Trial Outcomes & Findings for Study to Evaluate the Safety, Tolerability, PK and PD of PB2452 in Healthy Younger, Older and Elderly Subjects (NCT NCT03928353)
NCT ID: NCT03928353
Last Updated: 2024-05-01
Results Overview
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. A TEAE is defined as any AE not present before exposure to study drug or any AE already present that worsens in intensity or frequency after exposure to study drug. An SAE/suspected unexpected serious adverse reaction if, in the view of either the investigator or Sponsor, it results in any of the following outcomes: death, life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or congenital anomaly or birth defect. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
Day -3 up to Day 28
Results posted on
2024-05-01
Participant Flow
Healthy, younger, older, and elderly male and female participants were enrolled and randomized in a single center.
Participant milestones
| Measure |
Part A - Cohort 1
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 intravenously (IV) during the treatment period.
|
Part A - Cohort 2
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period. Following completion of Cohort 1, the previous Sponsor instructed the clinical site to administer study drug in the same manner as in Cohort 1 in Cohort 2.
|
Part A - Placebo (Pooled)
Older and elderly participants pretreated with ticagrelor + ASA received 0.9% sodium chloride IV during the treatment period.
|
Part B - Cohort 3
Healthy and younger participants pretreated with a high dose of ticagrelor (180 mg BID) received 36 g of PB252 IV during the treatment period.
|
Part B - Placebo
Healthy and younger participants pretreated with a high dose of ticagrelor (180 mg BID) received 0.9% sodium chloride IV during the treatment period.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
4
|
6
|
2
|
|
Overall Study
COMPLETED
|
6
|
5
|
4
|
6
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate the Safety, Tolerability, PK and PD of PB2452 in Healthy Younger, Older and Elderly Subjects
Baseline characteristics by cohort
| Measure |
Part A - Cohort 1
n=6 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Cohort 2
n=5 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Placebo
n=4 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 0.9% sodium chloride IV during the treatment period.
|
Part B - Cohort 3
n=6 Participants
Healthy and younger participants pretreated with a high dose of ticagrelor (180 mg BID) received 36 g of PB252 IV during the treatment period.
|
Part B - Placebo
n=2 Participants
Healthy and younger participants pretreated with a high dose of ticagrelor (180 mg BID) received 0.9% sodium chloride IV during the treatment period.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
59.0 years
STANDARD_DEVIATION 7.24 • n=5 Participants
|
63.8 years
STANDARD_DEVIATION 9.31 • n=7 Participants
|
60.5 years
STANDARD_DEVIATION 4.65 • n=5 Participants
|
34.7 years
STANDARD_DEVIATION 8.14 • n=4 Participants
|
30.5 years
STANDARD_DEVIATION 2.12 • n=21 Participants
|
51.48 years
STANDARD_DEVIATION 14.76 • n=8 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
|
Renal Function
Mild (Mild decrease in kidney function)
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
|
Renal Function
Normal (Normal kidney function)
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day -3 up to Day 28Population: All participants who received any amount of study drug.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. A TEAE is defined as any AE not present before exposure to study drug or any AE already present that worsens in intensity or frequency after exposure to study drug. An SAE/suspected unexpected serious adverse reaction if, in the view of either the investigator or Sponsor, it results in any of the following outcomes: death, life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or congenital anomaly or birth defect. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Part A - Cohort 1
n=6 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Cohort 2
n=5 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Cohort 1-2 (Pooled)
n=11 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Placebo (Pooled)
n=4 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 0.9% sodium chloride IV during the treatment period.
|
Part B - Cohort 3
n=6 Participants
Healthy and younger participants pretreated with a high dose of ticagrelor (180 mg BID) received 36 g of PB252 IV during the treatment period.
|
Part B - Placebo
n=2 Participants
Healthy and younger participants pretreated with a high dose of ticagrelor (180 mg BID) received 0.9% sodium chloride IV during the treatment period.
|
|---|---|---|---|---|---|---|
|
Number Of Participants With Treatment-emergent Adverse Events (TEAEs) And Serious Adverse Events (SAEs)
TEAEs
|
1 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
|
Number Of Participants With Treatment-emergent Adverse Events (TEAEs) And Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day -45 up to Day 28Population: All participants who received any amount of study drug.
Number of participants with clinically significant abnormal laboratory findings for hematology, coagulation, serum chemistry, and urinalysis.
Outcome measures
| Measure |
Part A - Cohort 1
n=6 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Cohort 2
n=5 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Cohort 1-2 (Pooled)
n=4 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Placebo (Pooled)
n=6 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 0.9% sodium chloride IV during the treatment period.
|
Part B - Cohort 3
n=2 Participants
Healthy and younger participants pretreated with a high dose of ticagrelor (180 mg BID) received 36 g of PB252 IV during the treatment period.
|
Part B - Placebo
Healthy and younger participants pretreated with a high dose of ticagrelor (180 mg BID) received 0.9% sodium chloride IV during the treatment period.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Clinical Laboratory Abnormalities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: BaselinePopulation: All participants who received any amount of study drug.
Outcome measures
| Measure |
Part A - Cohort 1
n=6 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Cohort 2
n=5 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Cohort 1-2 (Pooled)
n=11 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Placebo (Pooled)
n=4 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 0.9% sodium chloride IV during the treatment period.
|
Part B - Cohort 3
n=6 Participants
Healthy and younger participants pretreated with a high dose of ticagrelor (180 mg BID) received 36 g of PB252 IV during the treatment period.
|
Part B - Placebo
n=2 Participants
Healthy and younger participants pretreated with a high dose of ticagrelor (180 mg BID) received 0.9% sodium chloride IV during the treatment period.
|
|---|---|---|---|---|---|---|
|
Mean Diastolic Blood Pressure at Baseline
|
74.17 mmHg
Standard Deviation 8.42
|
67.60 mmHg
Standard Deviation 7.44
|
71.18 mmHg
Standard Deviation 8.33
|
75.25 mmHg
Standard Deviation 3.40
|
63.83 mmHg
Standard Deviation 5.91
|
61.50 mmHg
Standard Deviation 2.12
|
PRIMARY outcome
Timeframe: Day 1 (10, 20, 30, 45, and 60 minutes post-dose), Day 2, Day 3, Day 7, and Day 28Population: All participants who received any amount of study drug.
