Trial Outcomes & Findings for JKB-121 for the Treatment of Nonalcoholic Steatohepatitis (NCT NCT02442687)
NCT ID: NCT02442687
Last Updated: 2019-01-07
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
65 participants
Primary outcome timeframe
Baseline to week 24
Results posted on
2019-01-07
Participant Flow
Participant milestones
| Measure |
JKB 5 mg BID
JKB 121, 5 mg by mouth twice daily
|
JKB 10 mg BID
JKB 121, 10 mg by mouth twice daily
|
Placebo BID
Identical appearing placebo by mouth twice daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
22
|
22
|
|
Overall Study
COMPLETED
|
13
|
11
|
19
|
|
Overall Study
NOT COMPLETED
|
8
|
11
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
JKB-121 for the Treatment of Nonalcoholic Steatohepatitis
Baseline characteristics by cohort
| Measure |
JKB 5 mg BID
n=21 Participants
JKB 121, 5 mg twice daily
|
JKB 10 mg BID
n=22 Participants
JKB 121, 10 mg twice daily
|
Placebo BID
n=22 Participants
Identical appearing placebo
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
50.5 years
STANDARD_DEVIATION 12.9 • n=7 Participants
|
49.5 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
51 years
STANDARD_DEVIATION 11.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Ethnicity (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
|
|
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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
62 Participants
n=4 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
|
|
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
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
22 participants
n=7 Participants
|
22 participants
n=5 Participants
|
65 participants
n=4 Participants
|
|
Body Mass Index
|
40.0 kg/m^2
STANDARD_DEVIATION 6.8 • n=5 Participants
|
34.1 kg/m^2
STANDARD_DEVIATION 6.4 • n=7 Participants
|
35.4 kg/m^2
STANDARD_DEVIATION 6.5 • n=5 Participants
|
35.2 kg/m^2
STANDARD_DEVIATION 6.5 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 24Population: The per protocol population included only those patients with non-missing baseline (ie. screening) and the specified visit are included. If missing, the last valid measurement on or prior to the first date administration of study medication is used as baseline.
Outcome measures
| Measure |
JKB 121, 5 mg
n=17 Participants
JKB 121, 5 mg twice daily
JKB-121: 5 mg twice daily
|
JKB-121: 10 mg
n=11 Participants
JKB 121, 10 mg twice daily
JKB-121: 10 mg twice daily
|
Placebo
n=19 Participants
Identical appearing placebo
Placebo
|
|---|---|---|---|
|
Analysis of MRI-PDFF Change From Baseline to Week 24 (Per Protocol Population)
|
0.38 percentage of fat
Interval -1.95 to 2.72
|
-0.44 percentage of fat
Interval -3.63 to 2.74
|
-3.09 percentage of fat
Interval -5.28 to -0.91
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: The per protocol population included only those patients with non-missing baseline (ie. screening) and the specified visit are included. If missing, the last valid measurement on or prior to the first date administration of study medication is used as baseline.
Outcome measures
| Measure |
JKB 121, 5 mg
n=16 Participants
JKB 121, 5 mg twice daily
JKB-121: 5 mg twice daily
|
JKB-121: 10 mg
n=11 Participants
JKB 121, 10 mg twice daily
JKB-121: 10 mg twice daily
|
Placebo
n=20 Participants
Identical appearing placebo
Placebo
|
|---|---|---|---|
|
Analysis of MRI-PDFF Change From Baseline to Week 12 (Per Protocol Population)
|
-1.78 percentage
Interval -4.05 to 0.5
|
-1.50 percentage
Interval -4.56 to 1.56
|
-2.74 percentage
Interval -4.78 to -0.7
|
SECONDARY outcome
Timeframe: Baseline to week 24Population: The per protocol population included only those patients with non-missing baseline (ie. screening) and the specified visit are included. If missing, the last valid measurement on or prior to the first date administration of study medication is used as baseline.
