (Cohort 4) : 1% SJP-0132
n=4 Participants
Single dose of 1% SJP-0132 as Cohort 4
|
Single-dose (Cohort 1-4) : Placebo
n=12 Participants
Single dose of placebo as Cohort 1 to 4
|
Multiple-dose (Cohort 5) : 0.3% SJP-0132
n=12 Participants
Multiple dose of 0.3% SJP-0132 for 4 weeks as Cohort 5
|
Multiple-dose (Cohort 6) : 1% SJP-0132
Multiple dose of 1% SJP-0132 for 4 weeks as Cohort 6
|
Multiple-dose (Cohort 5, 6) : Placebo
Multiple dose of placebo for 4 weeks as Cohort 5 and 6
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC0-last)
|
0.28671 hr*ng/mL
Standard Deviation 0.158116
|
1.02449 hr*ng/mL
Standard Deviation 0.827814
|
0.85442 hr*ng/mL
Standard Deviation 0.462688
|
5.15571 hr*ng/mL
Standard Deviation 2.537673
|
0.32305 hr*ng/mL
Standard Deviation 0.178608
|
1.14604 hr*ng/mL
Standard Deviation 1.024450
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 2, 4, 8Population: Pharmacokinetic Set
Plasma were collected at 0, 0.25, 0.5, 1, 2, and 4 hours after dosing on Day 1, pre-dose on Day 2, Day 4 and Day 8. Accumulation ratios calculated as (predose plasma concentration \[Ctrough\] on Day 4) / (Ctrough on Day 2) and (Ctrough on Day 8) / (Ctrough on Day 2)
Outcome measures
| Measure |
Single-dose (Cohort 1) : 0.03% SJP-0132
n=12 Participants
Single dose of 0.03% SJP-0132 as Cohort 1
|
Single-dose (Cohort 2) : 0.1% SJP-0132
n=12 Participants
Single dose of 0.1% SJP-0132 as Cohort 2
|
Single-dose (Cohort 3) : 0.3% SJP-0132
Single dose of 0.3% SJP-0132 as Cohort 3
|
Single-dose (Cohort 4) : 1% SJP-0132
Single dose of 1% SJP-0132 as Cohort 4
|
Single-dose (Cohort 1-4) : Placebo
Single dose of placebo as Cohort 1 to 4
|
Multiple-dose (Cohort 5) : 0.3% SJP-0132
Multiple dose of 0.3% SJP-0132 for 4 weeks as Cohort 5
|
Multiple-dose (Cohort 6) : 1% SJP-0132
Multiple dose of 1% SJP-0132 for 4 weeks as Cohort 6
|
Multiple-dose (Cohort 5, 6) : Placebo
Multiple dose of placebo for 4 weeks as Cohort 5 and 6
|
|---|---|---|---|---|---|---|---|---|
|
Accumulation Ratio (Rac) After Multiple Dosing
Rac Day 4/Day 2
|
1.75758 Ratio
Standard Deviation 0.705735
|
1.67083 Ratio
Standard Deviation 0.812324
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Accumulation Ratio (Rac) After Multiple Dosing
Rac Day 8/Day 2
|
2.84759 Ratio
Standard Deviation 1.858905
|
2.79157 Ratio
Standard Deviation 1.676501
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 29Population: Full Analysis Set
Visual analog scale (VAS): "0" mean none, and "100" mean the worst imaginable for the symptom question.
Outcome measures
| Measure |
Single-dose (Cohort 1) : 0.03% SJP-0132
n=19 Participants
Single dose of 0.03% SJP-0132 as Cohort 1
|
Single-dose (Cohort 2) : 0.1% SJP-0132
n=20 Participants
Single dose of 0.1% SJP-0132 as Cohort 2
|
Single-dose (Cohort 3) : 0.3% SJP-0132
n=19 Participants
Single dose of 0.3% SJP-0132 as Cohort 3
|
Single-dose (Cohort 4) : 1% SJP-0132
Single dose of 1% SJP-0132 as Cohort 4
|
Single-dose (Cohort 1-4) : Placebo
Single dose of placebo as Cohort 1 to 4
|
Multiple-dose (Cohort 5) : 0.3% SJP-0132
Multiple dose of 0.3% SJP-0132 for 4 weeks as Cohort 5
|
Multiple-dose (Cohort 6) : 1% SJP-0132
Multiple dose of 1% SJP-0132 for 4 weeks as Cohort 6
|
Multiple-dose (Cohort 5, 6) : Placebo
Multiple dose of placebo for 4 weeks as Cohort 5 and 6
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Eye Dryness Symptom (VAS) at 4hour on Day 29
|
-34.2 units on a scale
Standard Deviation 21.97
|
-26.3 units on a scale
Standard Deviation 22.00
|
-29.8 units on a scale
Standard Deviation 30.13
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 29Population: Full Analysis Set
Change from baseline of central zone CFS score at the central zone on Day 29. CFS score at the central zone ranged from 0 to 5, where '0' represents no fluorescein staining, and '5' represents severe staining on the cornea. The higher scores mean worse outcomes. Results from the study eye are reported.
