Trial Outcomes & Findings for Phase 1 Study of PBTZ169 (NCT NCT03036163)
NCT ID: NCT03036163
Last Updated: 2020-04-13
Results Overview
The frequency of adverse events for which a relationship to the test drug PBTZ169 was noted
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
14±1 days after the drug administration (up to last visit time point)
Results posted on
2020-04-13
Participant Flow
Participant milestones
| Measure |
Cohort 1
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 40 mg (1 capsule)
PBTZ169 - 40 mg: 40 mg of PBTZ169 (1 capsule) orally once in fasting state
|
Cohort 2
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 80 mg (2 capsules)
PBTZ169 - 80 mg: 80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state
|
Cohort 3
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 160 mg (4 capsules)
PBTZ169 - 160 mg: 160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state
|
Cohort 4
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 320 mg (8 capsules)
PBTZ169 - 320 mg: 320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state
|
Cohort 5
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 640 mg (16 capsules)
PBTZ169 - 640 mg: 640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state
|
Cohort 6
5 healthy volunteers each of whom received а daily dose of 320 mg of PBTZ169 (8 capsules 40 mg) for 14 days
PBTZ169 - 320 mg (multiple administration): 320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days
|
Cohort 7
5 healthy volunteers each of whom received a daily dose of 640 mg of PBTZ169 (16 capsules 40 mg) for 14 days
PBTZ169 - 640 mg (multiple administration): 640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
5
|
5
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 1 Study of PBTZ169
Baseline characteristics by cohort
| Measure |
Cohort 1
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 40 mg (1 capsule)
PBTZ169 - 40 mg: 40 mg of PBTZ169 (1 capsule) orally once in fasting state
|
Cohort 2
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 80 mg (2 capsules)
PBTZ169 - 80 mg: 80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state
|
Cohort 3
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 160 mg (4 capsules)
PBTZ169 - 160 mg: 160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state
|
Cohort 4
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 320 mg (8 capsules)
PBTZ169 - 320 mg: 320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state
|
Cohort 5
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 640 mg (16 capsules)
PBTZ169 - 640 mg: 640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state
|
Cohort 6
n=5 Participants
5 healthy volunteers each of whom received а daily dose of 320 mg of PBTZ169 (8 capsules 40 mg) for 14 days
PBTZ169 - 320 mg (multiple administration): 320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days
|
Cohort 7
n=5 Participants
5 healthy volunteers each of whom received a daily dose of 640 mg of PBTZ169 (16 capsules 40 mg) for 14 days
PBTZ169 - 640 mg (multiple administration): 640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
28.8 years
STANDARD_DEVIATION 5.00 • n=99 Participants
|
27.8 years
STANDARD_DEVIATION 5.64 • n=107 Participants
|
31.8 years
STANDARD_DEVIATION 6.55 • n=206 Participants
|
31.2 years
STANDARD_DEVIATION 6.85 • n=7 Participants
|
29.0 years
STANDARD_DEVIATION 7.18 • n=31 Participants
|
22.6 years
STANDARD_DEVIATION 2.61 • n=30 Participants
|
28.6 years
STANDARD_DEVIATION 6.50 • n=3 Participants
|
27.6 years
STANDARD_DEVIATION 5.85 • n=6 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
40 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
40 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Region of Enrollment
Russia
|
6 participants
n=99 Participants
|
6 participants
n=107 Participants
|
6 participants
n=206 Participants
|
6 participants
n=7 Participants
|
6 participants
n=31 Participants
|
5 participants
n=30 Participants
|
5 participants
n=3 Participants
|
40 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: 14±1 days after the drug administration (up to last visit time point)Population: Safety population: subjects who received at least one dose of PBTZ169. The population was used for the analysis and evaluation of the demographic and other baseline data and all safety parameters including AEs, physical examination, evaluation of the vital signs, previous and current therapy, ECG, all laboratory tests