Outcome measures
| Measure |
JKB 121, 5 mg
n=17 Participants
JKB 121, 5 mg twice daily
JKB-121: 5 mg twice daily
|
JKB-121: 10 mg
n=11 Participants
JKB 121, 10 mg twice daily
JKB-121: 10 mg twice daily
|
Placebo
n=20 Participants
Identical appearing placebo
Placebo
|
|---|---|---|---|
|
Analysis of ALT Change From Baseline to Week 24 (Per Protocol Population)
|
-6.7 U/L
Interval -25.2 to 11.8
|
-1.3 U/L
Interval -25.6 to 23.0
|
-20.9 U/L
Interval -37.7 to -4.0
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: The per protocol population included only those patients with non-missing baseline (ie. screening) and the specified visit are included. If missing, the last valid measurement on or prior to the first date administration of study medication is used as baseline.
Outcome measures
| Measure |
JKB 121, 5 mg
n=17 Participants
JKB 121, 5 mg twice daily
JKB-121: 5 mg twice daily
|
JKB-121: 10 mg
n=11 Participants
JKB 121, 10 mg twice daily
JKB-121: 10 mg twice daily
|
Placebo
n=20 Participants
Identical appearing placebo
Placebo
|
|---|---|---|---|
|
Analysis of ALT Change From Baseline to Week 12 (Per Protocol Population)
|
-6.3 U/L
Interval -19.5 to 6.9
|
-9.9 U/L
Interval -27.2 to 7.4
|
-21.7 U/L
Interval -33.7 to -9.7
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: No subjects reached remission; analysis not performed.
Time to remission is the time in weeks from randomization to liver function remission, defined as two consecutive ALT values within normal range (\<40 U/L) during the treatment period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, week 24Population: Only patients with non-missing baseline and the specified visit are included.
Outcome measures
| Measure |
JKB 121, 5 mg
n=17 Participants
JKB 121, 5 mg twice daily
JKB-121: 5 mg twice daily
|
JKB-121: 10 mg
n=13 Participants
JKB 121, 10 mg twice daily
JKB-121: 10 mg twice daily
|
Placebo
n=20 Participants
Identical appearing placebo
Placebo
|
|---|---|---|---|
|
Change in BMI (Body Mass Index)
|
-0.18 kg/m^2
Interval -0.81 to 0.44
|
0.54 kg/m^2
Interval -0.21 to 1.3
|
-0.63 kg/m^2
Interval -1.2 to -0.05
|
SECONDARY outcome
Timeframe: Baseline, week 24Population: Only patients with non-missing baseline and the specified visit are included
Outcome measures
| Measure |
JKB 121, 5 mg
n=17 Participants
JKB 121, 5 mg twice daily
JKB-121: 5 mg twice daily
|
JKB-121: 10 mg
n=13 Participants
JKB 121, 10 mg twice daily
JKB-121: 10 mg twice daily
|
Placebo
n=20 Participants
Identical appearing placebo
Placebo
|
|---|---|---|---|
|
Change in Hemoglobin A1C
|
0.07 percentage of HbA1C
Interval -0.49 to 0.63
|
0.23 percentage of HbA1C
Interval -0.44 to 0.91
|
0.45 percentage of HbA1C
Interval -0.08 to 0.98
|
SECONDARY outcome
Timeframe: Baseline, week 24Population: Only patients with non-missing baseline and the specified visit are included.
HOMA-IR was calculated according to the formula: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5. Optimal Range: 1.0 (0.5-1.4). Lower values represent a better outcome.
Outcome measures
| Measure |
JKB 121, 5 mg
n=17 Participants
JKB 121, 5 mg twice daily
JKB-121: 5 mg twice daily
|
JKB-121: 10 mg
n=13 Participants
JKB 121, 10 mg twice daily
JKB-121: 10 mg twice daily
|
Placebo
n=19 Participants
Identical appearing placebo
Placebo
|
|---|---|---|---|
|
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
|
-1.013 HOMA-IR index
Interval -3.831 to 1.805
|
-0.679 HOMA-IR index
Interval -4.132 to 2.775
|
-0.404 HOMA-IR index
Interval -3.039 to 2.231
|
SECONDARY outcome
Timeframe: Baseline, week 24Outcome measures
| Measure |
JKB 121, 5 mg
n=17 Participants
JKB 121, 5 mg twice daily
JKB-121: 5 mg twice daily
|
JKB-121: 10 mg
n=13 Participants
JKB 121, 10 mg twice daily
JKB-121: 10 mg twice daily
|
Placebo
n=20 Participants
Identical appearing placebo
Placebo
|
|---|---|---|---|
|
Percent Change in Cholesterol
|
6.62 percent change
Interval -0.42 to 13.66
|
-2.55 percent change
Interval -11.03 to 5.94
|
2.26 percent change
Interval -4.18 to 8.7
|
SECONDARY outcome
Timeframe: Baseline, week 24Population: Only patients with non-missing baseline and the specified visit are included.