Outcome measures
| Measure |
Single-dose (Cohort 1) : 0.03% SJP-0132
n=20 Study eye
Single dose of 0.03% SJP-0132 as Cohort 1
|
Single-dose (Cohort 2) : 0.1% SJP-0132
n=20 Study eye
Single dose of 0.1% SJP-0132 as Cohort 2
|
Single-dose (Cohort 3) : 0.3% SJP-0132
n=19 Study eye
Single dose of 0.3% SJP-0132 as Cohort 3
|
Single-dose (Cohort 4) : 1% SJP-0132
Single dose of 1% SJP-0132 as Cohort 4
|
Single-dose (Cohort 1-4) : Placebo
Single dose of placebo as Cohort 1 to 4
|
Multiple-dose (Cohort 5) : 0.3% SJP-0132
Multiple dose of 0.3% SJP-0132 for 4 weeks as Cohort 5
|
Multiple-dose (Cohort 6) : 1% SJP-0132
Multiple dose of 1% SJP-0132 for 4 weeks as Cohort 6
|
Multiple-dose (Cohort 5, 6) : Placebo
Multiple dose of placebo for 4 weeks as Cohort 5 and 6
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Corneal Fluorescein Staining (CFS) Score at the Central Zone on Day 29
|
-1.1 score on a scale
Standard Deviation 1.19
|
-1.3 score on a scale
Standard Deviation 1.08
|
-1.2 score on a scale
Standard Deviation 1.36
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 29Population: Full Analysis Set.
Visual analog scale (VAS): "0" mean none, and "100" mean the worst imaginable for the symptom question. Results from pre-dose are reported.
Outcome measures
| Measure |
Single-dose (Cohort 1) : 0.03% SJP-0132
n=20 Participants
Single dose of 0.03% SJP-0132 as Cohort 1
|
Single-dose (Cohort 2) : 0.1% SJP-0132
n=20 Participants
Single dose of 0.1% SJP-0132 as Cohort 2
|
Single-dose (Cohort 3) : 0.3% SJP-0132
n=20 Participants
Single dose of 0.3% SJP-0132 as Cohort 3
|
Single-dose (Cohort 4) : 1% SJP-0132
Single dose of 1% SJP-0132 as Cohort 4
|
Single-dose (Cohort 1-4) : Placebo
Single dose of placebo as Cohort 1 to 4
|
Multiple-dose (Cohort 5) : 0.3% SJP-0132
Multiple dose of 0.3% SJP-0132 for 4 weeks as Cohort 5
|
Multiple-dose (Cohort 6) : 1% SJP-0132
Multiple dose of 1% SJP-0132 for 4 weeks as Cohort 6
|
Multiple-dose (Cohort 5, 6) : Placebo
Multiple dose of placebo for 4 weeks as Cohort 5 and 6
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Eye Dryness Symptom by Visual Analog Scale (VAS) in Each Timepoints
Day 2
|
-14.3 score on a scale
Standard Deviation 17.82
|
-12.1 score on a scale
Standard Deviation 17.92
|
-8.0 score on a scale
Standard Deviation 14.74
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Eye Dryness Symptom by Visual Analog Scale (VAS) in Each Timepoints
Day 8
|
-29.7 score on a scale
Standard Deviation 24.08
|
-22.3 score on a scale
Standard Deviation 21.33
|
-24.2 score on a scale
Standard Deviation 27.03
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Eye Dryness Symptom by Visual Analog Scale (VAS) in Each Timepoints
Day 15
|
-30.1 score on a scale
Standard Deviation 21.44
|
-17.6 score on a scale
Standard Deviation 21.03
|
-22.8 score on a scale
Standard Deviation 24.12
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Eye Dryness Symptom by Visual Analog Scale (VAS) in Each Timepoints
Day 22
|
-30.3 score on a scale
Standard Deviation 23.47
|
-21.9 score on a scale
Standard Deviation 22.21
|
-28.9 score on a scale
Standard Deviation 29.71
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Eye Dryness Symptom by Visual Analog Scale (VAS) in Each Timepoints
Day 29
|
-34.6 score on a scale
Standard Deviation 22.27
|
-23.9 score on a scale
Standard Deviation 22.46
|
-26.8 score on a scale
Standard Deviation 30.28
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8, 15, 22, 29Population: Full Analysis Set.