Diastolic blood pressure measurements were measured at specific time points.
Outcome measures
| Measure |
Part A - Cohort 1
n=6 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Cohort 2
n=5 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Cohort 1-2 (Pooled)
n=11 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Placebo (Pooled)
n=4 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 0.9% sodium chloride IV during the treatment period.
|
Part B - Cohort 3
n=6 Participants
Healthy and younger participants pretreated with a high dose of ticagrelor (180 mg BID) received 36 g of PB252 IV during the treatment period.
|
Part B - Placebo
n=2 Participants
Healthy and younger participants pretreated with a high dose of ticagrelor (180 mg BID) received 0.9% sodium chloride IV during the treatment period.
|
|---|---|---|---|---|---|---|
|
Percent Change In Diastolic Blood Pressure From Baseline To Day 28
Change from Baseline - Day 1/ 10 Minutes Postdose
|
-2.50 Percent change in DBP
Standard Deviation 9.15
|
-1.75 Percent change in DBP
Standard Deviation 5.91
|
-2.13 Percent change in DBP
Standard Deviation 7.14
|
-4.00 Percent change in DBP
Standard Deviation 9.90
|
4.00 Percent change in DBP
Standard Deviation 6.69
|
2.50 Percent change in DBP
Standard Deviation 7.78
|
|
Percent Change In Diastolic Blood Pressure From Baseline To Day 28
Change from Baseline - Day 1/ 20 Minutes Postdose
|
-4.33 Percent change in DBP
Standard Deviation 5.65
|
-4.75 Percent change in DBP
Standard Deviation 0.96
|
-4.50 Percent change in DBP
Standard Deviation 4.25
|
-5.67 Percent change in DBP
Standard Deviation 1.53
|
3.50 Percent change in DBP
Standard Deviation 8.83
|
1.00 Percent change in DBP
Standard Deviation 8.49
|
|
Percent Change In Diastolic Blood Pressure From Baseline To Day 28
Change from Baseline - Day 1/ 30 Minutes Postdose
|
-3.17 Percent change in DBP
Standard Deviation 8.33
|
-3.80 Percent change in DBP
Standard Deviation 2.59
|
-3.45 Percent change in DBP
Standard Deviation 6.12
|
-2.00 Percent change in DBP
Standard Deviation 2.83
|
9.00 Percent change in DBP
Standard Deviation 3.35
|
5.50 Percent change in DBP
Standard Deviation 3.54
|
|
Percent Change In Diastolic Blood Pressure From Baseline To Day 28
Change from Baseline - Day 3/ 48 Hour
|
-5.67 Percent change in DBP
Standard Deviation 14.39
|
-3.20 Percent change in DBP
Standard Deviation 5.63
|
-4.55 Percent change in DBP
Standard Deviation 10.86
|
-7.75 Percent change in DBP
Standard Deviation 10.81
|
2.67 Percent change in DBP
Standard Deviation 6.89
|
-1.00 Percent change in DBP
Standard Deviation 8.49
|
|
Percent Change In Diastolic Blood Pressure From Baseline To Day 28
Change from Baseline - Day 7
|
-6.00 Percent change in DBP
Standard Deviation 9.88
|
0.40 Percent change in DBP
Standard Deviation 6.91
|
-3.09 Percent change in DBP
Standard Deviation 8.89
|
-9.00 Percent change in DBP
Standard Deviation 6.68
|
6.50 Percent change in DBP
Standard Deviation 5.58
|
7.50 Percent change in DBP
Standard Deviation 7.78
|
|
Percent Change In Diastolic Blood Pressure From Baseline To Day 28
Change from Baseline - Day 28
|
4.67 Percent change in DBP
Standard Deviation 9.54
|
0.40 Percent change in DBP
Standard Deviation 5.94
|
2.73 Percent change in DBP
Standard Deviation 8.04
|
-3.75 Percent change in DBP
Standard Deviation 12.31
|
5.17 Percent change in DBP
Standard Deviation 7.31
|
10.00 Percent change in DBP
Standard Deviation 4.24
|
|
Percent Change In Diastolic Blood Pressure From Baseline To Day 28
Change from Baseline - Day 1/ 45 Minutes Postdose
|
-2.00 Percent change in DBP
Standard Deviation 2.53
|
-3.20 Percent change in DBP
Standard Deviation 4.76
|
-2.55 Percent change in DBP
Standard Deviation 3.56
|
-2.00 Percent change in DBP
Standard Deviation 7.39
|
3.83 Percent change in DBP
Standard Deviation 7.68
|
0 Percent change in DBP
Standard Deviation 9.90
|
|
Percent Change In Diastolic Blood Pressure From Baseline To Day 28
Change from Baseline Day 1/ 1 Hour Postdose
|
-3.67 Percent change in DBP
Standard Deviation 9.16
|
0.40 Percent change in DBP
Standard Deviation 6.58
|
-1.82 Percent change in DBP
Standard Deviation 7.99
|
-4.25 Percent change in DBP
Standard Deviation 9.98
|
4.67 Percent change in DBP
Standard Deviation 4.68
|
3.50 Percent change in DBP
Standard Deviation 13.44
|
|
Percent Change In Diastolic Blood Pressure From Baseline To Day 28
Change from Baseline - Day 2/ 24 Hour
|
-6.17 Percent change in DBP
Standard Deviation 8.54
|
-7.40 Percent change in DBP
Standard Deviation 4.62
|
-6.73 Percent change in DBP
Standard Deviation 6.74
|
-8.50 Percent change in DBP
Standard Deviation 6.03
|
-3.33 Percent change in DBP
Standard Deviation 4.68
|
1.50 Percent change in DBP
Standard Deviation 3.54
|
PRIMARY outcome
Timeframe: BaselinePopulation: All participants who received any amount of study drug.