Outcome measures
| Measure |
JKB 121, 5 mg
n=17 Participants
JKB 121, 5 mg twice daily
JKB-121: 5 mg twice daily
|
JKB-121: 10 mg
n=13 Participants
JKB 121, 10 mg twice daily
JKB-121: 10 mg twice daily
|
Placebo
n=20 Participants
Identical appearing placebo
Placebo
|
|---|---|---|---|
|
Percent Change in Triglycerides
|
18.12 percent change
Interval 0.94 to 35.3
|
2.62 percent change
Interval -18.14 to 23.38
|
3.78 percent change
Interval -11.96 to 19.52
|
SECONDARY outcome
Timeframe: Baseline, week 24Population: Only patients with non-missing baseline and the specified visit are included.
Outcome measures
| Measure |
JKB 121, 5 mg
n=17 Participants
JKB 121, 5 mg twice daily
JKB-121: 5 mg twice daily
|
JKB-121: 10 mg
n=13 Participants
JKB 121, 10 mg twice daily
JKB-121: 10 mg twice daily
|
Placebo
n=18 Participants
Identical appearing placebo
Placebo
|
|---|---|---|---|
|
Percent Change in Low Density Lipoprotein (LDL) Cholesterol
|
5.92 percent change
Interval -5.57 to 17.41
|
-4.79 percent change
Interval -18.73 to 9.15
|
1.50 percent change
Interval -9.58 to 12.57
|
SECONDARY outcome
Timeframe: Baseline, week 24Population: Only patients with non-missing baseline and the specified visit are included.
Outcome measures
| Measure |
JKB 121, 5 mg
n=17 Participants
JKB 121, 5 mg twice daily
JKB-121: 5 mg twice daily
|
JKB-121: 10 mg
n=13 Participants
JKB 121, 10 mg twice daily
JKB-121: 10 mg twice daily
|
Placebo
n=20 Participants
Identical appearing placebo
Placebo
|
|---|---|---|---|
|
Percent Change in High Density Lipoprotein (HDL)
|
2.70 percent change
Interval -7.01 to 12.41
|
-0.80 percent change
Interval -12.54 to 10.94
|
13.97 percent change
Interval 5.09 to 22.86
|
SECONDARY outcome
Timeframe: weeks 4, 8, 12, 16, 20, and 24Population: Number of subjects with a result at baseline and the specified visit. Baseline is defined as the measurement at Day 1.
Outcome measures
| Measure |
JKB 121, 5 mg
n=20 Participants
JKB 121, 5 mg twice daily
JKB-121: 5 mg twice daily
|
JKB-121: 10 mg
n=15 Participants
JKB 121, 10 mg twice daily
JKB-121: 10 mg twice daily
|
Placebo
n=22 Participants
Identical appearing placebo
Placebo
|
|---|---|---|---|
|
Mean Serum Aspartate Aminotransferase (AST)
Week 4
|
45.7 U/L
Standard Deviation 15.11
|
42.9 U/L
Standard Deviation 12.01
|
81.0 U/L
Standard Deviation 79.96
|
|
Mean Serum Aspartate Aminotransferase (AST)
Week 8
|
45.3 U/L
Standard Deviation 16.43
|
47.1 U/L
Standard Deviation 15.12
|
67.4 U/L
Standard Deviation 55.10
|
|
Mean Serum Aspartate Aminotransferase (AST)
Week 12
|
47.6 U/L
Standard Deviation 17.56
|
44.2 U/L
Standard Deviation 16.48
|
49.7 U/L
Standard Deviation 22.94
|
|
Mean Serum Aspartate Aminotransferase (AST)
Week 16
|
42.9 U/L
Standard Deviation 13.61
|
47.5 U/L
Standard Deviation 22.29
|
51.1 U/L
Standard Deviation 24.32
|
|
Mean Serum Aspartate Aminotransferase (AST)
Week 20
|
50.1 U/L
Standard Deviation 26.34
|
46.4 U/L
Standard Deviation 27.14
|
54.0 U/L
Standard Deviation 44.85
|
|
Mean Serum Aspartate Aminotransferase (AST)
Week 24
|
49.4 U/L
Standard Deviation 17.92
|
49.5 U/L
Standard Deviation 33.78
|
47.4 U/L
Standard Deviation 25.93
|
SECONDARY outcome
Timeframe: weeks 4, 8, 12, 16, 20, and 24Population: Number of subjects with a result at baseline and the specified visit. Baseline is defined as the measurement at Day 1.