Change from baseline of CFS score at the total zone of pre-dose in each time point. Total zone means a summary of central, superior, inferior, nasal, and temporal zones. The range of the score in each zone is 0 to 5 points, and the total score is 25 points. The higher scores mean worse outcomes.
Outcome measures
| Measure |
Single-dose (Cohort 1) : 0.03% SJP-0132
n=20 Study eye
Single dose of 0.03% SJP-0132 as Cohort 1
|
Single-dose (Cohort 2) : 0.1% SJP-0132
n=20 Study eye
Single dose of 0.1% SJP-0132 as Cohort 2
|
Single-dose (Cohort 3) : 0.3% SJP-0132
n=20 Study eye
Single dose of 0.3% SJP-0132 as Cohort 3
|
Single-dose (Cohort 4) : 1% SJP-0132
Single dose of 1% SJP-0132 as Cohort 4
|
Single-dose (Cohort 1-4) : Placebo
Single dose of placebo as Cohort 1 to 4
|
Multiple-dose (Cohort 5) : 0.3% SJP-0132
Multiple dose of 0.3% SJP-0132 for 4 weeks as Cohort 5
|
Multiple-dose (Cohort 6) : 1% SJP-0132
Multiple dose of 1% SJP-0132 for 4 weeks as Cohort 6
|
Multiple-dose (Cohort 5, 6) : Placebo
Multiple dose of placebo for 4 weeks as Cohort 5 and 6
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Corneal Fluorescein Staining (CFS) Score at Total Zone in Each Timepoints
Day 8
|
-1.9 score on a scale
Standard Deviation 4.84
|
0.6 score on a scale
Standard Deviation 2.74
|
-0.6 score on a scale
Standard Deviation 2.96
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Corneal Fluorescein Staining (CFS) Score at Total Zone in Each Timepoints
Day 15
|
-3.9 score on a scale
Standard Deviation 3.92
|
-0.2 score on a scale
Standard Deviation 4.76
|
-2.3 score on a scale
Standard Deviation 5.70
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Corneal Fluorescein Staining (CFS) Score at Total Zone in Each Timepoints
Day 22
|
-4.4 score on a scale
Standard Deviation 3.50
|
0.2 score on a scale
Standard Deviation 5.16
|
-1.4 score on a scale
Standard Deviation 3.85
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Corneal Fluorescein Staining (CFS) Score at Total Zone in Each Timepoints
Day 29
|
-3.4 score on a scale
Standard Deviation 3.82
|
-1.8 score on a scale
Standard Deviation 5.15
|
-1.8 score on a scale
Standard Deviation 4.94
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8, 15, 22, 29Population: Full Analysis Set.
The score in each zone is 0 to 5 points, and the maximum total score is 30 points. The higher scores mean worse outcomes. Results from the study eye are reported.