Outcome measures
| Measure |
Part A - Cohort 1
n=6 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Cohort 2
n=5 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Cohort 1-2 (Pooled)
n=11 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Placebo (Pooled)
n=4 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 0.9% sodium chloride IV during the treatment period.
|
Part B - Cohort 3
n=6 Participants
Healthy and younger participants pretreated with a high dose of ticagrelor (180 mg BID) received 36 g of PB252 IV during the treatment period.
|
Part B - Placebo
n=2 Participants
Healthy and younger participants pretreated with a high dose of ticagrelor (180 mg BID) received 0.9% sodium chloride IV during the treatment period.
|
|---|---|---|---|---|---|---|
|
Mean Systolic Blood Pressure at Baseline
|
128.33 mmHg
Standard Deviation 17.15
|
115.40 mmHg
Standard Deviation 11.08
|
122.45 mmHg
Standard Deviation 15.55
|
119.00 mmHg
Standard Deviation 17.80
|
113.14 mmHg
Standard Deviation 8.75
|
108.50 mmHg
Standard Deviation 0.71
|
PRIMARY outcome
Timeframe: Day 1 (10, 20, 30, 45, and 60 minutes post-dose), Day 2, Day 3, Day 7, and Day 28Population: All participants who received any amount of study drug.
Systolic blood pressure measurements were measured at specific time points.
Outcome measures
| Measure |
Part A - Cohort 1
n=6 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Cohort 2
n=5 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Cohort 1-2 (Pooled)
n=11 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Placebo (Pooled)
n=4 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 0.9% sodium chloride IV during the treatment period.
|
Part B - Cohort 3
n=6 Participants
Healthy and younger participants pretreated with a high dose of ticagrelor (180 mg BID) received 36 g of PB252 IV during the treatment period.
|
Part B - Placebo
n=2 Participants
Healthy and younger participants pretreated with a high dose of ticagrelor (180 mg BID) received 0.9% sodium chloride IV during the treatment period.
|
|---|---|---|---|---|---|---|
|
Percent Change In Systolic Blood Pressure From Baseline To Day 28
Change from Baseline - Day 28
|
1.50 Percent change in SBP
Standard Deviation 15.14
|
9.80 Percent change in SBP
Standard Deviation 10.96
|
5.27 Percent change in SBP
Standard Deviation 13.47
|
0 Percent change in SBP
Standard Deviation 10.92
|
9.67 Percent change in SBP
Standard Deviation 5.68
|
12.50 Percent change in SBP
Standard Deviation 4.95
|
|
Percent Change In Systolic Blood Pressure From Baseline To Day 28
Change from Baseline - Day 3/ 48 Hour
|
-17.17 Percent change in SBP
Standard Deviation 14.41
|
-4.00 Percent change in SBP
Standard Deviation 10.89
|
-11.18 Percent change in SBP
Standard Deviation 14.09
|
-9.00 Percent change in SBP
Standard Deviation 10.36
|
2.00 Percent change in SBP
Standard Deviation 4.10
|
1.50 Percent change in SBP
Standard Deviation 3.54
|
|
Percent Change In Systolic Blood Pressure From Baseline To Day 28
Change from Baseline - Day 1/ 10 Minutes Postdose
|
-6.75 Percent change in SBP
Standard Deviation 4.11
|
0.75 Percent change in SBP
Standard Deviation 5.85
|
-3.00 Percent change in SBP
Standard Deviation 6.16
|
-7.50 Percent change in SBP
Standard Deviation 20.51
|
5.83 Percent change in SBP
Standard Deviation 7.31
|
2.00 Percent change in SBP
Standard Deviation 11.31
|
|
Percent Change In Systolic Blood Pressure From Baseline To Day 28
Change from Baseline - Day 1/ 20 Minutes Postdose
|
-7.67 Percent change in SBP
Standard Deviation 13.98
|
2.75 Percent change in SBP
Standard Deviation 9.18
|
-3.50 Percent change in SBP
Standard Deviation 12.87
|
-6.33 Percent change in SBP
Standard Deviation 4.93
|
2.83 Percent change in SBP
Standard Deviation 5.81
|
-0.50 Percent change in SBP
Standard Deviation 0.71
|
|
Percent Change In Systolic Blood Pressure From Baseline To Day 28
Change from Baseline - Day 1/ 30 Minutes Postdose
|
-5.33 Percent change in SBP
Standard Deviation 14.07
|
-0.20 Percent change in SBP
Standard Deviation 4.09
|
-3.00 Percent change in SBP
Standard Deviation 10.62
|
-5.50 Percent change in SBP
Standard Deviation 9.19
|
-0.33 Percent change in SBP
Standard Deviation 4.63
|
2.50 Percent change in SBP
Standard Deviation 9.19
|
|
Percent Change In Systolic Blood Pressure From Baseline To Day 28
Change from Baseline - Day 1/ 45 Minutes Postdose
|
-7.33 Percent change in SBP
Standard Deviation 12.88
|
-3.80 Percent change in SBP
Standard Deviation 4.15
|
-5.73 Percent change in SBP
Standard Deviation 9.65
|
-2.25 Percent change in SBP
Standard Deviation 12.12
|
4.00 Percent change in SBP
Standard Deviation 5.59
|
3.50 Percent change in SBP
Standard Deviation 9.19
|
|
Percent Change In Systolic Blood Pressure From Baseline To Day 28
Change from Baseline Day 1/ 1 Hour Postdose
|
-8.00 Percent change in SBP
Standard Deviation 11.47
|
5.20 Percent change in SBP
Standard Deviation 14.31
|
-2.00 Percent change in SBP
Standard Deviation 13.97
|
1.00 Percent change in SBP
Standard Deviation 20.05
|
0.67 Percent change in SBP
Standard Deviation 5.89
|
-0.50 Percent change in SBP
Standard Deviation 12.02
|
|
Percent Change In Systolic Blood Pressure From Baseline To Day 28
Change from Baseline - Day 2/ 24 Hour
|
-14.00 Percent change in SBP
Standard Deviation 16.14
|
-5.60 Percent change in SBP
Standard Deviation 10.24
|
-10.18 Percent change in SBP
Standard Deviation 13.83
|
-2.75 Percent change in SBP
Standard Deviation 13.52
|
-2.33 Percent change in SBP
Standard Deviation 5.99
|
6.00 Percent change in SBP
Standard Deviation 1.41
|
|
Percent Change In Systolic Blood Pressure From Baseline To Day 28
Change from Baseline - Day 7
|
-6.33 Percent change in SBP
Standard Deviation 13.87
|
2.80 Percent change in SBP
Standard Deviation 14.55
|
-2.18 Percent change in SBP
Standard Deviation 14.27
|
-12.00 Percent change in SBP
Standard Deviation 12.73
|
6.67 Percent change in SBP
Standard Deviation 12.48
|
3.00 Percent change in SBP
Standard Deviation 7.07
|
PRIMARY outcome
Timeframe: BaselinePopulation: All participants who received any amount of study drug.