Outcome measures
| Measure |
JKB 121, 5 mg
n=20 Participants
JKB 121, 5 mg twice daily
JKB-121: 5 mg twice daily
|
JKB-121: 10 mg
n=15 Participants
JKB 121, 10 mg twice daily
JKB-121: 10 mg twice daily
|
Placebo
n=22 Participants
Identical appearing placebo
Placebo
|
|---|---|---|---|
|
Mean Serum Alanine Aminotransferase (ALT)
Week 4
|
65.8 U/L
Standard Deviation 28.28
|
70.4 U/L
Standard Deviation 26.33
|
95.0 U/L
Standard Deviation 66.36
|
|
Mean Serum Alanine Aminotransferase (ALT)
Week 8
|
63.8 U/L
Standard Deviation 26.03
|
77.4 U/L
Standard Deviation 41.18
|
79.4 U/L
Standard Deviation 42.62
|
|
Mean Serum Alanine Aminotransferase (ALT)
Week 12
|
67.9 U/L
Standard Deviation 36.23
|
65.3 U/L
Standard Deviation 28.09
|
69.8 U/L
Standard Deviation 39.27
|
|
Mean Serum Alanine Aminotransferase (ALT)
Week 16
|
61.5 U/L
Standard Deviation 29.06
|
69.5 U/L
Standard Deviation 43.98
|
68.7 U/L
Standard Deviation 33.19
|
|
Mean Serum Alanine Aminotransferase (ALT)
Week 20
|
61.1 U/L
Standard Deviation 33.08
|
63.8 U/L
Standard Deviation 37.96
|
70.7 U/L
Standard Deviation 43.59
|
|
Mean Serum Alanine Aminotransferase (ALT)
Week 24
|
67.3 U/L
Standard Deviation 33.80
|
68.2 U/L
Standard Deviation 46.34
|
67.6 U/L
Standard Deviation 48.06
|
SECONDARY outcome
Timeframe: weeks 4, 8, 12, 16, 20, and 24Population: Number of subjects with a result at baseline and the specified visit. Baseline is defined as the measurement at Day 1.
Outcome measures
| Measure |
JKB 121, 5 mg
n=20 Participants
JKB 121, 5 mg twice daily
JKB-121: 5 mg twice daily
|
JKB-121: 10 mg
n=15 Participants
JKB 121, 10 mg twice daily
JKB-121: 10 mg twice daily
|
Placebo
n=22 Participants
Identical appearing placebo
Placebo
|
|---|---|---|---|
|
Mean Serum Gamma-glutamyl Transpeptidase (GGT)
Week 4
|
68.4 U/L
Standard Deviation 38.07
|
83.8 U/L
Standard Deviation 48.85
|
165.0 U/L
Standard Deviation 149.38
|
|
Mean Serum Gamma-glutamyl Transpeptidase (GGT)
Week 8
|
73.7 U/L
Standard Deviation 48.74
|
74.6 U/L
Standard Deviation 35.02
|
147.5 U/L
Standard Deviation 123.42
|
|
Mean Serum Gamma-glutamyl Transpeptidase (GGT)
Week 12
|
79.2 U/L
Standard Deviation 58.32
|
74.3 U/L
Standard Deviation 36.99
|
133.8 U/L
Standard Deviation 115.93
|
|
Mean Serum Gamma-glutamyl Transpeptidase (GGT)
Week 16
|
78.3 U/L
Standard Deviation 54.85
|
69.8 U/L
Standard Deviation 33.49
|
134.7 U/L
Standard Deviation 139.93
|
|
Mean Serum Gamma-glutamyl Transpeptidase (GGT)
Week 20
|
75.4 U/L
Standard Deviation 52.80
|
64.1 U/L
Standard Deviation 30.65
|
132.9 U/L
Standard Deviation 144.28
|
|
Mean Serum Gamma-glutamyl Transpeptidase (GGT)
Week 24
|
86.6 U/L
Standard Deviation 79.47
|
68.2 U/L
Standard Deviation 30.79
|
109.7 U/L
Standard Deviation 92.10
|
SECONDARY outcome
Timeframe: Week 24Population: Number of subjects with an ALT result at the specified visit
Normal range is \<40 U/L
Outcome measures
| Measure |
JKB 121, 5 mg
n=18 Participants
JKB 121, 5 mg twice daily
JKB-121: 5 mg twice daily
|
JKB-121: 10 mg
n=13 Participants
JKB 121, 10 mg twice daily
JKB-121: 10 mg twice daily