Outcome measures
| Measure |
Single-dose (Cohort 1) : 0.03% SJP-0132
n=20 Study eye
Single dose of 0.03% SJP-0132 as Cohort 1
|
Single-dose (Cohort 2) : 0.1% SJP-0132
n=20 Study eye
Single dose of 0.1% SJP-0132 as Cohort 2
|
Single-dose (Cohort 3) : 0.3% SJP-0132
n=20 Study eye
Single dose of 0.3% SJP-0132 as Cohort 3
|
Single-dose (Cohort 4) : 1% SJP-0132
Single dose of 1% SJP-0132 as Cohort 4
|
Single-dose (Cohort 1-4) : Placebo
Single dose of placebo as Cohort 1 to 4
|
Multiple-dose (Cohort 5) : 0.3% SJP-0132
Multiple dose of 0.3% SJP-0132 for 4 weeks as Cohort 5
|
Multiple-dose (Cohort 6) : 1% SJP-0132
Multiple dose of 1% SJP-0132 for 4 weeks as Cohort 6
|
Multiple-dose (Cohort 5, 6) : Placebo
Multiple dose of placebo for 4 weeks as Cohort 5 and 6
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Conjunctival Lissamine Green Staining (CLGS) Score at Total Zone in Each Timepoints
Day 8
|
0.6 score on a scale
Standard Deviation 5.25
|
1.7 score on a scale
Standard Deviation 5.28
|
0.3 score on a scale
Standard Deviation 3.80
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Conjunctival Lissamine Green Staining (CLGS) Score at Total Zone in Each Timepoints
Day 15
|
0.5 score on a scale
Standard Deviation 5.66
|
2.1 score on a scale
Standard Deviation 5.35
|
1.6 score on a scale
Standard Deviation 3.93
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Conjunctival Lissamine Green Staining (CLGS) Score at Total Zone in Each Timepoints
Day 22
|
0.5 score on a scale
Standard Deviation 4.97
|
1.9 score on a scale
Standard Deviation 4.15
|
1.8 score on a scale
Standard Deviation 4.44
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Conjunctival Lissamine Green Staining (CLGS) Score at Total Zone in Each Timepoints
Day 29
|
0.5 score on a scale
Standard Deviation 5.95
|
1.4 score on a scale
Standard Deviation 5.43
|
2.3 score on a scale
Standard Deviation 4.26
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8, 15, 22, 29Population: Full Analysis Set.
Lissamine green staining of the lid wiper was graded from 0 to 3. The higher scores mean worse outcomes. Results from the study eye are reported.
Outcome measures
| Measure |
Single-dose (Cohort 1) : 0.03% SJP-0132
n=20 Study eye
Single dose of 0.03% SJP-0132 as Cohort 1
|
Single-dose (Cohort 2) : 0.1% SJP-0132
n=20 Study eye
Single dose of 0.1% SJP-0132 as Cohort 2
|
Single-dose (Cohort 3) : 0.3% SJP-0132
n=20 Study eye
Single dose of 0.3% SJP-0132 as Cohort 3
|
Single-dose (Cohort 4) : 1% SJP-0132
Single dose of 1% SJP-0132 as Cohort 4
|
Single-dose (Cohort 1-4) : Placebo
Single dose of placebo as Cohort 1 to 4
|
Multiple-dose (Cohort 5) : 0.3% SJP-0132
Multiple dose of 0.3% SJP-0132 for 4 weeks as Cohort 5
|
Multiple-dose (Cohort 6) : 1% SJP-0132
Multiple dose of 1% SJP-0132 for 4 weeks as Cohort 6
|
Multiple-dose (Cohort 5, 6) : Placebo
Multiple dose of placebo for 4 weeks as Cohort 5 and 6
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Lid Wiper Epitheliopathy Score in Each Timepoints
Day 8
|
-0.10 score on a scale
Standard Deviation 0.620
|
-0.33 score on a scale
Standard Deviation 0.520
|
-0.50 score on a scale
Standard Deviation 0.973
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Lid Wiper Epitheliopathy Score in Each Timepoints
Day 15
|
0.08 score on a scale
Standard Deviation 0.799
|
-0.40 score on a scale
Standard Deviation 0.641
|
-0.33 score on a scale
Standard Deviation 0.963
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Lid Wiper Epitheliopathy Score in Each Timepoints
Day 22
|
-0.13 score on a scale
Standard Deviation 0.496
|
-0.35 score on a scale
Standard Deviation 0.630
|
-0.18 score on a scale
Standard Deviation 0.989
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Lid Wiper Epitheliopathy Score in Each Timepoints
Day 29
|
-0.70 score on a scale
Standard Deviation 1.081
|
-0.43 score on a scale
Standard Deviation 0.730
|
-0.53 score on a scale
Standard Deviation 0.993
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8, 15, 22, 29Population: Full Analysis Set. One participant in placebo group was not completed the study.
Tear film break-up time is the time taken for the first dry spot to appear on the cornea after a complete blink.