Outcome measures
| Measure |
Part A - Cohort 1
n=6 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Cohort 2
n=5 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Cohort 1-2 (Pooled)
n=11 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Placebo (Pooled)
n=4 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 0.9% sodium chloride IV during the treatment period.
|
Part B - Cohort 3
n=6 Participants
Healthy and younger participants pretreated with a high dose of ticagrelor (180 mg BID) received 36 g of PB252 IV during the treatment period.
|
Part B - Placebo
n=2 Participants
Healthy and younger participants pretreated with a high dose of ticagrelor (180 mg BID) received 0.9% sodium chloride IV during the treatment period.
|
|---|---|---|---|---|---|---|
|
Mean Oral Body Temperature at Baseline
|
36.17 Degrees Celcius
Standard Deviation 0.34
|
35.88 Degrees Celcius
Standard Deviation 0.15
|
36.04 Degrees Celcius
Standard Deviation 0.30
|
36.25 Degrees Celcius
Standard Deviation 0.24
|
36.20 Degrees Celcius
Standard Deviation 0.38
|
36.35 Degrees Celcius
Standard Deviation 0.07
|
PRIMARY outcome
Timeframe: Day 1 (45 and 60 minutes post-dose), Day 2, Day 3, Day 7, and Day 28Population: All participants who received any amount of study drug.
Body temperature measurements were measured at specific time points.
Outcome measures
| Measure |
Part A - Cohort 1
n=6 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Cohort 2
n=5 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Cohort 1-2 (Pooled)
n=11 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Placebo (Pooled)
n=4 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 0.9% sodium chloride IV during the treatment period.
|
Part B - Cohort 3
n=6 Participants
Healthy and younger participants pretreated with a high dose of ticagrelor (180 mg BID) received 36 g of PB252 IV during the treatment period.
|
Part B - Placebo
n=2 Participants
Healthy and younger participants pretreated with a high dose of ticagrelor (180 mg BID) received 0.9% sodium chloride IV during the treatment period.
|
|---|---|---|---|---|---|---|
|
Percent Change In Oral Body Temperature From Baseline To Day 28
Change from Baseline - Day 1/ 45 Minutes Postdose
|
0.18 Percent change in oral body temperature
Standard Deviation 0.53
|
0 Percent change in oral body temperature
Standard Deviation 0.14
|
0.11 Percent change in oral body temperature
Standard Deviation 0.41
|
0.15 Percent change in oral body temperature
Standard Deviation 0.34
|
0.13 Percent change in oral body temperature
Standard Deviation 0.23
|
-0.10 Percent change in oral body temperature
Standard Deviation 0.28
|
|
Percent Change In Oral Body Temperature From Baseline To Day 28
Change from Baseline Day 1/ 1 Hour Postdose
|
-0.10 Percent change in oral body temperature
Standard Deviation 0.32
|
0 Percent change in oral body temperature
Standard Deviation 0.21
|
-0.05 Percent change in oral body temperature
Standard Deviation 0.27
|
0.15 Percent change in oral body temperature
Standard Deviation 0.26
|
0.20 Percent change in oral body temperature
Standard Deviation 0.17
|
0.10 Percent change in oral body temperature
Standard Deviation 0.42
|
|
Percent Change In Oral Body Temperature From Baseline To Day 28
Change from Baseline - Day 2/ 24 Hour
|
0.05 Percent change in oral body temperature
Standard Deviation 0.35
|
0.10 Percent change in oral body temperature
Standard Deviation 0.29
|
0.07 Percent change in oral body temperature
Standard Deviation 0.31
|
0.10 Percent change in oral body temperature
Standard Deviation 0.32
|
-0.03 Percent change in oral body temperature
Standard Deviation 0.43
|
-0.05 Percent change in oral body temperature
Standard Deviation 0.07
|
|
Percent Change In Oral Body Temperature From Baseline To Day 28
Change from Baseline - Day 3/ 48 Hour
|
-0.05 Percent change in oral body temperature
Standard Deviation 0.50
|
0.24 Percent change in oral body temperature
Standard Deviation 0.05
|
0.08 Percent change in oral body temperature
Standard Deviation 0.39
|
0.25 Percent change in oral body temperature
Standard Deviation 0.17
|
0.17 Percent change in oral body temperature
Standard Deviation 0.14
|
0 Percent change in oral body temperature
Standard Deviation 0.28
|
|
Percent Change In Oral Body Temperature From Baseline To Day 28
Change from Baseline - Day 7
|
0.02 Percent change in oral body temperature
Standard Deviation 0.34
|
0.44 Percent change in oral body temperature
Standard Deviation 0.29
|
0.21 Percent change in oral body temperature
Standard Deviation 0.38
|
0.07 Percent change in oral body temperature
Standard Deviation 0.19
|
0.25 Percent change in oral body temperature
Standard Deviation 0.29
|
0 Percent change in oral body temperature
Standard Deviation 0.28
|
|
Percent Change In Oral Body Temperature From Baseline To Day 28
Change from Baseline - Day 28
|
-0.33 Percent change in oral body temperature
Standard Deviation 0.34
|
0.34 Percent change in oral body temperature
Standard Deviation 0.15
|
-0.03 Percent change in oral body temperature
Standard Deviation 0.44
|
-0.15 Percent change in oral body temperature
Standard Deviation 0.19
|
0.30 Percent change in oral body temperature
Standard Deviation 0.23
|
-0.35 Percent change in oral body temperature
Standard Deviation 0.35
|
PRIMARY outcome
Timeframe: BaselinePopulation: All participants who received any amount of study drug.
Outcome measures
| Measure |
Part A - Cohort 1
n=6 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Cohort 2
n=5 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Cohort 1-2 (Pooled)
n=11 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Placebo (Pooled)
n=4 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 0.9% sodium chloride IV during the treatment period.
|
Part B - Cohort 3
n=6 Participants
Healthy and younger participants pretreated with a high dose of ticagrelor (180 mg BID) received 36 g of PB252 IV during the treatment period.
|
Part B - Placebo
n=2 Participants
Healthy and younger participants pretreated with a high dose of ticagrelor (180 mg BID) received 0.9% sodium chloride IV during the treatment period.
|
|---|---|---|---|---|---|---|
|
Mean Respiratory Rate at Baseline
|
14.33 Breaths per minute
Standard Deviation 1.51
|
13.60 Breaths per minute
Standard Deviation 2.61
|
14.00 Breaths per minute
Standard Deviation 2.00
|
12.50 Breaths per minute
Standard Deviation 2.52
|
15.67 Breaths per minute
Standard Deviation 2.94
|
17.00 Breaths per minute
Standard Deviation 1.41
|
PRIMARY outcome
Timeframe: Day 1 (45 and 60 minutes post-dose), Day 2, Day 3, Day 7, and Day 28Population: All participants who received any amount of study drug.
Respiratory rate measurements were measured at specific time points.
Outcome measures
| Measure |
Part A - Cohort 1
n=6 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Cohort 2
n=5 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Cohort 1-2 (Pooled)
n=11 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Placebo (Pooled)
n=4 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 0.9% sodium chloride IV during the treatment period.
|
Part B - Cohort 3
n=6 Participants
Healthy and younger participants pretreated with a high dose of ticagrelor (180 mg BID) received 36 g of PB252 IV during the treatment period.
|
Part B - Placebo
n=2 Participants
Healthy and younger participants pretreated with a high dose of ticagrelor (180 mg BID) received 0.9% sodium chloride IV during the treatment period.
|
|---|---|---|---|---|---|---|
|
Percent Change In Respiratory Rate From Baseline To Day 28
Change from Baseline - Day 28
|
-0.33 Percent change in respiratory rate
Standard Deviation 3.44
|
0.80 Percent change in respiratory rate
Standard Deviation 3.35
|
0.18 Percent change in respiratory rate
Standard Deviation 3.28
|
1.00 Percent change in respiratory rate
Standard Deviation 2.00
|
-3.67 Percent change in respiratory rate
Standard Deviation 4.08
|
-6.00 Percent change in respiratory rate
Standard Deviation 2.83
|
|
Percent Change In Respiratory Rate From Baseline To Day 28
Change from Baseline - Day 1/ 45 Minutes Postdose
|
-3.33 Percent change in respiratory rate
Standard Deviation 1.63
|
0.50 Percent change in respiratory rate
Standard Deviation 3.79
|
-1.80 Percent change in respiratory rate
Standard Deviation 3.19
|
-0.50 Percent change in respiratory rate
Standard Deviation 3.00
|
-1.00 Percent change in respiratory rate
Standard Deviation 2.10
|
-3.00 Percent change in respiratory rate
Standard Deviation 1.41
|
|
Percent Change In Respiratory Rate From Baseline To Day 28
Change from Baseline Day 1/ 1 Hour Postdose
|
-2.00 Percent change in respiratory rate
Standard Deviation 1.26
|
-0.40 Percent change in respiratory rate
Standard Deviation 3.85
|
-1.27 Percent change in respiratory rate
Standard Deviation 2.72
|
1.00 Percent change in respiratory rate
Standard Deviation 2.58
|
-4.33 Percent change in respiratory rate
Standard Deviation 3.44
|
-4.00 Percent change in respiratory rate
Standard Deviation 2.83
|
|
Percent Change In Respiratory Rate From Baseline To Day 28
Change from Baseline - Day 2/ 24 Hour
|
-0.67 Percent change in respiratory rate
Standard Deviation 3.27
|
2.40 Percent change in respiratory rate
Standard Deviation 2.19
|
0.73 Percent change in respiratory rate
Standard Deviation 3.13
|
1.50 Percent change in respiratory rate
Standard Deviation 1.91
|
-1.00 Percent change in respiratory rate
Standard Deviation 3.29
|
-4.00 Percent change in respiratory rate
Standard Deviation 2.83
|
|
Percent Change In Respiratory Rate From Baseline To Day 28
Change from Baseline - Day 3/ 48 Hour
|
-2.00 Percent change in respiratory rate
Standard Deviation 2.19
|
0.40 Percent change in respiratory rate
Standard Deviation 3.29
|
-0.91 Percent change in respiratory rate
Standard Deviation 2.88
|
0.50 Percent change in respiratory rate
Standard Deviation 1.00
|
-2.67 Percent change in respiratory rate
Standard Deviation 2.07
|
-3.00 Percent change in respiratory rate
Standard Deviation 1.41
|
|
Percent Change In Respiratory Rate From Baseline To Day 28
Change from Baseline - Day 7
|
-0.33 Percent change in respiratory rate
Standard Deviation 2.66
|
0.40 Percent change in respiratory rate
Standard Deviation 2.61
|
0 Percent change in respiratory rate
Standard Deviation 2.53
|
1.00 Percent change in respiratory rate
Standard Deviation 1.15
|
-2.00 Percent change in respiratory rate
Standard Deviation 2.53
|
-1.00 Percent change in respiratory rate
Standard Deviation 1.41
|
PRIMARY outcome
Timeframe: BaselinePopulation: All participants who received any amount of study drug.
Outcome measures
| Measure |
Part A - Cohort 1
n=6 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Cohort 2
n=5 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Cohort 1-2 (Pooled)
n=11 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Placebo (Pooled)
n=4 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 0.9% sodium chloride IV during the treatment period.
|
Part B - Cohort 3
n=6 Participants
Healthy and younger participants pretreated with a high dose of ticagrelor (180 mg BID) received 36 g of PB252 IV during the treatment period.
|
Part B - Placebo
n=2 Participants
Healthy and younger participants pretreated with a high dose of ticagrelor (180 mg BID) received 0.9% sodium chloride IV during the treatment period.
|
|---|---|---|---|---|---|---|
|
Mean Heart Rate at Baseline
|
70.17 Beats per minute
Standard Deviation 8.04
|
60.20 Beats per minute
Standard Deviation 5.89
|
65.64 Beats per minute
Standard Deviation 8.56
|
63.00 Beats per minute
Standard Deviation 10.74
|
65.50 Beats per minute
Standard Deviation 5.21
|
78.00 Beats per minute
Standard Deviation 29.70
|
PRIMARY outcome
Timeframe: Baseline, Day 1 (10, 20, 30, 45, and 60 minutes post-dose), Day 2, Day 3, Day 7, and Day 28Population: All participants who received any amount of study drug.
Heart rate measurements were measured at specific time points.
Outcome measures
| Measure |
Part A - Cohort 1
n=6 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Cohort 2
n=5 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Cohort 1-2 (Pooled)
n=11 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Placebo (Pooled)
n=4 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 0.9% sodium chloride IV during the treatment period.
|
Part B - Cohort 3
n=6 Participants
Healthy and younger participants pretreated with a high dose of ticagrelor (180 mg BID) received 36 g of PB252 IV during the treatment period.
|
Part B - Placebo
n=2 Participants
Healthy and younger participants pretreated with a high dose of ticagrelor (180 mg BID) received 0.9% sodium chloride IV during the treatment period.
|
|---|---|---|---|---|---|---|
|
Percent Change In Heart Rate From Baseline To Day 28
Change from Baseline - Day 1/ 10 Minutes Postdose
|
-5.25 Percent change in heart rate
Standard Deviation 11.24
|
0.50 Percent change in heart rate
Standard Deviation 6.61
|
-2.38 Percent change in heart rate
Standard Deviation 9.07
|
-4.00 Percent change in heart rate
Standard Deviation 7.07
|
-3.17 Percent change in heart rate
Standard Deviation 6.68
|
-16.00 Percent change in heart rate
Standard Deviation 21.21
|
|
Percent Change In Heart Rate From Baseline To Day 28
Change from Baseline - Day 1/ 20 Minutes Postdose
|
-4.17 Percent change in heart rate
Standard Deviation 9.41
|
-0.50 Percent change in heart rate
Standard Deviation 3.79
|
-2.70 Percent change in heart rate
Standard Deviation 7.59
|
0 Percent change in heart rate
Standard Deviation 9.85
|
-3.17 Percent change in heart rate
Standard Deviation 3.19
|
-11.50 Percent change in heart rate
Standard Deviation 16.26
|
|
Percent Change In Heart Rate From Baseline To Day 28
Change from Baseline - Day 1/ 30 Minutes Postdose
|
-4.50 Percent change in heart rate
Standard Deviation 8.53
|
-1.20 Percent change in heart rate
Standard Deviation 4.60
|
-3.00 Percent change in heart rate
Standard Deviation 6.91
|
-0.50 Percent change in heart rate
Standard Deviation 9.19
|
-4.83 Percent change in heart rate
Standard Deviation 5.95
|
-7.50 Percent change in heart rate
Standard Deviation 24.75
|
|
Percent Change In Heart Rate From Baseline To Day 28
Change from Baseline - Day 1/ 45 Minutes Postdose
|
-3.83 Percent change in heart rate
Standard Deviation 8.54
|
-1.80 Percent change in heart rate
Standard Deviation 4.44
|
-2.91 Percent change in heart rate
Standard Deviation 6.74
|
2.25 Percent change in heart rate
Standard Deviation 4.50
|
-3.83 Percent change in heart rate
Standard Deviation 4.36
|
-9.00 Percent change in heart rate
Standard Deviation 18.38
|
|
Percent Change In Heart Rate From Baseline To Day 28
Change from Baseline Day 1/ 1 Hour Postdose
|
-3.17 Percent change in heart rate
Standard Deviation 8.50
|
0 Percent change in heart rate
Standard Deviation 5.15
|
-1.73 Percent change in heart rate
Standard Deviation 7.03
|
1.75 Percent change in heart rate
Standard Deviation 7.41
|
-2.67 Percent change in heart rate
Standard Deviation 4.72
|
-13.00 Percent change in heart rate
Standard Deviation 18.38
|
|
Percent Change In Heart Rate From Baseline To Day 28
Change from Baseline - Day 2/ 24 Hour
|
-1.17 Percent change in heart rate
Standard Deviation 10.46
|
1.40 Percent change in heart rate
Standard Deviation 3.78
|
0 Percent change in heart rate
Standard Deviation 7.89
|
5.25 Percent change in heart rate
Standard Deviation 3.20
|
-0.33 Percent change in heart rate
Standard Deviation 6.50
|
-12.50 Percent change in heart rate
Standard Deviation 17.68
|
|
Percent Change In Heart Rate From Baseline To Day 28
Change from Baseline - Day 3/ 48 Hour
|
-3.50 Percent change in heart rate
Standard Deviation 8.64
|
1.80 Percent change in heart rate
Standard Deviation 6.69
|
-1.09 Percent change in heart rate
Standard Deviation 7.93
|
2.25 Percent change in heart rate
Standard Deviation 5.74
|
-1.00 Percent change in heart rate
Standard Deviation 4.94
|
-12.50 Percent change in heart rate
Standard Deviation 12.02
|
|
Percent Change In Heart Rate From Baseline To Day 28
Change from Baseline - Day 7
|
-1.67 Percent change in heart rate
Standard Deviation 9.07
|
5.40 Percent change in heart rate
Standard Deviation 5.68
|
1.55 Percent change in heart rate
Standard Deviation 8.23
|
0 Percent change in heart rate
Standard Deviation 12.19
|
-4.00 Percent change in heart rate
Standard Deviation 5.55
|
-15.50 Percent change in heart rate
Standard Deviation 21.92
|
|
Percent Change In Heart Rate From Baseline To Day 28
Change from Baseline - Day 28
|
-5.17 Percent change in heart rate
Standard Deviation 7.52
|
1.40 Percent change in heart rate
Standard Deviation 6.62
|
-2.18 Percent change in heart rate
Standard Deviation 7.59
|
-1.75 Percent change in heart rate
Standard Deviation 13.62
|
-4.33 Percent change in heart rate
Standard Deviation 6.59
|
-18.00 Percent change in heart rate
Standard Deviation 24.04
|
PRIMARY outcome
Timeframe: Up to Day 28Population: All participants who received any amount of study drug.
Number of participants per cohort with clinically significant ECG findings.
Outcome measures
| Measure |
Part A - Cohort 1
n=6 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Cohort 2
n=5 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Cohort 1-2 (Pooled)
n=4 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Placebo (Pooled)
n=6 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 0.9% sodium chloride IV during the treatment period.
|
Part B - Cohort 3
n=2 Participants
Healthy and younger participants pretreated with a high dose of ticagrelor (180 mg BID) received 36 g of PB252 IV during the treatment period.
|
Part B - Placebo
Healthy and younger participants pretreated with a high dose of ticagrelor (180 mg BID) received 0.9% sodium chloride IV during the treatment period.
|
|---|---|---|---|---|---|---|
|
Incidence Of Clinically Significant 12-Lead Electrocardiogram (ECG) Findings
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Day -3, Day 1, Day 7, and Day 28Population: All participants who received any amount of study drug.
Number of participants who developed ADAs to PB2452.
Outcome measures
| Measure |
Part A - Cohort 1
n=6 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Cohort 2
n=5 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Cohort 1-2 (Pooled)
n=11 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Placebo (Pooled)
n=4 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 0.9% sodium chloride IV during the treatment period.
|
Part B - Cohort 3
n=6 Participants
Healthy and younger participants pretreated with a high dose of ticagrelor (180 mg BID) received 36 g of PB252 IV during the treatment period.
|
Part B - Placebo
n=2 Participants
Healthy and younger participants pretreated with a high dose of ticagrelor (180 mg BID) received 0.9% sodium chloride IV during the treatment period.
|
|---|---|---|---|---|---|---|
|
Participants Experiencing Anti-drug Antibodies (ADAs)
Day -3
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participants Experiencing Anti-drug Antibodies (ADAs)
Day 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participants Experiencing Anti-drug Antibodies (ADAs)
Day 7
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Participants Experiencing Anti-drug Antibodies (ADAs)
Day 28
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline through Day 28Population: All participants who received any amount of study drug.
Participants with adverse events noted during physical exam between baseline and end of study.
Outcome measures
| Measure |
Part A - Cohort 1
n=6 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Cohort 2
n=5 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Cohort 1-2 (Pooled)
n=4 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 18 g of PB2452 IV during the treatment period.
|
Part A - Placebo (Pooled)
n=6 Participants
Older and elderly participants pretreated with ticagrelor + ASA received 0.9% sodium chloride IV during the treatment period.
|
Part B - Cohort 3
n=2 Participants
Healthy and younger participants pretreated with a high dose of ticagrelor (180 mg BID) received 36 g of PB252 IV during the treatment period.
|
Part B - Placebo
Healthy and younger participants pretreated with a high dose of ticagrelor (180 mg BID) received 0.9% sodium chloride IV during the treatment period.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events During Physical Examination
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
Adverse Events
Part A - Cohort 1: 18 g PB2452 (ASA + Ticagrelor Pre-Trx)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A - Cohort 2: 18 g PB2452 (ASA + Ticagrelor Pre-Trx)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A - Cohorts 1-2 Placebo: (ASA + Ticagrelor Pre-Trx)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part B - Cohort 3: 36 g PB2452 (Ticagrelor Pre-Trx)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part B - Cohort 3 Placebo: (Ticagrelor Pre-Trx)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A - Cohort 1: 18 g PB2452 (ASA + Ticagrelor Pre-Trx)
n=6 participants at risk
ASA + Ticagrelor Oral Tablet - Pre-Treatment: ASA 81 mg and Ticagrelor 180 mg + 90 mg BID for 5 doses prior to PB2452 administration
PB2452 Infusion: initial administration of 6 g bolus infused over 10 minutes followed by 6 g infused over the next 4 hours, followed by 6 g infused over the next 12 hours for a total of a 16-hour and 10 minutes infusion.
|
Part A - Cohort 2: 18 g PB2452 (ASA + Ticagrelor Pre-Trx)
n=5 participants at risk
ASA + Ticagrelor Oral Tablet - Pre-Treatment: ASA 81 mg and Ticagrelor 180 mg + 90 mg BID for 5 doses prior to PB2452 administration
PB2452 Infusion: initial administration of 6 g bolus infused over 10 minutes followed by 6 g infused over the next 4 hours, followed by 6 g infused over the next 12 hours for a total of a 16-hour and 10 minutes infusion.
|
Part A - Cohorts 1-2 Placebo: (ASA + Ticagrelor Pre-Trx)
n=4 participants at risk
Placebo - 0.9% Sodium Chloride
ASA + Ticagrelor Oral Tablet - Pre-Treatment: ASA 81 mg and Ticagrelor 180 mg + 90 mg BID for 5 doses prior to PB2452 administration
Placebo - Sodium Chloride: initial administration of 6 g bolus infused over 10 minutes followed by 6 g infused over the next 4 hours, followed by 6 g infused over the next 12 hours for a total of a 16-hour and 10 minutes infusion.
|
Part B - Cohort 3: 36 g PB2452 (Ticagrelor Pre-Trx)
n=6 participants at risk
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg BID for 5 doses prior to PB2452 administration
PB2452 Infusion: initial administration of 12 g bolus infused over 10 minutes followed by 12 g infused over the next 6 hours, followed by 12 g infused over 18 hours for a total of 24-hour and 10 minutes infusion.
|
Part B - Cohort 3 Placebo: (Ticagrelor Pre-Trx)
n=2 participants at risk
Placebo - 0.9% Sodium Chloride
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg BID for 5 doses prior to PB2452 administration
Placebo - Sodium Chloride: initial administration of 12 g bolus infused over 10 minutes followed by 12 g infused over the next 6 hours, followed by 12 g infused over 18 hours for a total of 24-hour and 10 minutes infusion.
|
|---|---|---|---|---|---|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/6 • Day -3 (Pretreatment) up to Day 28
|
20.0%
1/5 • Number of events 1 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/4 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/6 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/2 • Day -3 (Pretreatment) up to Day 28
|
Other adverse events
| Measure |
Part A - Cohort 1: 18 g PB2452 (ASA + Ticagrelor Pre-Trx)
n=6 participants at risk
ASA + Ticagrelor Oral Tablet - Pre-Treatment: ASA 81 mg and Ticagrelor 180 mg + 90 mg BID for 5 doses prior to PB2452 administration
PB2452 Infusion: initial administration of 6 g bolus infused over 10 minutes followed by 6 g infused over the next 4 hours, followed by 6 g infused over the next 12 hours for a total of a 16-hour and 10 minutes infusion.