The frequency of adverse events for which a relationship to the test drug PBTZ169 was noted
Outcome measures
| Measure |
Cohort 6
n=5 Participants
5 healthy volunteers each of whom received а daily dose of 320 mg of PBTZ169 (8 capsules 40 mg) for 14 days
PBTZ169 - 320 mg (multiple administration): 320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days
|
Cohort 7
n=5 Participants
5 healthy volunteers each of whom received a daily dose of 640 mg of PBTZ169 (16 capsules 40 mg) for 14 days
PBTZ169 - 640 mg (multiple administration): 640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days
|
Cohort 1
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 40 mg (1 capsule)
PBTZ169 - 40 mg: 40 mg of PBTZ169 (1 capsule) orally once in fasting state
|
Cohort 2
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 80 mg (2 capsules)
PBTZ169 - 80 mg: 80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state
|
Cohort 3
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 160 mg (4 capsules)
PBTZ169 - 160 mg: 160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state
|
Cohort 4
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 320 mg (8 capsules)
PBTZ169 - 320 mg: 320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state
|
Cohort 5
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 640 mg (16 capsules)
PBTZ169 - 640 mg: 640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state
|
|---|---|---|---|---|---|---|---|
|
Incidence of Drug-related Adverse Events [Safety and Tolerability]
|
1 participants
|
1 participants
|
2 participants
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Up to 72 hours after the last drug administrationPopulation: Pharmacokinetics analysis population (PKA): C1-5: sbjs who received PBTZ169 and had at least one measurement of PBTZ169 concentration; C6-7: sbjs who received PBTZ169 at least 7 times and had measurements of PBTZ169 concentration after the first and seventh administration.
Up to 72 hours after the last drug administration: Single dosing (Cohorts 1-5): up to Day 4 (72 h after the dosing (Day 1)) Multiple dosing (Cohorts 6. 7): up to Day 17 (72 h after the last (14th) dosing)
Outcome measures
| Measure |
Cohort 6
n=5 Participants
5 healthy volunteers each of whom received а daily dose of 320 mg of PBTZ169 (8 capsules 40 mg) for 14 days
PBTZ169 - 320 mg (multiple administration): 320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days
|
Cohort 7
n=5 Participants
5 healthy volunteers each of whom received a daily dose of 640 mg of PBTZ169 (16 capsules 40 mg) for 14 days
PBTZ169 - 640 mg (multiple administration): 640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days
|
Cohort 1
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 40 mg (1 capsule)
PBTZ169 - 40 mg: 40 mg of PBTZ169 (1 capsule) orally once in fasting state
|
Cohort 2
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 80 mg (2 capsules)
PBTZ169 - 80 mg: 80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state
|
Cohort 3
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 160 mg (4 capsules)
PBTZ169 - 160 mg: 160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state
|
Cohort 4
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 320 mg (8 capsules)
PBTZ169 - 320 mg: 320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state
|
Cohort 5
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 640 mg (16 capsules)
PBTZ169 - 640 mg: 640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state
|
|---|---|---|---|---|---|---|---|
|
Peak Plasma Concentration (Сmax) of PBTZ169
Dosing day / Day 1
|
190.82 ng/ml
Standard Deviation 37.51
|
250.54 ng/ml
Standard Deviation 144.33
|
40.67 ng/ml
Standard Deviation 15.28
|
66.99 ng/ml
Standard Deviation 33.81
|
135.85 ng/ml
Standard Deviation 46.32
|
156.25 ng/ml
Standard Deviation 65.54
|
349.67 ng/ml
Standard Deviation 145.92
|
|
Peak Plasma Concentration (Сmax) of PBTZ169
Day 7
|
243.22 ng/ml
Standard Deviation 59.51
|
278.64 ng/ml
Standard Deviation 70.68
|
—
|
—
|
—
|
—
|
—
|
|
Peak Plasma Concentration (Сmax) of PBTZ169
Day 14
|
300.55 ng/ml
Standard Deviation 82.24
|
453.73 ng/ml
Standard Deviation 111.85
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 72 hours after the last drug administrationPopulation: PKA
Single dosing (Cohorts 1-5): data for the dosing day (Day 1). Multiple dosing (Cohorts 6, 7): data for days 1 (1st dose), 7 and 14 (last dose)
Outcome measures
| Measure |
Cohort 6
n=5 Participants