Outcome measures
| Measure |
Single-dose (Cohort 1) : 0.03% SJP-0132
n=20 Study eye
Single dose of 0.03% SJP-0132 as Cohort 1
|
Single-dose (Cohort 2) : 0.1% SJP-0132
n=20 Study eye
Single dose of 0.1% SJP-0132 as Cohort 2
|
Single-dose (Cohort 3) : 0.3% SJP-0132
n=20 Study eye
Single dose of 0.3% SJP-0132 as Cohort 3
|
Single-dose (Cohort 4) : 1% SJP-0132
Single dose of 1% SJP-0132 as Cohort 4
|
Single-dose (Cohort 1-4) : Placebo
Single dose of placebo as Cohort 1 to 4
|
Multiple-dose (Cohort 5) : 0.3% SJP-0132
Multiple dose of 0.3% SJP-0132 for 4 weeks as Cohort 5
|
Multiple-dose (Cohort 6) : 1% SJP-0132
Multiple dose of 1% SJP-0132 for 4 weeks as Cohort 6
|
Multiple-dose (Cohort 5, 6) : Placebo
Multiple dose of placebo for 4 weeks as Cohort 5 and 6
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Tear Film Break-up Time (TFBUT) in Each Timepoints
Day 8
|
0.54 sec
Standard Deviation 2.580
|
-0.04 sec
Standard Deviation 1.834
|
0.52 sec
Standard Deviation 2.024
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Tear Film Break-up Time (TFBUT) in Each Timepoints
Day 15
|
1.26 sec
Standard Deviation 2.848
|
0 sec
Standard Deviation 1.789
|
-0.08 sec
Standard Deviation 2.755
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Tear Film Break-up Time (TFBUT) in Each Timepoints
Day 22
|
0.98 sec
Standard Deviation 2.560
|
-0.29 sec
Standard Deviation 1.178
|
0.89 sec
Standard Deviation 2.212
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Tear Film Break-up Time (TFBUT) in Each Timepoints
Day 29
|
1.29 sec
Standard Deviation 3.435
|
0.32 sec
Standard Deviation 2.147
|
0.66 sec
Standard Deviation 1.720
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8, 15, 22, 29Population: Full Analysis Set.
The OSDI questionnaire consists of 12 questions regarding ocular symptoms, environmental triggers, and vision-related functioning. The participant was asked to rate each question using a 5-point scale (0 to 4), where 0 = none of the time; 1 = some of the time; 2 = half of the time; 3 = most of the time; and 4 = all of the time. The total OSDI was calculated from the raw scores of each of the 12 questions based on the formula: (\[sum of scores for all questions answered\] X 25)/(\[total number of questions answered\]). The OSDI can range from 0 (normal) to 100 (abnormal).
Outcome measures
| Measure |
Single-dose (Cohort 1) : 0.03% SJP-0132
n=20 Participants
Single dose of 0.03% SJP-0132 as Cohort 1
|
Single-dose (Cohort 2) : 0.1% SJP-0132
n=20 Participants
Single dose of 0.1% SJP-0132 as Cohort 2
|
Single-dose (Cohort 3) : 0.3% SJP-0132
n=20 Participants
Single dose of 0.3% SJP-0132 as Cohort 3
|
Single-dose (Cohort 4) : 1% SJP-0132
Single dose of 1% SJP-0132 as Cohort 4
|
Single-dose (Cohort 1-4) : Placebo
Single dose of placebo as Cohort 1 to 4
|
Multiple-dose (Cohort 5) : 0.3% SJP-0132
Multiple dose of 0.3% SJP-0132 for 4 weeks as Cohort 5
|
Multiple-dose (Cohort 6) : 1% SJP-0132
Multiple dose of 1% SJP-0132 for 4 weeks as Cohort 6
|
Multiple-dose (Cohort 5, 6) : Placebo
Multiple dose of placebo for 4 weeks as Cohort 5 and 6
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Ocular Surface Disease Index (OSDI)
Day 8
|
-24.19 score on a scale
Standard Deviation 22.037
|
-9.67 score on a scale
Standard Deviation 19.494
|
-28.17 score on a scale
Standard Deviation 18.536
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Ocular Surface Disease Index (OSDI)
Day 15
|
-22.94 score on a scale
Standard Deviation 22.554
|
-9.94 score on a scale
Standard Deviation 20.342
|
-23.91 score on a scale
Standard Deviation 17.298
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Ocular Surface Disease Index (OSDI)
Day 22
|
-24.02 score on a scale
Standard Deviation 22.182
|
-9.04 score on a scale
Standard Deviation 20.266
|
-22.21 score on a scale
Standard Deviation 20.100
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Ocular Surface Disease Index (OSDI)
Day 29
|
-24.38 score on a scale
Standard Deviation 21.891
|
-9.30 score on a scale
Standard Deviation 22.785
|
-23.54 score on a scale
Standard Deviation 23.508
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 29Population: Full Analysis Set
The participants rated the frequency on a scale of 0 (never) to 4 (constant) with which they have experienced 3 symptoms (watery eyes, discomfort and dryness). The participant was also asked to rate the intensity of discomfort and dryness on a scale of 0 (never have it) to 5 (very intense). Total DEQ-5 score was the sum of scores for frequency and intensity of dryness and discomfort plus frequency of watery eyes. Maximum score is 22. Higher scores mean a worse outcome.