|
Placebo
n=21 Participants
Identical appearing placebo
Placebo
|
|---|---|---|---|
|
Number of Subjects With ALT in Normal Range at Week 24
|
5 Participants
|
4 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12, and 24 hoursPopulation: PK Substudy Population
Outcome measures
| Measure |
JKB 121, 5 mg
n=3 Participants
JKB 121, 5 mg twice daily
JKB-121: 5 mg twice daily
|
JKB-121: 10 mg
n=3 Participants
JKB 121, 10 mg twice daily
JKB-121: 10 mg twice daily
|
Placebo
Identical appearing placebo
Placebo
|
|---|---|---|---|
|
Maximum Observed Concentrations (Cmax)
|
5.26 ng/mL
Standard Deviation 1.731
|
14.33 ng/mL
Standard Deviation 1.986
|
—
|
SECONDARY outcome
Timeframe: pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12, and 24 hoursPopulation: PK Substudy Population
Outcome measures
| Measure |
JKB 121, 5 mg
n=3 Participants
JKB 121, 5 mg twice daily
JKB-121: 5 mg twice daily
|
JKB-121: 10 mg
n=3 Participants
JKB 121, 10 mg twice daily
JKB-121: 10 mg twice daily
|
Placebo
Identical appearing placebo
Placebo
|
|---|---|---|---|
|
Minimum Observed Concentration (Cmin)
|
0.349 ng/mL
Standard Deviation 0.1595
|
1.512 ng/mL
Standard Deviation 1.0702
|
—
|
SECONDARY outcome
Timeframe: pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12, and 24 hoursPopulation: PK Substudy Population
Outcome measures
| Measure |
JKB 121, 5 mg
n=3 Participants
JKB 121, 5 mg twice daily
JKB-121: 5 mg twice daily
|
JKB-121: 10 mg
n=3 Participants
JKB 121, 10 mg twice daily
JKB-121: 10 mg twice daily
|
Placebo
Identical appearing placebo
Placebo
|
|---|---|---|---|
|
Area Under Concentration-time (AUC)
time 0 to infinity
|
38.50 h*ng/mL
Standard Deviation 13.578
|
71.24 h*ng/mL
Standard Deviation 16.562
|
—
|
|
Area Under Concentration-time (AUC)
time 0 to time of last quantifiable concentration
|
26.29 h*ng/mL
Standard Deviation 9.443
|
46.55 h*ng/mL
Standard Deviation 5.312
|
—
|
|
Area Under Concentration-time (AUC)
time 0 to 12 hours
|
26.29 h*ng/mL
Standard Deviation 9.443
|
50.44 h*ng/mL
Standard Deviation 5.388
|
—
|
SECONDARY outcome
Timeframe: pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12, and 24 hoursPopulation: PK Substudy Population
Outcome measures
| Measure |
JKB 121, 5 mg
n=3 Participants
JKB 121, 5 mg twice daily
JKB-121: 5 mg twice daily
|
JKB-121: 10 mg
n=3 Participants
JKB 121, 10 mg twice daily
JKB-121: 10 mg twice daily
|
Placebo
Identical appearing placebo
Placebo
|
|---|---|---|---|
|
Half-life
|
8.55 h
Standard Deviation 1.439
|
6.95 h
Standard Deviation 2.670
|
—
|
Adverse Events
JKB 5 mg Twice Daily
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo Twice Daily
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
JKB 121 10 mg Twice Daily
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
JKB 5 mg Twice Daily
n=21 participants at risk
JKB 121, 5 mg twice daily
|
Placebo Twice Daily
n=22 participants at risk
Placebo, twice daily
|
JKB 121 10 mg Twice Daily
n=22 participants at risk
JKB 121, 10 mg twice daily
|
|---|---|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