5 healthy volunteers each of whom received а daily dose of 320 mg of PBTZ169 (8 capsules 40 mg) for 14 days
PBTZ169 - 320 mg (multiple administration): 320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days
|
Cohort 7
n=5 Participants
5 healthy volunteers each of whom received a daily dose of 640 mg of PBTZ169 (16 capsules 40 mg) for 14 days
PBTZ169 - 640 mg (multiple administration): 640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days
|
Cohort 1
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 40 mg (1 capsule)
PBTZ169 - 40 mg: 40 mg of PBTZ169 (1 capsule) orally once in fasting state
|
Cohort 2
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 80 mg (2 capsules)
PBTZ169 - 80 mg: 80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state
|
Cohort 3
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 160 mg (4 capsules)
PBTZ169 - 160 mg: 160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state
|
Cohort 4
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 320 mg (8 capsules)
PBTZ169 - 320 mg: 320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state
|
Cohort 5
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 640 mg (16 capsules)
PBTZ169 - 640 mg: 640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state
|
|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Concentration (Tmax) of PBTZ169
Dosing day / Day 1
|
1.50 h
Interval 0.5 to 4.0
|
1.50 h
Interval 0.75 to 2.0
|
2.50 h
Interval 1.5 to 4.0
|
1.50 h
Interval 0.75 to 3.5
|
2.00 h
Interval 0.75 to 2.5
|
2.50 h
Interval 0.75 to 5.0
|
1.50 h
Interval 0.75 to 3.0
|
|
Time to Reach Maximum Concentration (Tmax) of PBTZ169
Day 7
|
2.00 h
Interval 1.5 to 4.0
|
2.00 h
Interval 0.75 to 4.0
|
—
|
—
|
—
|
—
|
—
|
|
Time to Reach Maximum Concentration (Tmax) of PBTZ169
Day 14
|
2.00 h
Interval 1.0 to 4.0
|
2.00 h
Interval 1.5 to 2.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 72 hours after the last drug administrationPopulation: PKA: C1-5 - SAD, C6-7 - MAD for 14 days
In the time interval from 0 to infinity
Outcome measures
| Measure |
Cohort 6
n=5 Participants
5 healthy volunteers each of whom received а daily dose of 320 mg of PBTZ169 (8 capsules 40 mg) for 14 days
PBTZ169 - 320 mg (multiple administration): 320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days
|
Cohort 7
n=5 Participants
5 healthy volunteers each of whom received a daily dose of 640 mg of PBTZ169 (16 capsules 40 mg) for 14 days
PBTZ169 - 640 mg (multiple administration): 640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days
|
Cohort 1
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 40 mg (1 capsule)
PBTZ169 - 40 mg: 40 mg of PBTZ169 (1 capsule) orally once in fasting state
|
Cohort 2
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 80 mg (2 capsules)
PBTZ169 - 80 mg: 80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state
|
Cohort 3
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 160 mg (4 capsules)
PBTZ169 - 160 mg: 160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state
|
Cohort 4
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 320 mg (8 capsules)
PBTZ169 - 320 mg: 320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state
|
Cohort 5
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 640 mg (16 capsules)
PBTZ169 - 640 mg: 640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state
|
|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve (AUC0-∞)
Dosing day / Day 1
|
1450.21 ng*h/ml
Standard Deviation 586.73
|
1696.28 ng*h/ml
Standard Deviation 993.13
|
349.25 ng*h/ml
Standard Deviation 206.53
|
452.83 ng*h/ml
Standard Deviation 148.58
|
1096.36 ng*h/ml
Standard Deviation 543.62
|
1329.65 ng*h/ml
Standard Deviation 250.95
|
3028.04 ng*h/ml
Standard Deviation 1286.88
|
|
Area Under the Concentration-time Curve (AUC0-∞)
Day 7
|
2747.33 ng*h/ml
Standard Deviation 795.07
|
3024.29 ng*h/ml
Standard Deviation 726.15
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Concentration-time Curve (AUC0-∞)
Day 14
|
3410.12 ng*h/ml
Standard Deviation 1204.07
|
4358.90 ng*h/ml
Standard Deviation 649.33
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 72 hours after the last drug administrationPopulation: PKA
Single dosing (Cohorts 1-5): data for the dosing day (Day 1). Multiple dosing (Cohorts 6, 7): data for days 1 (1st dose), 7 and 14 (last dose)
Outcome measures
| Measure |
Cohort 6
n=5 Participants
5 healthy volunteers each of whom received а daily dose of 320 mg of PBTZ169 (8 capsules 40 mg) for 14 days
PBTZ169 - 320 mg (multiple administration): 320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days
|
Cohort 7
n=5 Participants
5 healthy volunteers each of whom received a daily dose of 640 mg of PBTZ169 (16 capsules 40 mg) for 14 days
PBTZ169 - 640 mg (multiple administration): 640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days
|
Cohort 1
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 40 mg (1 capsule)
PBTZ169 - 40 mg: 40 mg of PBTZ169 (1 capsule) orally once in fasting state
|
Cohort 2
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 80 mg (2 capsules)
PBTZ169 - 80 mg: 80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state
|
Cohort 3
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 160 mg (4 capsules)
PBTZ169 - 160 mg: 160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state
|
Cohort 4
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 320 mg (8 capsules)
PBTZ169 - 320 mg: 320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state
|
Cohort 5
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 640 mg (16 capsules)
PBTZ169 - 640 mg: 640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state
|
|---|---|---|---|---|---|---|---|
|
Plasma Half-life Time (T1/2) of PBTZ169
Dosing day / Day 1
|
12.40 h
Standard Deviation 5.72
|
9.98 h
Standard Deviation 2.20
|
14.306 h
Standard Deviation 4.516
|
10.182 h
Standard Deviation 3.663
|
16.147 h
Standard Deviation 3.461
|
16.447 h
Standard Deviation 2.947
|
18.175 h
Standard Deviation 3.824
|
|
Plasma Half-life Time (T1/2) of PBTZ169
Day 7
|
12.62 h
Standard Deviation 5.02
|
14.16 h
Standard Deviation 1.92
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Half-life Time (T1/2) of PBTZ169
Day 14
|
17.16 h
Standard Deviation 4.35
|
17.95 h
Standard Deviation 2.50
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 72 hours after the last drug administrationPopulation: PKA
Outcome measures
| Measure |
Cohort 6
n=5 Participants
5 healthy volunteers each of whom received а daily dose of 320 mg of PBTZ169 (8 capsules 40 mg) for 14 days
PBTZ169 - 320 mg (multiple administration): 320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days
|
Cohort 7
n=5 Participants
5 healthy volunteers each of whom received a daily dose of 640 mg of PBTZ169 (16 capsules 40 mg) for 14 days
PBTZ169 - 640 mg (multiple administration): 640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days
|
Cohort 1
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 40 mg (1 capsule)
PBTZ169 - 40 mg: 40 mg of PBTZ169 (1 capsule) orally once in fasting state
|
Cohort 2
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 80 mg (2 capsules)
PBTZ169 - 80 mg: 80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state
|
Cohort 3
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 160 mg (4 capsules)
PBTZ169 - 160 mg: 160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state
|
Cohort 4
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 320 mg (8 capsules)
PBTZ169 - 320 mg: 320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state
|
Cohort 5
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 640 mg (16 capsules)
PBTZ169 - 640 mg: 640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state
|
|---|---|---|---|---|---|---|---|
|
Mean Plasma Retention Time (MRT) of PBTZ169
Dosing day / Day 1
|
7.65 h
Standard Deviation 0.61
|
7.70 h
Standard Deviation 0.43
|
15.70 h
Standard Deviation 6.12
|
13.02 h
Standard Deviation 4.26
|
15.44 h
Standard Deviation 3.88
|
17.38 h
Standard Deviation 3.68
|
19.30 h
Standard Deviation 4.16
|
|
Mean Plasma Retention Time (MRT) of PBTZ169
Day 7
|
8.35 h
Standard Deviation 0.75
|
8.45 h
Standard Deviation 0.80
|
—
|
—
|
—
|
—
|
—
|
|
Mean Plasma Retention Time (MRT) of PBTZ169
Day 14
|
16.78 h
Standard Deviation 1.71
|
17.89 h
Standard Deviation 2.25
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 72 hours after the last drug administrationPopulation: PKA
The Cl parameter was calculated using the following formulas: for Day 1: Cl=D/AUCinf; for Days 7 and 14: Clss=D/AUCτ
Outcome measures
| Measure |
Cohort 6
n=5 Participants
5 healthy volunteers each of whom received а daily dose of 320 mg of PBTZ169 (8 capsules 40 mg) for 14 days
PBTZ169 - 320 mg (multiple administration): 320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days
|
Cohort 7
n=5 Participants
5 healthy volunteers each of whom received a daily dose of 640 mg of PBTZ169 (16 capsules 40 mg) for 14 days