Outcome measures
| Measure |
Single-dose (Cohort 1) : 0.03% SJP-0132
n=20 Participants
Single dose of 0.03% SJP-0132 as Cohort 1
|
Single-dose (Cohort 2) : 0.1% SJP-0132
n=20 Participants
Single dose of 0.1% SJP-0132 as Cohort 2
|
Single-dose (Cohort 3) : 0.3% SJP-0132
n=19 Participants
Single dose of 0.3% SJP-0132 as Cohort 3
|
Single-dose (Cohort 4) : 1% SJP-0132
Single dose of 1% SJP-0132 as Cohort 4
|
Single-dose (Cohort 1-4) : Placebo
Single dose of placebo as Cohort 1 to 4
|
Multiple-dose (Cohort 5) : 0.3% SJP-0132
Multiple dose of 0.3% SJP-0132 for 4 weeks as Cohort 5
|
Multiple-dose (Cohort 6) : 1% SJP-0132
Multiple dose of 1% SJP-0132 for 4 weeks as Cohort 6
|
Multiple-dose (Cohort 5, 6) : Placebo
Multiple dose of placebo for 4 weeks as Cohort 5 and 6
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Dry Eye Questionnaire 5 (DEQ-5) Scores
|
-6.0 score on a scale
Standard Deviation 3.46
|
-4.9 score on a scale
Standard Deviation 4.00
|
-3.6 score on a scale
Standard Deviation 3.59
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 29Population: Full Analysis Set
Levels of the inflammatory marker Matrix Metalloproteinase-9 (MMP-9) were measured in each eye using InflammaDry. The test was recorded as either positive or negative. Results from the study eye are reported.
Outcome measures
| Measure |
Single-dose (Cohort 1) : 0.03% SJP-0132
n=20 Study eye
Single dose of 0.03% SJP-0132 as Cohort 1
|
Single-dose (Cohort 2) : 0.1% SJP-0132
n=20 Study eye
Single dose of 0.1% SJP-0132 as Cohort 2
|
Single-dose (Cohort 3) : 0.3% SJP-0132
n=20 Study eye
Single dose of 0.3% SJP-0132 as Cohort 3
|
Single-dose (Cohort 4) : 1% SJP-0132
Single dose of 1% SJP-0132 as Cohort 4
|
Single-dose (Cohort 1-4) : Placebo
Single dose of placebo as Cohort 1 to 4
|
Multiple-dose (Cohort 5) : 0.3% SJP-0132
Multiple dose of 0.3% SJP-0132 for 4 weeks as Cohort 5
|
Multiple-dose (Cohort 6) : 1% SJP-0132
Multiple dose of 1% SJP-0132 for 4 weeks as Cohort 6
|
Multiple-dose (Cohort 5, 6) : Placebo
Multiple dose of placebo for 4 weeks as Cohort 5 and 6
|
|---|---|---|---|---|---|---|---|---|
|
Change in Matrix Metalloproteinase-9 (MMP-9)
Baseline · Positive
|
14 Study eye
|
2 Study eye
|
8 Study eye
|
—
|
—
|
—
|
—
|
—
|
|
Change in Matrix Metalloproteinase-9 (MMP-9)
Baseline · Negative
|
6 Study eye
|
18 Study eye
|
12 Study eye
|
—
|
—
|
—
|
—
|
—
|
|
Change in Matrix Metalloproteinase-9 (MMP-9)
Baseline · Missing
|
0 Study eye
|
0 Study eye
|
0 Study eye
|
—
|
—
|
—
|
—
|
—
|
|
Change in Matrix Metalloproteinase-9 (MMP-9)
Day 29 · Positive
|
2 Study eye
|
4 Study eye
|
7 Study eye
|
—
|
—
|
—
|
—
|
—
|
|
Change in Matrix Metalloproteinase-9 (MMP-9)
Day 29 · Negative
|
18 Study eye
|
16 Study eye
|
12 Study eye
|
—
|
—
|
—
|
—
|
—
|
|
Change in Matrix Metalloproteinase-9 (MMP-9)
Day 29 · Missing
|
0 Study eye
|
0 Study eye
|
1 Study eye
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Single-dose (Cohort 1) : SJP-0132 Low Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Single-dose (Cohort 2) : SJP-0132 Mid-Low Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Single-dose (Cohort 3) : SJP-0132 Mid-High Dose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Single-dose (Cohort 4) : SJP-0132 High Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Single-dose (Cohort 1-4) : Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Multiple-dose (Cohort 5) : SJP-0132 Mid-High Dose
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Multiple-dose (Cohort 6) : SJP-0132 High Dose
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Multiple-dose (Cohort 5, 6) : Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Single-dose (Cohort 1) : SJP-0132 Low Dose
n=6 participants at risk
Single dose of Low strength of SJP-0132 as Cohort 1
|
Single-dose (Cohort 2) : SJP-0132 Mid-Low Dose
n=6 participants at risk
Single dose of Mid-Low strength of SJP-0132 as Cohort 2
|
Single-dose (Cohort 3) : SJP-0132 Mid-High Dose
n=5 participants at risk
Single dose of Mid-High strength of SJP-0132 as Cohort 3
|
Single-dose (Cohort 4) : SJP-0132 High Dose
n=4 participants at risk
Single dose of High strength of SJP-0132 as Cohort 4
|
Single-dose (Cohort 1-4) : Placebo
n=8 participants at risk
Single dose of placebo as Cohort 1 to 4
|
Multiple-dose (Cohort 5) : SJP-0132 Mid-High Dose
n=20 participants at risk
Multiple dose of Mid-High strength of SJP-0132 for 4 weeks as Cohort 5
|
Multiple-dose (Cohort 6) : SJP-0132 High Dose
n=20 participants at risk
Multiple dose of High strength of SJP-0132 for 4 weeks as Cohort 6
|
Multiple-dose (Cohort 5, 6) : Placebo
n=20 participants at risk
Multiple dose of placebo for 4 weeks as Cohort 5 and 6
|
|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/6 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
40.0%
2/5 • Number of events 2 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/4 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/8 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/20 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
5.0%
1/20 • Number of events 1 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
5.0%
1/20 • Number of events 1 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
|
Eye disorders
Conjunctival hemorrhage
|
0.00%