4.8%
1/21 • Number of events 1 • 6 month
|
0.00%
0/22 • 6 month
|
0.00%
0/22 • 6 month
|
|
Respiratory, thoracic and mediastinal disorders
Acute on Chronic Hypoxemic Respiratory Failure
|
0.00%
0/21 • 6 month
|
0.00%
0/22 • 6 month
|
4.5%
1/22 • Number of events 1 • 6 month
|
Other adverse events
| Measure |
JKB 5 mg Twice Daily
n=21 participants at risk
JKB 121, 5 mg twice daily
|
Placebo Twice Daily
n=22 participants at risk
Placebo, twice daily
|
JKB 121 10 mg Twice Daily
n=22 participants at risk
JKB 121, 10 mg twice daily
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
23.8%
5/21 • Number of events 5 • 6 month
|
22.7%
5/22 • Number of events 5 • 6 month
|
36.4%
8/22 • Number of events 8 • 6 month
|
|
Gastrointestinal disorders
Diarrhea
|
19.0%
4/21 • Number of events 4 • 6 month
|
4.5%
1/22 • Number of events 1 • 6 month
|
9.1%
2/22 • Number of events 2 • 6 month
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
1/21 • Number of events 1 • 6 month
|
4.5%
1/22 • Number of events 1 • 6 month
|
9.1%
2/22 • Number of events 2 • 6 month
|
|
General disorders
Fatigue
|
4.8%
1/21 • Number of events 1 • 6 month
|
4.5%
1/22 • Number of events 1 • 6 month
|
9.1%
2/22 • Number of events 2 • 6 month
|
|
Nervous system disorders
Dizziness
|
14.3%
3/21 • Number of events 3 • 6 month
|
0.00%
0/22 • 6 month
|
36.4%
8/22 • Number of events 8 • 6 month
|
|
Psychiatric disorders
Insomnia
|
9.5%
2/21 • Number of events 2 • 6 month
|
0.00%
0/22 • 6 month
|
9.1%
2/22 • Number of events 2 • 6 month
|
|
Psychiatric disorders
Abnormal dreams
|
4.8%
1/21 • Number of events 1 • 6 month
|
0.00%
0/22 • 6 month
|
4.5%
1/22 • Number of events 1 • 6 month
|
|
Respiratory, thoracic and mediastinal disorders
Oralpharyngeal pain
|
9.5%
2/21 • Number of events 2 • 6 month
|
0.00%
0/22 • 6 month
|
0.00%
0/22 • 6 month
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
4.8%
1/21 • Number of events 1 • 6 month
|
0.00%
0/22 • 6 month
|
0.00%
0/22 • 6 month
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.8%
1/21 • Number of events 1 • 6 month
|
4.5%
1/22 • Number of events 1 • 6 month
|
0.00%
0/22 • 6 month
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congetion
|
0.00%
0/21 • 6 month
|
4.5%
1/22 • Number of events 1 • 6 month
|
4.5%
1/22 • Number of events 1 • 6 month
|
|
Injury, poisoning and procedural complications
Injury
|
9.5%
2/21 • Number of events 2 • 6 month
|
9.1%
2/22 • Number of events 2 • 6 month
|
4.5%
1/22 • Number of events 1 • 6 month
|
|
Renal and urinary disorders
Urinary Tract Infection
|
4.8%
1/21 • Number of events 1 • 6 month
|
4.5%
1/22 • Number of events 1 • 6 month
|
9.1%
2/22 • Number of events 2 • 6 month
|
|
Reproductive system and breast disorders
Nasopharynitis
|
4.8%
1/21 • Number of events 1 • 6 month
|
9.1%
2/22 • Number of events 2 • 6 month
|
4.5%
1/22 • Number of events 1 • 6 month
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
0.00%
0/21 • 6 month
|
9.1%
2/22 • Number of events 2 • 6 month
|
0.00%
0/22 • 6 month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place