PBTZ169 - 640 mg (multiple administration): 640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days
|
Cohort 1
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 40 mg (1 capsule)
PBTZ169 - 40 mg: 40 mg of PBTZ169 (1 capsule) orally once in fasting state
|
Cohort 2
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 80 mg (2 capsules)
PBTZ169 - 80 mg: 80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state
|
Cohort 3
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 160 mg (4 capsules)
PBTZ169 - 160 mg: 160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state
|
Cohort 4
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 320 mg (8 capsules)
PBTZ169 - 320 mg: 320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state
|
Cohort 5
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 640 mg (16 capsules)
PBTZ169 - 640 mg: 640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state
|
|---|---|---|---|---|---|---|---|
|
Total (Plasma) Clearance (Cl) of PBTZ169
Dosing day / Day 1
|
244.15 L/h
Standard Deviation 74.982
|
462.83 L/h
Standard Deviation 197.223
|
147.35 L/h
Standard Deviation 71.97
|
190.75 L/h
Standard Deviation 52.79
|
173.96 L/h
Standard Deviation 69.47
|
248.08 L/h
Standard Deviation 47.99
|
240.40 L/h
Standard Deviation 89.12
|
|
Total (Plasma) Clearance (Cl) of PBTZ169
Day 7
|
197.223 L/h
Standard Deviation 45.706
|
310.74 L/h
Standard Deviation 76.273
|
—
|
—
|
—
|
—
|
—
|
|
Total (Plasma) Clearance (Cl) of PBTZ169
Day 14
|
146.44 L/h
Standard Deviation 45.573
|
224.79 L/h
Standard Deviation 42.994
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 72 hours after the last drug administrationPopulation: PKA
Outcome measures
| Measure |
Cohort 6
n=5 Participants
5 healthy volunteers each of whom received а daily dose of 320 mg of PBTZ169 (8 capsules 40 mg) for 14 days
PBTZ169 - 320 mg (multiple administration): 320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days
|
Cohort 7
n=5 Participants
5 healthy volunteers each of whom received a daily dose of 640 mg of PBTZ169 (16 capsules 40 mg) for 14 days
PBTZ169 - 640 mg (multiple administration): 640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days
|
Cohort 1
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 40 mg (1 capsule)
PBTZ169 - 40 mg: 40 mg of PBTZ169 (1 capsule) orally once in fasting state
|
Cohort 2
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 80 mg (2 capsules)
PBTZ169 - 80 mg: 80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state
|
Cohort 3
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 160 mg (4 capsules)
PBTZ169 - 160 mg: 160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state
|
Cohort 4
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 320 mg (8 capsules)
PBTZ169 - 320 mg: 320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state
|
Cohort 5
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 640 mg (16 capsules)
PBTZ169 - 640 mg: 640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state
|
|---|---|---|---|---|---|---|---|
|
Volume of Distribution (Vd) of PBTZ169
Dosing day / Day 1
|
3924.74 L
Standard Deviation 401.074
|
6521.98 L
Standard Deviation 2719.519
|
2762.47 L
Standard Deviation 1052.08
|
2949.95 L
Standard Deviation 1652.24
|
3903.25 L
Standard Deviation 1354.34
|
5801.14 L
Standard Deviation 1006.47
|
6359.85 L
Standard Deviation 2861.493
|
|
Volume of Distribution (Vd) of PBTZ169
Day 7
|
2957.51 L
Standard Deviation 1671.483
|
6114.55 L
Standard Deviation 1680.928
|
—
|
—
|
—
|
—
|
—
|
|
Volume of Distribution (Vd) of PBTZ169
Day 14
|
3392.46 L
Standard Deviation 2005.822
|
4067.27 L
Standard Deviation 2374.585
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 72 hours after the last drug administrationPopulation: PKA
Data for doses 320 mg (Cohorts 4 and 6, total 11 volunters) \& 640 mg (Cohorts 5 and 7, total 11 volunters) were combined
Outcome measures
| Measure |
Cohort 6
n=5 Participants
5 healthy volunteers each of whom received а daily dose of 320 mg of PBTZ169 (8 capsules 40 mg) for 14 days
PBTZ169 - 320 mg (multiple administration): 320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days
|
Cohort 7
n=5 Participants
5 healthy volunteers each of whom received a daily dose of 640 mg of PBTZ169 (16 capsules 40 mg) for 14 days
PBTZ169 - 640 mg (multiple administration): 640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days
|
Cohort 1
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 40 mg (1 capsule)
PBTZ169 - 40 mg: 40 mg of PBTZ169 (1 capsule) orally once in fasting state
|
Cohort 2
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 80 mg (2 capsules)
PBTZ169 - 80 mg: 80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state
|
Cohort 3
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 160 mg (4 capsules)
PBTZ169 - 160 mg: 160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state
|
Cohort 4
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 320 mg (8 capsules)
PBTZ169 - 320 mg: 320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state
|
Cohort 5
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 640 mg (16 capsules)
PBTZ169 - 640 mg: 640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state
|
|---|---|---|---|---|---|---|---|
|
Elimination Constant (Kel) of PBTZ169
|
0.066 1/h
Standard Deviation 0.0212
|
0.066 1/h
Standard Deviation 0.0151
|
0.052 1/h
Standard Deviation 0.01329
|
0.077 1/h
Standard Deviation 0.0266
|
0.063 1/h
Standard Deviation 0.0082
|
0.066 1/h
Standard Deviation 0.0212
|
0.066 1/h
Standard Deviation 0.0151
|
SECONDARY outcome
Timeframe: Up to 24 hours after the drug administrationPopulation: PKA
The renal clearance was calculated using values of the cumulative excretion in urine (from zero to 24 hours) and the area under the pharmacokinetic curve (from zero to 24 hours) (the ratio of the cumulative excretion to AUC0-24)
Outcome measures
| Measure |
Cohort 6
n=5 Participants
5 healthy volunteers each of whom received а daily dose of 320 mg of PBTZ169 (8 capsules 40 mg) for 14 days
PBTZ169 - 320 mg (multiple administration): 320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days
|
Cohort 7
n=5 Participants
5 healthy volunteers each of whom received a daily dose of 640 mg of PBTZ169 (16 capsules 40 mg) for 14 days
PBTZ169 - 640 mg (multiple administration): 640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days
|
Cohort 1
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 40 mg (1 capsule)
PBTZ169 - 40 mg: 40 mg of PBTZ169 (1 capsule) orally once in fasting state
|
Cohort 2
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 80 mg (2 capsules)
PBTZ169 - 80 mg: 80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state
|
Cohort 3
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 160 mg (4 capsules)
PBTZ169 - 160 mg: 160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state
|
Cohort 4
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 320 mg (8 capsules)
PBTZ169 - 320 mg: 320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state
|
Cohort 5
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 640 mg (16 capsules)
PBTZ169 - 640 mg: 640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state
|
|---|---|---|---|---|---|---|---|
|
Renal Clearance (Clren) of PBTZ169
Dosing day / Day 1
|
8.5 mL/h
Standard Deviation 5.8
|
11.2 mL/h
Standard Deviation 2.9
|
12.12 mL/h
Standard Deviation 7.62
|
12.64 mL/h
Standard Deviation 7.72
|
7.16 mL/h
Standard Deviation 3.80
|
11.81 mL/h
Standard Deviation 1.22
|
17.72 mL/h
Standard Deviation 6.37
|
|
Renal Clearance (Clren) of PBTZ169
Day 14
|
5.7 mL/h
Standard Deviation 3.3
|
7.6 mL/h
Standard Deviation 3.2
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 72 hours after the last drug administrationFor cohorts 6 and 7 (multiple administration) only
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 72 hours after the last drug administrationFor cohorts 6 and 7 (multiple administration) only
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 72 hours after the last drug administrationFor cohorts 6 and 7 (multiple administration) only
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 72 hours after the last drug administrationFor cohorts 6 and 7 (multiple administration) only
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 72 hours after the last drug administrationPopulation: PKA
The area under the concentration-time curve from 0 to last blood sampling
Outcome measures
| Measure |
Cohort 6
5 healthy volunteers each of whom received а daily dose of 320 mg of PBTZ169 (8 capsules 40 mg) for 14 days
PBTZ169 - 320 mg (multiple administration): 320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days
|
Cohort 7
5 healthy volunteers each of whom received a daily dose of 640 mg of PBTZ169 (16 capsules 40 mg) for 14 days
PBTZ169 - 640 mg (multiple administration): 640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days
|
Cohort 1
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 40 mg (1 capsule)
PBTZ169 - 40 mg: 40 mg of PBTZ169 (1 capsule) orally once in fasting state
|
Cohort 2
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 80 mg (2 capsules)
PBTZ169 - 80 mg: 80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state
|
Cohort 3
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 160 mg (4 capsules)
PBTZ169 - 160 mg: 160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state
|
Cohort 4
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 320 mg (8 capsules)
PBTZ169 - 320 mg: 320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state
|
Cohort 5
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 640 mg (16 capsules)
PBTZ169 - 640 mg: 640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state
|
|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve (AUC0-t)
|
—
|
—
|
260.47 ng*h/ml
Standard Deviation 119.06
|
381.17 ng*h/ml
Standard Deviation 149.39
|
994.49 ng*h/ml
Standard Deviation 462.00
|
1193.70 ng*h/ml
Standard Deviation 212.53
|
2880.86 ng*h/ml
Standard Deviation 1219.30
|
SECONDARY outcome
Timeframe: Up to 72 hours after the last drug administrationPopulation: PKA
AUC0-t/AUC0-∞ ratio
Outcome measures
| Measure |
Cohort 6
5 healthy volunteers each of whom received а daily dose of 320 mg of PBTZ169 (8 capsules 40 mg) for 14 days
PBTZ169 - 320 mg (multiple administration): 320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days
|
Cohort 7
5 healthy volunteers each of whom received a daily dose of 640 mg of PBTZ169 (16 capsules 40 mg) for 14 days
PBTZ169 - 640 mg (multiple administration): 640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days
|
Cohort 1
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 40 mg (1 capsule)
PBTZ169 - 40 mg: 40 mg of PBTZ169 (1 capsule) orally once in fasting state
|
Cohort 2
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 80 mg (2 capsules)
PBTZ169 - 80 mg: 80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state
|
Cohort 3
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 160 mg (4 capsules)
PBTZ169 - 160 mg: 160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state
|
Cohort 4
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 320 mg (8 capsules)
PBTZ169 - 320 mg: 320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state
|
Cohort 5
n=6 Participants
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 640 mg (16 capsules)
PBTZ169 - 640 mg: 640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state
|
|---|---|---|---|---|---|---|---|
|
AUC0-t/AUC0-∞
|
—
|
—
|
0.784 ratio
|
0.829 ratio
|
0.917 ratio
|
0.899 ratio
|
0.951 ratio
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 5
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 6
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 7
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1
n=6 participants at risk
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 40 mg (1 capsule)
PBTZ169 - 40 mg: 40 mg of PBTZ169 (1 capsule) orally once in fasting state
|
Cohort 2
n=6 participants at risk
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 80 mg (2 capsules)
PBTZ169 - 80 mg: 80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state
|
Cohort 3
n=6 participants at risk
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 160 mg (4 capsules)
PBTZ169 - 160 mg: 160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state
|
Cohort 4
n=6 participants at risk
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 320 mg (8 capsules)
PBTZ169 - 320 mg: 320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state
|
Cohort 5
n=6 participants at risk
6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 640 mg (16 capsules)
PBTZ169 - 640 mg: 640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state
|
Cohort 6
n=5 participants at risk
5 healthy volunteers each of whom received а daily dose of 320 mg of PBTZ169 (8 capsules 40 mg) for 14 days
PBTZ169 - 320 mg (multiple administration): 320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days
|
Cohort 7
n=5 participants at risk
5 healthy volunteers each of whom received a daily dose of 640 mg of PBTZ169 (16 capsules 40 mg) for 14 days
PBTZ169 - 640 mg (multiple administration): 640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days
|
|---|---|---|---|---|---|---|---|
|
Investigations
Blood glucose increased
|
0.00%
0/6 • SAD: 14±1 days after PBTZ169 administration (Day 14±1); MAD: 21±1 days after the last (14th) PBTZ169 administration (Day 35±1).
|
16.7%
1/6 • Number of events 1 • SAD: 14±1 days after PBTZ169 administration (Day 14±1); MAD: 21±1 days after the last (14th) PBTZ169 administration (Day 35±1).
|
0.00%
0/6 • SAD: 14±1 days after PBTZ169 administration (Day 14±1); MAD: 21±1 days after the last (14th) PBTZ169 administration (Day 35±1).
|
0.00%
0/6 • SAD: 14±1 days after PBTZ169 administration (Day 14±1); MAD: 21±1 days after the last (14th) PBTZ169 administration (Day 35±1).
|
0.00%
0/6 • SAD: 14±1 days after PBTZ169 administration (Day 14±1); MAD: 21±1 days after the last (14th) PBTZ169 administration (Day 35±1).
|
0.00%
0/5 • SAD: 14±1 days after PBTZ169 administration (Day 14±1); MAD: 21±1 days after the last (14th) PBTZ169 administration (Day 35±1).
|
0.00%
0/5 • SAD: 14±1 days after PBTZ169 administration (Day 14±1); MAD: 21±1 days after the last (14th) PBTZ169 administration (Day 35±1).
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 2 • SAD: 14±1 days after PBTZ169 administration (Day 14±1); MAD: 21±1 days after the last (14th) PBTZ169 administration (Day 35±1).
|
16.7%
1/6 • Number of events 1 • SAD: 14±1 days after PBTZ169 administration (Day 14±1); MAD: 21±1 days after the last (14th) PBTZ169 administration (Day 35±1).
|
16.7%
1/6 • Number of events 1 • SAD: 14±1 days after PBTZ169 administration (Day 14±1); MAD: 21±1 days after the last (14th) PBTZ169 administration (Day 35±1).
|
0.00%
0/6 • SAD: 14±1 days after PBTZ169 administration (Day 14±1); MAD: 21±1 days after the last (14th) PBTZ169 administration (Day 35±1).
|
0.00%
0/6 • SAD: 14±1 days after PBTZ169 administration (Day 14±1); MAD: 21±1 days after the last (14th) PBTZ169 administration (Day 35±1).
|
0.00%
0/5 • SAD: 14±1 days after PBTZ169 administration (Day 14±1); MAD: 21±1 days after the last (14th) PBTZ169 administration (Day 35±1).
|
0.00%
0/5 • SAD: 14±1 days after PBTZ169 administration (Day 14±1); MAD: 21±1 days after the last (14th) PBTZ169 administration (Day 35±1).
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/6 • SAD: 14±1 days after PBTZ169 administration (Day 14±1); MAD: 21±1 days after the last (14th) PBTZ169 administration (Day 35±1).
|
0.00%
0/6 • SAD: 14±1 days after PBTZ169 administration (Day 14±1); MAD: 21±1 days after the last (14th) PBTZ169 administration (Day 35±1).
|
0.00%
0/6 • SAD: 14±1 days after PBTZ169 administration (Day 14±1); MAD: 21±1 days after the last (14th) PBTZ169 administration (Day 35±1).
|
0.00%
0/6 • SAD: 14±1 days after PBTZ169 administration (Day 14±1); MAD: 21±1 days after the last (14th) PBTZ169 administration (Day 35±1).
|
0.00%
0/6 • SAD: 14±1 days after PBTZ169 administration (Day 14±1); MAD: 21±1 days after the last (14th) PBTZ169 administration (Day 35±1).
|
0.00%
0/5 • SAD: 14±1 days after PBTZ169 administration (Day 14±1); MAD: 21±1 days after the last (14th) PBTZ169 administration (Day 35±1).
|
20.0%
1/5 • Number of events 1 • SAD: 14±1 days after PBTZ169 administration (Day 14±1); MAD: 21±1 days after the last (14th) PBTZ169 administration (Day 35±1).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed
- Publication restrictions are in place
Restriction type: OTHER