|
Part A - Cohort 2: 18 g PB2452 (ASA + Ticagrelor Pre-Trx)
n=5 participants at risk
ASA + Ticagrelor Oral Tablet - Pre-Treatment: ASA 81 mg and Ticagrelor 180 mg + 90 mg BID for 5 doses prior to PB2452 administration
PB2452 Infusion: initial administration of 6 g bolus infused over 10 minutes followed by 6 g infused over the next 4 hours, followed by 6 g infused over the next 12 hours for a total of a 16-hour and 10 minutes infusion.
|
Part A - Cohorts 1-2 Placebo: (ASA + Ticagrelor Pre-Trx)
n=4 participants at risk
Placebo - 0.9% Sodium Chloride
ASA + Ticagrelor Oral Tablet - Pre-Treatment: ASA 81 mg and Ticagrelor 180 mg + 90 mg BID for 5 doses prior to PB2452 administration
Placebo - Sodium Chloride: initial administration of 6 g bolus infused over 10 minutes followed by 6 g infused over the next 4 hours, followed by 6 g infused over the next 12 hours for a total of a 16-hour and 10 minutes infusion.
|
Part B - Cohort 3: 36 g PB2452 (Ticagrelor Pre-Trx)
n=6 participants at risk
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg BID for 5 doses prior to PB2452 administration
PB2452 Infusion: initial administration of 12 g bolus infused over 10 minutes followed by 12 g infused over the next 6 hours, followed by 12 g infused over 18 hours for a total of 24-hour and 10 minutes infusion.
|
Part B - Cohort 3 Placebo: (Ticagrelor Pre-Trx)
n=2 participants at risk
Placebo - 0.9% Sodium Chloride
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg BID for 5 doses prior to PB2452 administration
Placebo - Sodium Chloride: initial administration of 12 g bolus infused over 10 minutes followed by 12 g infused over the next 6 hours, followed by 12 g infused over 18 hours for a total of 24-hour and 10 minutes infusion.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/5 • Day -3 (Pretreatment) up to Day 28
|
25.0%
1/4 • Number of events 1 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/6 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/2 • Day -3 (Pretreatment) up to Day 28
|
|
Gastrointestinal disorders
Infrequent bowel movements
|
0.00%
0/6 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/5 • Day -3 (Pretreatment) up to Day 28
|
25.0%
1/4 • Number of events 1 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/6 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/2 • Day -3 (Pretreatment) up to Day 28
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/5 • Day -3 (Pretreatment) up to Day 28
|
25.0%
1/4 • Number of events 1 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/6 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/2 • Day -3 (Pretreatment) up to Day 28
|
|
General disorders
Infusion site erythema
|
0.00%
0/6 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/5 • Day -3 (Pretreatment) up to Day 28
|
25.0%
1/4 • Number of events 1 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/6 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/2 • Day -3 (Pretreatment) up to Day 28
|
|
General disorders
Vessel puncture site bruise
|
16.7%
1/6 • Number of events 1 • Day -3 (Pretreatment) up to Day 28
|
20.0%
1/5 • Number of events 1 • Day -3 (Pretreatment) up to Day 28
|
25.0%
1/4 • Number of events 1 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/6 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/2 • Day -3 (Pretreatment) up to Day 28
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/6 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/5 • Day -3 (Pretreatment) up to Day 28
|
25.0%
1/4 • Number of events 1 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/6 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/2 • Day -3 (Pretreatment) up to Day 28
|
|
Investigations
Electrocardiogram t wave inversion
|
0.00%
0/6 • Day -3 (Pretreatment) up to Day 28
|
20.0%
1/5 • Number of events 1 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/4 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/6 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/2 • Day -3 (Pretreatment) up to Day 28
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Day -3 (Pretreatment) up to Day 28
|
20.0%
1/5 • Number of events 1 • Day -3 (Pretreatment) up to Day 28
|
25.0%
1/4 • Number of events 1 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/6 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/2 • Day -3 (Pretreatment) up to Day 28
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Day -3 (Pretreatment) up to Day 28
|
20.0%
1/5 • Number of events 1 • Day -3 (Pretreatment) up to Day 28
|
25.0%
1/4 • Number of events 1 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/6 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/2 • Day -3 (Pretreatment) up to Day 28
|
|
General disorders
Feeling hot
|
0.00%
0/6 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/5 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/4 • Day -3 (Pretreatment) up to Day 28
|
16.7%
1/6 • Number of events 1 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/2 • Day -3 (Pretreatment) up to Day 28
|
|
General disorders
Infusion site bruising
|
0.00%
0/6 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/5 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/4 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/6 • Day -3 (Pretreatment) up to Day 28
|
50.0%
1/2 • Number of events 1 • Day -3 (Pretreatment) up to Day 28
|
|
General disorders
Infusion site extravasation
|
0.00%
0/6 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/5 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/4 • Day -3 (Pretreatment) up to Day 28
|
16.7%
1/6 • Number of events 1 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/2 • Day -3 (Pretreatment) up to Day 28
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/5 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/4 • Day -3 (Pretreatment) up to Day 28
|
16.7%
1/6 • Number of events 1 • Day -3 (Pretreatment) up to Day 28
|
50.0%
1/2 • Number of events 1 • Day -3 (Pretreatment) up to Day 28
|
|
Infections and infestations
Folliculitis
|
0.00%
0/6 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/5 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/4 • Day -3 (Pretreatment) up to Day 28
|
16.7%
1/6 • Number of events 1 • Day -3 (Pretreatment) up to Day 28
|
50.0%
1/2 • Number of events 1 • Day -3 (Pretreatment) up to Day 28
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/5 • Day -3 (Pretreatment) up to Day 28
|
0.00%
0/4 • Day -3 (Pretreatment) up to Day 28
|
16.7%
1/6 • Number of events 1 • Day -3 (Pretreatment) up to Day 28
|
50.0%
1/2 • Number of events 1 • Day -3 (Pretreatment) up to Day 28
|
Additional Information
Michele LaRussa SVP, Chief Regulatory Officer
SFJ Pharmaceuticals, Inc.
Phone: 925-223-6233
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place