0/6 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/6 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/5 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/4 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/8 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/20 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/20 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
5.0%
1/20 • Number of events 1 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/6 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/5 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/4 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/8 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/20 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/20 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
5.0%
1/20 • Number of events 1 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/6 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/5 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/4 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/8 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
5.0%
1/20 • Number of events 1 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/20 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
5.0%
1/20 • Number of events 1 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/6 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/6 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/5 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/4 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/8 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/20 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/20 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
5.0%
1/20 • Number of events 1 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/6 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/5 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/4 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/8 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/20 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
5.0%
1/20 • Number of events 1 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/20 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/6 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/6 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/5 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/4 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/8 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/20 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/20 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
5.0%
1/20 • Number of events 1 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/6 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/5 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/4 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/8 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/20 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
5.0%
1/20 • Number of events 1 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
5.0%
1/20 • Number of events 1 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/6 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/5 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/4 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/8 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/20 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/20 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
5.0%
1/20 • Number of events 1 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/6 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/5 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/4 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/8 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/20 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/20 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
5.0%
1/20 • Number of events 1 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/6 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/6 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/5 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/4 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/8 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/20 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
5.0%
1/20 • Number of events 1 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/20 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
|
Skin and subcutaneous tissue disorders
Sensitive skin
|
0.00%
0/6 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/6 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/5 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/4 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/8 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/20 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
5.0%
1/20 • Number of events 1 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/20 • Day 2 for cohort 1-4, Day 29 for cohort 5-6
Adverse events are reported as Treatment-Emergent Adverse Events (TEAEs), which are defined as any event not present before exposure to the study drug or any event already presented that worsened in either intensity or frequency after exposure to the study drug.
|
Additional Information
Director, Clinical Development
Senju Pharmaceutical Co. Ltd.
Phone: +81 078 777 1018
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER