Trial Outcomes & Findings for Study to Evaluate the Safety, Tolerability, PK, and PD of PB2452 in Healthy Volunteers (NCT NCT03492385)
NCT ID: NCT03492385
Last Updated: 2024-11-04
Results Overview
An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
64 participants
Primary outcome timeframe
Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until Day 28
Results posted on
2024-11-04
Participant Flow
Healthy participants who met all the inclusion criteria and none of the exclusion criteria were randomly assigned to receive either PB2452 or placebo in a ratio of 3:1 in all treatment cohorts.
Participant milestones
| Measure |
Cohort 1: 100 mg PB2452 (no Ticagrelor)
PB2452 Infusion: single 30-minute intravenous (IV) infusion of 100 mg PB2452
|
Cohort 2: 300 mg PB2452 (no Ticagrelor)
PB2452 Infusion: single 30-minute IV infusion of 300 mg PB2452
|
Cohort 3: 1000 mg PB2452 (no Ticagrelor)
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
|
Cohort 1 to 3: Placebo
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 4: 1000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg twice daily (BID) for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 5: 3000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single 30-minute IV infusion of 3000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 6: 9000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single 30-minute IV infusion of 9000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 4 to 6: Placebo
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 7: 18000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 8 hours
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 8: 18000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 12 hours
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 9: 18000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 20 minutes
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 10: 18000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 12 minutes
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 7 to 10: Placebo
Placebo - Sodium Chloride: single 8-hour to 16.5-hour IV infusion of placebo
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
6
|
6
|
6
|
6
|
6
|
6
|
3
|
6
|
7
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
6
|
6
|
6
|
6
|
6
|
6
|
3
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
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 Volunteers
Baseline characteristics by cohort
| Measure |
Cohort 1: 100 mg PB2452 (no Ticagrelor)
n=3 Participants
PB2452 Infusion: single 30-minute IV infusion of 100 mg PB2452
|
Cohort 2: 300 mg PB2452 (no Ticagrelor)
n=3 Participants
PB2452 Infusion: single 30-minute IV infusion of 300 mg PB2452
|
Cohort 3: 1000 mg PB2452 (no Ticagrelor)
n=3 Participants
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
|
Cohort 1 to 3: Placebo
n=3 Participants
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 4: 1000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 5: 3000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 3000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 6: 9000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 9000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 4 to 6: Placebo
n=6 Participants
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 7: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 8 hours
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 8: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 12 hours
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 9: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=3 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 20 minutes
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 10: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 12 minutes
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 7 to 10: Placebo
n=7 Participants
Placebo - Sodium Chloride: single 8-hour to 16.5-hour IV infusion of placebo
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
27.7 years
STANDARD_DEVIATION 2.89 • n=5 Participants
|
30.0 years
STANDARD_DEVIATION 10.58 • n=7 Participants
|
40.0 years
STANDARD_DEVIATION 12.49 • n=5 Participants
|
28.0 years
STANDARD_DEVIATION 9.17 • n=4 Participants
|
30.7 years
STANDARD_DEVIATION 5.99 • n=21 Participants
|
30.2 years
STANDARD_DEVIATION 9.95 • n=10 Participants
|
33.8 years
STANDARD_DEVIATION 11.96 • n=115 Participants
|
30.7 years
STANDARD_DEVIATION 5.79 • n=24 Participants
|
26.7 years
STANDARD_DEVIATION 8.87 • n=42 Participants
|
29.7 years
STANDARD_DEVIATION 8.04 • n=42 Participants
|
30.7 years
STANDARD_DEVIATION 5.86 • n=42 Participants
|
28.7 years
STANDARD_DEVIATION 9.03 • n=42 Participants
|
39.4 years
STANDARD_DEVIATION 7.16 • n=36 Participants
|
31.4 years
STANDARD_DEVIATION 8.71 • n=36 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
30 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
5 Participants
n=36 Participants
|
34 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
28 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
4 Participants
n=36 Participants
|
36 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
34 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
5 Participants
n=36 Participants
|
26 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until Day 28Population: Safety population: all participants who received any amount of study drug.
An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related.
Outcome measures
| Measure |
Cohort 1: 100 mg PB2452 (no Ticagrelor)
n=3 Participants
PB2452 Infusion: single 30-minute IV infusion of 100 mg PB2452
|
Cohort 2: 300 mg PB2452 (no Ticagrelor)
n=3 Participants
PB2452 Infusion: single 30-minute IV infusion of 300 mg PB2452
|
Cohort 3: 1000 mg PB2452 (no Ticagrelor)
n=3 Participants
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
|
Cohort 1 to 3: Placebo
n=3 Participants
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 4: 1000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 5: 3000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 3000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 6: 9000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 9000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 4 to 6: Placebo
n=6 Participants
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 7: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 8 hours
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 8: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 12 hours
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 9: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=3 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 20 minutes
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 10: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 12 minutes
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 7 to 10: Placebo
n=7 Participants
Placebo - Sodium Chloride: single 8-hour to 16.5-hour IV infusion of placebo
|
All PB2452
All participants in any cohorts who received PB2452.
|
All Placebo
All participants in any cohorts who received placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Any Treatment-Emergent AE
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
6 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
Any study-drug-related TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
Any severe TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
Any SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
Any AE leading to early study discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
Any dose limiting toxicity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
Any death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 30 Day - Starting day of dosingPopulation: Safety population: all participants who received any amount of study drug.
Number of participants with clinically significant abnormal laboratory findings for hematology, coagulation, serum chemistry, urinalysis and drug tests.
Outcome measures
| Measure |
Cohort 1: 100 mg PB2452 (no Ticagrelor)
n=3 Participants
PB2452 Infusion: single 30-minute IV infusion of 100 mg PB2452
|
Cohort 2: 300 mg PB2452 (no Ticagrelor)
n=3 Participants
PB2452 Infusion: single 30-minute IV infusion of 300 mg PB2452
|
Cohort 3: 1000 mg PB2452 (no Ticagrelor)
n=3 Participants
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
|
Cohort 1 to 3: Placebo
n=3 Participants
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 4: 1000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 5: 3000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 3000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 6: 9000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 9000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 4 to 6: Placebo
n=6 Participants
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 7: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 8 hours
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 8: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 12 hours
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 9: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=3 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 20 minutes
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 10: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 12 minutes
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 7 to 10: Placebo
n=7 Participants
Placebo - Sodium Chloride: single 8-hour to 16.5-hour IV infusion of placebo
|
All PB2452
All participants in any cohorts who received PB2452.
|
All Placebo
All participants in any cohorts who received placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1, 2, 3, 4, 7 and 28Population: Safety population: all participants who received any amount of study drug.
Diastolic blood pressure measurements were measured at specific time points.
Outcome measures
| Measure |
Cohort 1: 100 mg PB2452 (no Ticagrelor)
n=3 Participants
PB2452 Infusion: single 30-minute IV infusion of 100 mg PB2452
|
Cohort 2: 300 mg PB2452 (no Ticagrelor)
n=3 Participants
PB2452 Infusion: single 30-minute IV infusion of 300 mg PB2452
|
Cohort 3: 1000 mg PB2452 (no Ticagrelor)
n=3 Participants
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
|
Cohort 1 to 3: Placebo
n=3 Participants
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 4: 1000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 5: 3000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 3000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 6: 9000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 9000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 4 to 6: Placebo
n=6 Participants
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 7: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 8 hours
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 8: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 12 hours
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 9: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=3 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 20 minutes
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 10: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 12 minutes
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 7 to 10: Placebo
n=7 Participants
Placebo - Sodium Chloride: single 8-hour to 16.5-hour IV infusion of placebo
|
All PB2452
All participants in any cohorts who received PB2452.
|
All Placebo
All participants in any cohorts who received placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Diastolic Blood Pressure
Change from Baseline - Day 28
|
12.0 mmHg
Standard Deviation 7.94
|
5.0 mmHg
Standard Deviation 2.65
|
1.3 mmHg
Standard Deviation 1.53
|
4.0 mmHg
Standard Deviation 4.58
|
8.8 mmHg
Standard Deviation 7.08
|
6.7 mmHg
Standard Deviation 5.61
|
4.7 mmHg
Standard Deviation 5.43
|
5.7 mmHg
Standard Deviation 4.89
|
3.5 mmHg
Standard Deviation 3.83
|
7.8 mmHg
Standard Deviation 5.98
|
-5.0 mmHg
Standard Deviation 12.00
|
9.2 mmHg
Standard Deviation 6.85
|
4.9 mmHg
Standard Deviation 10.17
|
—
|
—
|
|
Change in Diastolic Blood Pressure
Change from Baseline - Day 1/0.5 Hour
|
1.7 mmHg
Standard Deviation 6.66
|
-2.3 mmHg
Standard Deviation 7.57
|
5.7 mmHg
Standard Deviation 3.21
|
-1.7 mmHg
Standard Deviation 10.02
|
-0.8 mmHg
Standard Deviation 7.76
|
-2.7 mmHg
Standard Deviation 5.39
|
-0.5 mmHg
Standard Deviation 3.39
|
-1.3 mmHg
Standard Deviation 5.13
|
-2.5 mmHg
Standard Deviation 3.70
|
4.5 mmHg
Standard Deviation 3.51
|
-4.0 mmHg
Standard Deviation 4.58
|
-2.5 mmHg
Standard Deviation 5.96
|
-1.4 mmHg
Standard Deviation 8.30
|
—
|
—
|
|
Change in Diastolic Blood Pressure
Change from Baseline - Day 1/0.75 Hour
|
0.7 mmHg
Standard Deviation 10.21
|
-1.0 mmHg
Standard Deviation 8.89
|
3.3 mmHg
Standard Deviation 6.43
|
-0.3 mmHg
Standard Deviation 9.07
|
0.3 mmHg
Standard Deviation 9.29
|
-1.0 mmHg
Standard Deviation 1.79
|
-1.2 mmHg
Standard Deviation 3.54
|
1.3 mmHg
Standard Deviation 5.54
|
1.5 mmHg
Standard Deviation 9.97
|
-0.3 mmHg
Standard Deviation 7.28
|
-2.3 mmHg
Standard Deviation 1.53
|
-2.0 mmHg
Standard Deviation 6.48
|
-0.4 mmHg
Standard Deviation 8.92
|
—
|
—
|
|
Change in Diastolic Blood Pressure
Change from Baseline - Day 1/1 Hour
|
-0.7 mmHg
Standard Deviation 11.37
|
0 mmHg
Standard Deviation 4.58
|
2.7 mmHg
Standard Deviation 6.66
|
4.0 mmHg
Standard Deviation 6.24
|
3.5 mmHg
Standard Deviation 8.78
|
0.3 mmHg
Standard Deviation 3.33
|
0.3 mmHg
Standard Deviation 3.98
|
2.8 mmHg
Standard Deviation 6.43
|
3.8 mmHg
Standard Deviation 11.18
|
0.5 mmHg
Standard Deviation 5.54
|
-6.7 mmHg
Standard Deviation 1.53
|
-1.7 mmHg
Standard Deviation 6.83
|
2.1 mmHg
Standard Deviation 9.69
|
—
|
—
|
|
Change in Diastolic Blood Pressure
Change from Baseline - Day 1/2 Hour
|
12.7 mmHg
Standard Deviation 7.23
|
1.0 mmHg
Standard Deviation 2.00
|
0.7 mmHg
Standard Deviation 1.53
|
-1.7 mmHg
Standard Deviation 8.14
|
1.0 mmHg
Standard Deviation 6.84
|
-1.5 mmHg
Standard Deviation 3.94
|
0 mmHg
Standard Deviation 3.58
|
-0.3 mmHg
Standard Deviation 3.33
|
2.7 mmHg
Standard Deviation 9.58
|
-1.0 mmHg
Standard Deviation 6.54
|
-5.3 mmHg
Standard Deviation 1.53
|
-2.6 mmHg
Standard Deviation 4.67
|
2.9 mmHg
Standard Deviation 9.39
|
—
|
—
|
|
Change in Diastolic Blood Pressure
Change from Baseline - Day 1/4 Hour
|
1.3 mmHg
Standard Deviation 3.21
|
-9.0 mmHg
Standard Deviation 2.00
|
-0.3 mmHg
Standard Deviation 1.53
|
-3.3 mmHg
Standard Deviation 8.02
|
-2.2 mmHg
Standard Deviation 5.53
|
-3.3 mmHg
Standard Deviation 4.72
|
-0.5 mmHg
Standard Deviation 5.47
|
-1.5 mmHg
Standard Deviation 4.04
|
-3.8 mmHg
Standard Deviation 7.31
|
-1.5 mmHg
Standard Deviation 6.16
|
-8.7 mmHg
Standard Deviation 5.51
|
1.3 mmHg
Standard Deviation 9.69
|
0.7 mmHg
Standard Deviation 9.60
|
—
|
—
|
|
Change in Diastolic Blood Pressure
Change from Baseline - Day 1/8 Hour
|
0.3 mmHg
Standard Deviation 7.02
|
-8.7 mmHg
Standard Deviation 4.93
|
-1.3 mmHg
Standard Deviation 4.51
|
2.7 mmHg
Standard Deviation 4.62
|
-4.2 mmHg
Standard Deviation 9.91
|
-3.3 mmHg
Standard Deviation 8.02
|
-0.2 mmHg
Standard Deviation 5.67
|
-0.7 mmHg
Standard Deviation 6.02
|
-3.7 mmHg
Standard Deviation 6.02
|
-3.2 mmHg
Standard Deviation 5.72
|
-10.3 mmHg
Standard Deviation 5.03
|
-3.2 mmHg
Standard Deviation 5.60
|
-3.1 mmHg
Standard Deviation 12.19
|
—
|
—
|
|
Change in Diastolic Blood Pressure
Change from Baseline - Day 2/24 Hour
|
3.0 mmHg
Standard Deviation 5.57
|
-2.7 mmHg
Standard Deviation 4.73
|
2.3 mmHg
Standard Deviation 1.15
|
-2.7 mmHg
Standard Deviation 4.04
|
1.2 mmHg
Standard Deviation 5.08
|
-2.3 mmHg
Standard Deviation 4.37
|
-0.3 mmHg
Standard Deviation 5.28
|
1.7 mmHg
Standard Deviation 6.12
|
-2.2 mmHg
Standard Deviation 3.31
|
-2.3 mmHg
Standard Deviation 8.14
|
-3.3 mmHg
Standard Deviation 6.66
|
-3.3 mmHg
Standard Deviation 5.57
|
-1.7 mmHg
Standard Deviation 8.75
|
—
|
—
|
|
Change in Diastolic Blood Pressure
Change from Baseline - Day 2/30 Hour
|
4.0 mmHg
Standard Deviation 4.36
|
-5.7 mmHg
Standard Deviation 8.02
|
-4.7 mmHg
Standard Deviation 4.04
|
-6.7 mmHg
Standard Deviation 9.61
|
-2.2 mmHg
Standard Deviation 5.60
|
-4.5 mmHg
Standard Deviation 6.22
|
-2.5 mmHg
Standard Deviation 4.93
|
-5.3 mmHg
Standard Deviation 4.68
|
-6.2 mmHg
Standard Deviation 2.56
|
-5.0 mmHg
Standard Deviation 8.58
|
-7.7 mmHg
Standard Deviation 8.74
|
-3.0 mmHg
Standard Deviation 4.98
|
-3.1 mmHg
Standard Deviation 13.04
|
—
|
—
|
|
Change in Diastolic Blood Pressure
Change from Baseline - Day 2/36 Hour
|
3.3 mmHg
Standard Deviation 5.51
|
-7.7 mmHg
Standard Deviation 5.86
|
-0.7 mmHg
Standard Deviation 5.03
|
-5.3 mmHg
Standard Deviation 6.81
|
0.2 mmHg
Standard Deviation 9.06
|
-2.0 mmHg
Standard Deviation 5.66
|
-3.5 mmHg
Standard Deviation 5.13
|
-4.3 mmHg
Standard Deviation 7.03
|
-4.3 mmHg
Standard Deviation 4.13
|
-7.0 mmHg
Standard Deviation 7.13
|
-11.7 mmHg
Standard Deviation 8.08
|
-5.8 mmHg
Standard Deviation 3.66
|
-4.7 mmHg
Standard Deviation 8.20
|
—
|
—
|
|
Change in Diastolic Blood Pressure
Change from Baseline - Day 3/42 Hour
|
1.0 mmHg
Standard Deviation 12.12
|
-9.3 mmHg
Standard Deviation 1.53
|
-6.0 mmHg
Standard Deviation 3.46
|
-3.3 mmHg
Standard Deviation 7.02
|
-7.2 mmHg
Standard Deviation 7.81
|
-3.2 mmHg
Standard Deviation 3.87
|
-1.2 mmHg
Standard Deviation 5.95
|
-5.5 mmHg
Standard Deviation 3.45
|
-4.0 mmHg
Standard Deviation 4.43
|
-6.2 mmHg
Standard Deviation 10.96
|
-12.7 mmHg
Standard Deviation 3.21
|
-8.0 mmHg
Standard Deviation 10.20
|
-9.7 mmHg
Standard Deviation 8.90
|
—
|
—
|
|
Change in Diastolic Blood Pressure
Change from Baseline - Day 3/48 Hour
|
5.0 mmHg
Standard Deviation 5.29
|
-1.0 mmHg
Standard Deviation 4.00
|
-1.7 mmHg
Standard Deviation 6.43
|
-3.3 mmHg
Standard Deviation 13.50
|
3.8 mmHg
Standard Deviation 7.14
|
-0.2 mmHg
Standard Deviation 4.83
|
5.8 mmHg
Standard Deviation 10.01
|
-0.2 mmHg
Standard Deviation 3.97
|
-1.8 mmHg
Standard Deviation 3.97
|
-0.2 mmHg
Standard Deviation 4.71
|
-7.0 mmHg
Standard Deviation 3.46
|
-4.5 mmHg
Standard Deviation 6.41
|
-2.3 mmHg
Standard Deviation 9.79
|
—
|
—
|
|
Change in Diastolic Blood Pressure
Change from Baseline - Day 4
|
7.7 mmHg
Standard Deviation 9.45
|
3.7 mmHg
Standard Deviation 4.16
|
2.7 mmHg
Standard Deviation 3.06
|
5.3 mmHg
Standard Deviation 3.79
|
8.2 mmHg
Standard Deviation 5.42
|
5.8 mmHg
Standard Deviation 5.71
|
4.7 mmHg
Standard Deviation 4.97
|
2.0 mmHg
Standard Deviation 6.16
|
3.8 mmHg
Standard Deviation 4.40
|
-4.2 mmHg
Standard Deviation 7.78
|
-10.3 mmHg
Standard Deviation 4.16
|
-0.8 mmHg
Standard Deviation 6.40
|
-1.9 mmHg
Standard Deviation 9.62
|
—
|
—
|
|
Change in Diastolic Blood Pressure
Change from Baseline - Day 7
|
9.0 mmHg
Standard Deviation 10.58
|
-1.3 mmHg
Standard Deviation 6.81
|
6.3 mmHg
Standard Deviation 3.06
|
6.0 mmHg
Standard Deviation 6.08
|
7.0 mmHg
Standard Deviation 5.44
|
3.2 mmHg
Standard Deviation 7.08
|
4.2 mmHg
Standard Deviation 3.87
|
0.7 mmHg
Standard Deviation 7.34
|
0.2 mmHg
Standard Deviation 7.33
|
6.5 mmHg
Standard Deviation 8.57
|
-5.0 mmHg
Standard Deviation 15.62
|
5.3 mmHg
Standard Deviation 10.63
|
7.4 mmHg
Standard Deviation 14.39
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1, 2, 3, 4, 7 and 28Population: Safety population: all participants who received any amount of study drug.
Systolic blood pressure measurements were measured at specific time points.
Outcome measures
| Measure |
Cohort 1: 100 mg PB2452 (no Ticagrelor)
n=3 Participants
PB2452 Infusion: single 30-minute IV infusion of 100 mg PB2452
|
Cohort 2: 300 mg PB2452 (no Ticagrelor)
n=3 Participants
PB2452 Infusion: single 30-minute IV infusion of 300 mg PB2452
|
Cohort 3: 1000 mg PB2452 (no Ticagrelor)
n=3 Participants
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
|
Cohort 1 to 3: Placebo
n=3 Participants
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 4: 1000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 5: 3000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 3000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 6: 9000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 9000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 4 to 6: Placebo
n=6 Participants
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 7: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 8 hours
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 8: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 12 hours
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 9: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=3 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 20 minutes
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 10: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 12 minutes
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 7 to 10: Placebo
n=7 Participants
Placebo - Sodium Chloride: single 8-hour to 16.5-hour IV infusion of placebo
|
All PB2452
All participants in any cohorts who received PB2452.
|
All Placebo
All participants in any cohorts who received placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Systolic Blood Pressure
Change from Baseline - Day 1/0.5 Hour
|
3.0 mmHg
Standard Deviation 15.10
|
-0.7 mmHg
Standard Deviation 8.33
|
6.7 mmHg
Standard Deviation 6.51
|
0.3 mmHg
Standard Deviation 12.86
|
-4.8 mmHg
Standard Deviation 4.75
|
-0.3 mmHg
Standard Deviation 2.42
|
1.3 mmHg
Standard Deviation 2.73
|
-3.0 mmHg
Standard Deviation 6.87
|
1.5 mmHg
Standard Deviation 6.61
|
-0.3 mmHg
Standard Deviation 8.30
|
4.7 mmHg
Standard Deviation 7.37
|
-1.7 mmHg
Standard Deviation 4.63
|
-0.7 mmHg
Standard Deviation 4.68
|
—
|
—
|
|
Change in Systolic Blood Pressure
Change from Baseline - Day 1/0.75 Hour
|
4.0 mmHg
Standard Deviation 5.00
|
2.0 mmHg
Standard Deviation 4.36
|
2.3 mmHg
Standard Deviation 6.03
|
1.0 mmHg
Standard Deviation 13.23
|
-1.2 mmHg
Standard Deviation 6.24
|
0.2 mmHg
Standard Deviation 3.43
|
2.8 mmHg
Standard Deviation 2.93
|
1.3 mmHg
Standard Deviation 8.12
|
11.5 mmHg
Standard Deviation 12.93
|
-1.2 mmHg
Standard Deviation 11.13
|
-6.0 mmHg
Standard Deviation 5.29
|
-3.3 mmHg
Standard Deviation 4.80
|
-1.4 mmHg
Standard Deviation 7.28
|
—
|
—
|
|
Change in Systolic Blood Pressure
Change from Baseline - Day 1/1 Hour
|
7.7 mmHg
Standard Deviation 5.13
|
2.7 mmHg
Standard Deviation 3.06
|
3.0 mmHg
Standard Deviation 4.58
|
2.0 mmHg
Standard Deviation 4.36
|
2.7 mmHg
Standard Deviation 5.20
|
1.7 mmHg
Standard Deviation 5.61
|
1.2 mmHg
Standard Deviation 1.72
|
-0.5 mmHg
Standard Deviation 6.44
|
8.0 mmHg
Standard Deviation 12.21
|
0.2 mmHg
Standard Deviation 6.85
|
4.7 mmHg
Standard Deviation 7.57
|
-1.7 mmHg
Standard Deviation 6.65
|
1.0 mmHg
Standard Deviation 9.04
|
—
|
—
|
|
Change in Systolic Blood Pressure
Change from Baseline - Day 1/2 Hour
|
5.7 mmHg
Standard Deviation 10.21
|
-1.3 mmHg
Standard Deviation 4.93
|
1.7 mmHg
Standard Deviation 9.07
|
-0.3 mmHg
Standard Deviation 5.86
|
-2.5 mmHg
Standard Deviation 10.19
|
-1.2 mmHg
Standard Deviation 4.45
|
0.3 mmHg
Standard Deviation 5.79
|
-1.7 mmHg
Standard Deviation 5.61
|
7.8 mmHg
Standard Deviation 7.44
|
-3.2 mmHg
Standard Deviation 10.15
|
-4.7 mmHg
Standard Deviation 2.52
|
1.0 mmHg
Standard Deviation 2.12
|
1.0 mmHg
Standard Deviation 6.22
|
—
|
—
|
|
Change in Systolic Blood Pressure
Change from Baseline - Day 1/4 Hour
|
5.7 mmHg
Standard Deviation 9.87
|
-4.0 mmHg
Standard Deviation 3.61
|
1.3 mmHg
Standard Deviation 3.21
|
-1.3 mmHg
Standard Deviation 8.14
|
-2.3 mmHg
Standard Deviation 3.50
|
-1.5 mmHg
Standard Deviation 4.32
|
-1.3 mmHg
Standard Deviation 5.13
|
-0.8 mmHg
Standard Deviation 7.78
|
0.3 mmHg
Standard Deviation 3.14
|
-1.7 mmHg
Standard Deviation 13.29
|
-7.0 mmHg
Standard Deviation 16.52
|
1.2 mmHg
Standard Deviation 6.49
|
0.1 mmHg
Standard Deviation 11.35
|
—
|
—
|
|
Change in Systolic Blood Pressure
Change from Baseline - Day 1/8 Hour
|
0.7 mmHg
Standard Deviation 11.02
|
-1.0 mmHg
Standard Deviation 4.36
|
-2.0 mmHg
Standard Deviation 1.73
|
-1.3 mmHg
Standard Deviation 18.77
|
-2.2 mmHg
Standard Deviation 11.05
|
-2.3 mmHg
Standard Deviation 3.67
|
1.8 mmHg
Standard Deviation 10.30
|
0 mmHg
Standard Deviation 6.32
|
-0.8 mmHg
Standard Deviation 6.18
|
-4.8 mmHg
Standard Deviation 10.28
|
-11.7 mmHg
Standard Deviation 8.62
|
0.8 mmHg
Standard Deviation 6.62
|
-0.7 mmHg
Standard Deviation 11.43
|
—
|
—
|
|
Change in Systolic Blood Pressure
Change from Baseline - Day 2/24 Hour
|
4.7 mmHg
Standard Deviation 5.13
|
-3.7 mmHg
Standard Deviation 11.59
|
5.7 mmHg
Standard Deviation 7.77
|
3.7 mmHg
Standard Deviation 9.61
|
-2.8 mmHg
Standard Deviation 3.71
|
-1.7 mmHg
Standard Deviation 5.96
|
3.5 mmHg
Standard Deviation 8.46
|
1.8 mmHg
Standard Deviation 8.35
|
1.3 mmHg
Standard Deviation 6.09
|
-7.0 mmHg
Standard Deviation 16.46
|
1.7 mmHg
Standard Deviation 12.86
|
-0.5 mmHg
Standard Deviation 8.60
|
1.9 mmHg
Standard Deviation 7.95
|
—
|
—
|
|
Change in Systolic Blood Pressure
Change from Baseline - Day 2/30 Hour
|
4.0 mmHg
Standard Deviation 12.12
|
1.0 mmHg
Standard Deviation 10.15
|
0.7 mmHg
Standard Deviation 4.51
|
4.3 mmHg
Standard Deviation 12.10
|
-3.3 mmHg
Standard Deviation 6.86
|
-4.2 mmHg
Standard Deviation 11.27
|
-0.7 mmHg
Standard Deviation 6.22
|
-4.0 mmHg
Standard Deviation 8.79
|
-1.5 mmHg
Standard Deviation 2.26
|
-3.7 mmHg
Standard Deviation 13.91
|
-0.7 mmHg
Standard Deviation 15.95
|
-4.0 mmHg
Standard Deviation 6.13
|
-3.3 mmHg
Standard Deviation 14.07
|
—
|
—
|
|
Change in Systolic Blood Pressure
Change from Baseline - Day 2/36 Hour
|
1.0 mmHg
Standard Deviation 6.08
|
-0.7 mmHg
Standard Deviation 7.77
|
5.0 mmHg
Standard Deviation 6.00
|
-2.7 mmHg
Standard Deviation 5.86
|
3.8 mmHg
Standard Deviation 10.40
|
2.2 mmHg
Standard Deviation 5.23
|
-2.8 mmHg
Standard Deviation 8.52
|
-0.2 mmHg
Standard Deviation 11.62
|
1.0 mmHg
Standard Deviation 4.10
|
-3.0 mmHg
Standard Deviation 11.26
|
-0.7 mmHg
Standard Deviation 15.14
|
1.5 mmHg
Standard Deviation 9.97
|
1.9 mmHg
Standard Deviation 13.12
|
—
|
—
|
|
Change in Systolic Blood Pressure
Change from Baseline - Day 3/42 Hour
|
2.3 mmHg
Standard Deviation 9.07
|
-9.7 mmHg
Standard Deviation 2.52
|
3.0 mmHg
Standard Deviation 12.12
|
-6.0 mmHg
Standard Deviation 4.58
|
-8.2 mmHg
Standard Deviation 8.77
|
-3.3 mmHg
Standard Deviation 8.31
|
-3.0 mmHg
Standard Deviation 6.69
|
-3.8 mmHg
Standard Deviation 10.46
|
-7.7 mmHg
Standard Deviation 7.63
|
-10.0 mmHg
Standard Deviation 12.96
|
-2.7 mmHg
Standard Deviation 14.15
|
-7.3 mmHg
Standard Deviation 14.79
|
-7.7 mmHg
Standard Deviation 17.97
|
—
|
—
|
|
Change in Systolic Blood Pressure
Change from Baseline - Day 3/48 Hour
|
2.0 mmHg
Standard Deviation 8.72
|
5.3 mmHg
Standard Deviation 7.57
|
0.3 mmHg
Standard Deviation 7.77
|
0.3 mmHg
Standard Deviation 3.21
|
3.8 mmHg
Standard Deviation 7.78
|
3.7 mmHg
Standard Deviation 7.97
|
4.3 mmHg
Standard Deviation 8.98
|
1.5 mmHg
Standard Deviation 6.25
|
1.0 mmHg
Standard Deviation 5.90
|
-0.5 mmHg
Standard Deviation 11.26
|
3.0 mmHg
Standard Deviation 11.53
|
-2.3 mmHg
Standard Deviation 12.42
|
-1.1 mmHg
Standard Deviation 12.39
|
—
|
—
|
|
Change in Systolic Blood Pressure
Change from Baseline - Day 4
|
15.0 mmHg
Standard Deviation 2.65
|
1.0 mmHg
Standard Deviation 5.57
|
2.3 mmHg
Standard Deviation 9.07
|
6.3 mmHg
Standard Deviation 3.79
|
1.0 mmHg
Standard Deviation 3.95
|
2.3 mmHg
Standard Deviation 5.16
|
-2.3 mmHg
Standard Deviation 6.98
|
6.7 mmHg
Standard Deviation 11.34
|
2.7 mmHg
Standard Deviation 10.58
|
-5.3 mmHg
Standard Deviation 11.22
|
-4.3 mmHg
Standard Deviation 14.47
|
1.3 mmHg
Standard Deviation 7.87
|
-4.4 mmHg
Standard Deviation 12.95
|
—
|
—
|
|
Change in Systolic Blood Pressure
Change from Baseline - Day 7
|
11.7 mmHg
Standard Deviation 5.51
|
5.7 mmHg
Standard Deviation 15.50
|
6.3 mmHg
Standard Deviation 13.50
|
7.7 mmHg
Standard Deviation 7.51
|
4.8 mmHg
Standard Deviation 5.91
|
5.2 mmHg
Standard Deviation 6.68
|
0.2 mmHg
Standard Deviation 4.58
|
1.7 mmHg
Standard Deviation 10.97
|
1.6 mmHg
Standard Deviation 10.21
|
3.5 mmHg
Standard Deviation 12.82
|
3.3 mmHg
Standard Deviation 16.62
|
4.5 mmHg
Standard Deviation 8.69
|
10.1 mmHg
Standard Deviation 13.80
|
—
|
—
|
|
Change in Systolic Blood Pressure
Change from Baseline - Day 28
|
12.0 mmHg
Standard Deviation 7.21
|
6.3 mmHg
Standard Deviation 6.51
|
1.0 mmHg
Standard Deviation 8.19
|
0.7 mmHg
Standard Deviation 8.74
|
10.0 mmHg
Standard Deviation 10.55
|
3.5 mmHg
Standard Deviation 9.83
|
6.0 mmHg
Standard Deviation 7.46
|
0.8 mmHg
Standard Deviation 8.38
|
8.7 mmHg
Standard Deviation 4.93
|
3.8 mmHg
Standard Deviation 10.19
|
-0.3 mmHg
Standard Deviation 17.01
|
8.7 mmHg
Standard Deviation 11.04
|
10.6 mmHg
Standard Deviation 12.91
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1, 2, 3, 4, 7 and 28Population: Safety population: all participants who received any amount of study drug.
Body temperature measurements were measured at specific time points.
Outcome measures
| Measure |
Cohort 1: 100 mg PB2452 (no Ticagrelor)
n=3 Participants
PB2452 Infusion: single 30-minute IV infusion of 100 mg PB2452
|
Cohort 2: 300 mg PB2452 (no Ticagrelor)
n=3 Participants
PB2452 Infusion: single 30-minute IV infusion of 300 mg PB2452
|
Cohort 3: 1000 mg PB2452 (no Ticagrelor)
n=3 Participants
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
|
Cohort 1 to 3: Placebo
n=3 Participants
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 4: 1000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 5: 3000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 3000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 6: 9000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 9000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 4 to 6: Placebo
n=6 Participants
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 7: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 8 hours
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 8: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 12 hours
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 9: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=3 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 20 minutes
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 10: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 12 minutes
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 7 to 10: Placebo
n=7 Participants
Placebo - Sodium Chloride: single 8-hour to 16.5-hour IV infusion of placebo
|
All PB2452
All participants in any cohorts who received PB2452.
|
All Placebo
All participants in any cohorts who received placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change In Oral Body Temperature
Change from Baseline - Day 1/0.75 Hour
|
0.03 Degrees Celsius
Standard Deviation 0.231
|
-0.20 Degrees Celsius
Standard Deviation 0.361
|
0.13 Degrees Celsius
Standard Deviation 0.115
|
0 Degrees Celsius
Standard Deviation 0.265
|
0.12 Degrees Celsius
Standard Deviation 0.248
|
0.07 Degrees Celsius
Standard Deviation 0.234
|
-0.03 Degrees Celsius
Standard Deviation 0.301
|
0.03 Degrees Celsius
Standard Deviation 0.273
|
0.07 Degrees Celsius
Standard Deviation 0.186
|
0.03 Degrees Celsius
Standard Deviation 0.242
|
0.10 Degrees Celsius
Standard Deviation 0.173
|
0.03 Degrees Celsius
Standard Deviation 0.186
|
0.03 Degrees Celsius
Standard Deviation 0.304
|
—
|
—
|
|
Change In Oral Body Temperature
Change from Baseline - Day 2/36 Hour
|
0.17 Degrees Celsius
Standard Deviation 0.666
|
-0.47 Degrees Celsius
Standard Deviation 0.351
|
0.30 Degrees Celsius
Standard Deviation 0.361
|
0.23 Degrees Celsius
Standard Deviation 0.306
|
0.18 Degrees Celsius
Standard Deviation 0.232
|
0.03 Degrees Celsius
Standard Deviation 0.280
|
-0.10 Degrees Celsius
Standard Deviation 0.253
|
0.07 Degrees Celsius
Standard Deviation 0.273
|
-0.10 Degrees Celsius
Standard Deviation 0.283
|
-0.27 Degrees Celsius
Standard Deviation 0.250
|
0.13 Degrees Celsius
Standard Deviation 0.416
|
-0.03 Degrees Celsius
Standard Deviation 0.423
|
-0.11 Degrees Celsius
Standard Deviation 0.463
|
—
|
—
|
|
Change In Oral Body Temperature
Change from Baseline - Day 3/42 Hour
|
-0.10 Degrees Celsius
Standard Deviation 0.400
|
-0.83 Degrees Celsius
Standard Deviation 0.231
|
-0.30 Degrees Celsius
Standard Deviation 0.200
|
-0.33 Degrees Celsius
Standard Deviation 0.603
|
-0.37 Degrees Celsius
Standard Deviation 0.314
|
-0.23 Degrees Celsius
Standard Deviation 0.333
|
-0.43 Degrees Celsius
Standard Deviation 0.403
|
-0.38 Degrees Celsius
Standard Deviation 0.343
|
-0.57 Degrees Celsius
Standard Deviation 0.163
|
-0.28 Degrees Celsius
Standard Deviation 0.454
|
-0.37 Degrees Celsius
Standard Deviation 0.208
|
-0.52 Degrees Celsius
Standard Deviation 0.232
|
-0.29 Degrees Celsius
Standard Deviation 0.353
|
—
|
—
|
|
Change In Oral Body Temperature
Change from Baseline - Day 3/48 Hour
|
-0.20 Degrees Celsius
Standard Deviation 0.529
|
-0.27 Degrees Celsius
Standard Deviation 0.058
|
-0.13 Degrees Celsius
Standard Deviation 0.208
|
-0.20 Degrees Celsius
Standard Deviation 0.200
|
0.18 Degrees Celsius
Standard Deviation 0.172
|
-0.20 Degrees Celsius
Standard Deviation 0.261
|
-0.37 Degrees Celsius
Standard Deviation 0.497
|
-0.10 Degrees Celsius
Standard Deviation 0.374
|
0.03 Degrees Celsius
Standard Deviation 0.333
|
-0.20 Degrees Celsius
Standard Deviation 0.276
|
0.10 Degrees Celsius
Standard Deviation 0.100
|
-0.23 Degrees Celsius
Standard Deviation 0.372
|
-0.01 Degrees Celsius
Standard Deviation 0.344
|
—
|
—
|
|
Change In Oral Body Temperature
Change from Baseline - Day 4
|
0 Degrees Celsius
Standard Deviation 0.300
|
-0.27 Degrees Celsius
Standard Deviation 0.153
|
0.07 Degrees Celsius
Standard Deviation 0.404
|
-0.27 Degrees Celsius
Standard Deviation 0.651
|
0.10 Degrees Celsius
Standard Deviation 0.438
|
0.08 Degrees Celsius
Standard Deviation 0.417
|
-0.15 Degrees Celsius
Standard Deviation 0.327
|
-0.12 Degrees Celsius
Standard Deviation 0.488
|
-0.33 Degrees Celsius
Standard Deviation 0.294
|
-0.08 Degrees Celsius
Standard Deviation 0.293
|
0.33 Degrees Celsius
Standard Deviation 0.306
|
-0.20 Degrees Celsius
Standard Deviation 0.283
|
0.03 Degrees Celsius
Standard Deviation 0.293
|
—
|
—
|
|
Change In Oral Body Temperature
Change from Baseline - Day 7
|
-0.03 Degrees Celsius
Standard Deviation 0.551
|
-0.53 Degrees Celsius
Standard Deviation 0.404
|
0 Degrees Celsius
Standard Deviation 0.265
|
-0.50 Degrees Celsius
Standard Deviation 0.700
|
-0.13 Degrees Celsius
Standard Deviation 0.333
|
0.50 Degrees Celsius
Standard Deviation 0.363
|
-0.32 Degrees Celsius
Standard Deviation 0.293
|
-0.08 Degrees Celsius
Standard Deviation 0.147
|
-0.04 Degrees Celsius
Standard Deviation 0.241
|
-0.33 Degrees Celsius
Standard Deviation 0.367
|
0.37 Degrees Celsius
Standard Deviation 0.231
|
-0.43 Degrees Celsius
Standard Deviation 0.468
|
-0.14 Degrees Celsius
Standard Deviation 0.294
|
—
|
—
|
|
Change In Oral Body Temperature
Change from Baseline - Day 28
|
-0.20 Degrees Celsius
Standard Deviation 0.624
|
-0.43 Degrees Celsius
Standard Deviation 0.058
|
-0.10 Degrees Celsius
Standard Deviation 0.200
|
-0.37 Degrees Celsius
Standard Deviation 0.569
|
-0.20 Degrees Celsius
Standard Deviation 0.303
|
0.03 Degrees Celsius
Standard Deviation 0.408
|
-0.03 Degrees Celsius
Standard Deviation 0.383
|
-0.18 Degrees Celsius
Standard Deviation 0.293
|
-0.08 Degrees Celsius
Standard Deviation 0.458
|
-0.45 Degrees Celsius
Standard Deviation 0.302
|
-0.07 Degrees Celsius
Standard Deviation 0.651
|
-0.35 Degrees Celsius
Standard Deviation 0.509
|
-0.13 Degrees Celsius
Standard Deviation 0.390
|
—
|
—
|
|
Change In Oral Body Temperature
Change from Baseline - Day 1/0.5 Hour
|
—
|
—
|
-0.23 Degrees Celsius
Standard Deviation 0.321
|
0.30 Degrees Celsius
Standard Deviation NA
The "n" for this parameter at Day 1/0.5h is 1, therefore, there is no standard deviation.
|
0.12 Degrees Celsius
Standard Deviation 0.183
|
-0.05 Degrees Celsius
Standard Deviation 0.217
|
-0.15 Degrees Celsius
Standard Deviation 0.207
|
-0.02 Degrees Celsius
Standard Deviation 0.313
|
0.05 Degrees Celsius
Standard Deviation 0.265
|
-0.03 Degrees Celsius
Standard Deviation 0.465
|
-0.17 Degrees Celsius
Standard Deviation 0.473
|
-0.10 Degrees Celsius
Standard Deviation 0.141
|
-0.41 Degrees Celsius
Standard Deviation 1.512
|
—
|
—
|
|
Change In Oral Body Temperature
Change from Baseline - Day 1/1 Hour
|
-0.13 Degrees Celsius
Standard Deviation 0.306
|
-0.17 Degrees Celsius
Standard Deviation 0.208
|
0.07 Degrees Celsius
Standard Deviation 0.231
|
-0.57 Degrees Celsius
Standard Deviation 1.002
|
0.07 Degrees Celsius
Standard Deviation 0.186
|
-0.05 Degrees Celsius
Standard Deviation 0.308
|
-0.13 Degrees Celsius
Standard Deviation 0.121
|
0 Degrees Celsius
Standard Deviation 0.434
|
0 Degrees Celsius
Standard Deviation 0.228
|
-0.07 Degrees Celsius
Standard Deviation 0.197
|
0.10 Degrees Celsius
Standard Deviation 0.265
|
-0.05 Degrees Celsius
Standard Deviation 0.207
|
0.01 Degrees Celsius
Standard Deviation 0.402
|
—
|
—
|
|
Change In Oral Body Temperature
Change from Baseline - Day 1/2 Hour
|
-0.03 Degrees Celsius
Standard Deviation 0.379
|
-0.03 Degrees Celsius
Standard Deviation 0.115
|
0.17 Degrees Celsius
Standard Deviation 0.351
|
0.10 Degrees Celsius
Standard Deviation 0
|
0.05 Degrees Celsius
Standard Deviation 0.187
|
-0.02 Degrees Celsius
Standard Deviation 0.248
|
-0.03 Degrees Celsius
Standard Deviation 0.207
|
0.10 Degrees Celsius
Standard Deviation 0.341
|
0.07 Degrees Celsius
Standard Deviation 0.339
|
-0.08 Degrees Celsius
Standard Deviation 0.194
|
0.10 Degrees Celsius
Standard Deviation 0.200
|
-0.20 Degrees Celsius
Standard Deviation 0.274
|
0 Degrees Celsius
Standard Deviation 0.277
|
—
|
—
|
|
Change In Oral Body Temperature
Change from Baseline - Day 1/4 Hour
|
0.17 Degrees Celsius
Standard Deviation 0.289
|
-0.20 Degrees Celsius
Standard Deviation 0.200
|
0.07 Degrees Celsius
Standard Deviation 0.058
|
0.17 Degrees Celsius
Standard Deviation 0.153
|
0.10 Degrees Celsius
Standard Deviation 0.155
|
0.18 Degrees Celsius
Standard Deviation 0.271
|
0.07 Degrees Celsius
Standard Deviation 0.294
|
0.20 Degrees Celsius
Standard Deviation 0.253
|
0.07 Degrees Celsius
Standard Deviation 0.403
|
0.22 Degrees Celsius
Standard Deviation 0.479
|
0.20 Degrees Celsius
Standard Deviation 0.361
|
0.13 Degrees Celsius
Standard Deviation 0.361
|
0.13 Degrees Celsius
Standard Deviation 0.350
|
—
|
—
|
|
Change In Oral Body Temperature
Change from Baseline - Day 1/8 Hour
|
0.30 Degrees Celsius
Standard Deviation 0.436
|
0.07 Degrees Celsius
Standard Deviation 0.153
|
0.03 Degrees Celsius
Standard Deviation 0.153
|
0.60 Degrees Celsius
Standard Deviation 0.624
|
0.18 Degrees Celsius
Standard Deviation 0.248
|
0.33 Degrees Celsius
Standard Deviation 0.585
|
-0.07 Degrees Celsius
Standard Deviation 0.383
|
-0.07 Degrees Celsius
Standard Deviation 0.225
|
0.17 Degrees Celsius
Standard Deviation 0.273
|
0.04 Degrees Celsius
Standard Deviation 0.288
|
0.27 Degrees Celsius
Standard Deviation 0.058
|
0.03 Degrees Celsius
Standard Deviation 0.288
|
0.10 Degrees Celsius
Standard Deviation 0.346
|
—
|
—
|
|
Change In Oral Body Temperature
Change from Baseline - Day 2/24 Hour
|
-0.13 Degrees Celsius
Standard Deviation 0.306
|
-0.43 Degrees Celsius
Standard Deviation 0.058
|
-0.13 Degrees Celsius
Standard Deviation 0.306
|
-0.17 Degrees Celsius
Standard Deviation 0.404
|
0.20 Degrees Celsius
Standard Deviation 0.297
|
-0.08 Degrees Celsius
Standard Deviation 0.264
|
-0.18 Degrees Celsius
Standard Deviation 0.325
|
-0.15 Degrees Celsius
Standard Deviation 0.226
|
-0.32 Degrees Celsius
Standard Deviation 0.397
|
-0.15 Degrees Celsius
Standard Deviation 0.356
|
-0.10 Degrees Celsius
Standard Deviation 0.100
|
-0.18 Degrees Celsius
Standard Deviation 0.454
|
-0.30 Degrees Celsius
Standard Deviation 0.416
|
—
|
—
|
|
Change In Oral Body Temperature
Change from Baseline - Day 2/30 Hour
|
0.30 Degrees Celsius
Standard Deviation 0.608
|
-0.30 Degrees Celsius
Standard Deviation 0.100
|
-0.17 Degrees Celsius
Standard Deviation 0.058
|
0.27 Degrees Celsius
Standard Deviation 0.153
|
0.30 Degrees Celsius
Standard Deviation 0.303
|
0.20 Degrees Celsius
Standard Deviation 0.316
|
-0.17 Degrees Celsius
Standard Deviation 0.592
|
-0.03 Degrees Celsius
Standard Deviation 0.361
|
0.02 Degrees Celsius
Standard Deviation 0.343
|
0 Degrees Celsius
Standard Deviation 0.590
|
-0.17 Degrees Celsius
Standard Deviation 0.404
|
-0.15 Degrees Celsius
Standard Deviation 0.251
|
-0.07 Degrees Celsius
Standard Deviation 0.419
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1, 2, 3, 4, 7 and 28Population: Safety population: all participants who received any amount of study drug.
Respiratory rate measurements were measured at specific time points.
Outcome measures
| Measure |
Cohort 1: 100 mg PB2452 (no Ticagrelor)
n=3 Participants
PB2452 Infusion: single 30-minute IV infusion of 100 mg PB2452
|
Cohort 2: 300 mg PB2452 (no Ticagrelor)
n=3 Participants
PB2452 Infusion: single 30-minute IV infusion of 300 mg PB2452
|
Cohort 3: 1000 mg PB2452 (no Ticagrelor)
n=3 Participants
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
|
Cohort 1 to 3: Placebo
n=3 Participants
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 4: 1000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 5: 3000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 3000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 6: 9000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 9000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 4 to 6: Placebo
n=6 Participants
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 7: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 8 hours
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 8: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 12 hours
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 9: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=3 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 20 minutes
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 10: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 12 minutes
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 7 to 10: Placebo
n=7 Participants
Placebo - Sodium Chloride: single 8-hour to 16.5-hour IV infusion of placebo
|
All PB2452
All participants in any cohorts who received PB2452.
|
All Placebo
All participants in any cohorts who received placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change In Respiratory Rate
Change from Baseline - Day 1/0.5 Hour
|
0 Breaths per minute
Standard Deviation 0
|
0 Breaths per minute
Standard Deviation 0
|
-2.0 Breaths per minute
Standard Deviation 0
|
-2.0 Breaths per minute
Standard Deviation NA
The "n" for this parameter at Day 1/0.5h is 1, therefore, there is no standard deviation.
|
-1.3 Breaths per minute
Standard Deviation 3.27
|
0.3 Breaths per minute
Standard Deviation 2.94
|
0 Breaths per minute
Standard Deviation 0
|
-1.0 Breaths per minute
Standard Deviation 2.10
|
0.5 Breaths per minute
Standard Deviation 1.91
|
-1.0 Breaths per minute
Standard Deviation 1.15
|
-0.7 Breaths per minute
Standard Deviation 3.06
|
-0.7 Breaths per minute
Standard Deviation 3.01
|
-0.6 Breaths per minute
Standard Deviation 3.60
|
—
|
—
|
|
Change In Respiratory Rate
Change from Baseline - Day 1/0.75 Hour
|
-0.7 Breaths per minute
Standard Deviation 2.31
|
3.3 Breaths per minute
Standard Deviation 1.15
|
-1.3 Breaths per minute
Standard Deviation 3.06
|
-1.3 Breaths per minute
Standard Deviation 4.16
|
-1.3 Breaths per minute
Standard Deviation 4.32
|
0 Breaths per minute
Standard Deviation 2.19
|
0.7 Breaths per minute
Standard Deviation 1.63
|
-1.7 Breaths per minute
Standard Deviation 2.94
|
-0.7 Breaths per minute
Standard Deviation 3.50
|
-1.0 Breaths per minute
Standard Deviation 2.45
|
-2.0 Breaths per minute
Standard Deviation 4.00
|
-0.3 Breaths per minute
Standard Deviation 3.20
|
-0.9 Breaths per minute
Standard Deviation 2.27
|
—
|
—
|
|
Change In Respiratory Rate
Change from Baseline - Day 1/1 Hour
|
-3.3 Breaths per minute
Standard Deviation 2.31
|
2.7 Breaths per minute
Standard Deviation 2.31
|
0.7 Breaths per minute
Standard Deviation 3.06
|
-1.3 Breaths per minute
Standard Deviation 4.16
|
-1.0 Breaths per minute
Standard Deviation 3.95
|
0.3 Breaths per minute
Standard Deviation 2.34
|
1.3 Breaths per minute
Standard Deviation 1.03
|
-0.3 Breaths per minute
Standard Deviation 2.94
|
-0.7 Breaths per minute
Standard Deviation 2.07
|
0 Breaths per minute
Standard Deviation 2.83
|
-2.7 Breaths per minute
Standard Deviation 3.06
|
-1.0 Breaths per minute
Standard Deviation 3.29
|
0.3 Breaths per minute
Standard Deviation 3.90
|
—
|
—
|
|
Change In Respiratory Rate
Change from Baseline - Day 1/2 Hour
|
-1.3 Breaths per minute
Standard Deviation 1.15
|
0 Breaths per minute
Standard Deviation 2.00
|
0.7 Breaths per minute
Standard Deviation 2.31
|
0 Breaths per minute
Standard Deviation 2.00
|
-1.3 Breaths per minute
Standard Deviation 3.01
|
1.3 Breaths per minute
Standard Deviation 3.27
|
3.3 Breaths per minute
Standard Deviation 1.63
|
0 Breaths per minute
Standard Deviation 3.35
|
0.7 Breaths per minute
Standard Deviation 3.01
|
0.3 Breaths per minute
Standard Deviation 2.66
|
-0.7 Breaths per minute
Standard Deviation 5.03
|
-0.8 Breaths per minute
Standard Deviation 3.03
|
1.4 Breaths per minute
Standard Deviation 3.60
|
—
|
—
|
|
Change In Respiratory Rate
Change from Baseline - Day 1/4 Hour
|
-0.7 Breaths per minute
Standard Deviation 1.15
|
0 Breaths per minute
Standard Deviation 2.00
|
-2.0 Breaths per minute
Standard Deviation 2.00
|
-0.7 Breaths per minute
Standard Deviation 3.06
|
-2.3 Breaths per minute
Standard Deviation 4.63
|
1.0 Breaths per minute
Standard Deviation 2.10
|
1.7 Breaths per minute
Standard Deviation 2.34
|
0 Breaths per minute
Standard Deviation 1.26
|
0.3 Breaths per minute
Standard Deviation 4.27
|
0.3 Breaths per minute
Standard Deviation 0.82
|
2.0 Breaths per minute
Standard Deviation 4.00
|
-2.3 Breaths per minute
Standard Deviation 2.34
|
-0.3 Breaths per minute
Standard Deviation 3.73
|
—
|
—
|
|
Change In Respiratory Rate
Change from Baseline - Day 1/8 Hour
|
1.3 Breaths per minute
Standard Deviation 3.06
|
5.3 Breaths per minute
Standard Deviation 1.15
|
-2.0 Breaths per minute
Standard Deviation 4.00
|
1.3 Breaths per minute
Standard Deviation 7.02
|
-0.3 Breaths per minute
Standard Deviation 2.94
|
3.0 Breaths per minute
Standard Deviation 2.76
|
-1.0 Breaths per minute
Standard Deviation 2.76
|
0.3 Breaths per minute
Standard Deviation 3.20
|
2.0 Breaths per minute
Standard Deviation 2.53
|
-2.0 Breaths per minute
Standard Deviation 5.83
|
-2.0 Breaths per minute
Standard Deviation 5.29
|
-0.3 Breaths per minute
Standard Deviation 0.82
|
0.6 Breaths per minute
Standard Deviation 4.58
|
—
|
—
|
|
Change In Respiratory Rate
Change from Baseline - Day 2/24 Hour
|
-2.0 Breaths per minute
Standard Deviation 0
|
1.3 Breaths per minute
Standard Deviation 3.06
|
-0.7 Breaths per minute
Standard Deviation 2.31
|
0.7 Breaths per minute
Standard Deviation 2.31
|
-3.0 Breaths per minute
Standard Deviation 3.03
|
-1.0 Breaths per minute
Standard Deviation 2.10
|
2.3 Breaths per minute
Standard Deviation 2.66
|
-1.0 Breaths per minute
Standard Deviation 2.10
|
-1.0 Breaths per minute
Standard Deviation 2.10
|
-1.0 Breaths per minute
Standard Deviation 3.03
|
-3.3 Breaths per minute
Standard Deviation 1.15
|
-1.3 Breaths per minute
Standard Deviation 4.32
|
-1.4 Breaths per minute
Standard Deviation 2.51
|
—
|
—
|
|
Change In Respiratory Rate
Change from Baseline - Day 2/30 Hour
|
2.7 Breaths per minute
Standard Deviation 3.06
|
3.3 Breaths per minute
Standard Deviation 2.31
|
0.7 Breaths per minute
Standard Deviation 1.15
|
1.3 Breaths per minute
Standard Deviation 5.03
|
0.7 Breaths per minute
Standard Deviation 4.84
|
1.0 Breaths per minute
Standard Deviation 2.10
|
2.7 Breaths per minute
Standard Deviation 2.42
|
0 Breaths per minute
Standard Deviation 5.51
|
-2.7 Breaths per minute
Standard Deviation 2.73
|
1.7 Breaths per minute
Standard Deviation 2.34
|
-0.7 Breaths per minute
Standard Deviation 4.62
|
0 Breaths per minute
Standard Deviation 1.79
|
-0.3 Breaths per minute
Standard Deviation 4.07
|
—
|
—
|
|
Change In Respiratory Rate
Change from Baseline - Day 2/36 Hour
|
2.0 Breaths per minute
Standard Deviation 4.00
|
6.0 Breaths per minute
Standard Deviation 0
|
-1.3 Breaths per minute
Standard Deviation 3.06
|
-0.7 Breaths per minute
Standard Deviation 6.43
|
-1.0 Breaths per minute
Standard Deviation 3.74
|
0.7 Breaths per minute
Standard Deviation 2.07
|
-0.7 Breaths per minute
Standard Deviation 2.07
|
-2.0 Breaths per minute
Standard Deviation 3.58
|
0.3 Breaths per minute
Standard Deviation 2.66
|
0.7 Breaths per minute
Standard Deviation 2.42
|
1.3 Breaths per minute
Standard Deviation 3.06
|
0 Breaths per minute
Standard Deviation 2.53
|
0.9 Breaths per minute
Standard Deviation 3.63
|
—
|
—
|
|
Change In Respiratory Rate
Change from Baseline - Day 3/42 Hour
|
-0.7 Breaths per minute
Standard Deviation 3.06
|
3.3 Breaths per minute
Standard Deviation 2.31
|
-4.7 Breaths per minute
Standard Deviation 2.31
|
0.7 Breaths per minute
Standard Deviation 6.11
|
-0.7 Breaths per minute
Standard Deviation 2.42
|
0.3 Breaths per minute
Standard Deviation 3.44
|
2.7 Breaths per minute
Standard Deviation 3.50
|
-1.0 Breaths per minute
Standard Deviation 2.10
|
-1.0 Breaths per minute
Standard Deviation 3.29
|
2.0 Breaths per minute
Standard Deviation 1.79
|
1.3 Breaths per minute
Standard Deviation 4.16
|
0.3 Breaths per minute
Standard Deviation 1.97
|
2.9 Breaths per minute
Standard Deviation 2.79
|
—
|
—
|
|
Change In Respiratory Rate
Change from Baseline - Day 3/48 Hour
|
-2.7 Breaths per minute
Standard Deviation 1.15
|
1.3 Breaths per minute
Standard Deviation 2.31
|
-0.7 Breaths per minute
Standard Deviation 1.15
|
1.3 Breaths per minute
Standard Deviation 3.06
|
-1.7 Breaths per minute
Standard Deviation 4.27
|
-0.3 Breaths per minute
Standard Deviation 2.34
|
0.7 Breaths per minute
Standard Deviation 2.07
|
0.3 Breaths per minute
Standard Deviation 2.34
|
-0.7 Breaths per minute
Standard Deviation 2.42
|
-0.7 Breaths per minute
Standard Deviation 1.63
|
-1.3 Breaths per minute
Standard Deviation 3.06
|
-0.7 Breaths per minute
Standard Deviation 2.73
|
0.6 Breaths per minute
Standard Deviation 3.95
|
—
|
—
|
|
Change In Respiratory Rate
Change from Baseline - Day 4
|
-0.7 Breaths per minute
Standard Deviation 6.11
|
4.7 Breaths per minute
Standard Deviation 3.06
|
-2.0 Breaths per minute
Standard Deviation 2.00
|
0.7 Breaths per minute
Standard Deviation 3.06
|
-1.0 Breaths per minute
Standard Deviation 2.10
|
-0.3 Breaths per minute
Standard Deviation 2.34
|
4.0 Breaths per minute
Standard Deviation 1.79
|
1.0 Breaths per minute
Standard Deviation 2.76
|
1.0 Breaths per minute
Standard Deviation 2.76
|
2.3 Breaths per minute
Standard Deviation 3.67
|
0 Breaths per minute
Standard Deviation 5.29
|
-0.3 Breaths per minute
Standard Deviation 1.97
|
0.3 Breaths per minute
Standard Deviation 3.15
|
—
|
—
|
|
Change In Respiratory Rate
Change from Baseline - Day 7
|
1.3 Breaths per minute
Standard Deviation 4.16
|
2.0 Breaths per minute
Standard Deviation 0
|
-1.3 Breaths per minute
Standard Deviation 1.15
|
1.3 Breaths per minute
Standard Deviation 5.03
|
-2.7 Breaths per minute
Standard Deviation 3.50
|
0.7 Breaths per minute
Standard Deviation 3.01
|
2.7 Breaths per minute
Standard Deviation 3.01
|
-1.3 Breaths per minute
Standard Deviation 1.63
|
0.4 Breaths per minute
Standard Deviation 2.61
|
3.7 Breaths per minute
Standard Deviation 1.51
|
-0.7 Breaths per minute
Standard Deviation 4.62
|
-1.0 Breaths per minute
Standard Deviation 2.10
|
1.7 Breaths per minute
Standard Deviation 2.93
|
—
|
—
|
|
Change In Respiratory Rate
Change from Baseline - Day 28
|
0.7 Breaths per minute
Standard Deviation 1.15
|
4.0 Breaths per minute
Standard Deviation 0
|
-1.3 Breaths per minute
Standard Deviation 1.15
|
1.3 Breaths per minute
Standard Deviation 3.06
|
-2.0 Breaths per minute
Standard Deviation 2.19
|
-2.0 Breaths per minute
Standard Deviation 1.26
|
0 Breaths per minute
Standard Deviation 2.19
|
-0.7 Breaths per minute
Standard Deviation 2.42
|
-0.7 Breaths per minute
Standard Deviation 4.84
|
0.7 Breaths per minute
Standard Deviation 3.27
|
0.7 Breaths per minute
Standard Deviation 4.16
|
-0.3 Breaths per minute
Standard Deviation 3.88
|
0.3 Breaths per minute
Standard Deviation 2.69
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1, 2, 3, 4, 7 and 28Population: Safety population: all participants who received any amount of study drug.
Heart rate measurements were measured at specific time points.
Outcome measures
| Measure |
Cohort 1: 100 mg PB2452 (no Ticagrelor)
n=3 Participants
PB2452 Infusion: single 30-minute IV infusion of 100 mg PB2452
|
Cohort 2: 300 mg PB2452 (no Ticagrelor)
n=3 Participants
PB2452 Infusion: single 30-minute IV infusion of 300 mg PB2452
|
Cohort 3: 1000 mg PB2452 (no Ticagrelor)
n=3 Participants
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
|
Cohort 1 to 3: Placebo
n=3 Participants
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 4: 1000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 5: 3000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 3000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 6: 9000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 9000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 4 to 6: Placebo
n=6 Participants
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 7: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 8 hours
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 8: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 12 hours
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 9: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=3 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 20 minutes
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 10: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 12 minutes
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 7 to 10: Placebo
n=7 Participants
Placebo - Sodium Chloride: single 8-hour to 16.5-hour IV infusion of placebo
|
All PB2452
All participants in any cohorts who received PB2452.
|
All Placebo
All participants in any cohorts who received placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change In Heart Rate
Change from Baseline - Day 1/0.5 Hour
|
-8.3 Beats per minute
Standard Deviation 3.21
|
4.0 Beats per minute
Standard Deviation 3.46
|
-7.0 Beats per minute
Standard Deviation 6.08
|
3.0 Beats per minute
Standard Deviation 8.00
|
3.5 Beats per minute
Standard Deviation 8.12
|
-5.5 Beats per minute
Standard Deviation 3.39
|
-0.2 Beats per minute
Standard Deviation 6.21
|
-3.0 Beats per minute
Standard Deviation 9.53
|
-2.5 Beats per minute
Standard Deviation 5.07
|
-5.5 Beats per minute
Standard Deviation 5.80
|
-4.0 Beats per minute
Standard Deviation 9.54
|
-1.0 Beats per minute
Standard Deviation 3.35
|
-4.6 Beats per minute
Standard Deviation 7.23
|
—
|
—
|
|
Change In Heart Rate
Change from Baseline - Day 2/24 Hour
|
-2.0 Beats per minute
Standard Deviation 3.00
|
9.0 Beats per minute
Standard Deviation 8.19
|
-10.7 Beats per minute
Standard Deviation 4.73
|
-0.3 Beats per minute
Standard Deviation 4.73
|
-3.0 Beats per minute
Standard Deviation 5.40
|
2.0 Beats per minute
Standard Deviation 3.85
|
0.8 Beats per minute
Standard Deviation 5.15
|
0.3 Beats per minute
Standard Deviation 10.65
|
0.8 Beats per minute
Standard Deviation 3.87
|
-4.5 Beats per minute
Standard Deviation 4.76
|
-2.0 Beats per minute
Standard Deviation 3.00
|
1.3 Beats per minute
Standard Deviation 6.41
|
-2.4 Beats per minute
Standard Deviation 5.09
|
—
|
—
|
|
Change In Heart Rate
Change from Baseline - Day 2/30 Hour
|
0 Beats per minute
Standard Deviation 6.08
|
11.7 Beats per minute
Standard Deviation 3.21
|
0 Beats per minute
Standard Deviation 3.61
|
4.3 Beats per minute
Standard Deviation 4.73
|
10.0 Beats per minute
Standard Deviation 5.22
|
6.8 Beats per minute
Standard Deviation 7.28
|
3.2 Beats per minute
Standard Deviation 6.43
|
3.5 Beats per minute
Standard Deviation 11.15
|
6.8 Beats per minute
Standard Deviation 6.55
|
6.3 Beats per minute
Standard Deviation 6.65
|
0 Beats per minute
Standard Deviation 4.36
|
8.2 Beats per minute
Standard Deviation 5.88
|
3.4 Beats per minute
Standard Deviation 5.50
|
—
|
—
|
|
Change In Heart Rate
Change from Baseline - Day 2/36 Hour
|
2.3 Beats per minute
Standard Deviation 8.50
|
12.0 Beats per minute
Standard Deviation 9.64
|
-2.0 Beats per minute
Standard Deviation 4.00
|
5.0 Beats per minute
Standard Deviation 8.54
|
9.0 Beats per minute
Standard Deviation 6.00
|
7.4 Beats per minute
Standard Deviation 5.86
|
8.8 Beats per minute
Standard Deviation 6.85
|
3.2 Beats per minute
Standard Deviation 11.89
|
8.0 Beats per minute
Standard Deviation 5.10
|
10.0 Beats per minute
Standard Deviation 8.88
|
3.3 Beats per minute
Standard Deviation 3.21
|
12.7 Beats per minute
Standard Deviation 8.73
|
2.3 Beats per minute
Standard Deviation 7.74
|
—
|
—
|
|
Change In Heart Rate
Change from Baseline - Day 1/0.75 Hour
|
-3.0 Beats per minute
Standard Deviation 1.73
|
5.7 Beats per minute
Standard Deviation 1.53
|
-6.7 Beats per minute
Standard Deviation 4.16
|
5.7 Beats per minute
Standard Deviation 7.51
|
2.2 Beats per minute
Standard Deviation 9.06
|
-0.2 Beats per minute
Standard Deviation 5.95
|
-5.2 Beats per minute
Standard Deviation 2.14
|
-1.7 Beats per minute
Standard Deviation 11.64
|
1.5 Beats per minute
Standard Deviation 3.83
|
-5.3 Beats per minute
Standard Deviation 3.39
|
-5.3 Beats per minute
Standard Deviation 6.66
|
1.3 Beats per minute
Standard Deviation 5.54
|
-2.6 Beats per minute
Standard Deviation 5.38
|
—
|
—
|
|
Change In Heart Rate
Change from Baseline - Day 1/1 Hour
|
-0.3 Beats per minute
Standard Deviation 1.53
|
4.3 Beats per minute
Standard Deviation 1.53
|
-7.0 Beats per minute
Standard Deviation 4.58
|
5.7 Beats per minute
Standard Deviation 9.29
|
2.3 Beats per minute
Standard Deviation 5.47
|
0 Beats per minute
Standard Deviation 3.58
|
-4.7 Beats per minute
Standard Deviation 3.88
|
-2.0 Beats per minute
Standard Deviation 10.71
|
0.2 Beats per minute
Standard Deviation 3.43
|
-5.7 Beats per minute
Standard Deviation 5.13
|
-7.3 Beats per minute
Standard Deviation 7.51
|
1.0 Beats per minute
Standard Deviation 2.37
|
-2.7 Beats per minute
Standard Deviation 3.59
|
—
|
—
|
|
Change In Heart Rate
Change from Baseline - Day 1/2 Hour
|
-3.7 Beats per minute
Standard Deviation 4.62
|
6.0 Beats per minute
Standard Deviation 1.00
|
-7.3 Beats per minute
Standard Deviation 6.43
|
1.3 Beats per minute
Standard Deviation 0.58
|
3.0 Beats per minute
Standard Deviation 4.10
|
1.7 Beats per minute
Standard Deviation 5.09
|
-5.0 Beats per minute
Standard Deviation 3.79
|
-2.5 Beats per minute
Standard Deviation 9.79
|
2.7 Beats per minute
Standard Deviation 11.96
|
-5.8 Beats per minute
Standard Deviation 6.62
|
-3.7 Beats per minute
Standard Deviation 9.71
|
-3.2 Beats per minute
Standard Deviation 0.84
|
-2.9 Beats per minute
Standard Deviation 6.36
|
—
|
—
|
|
Change In Heart Rate
Change from Baseline - Day 1/4 Hour
|
-0.3 Beats per minute
Standard Deviation 2.89
|
13.7 Beats per minute
Standard Deviation 4.04
|
-3.7 Beats per minute
Standard Deviation 3.21
|
5.0 Beats per minute
Standard Deviation 8.00
|
5.7 Beats per minute
Standard Deviation 4.63
|
1.8 Beats per minute
Standard Deviation 3.82
|
1.5 Beats per minute
Standard Deviation 7.53
|
3.8 Beats per minute
Standard Deviation 9.79
|
4.8 Beats per minute
Standard Deviation 2.56
|
-0.2 Beats per minute
Standard Deviation 6.11
|
-0.3 Beats per minute
Standard Deviation 3.06
|
6.0 Beats per minute
Standard Deviation 3.58
|
1.6 Beats per minute
Standard Deviation 7.81
|
—
|
—
|
|
Change In Heart Rate
Change from Baseline - Day 1/8 Hour
|
1.7 Beats per minute
Standard Deviation 5.03
|
14.7 Beats per minute
Standard Deviation 0.58
|
-5.7 Beats per minute
Standard Deviation 4.73
|
7.3 Beats per minute
Standard Deviation 14.47
|
8.0 Beats per minute
Standard Deviation 8.32
|
5.8 Beats per minute
Standard Deviation 7.76
|
3.2 Beats per minute
Standard Deviation 6.15
|
4.3 Beats per minute
Standard Deviation 15.42
|
6.5 Beats per minute
Standard Deviation 2.88
|
4.0 Beats per minute
Standard Deviation 10.65
|
2.7 Beats per minute
Standard Deviation 1.53
|
8.5 Beats per minute
Standard Deviation 6.16
|
5.9 Beats per minute
Standard Deviation 7.47
|
—
|
—
|
|
Change In Heart Rate
Change from Baseline - Day 3/42 Hour
|
2.0 Beats per minute
Standard Deviation 3.00
|
8.3 Beats per minute
Standard Deviation 4.04
|
-3.0 Beats per minute
Standard Deviation 5.57
|
2.0 Beats per minute
Standard Deviation 6.08
|
5.2 Beats per minute
Standard Deviation 8.89
|
-2.5 Beats per minute
Standard Deviation 2.35
|
4.8 Beats per minute
Standard Deviation 11.07
|
-1.8 Beats per minute
Standard Deviation 9.47
|
2.0 Beats per minute
Standard Deviation 6.96
|
-1.5 Beats per minute
Standard Deviation 6.66
|
0.7 Beats per minute
Standard Deviation 5.51
|
1.5 Beats per minute
Standard Deviation 5.68
|
-0.1 Beats per minute
Standard Deviation 9.15
|
—
|
—
|
|
Change In Heart Rate
Change from Baseline - Day 3/48 Hour
|
-1.0 Beats per minute
Standard Deviation 7.00
|
10.3 Beats per minute
Standard Deviation 7.02
|
-9.3 Beats per minute
Standard Deviation 5.86
|
-3.3 Beats per minute
Standard Deviation 5.69
|
2.8 Beats per minute
Standard Deviation 3.19
|
1.7 Beats per minute
Standard Deviation 5.82
|
-0.2 Beats per minute
Standard Deviation 5.42
|
2.0 Beats per minute
Standard Deviation 7.77
|
2.0 Beats per minute
Standard Deviation 2.00
|
-2.8 Beats per minute
Standard Deviation 6.34
|
1.7 Beats per minute
Standard Deviation 1.15
|
3.8 Beats per minute
Standard Deviation 4.79
|
-1.1 Beats per minute
Standard Deviation 5.21
|
—
|
—
|
|
Change In Heart Rate
Change from Baseline - Day 4
|
6.0 Beats per minute
Standard Deviation 8.89
|
9.0 Beats per minute
Standard Deviation 7.55
|
-8.3 Beats per minute
Standard Deviation 7.37
|
1.3 Beats per minute
Standard Deviation 12.50
|
6.7 Beats per minute
Standard Deviation 9.03
|
5.2 Beats per minute
Standard Deviation 9.89
|
-3.5 Beats per minute
Standard Deviation 3.73
|
2.5 Beats per minute
Standard Deviation 7.74
|
5.0 Beats per minute
Standard Deviation 5.40
|
3.5 Beats per minute
Standard Deviation 13.03
|
7.7 Beats per minute
Standard Deviation 7.77
|
3.5 Beats per minute
Standard Deviation 8.38
|
1.4 Beats per minute
Standard Deviation 7.96
|
—
|
—
|
|
Change In Heart Rate
Change from Baseline - Day 7
|
-4.3 Beats per minute
Standard Deviation 3.21
|
8.0 Beats per minute
Standard Deviation 11.36
|
-10.7 Beats per minute
Standard Deviation 8.74
|
0.3 Beats per minute
Standard Deviation 11.15
|
4.2 Beats per minute
Standard Deviation 8.61
|
5.8 Beats per minute
Standard Deviation 10.57
|
-5.8 Beats per minute
Standard Deviation 5.85
|
-4.8 Beats per minute
Standard Deviation 12.67
|
0.8 Beats per minute
Standard Deviation 3.96
|
-4.5 Beats per minute
Standard Deviation 8.48
|
-12.0 Beats per minute
Standard Deviation 10.39
|
2.3 Beats per minute
Standard Deviation 7.31
|
1.7 Beats per minute
Standard Deviation 7.34
|
—
|
—
|
|
Change In Heart Rate
Change from Baseline - Day 28
|
-7.7 Beats per minute
Standard Deviation 7.77
|
4.0 Beats per minute
Standard Deviation 6.56
|
-8.3 Beats per minute
Standard Deviation 8.08
|
-9.3 Beats per minute
Standard Deviation 9.07
|
-1.7 Beats per minute
Standard Deviation 5.54
|
-4.0 Beats per minute
Standard Deviation 3.63
|
-6.5 Beats per minute
Standard Deviation 8.73
|
-4.8 Beats per minute
Standard Deviation 6.85
|
-1.0 Beats per minute
Standard Deviation 3.58
|
0.2 Beats per minute
Standard Deviation 11.36
|
-12.0 Beats per minute
Standard Deviation 16.00
|
-4.7 Beats per minute
Standard Deviation 1.75
|
-0.1 Beats per minute
Standard Deviation 12.06
|
—
|
—
|
PRIMARY outcome
Timeframe: 60 days - Starting up to 28 days prior to dosingPopulation: Safety population: all participants who received any amount of study drug.
Number of participants per cohort with clinically significant ECG findings.
Outcome measures
| Measure |
Cohort 1: 100 mg PB2452 (no Ticagrelor)
n=3 Participants
PB2452 Infusion: single 30-minute IV infusion of 100 mg PB2452
|
Cohort 2: 300 mg PB2452 (no Ticagrelor)
n=3 Participants
PB2452 Infusion: single 30-minute IV infusion of 300 mg PB2452
|
Cohort 3: 1000 mg PB2452 (no Ticagrelor)
n=3 Participants
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
|
Cohort 1 to 3: Placebo
n=3 Participants
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 4: 1000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 5: 3000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 3000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 6: 9000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 9000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 4 to 6: Placebo
n=6 Participants
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 7: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 8 hours
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 8: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 12 hours
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 9: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=3 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 20 minutes
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 10: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 12 minutes
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 7 to 10: Placebo
n=7 Participants
Placebo - Sodium Chloride: single 8-hour to 16.5-hour IV infusion of placebo
|
All PB2452
All participants in any cohorts who received PB2452.
|
All Placebo
All participants in any cohorts who received placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Incidence of Clinically Significant 12-Lead Electrocardiogram (ECG) Findings
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 3 Days - Starting 1 day prior to dosing up to 2 days after dosingPopulation: Safety population: all participants who received any amount of study drug.
Number of participants per cohort with clinically significant cardiac telemetry findings.
Outcome measures
| Measure |
Cohort 1: 100 mg PB2452 (no Ticagrelor)
n=3 Participants
PB2452 Infusion: single 30-minute IV infusion of 100 mg PB2452
|
Cohort 2: 300 mg PB2452 (no Ticagrelor)
n=3 Participants
PB2452 Infusion: single 30-minute IV infusion of 300 mg PB2452
|
Cohort 3: 1000 mg PB2452 (no Ticagrelor)
n=3 Participants
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
|
Cohort 1 to 3: Placebo
n=3 Participants
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 4: 1000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 5: 3000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 3000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 6: 9000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 9000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 4 to 6: Placebo
n=6 Participants
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 7: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 8 hours
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 8: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 12 hours
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 9: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=3 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 20 minutes
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 10: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 12 minutes
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 7 to 10: Placebo
n=7 Participants
Placebo - Sodium Chloride: single 8-hour to 16.5-hour IV infusion of placebo
|
All PB2452
All participants in any cohorts who received PB2452.
|
All Placebo
All participants in any cohorts who received placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Incidence of Clinically Significant Cardiac Telemetry Findings
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day -3, Day -1, Day 7, and Day 28Population: Safety population: all participants who received any amount of study drug.
Incidence of Immunogenicity.
Outcome measures
| Measure |
Cohort 1: 100 mg PB2452 (no Ticagrelor)
n=3 Participants
PB2452 Infusion: single 30-minute IV infusion of 100 mg PB2452
|
Cohort 2: 300 mg PB2452 (no Ticagrelor)
n=3 Participants
PB2452 Infusion: single 30-minute IV infusion of 300 mg PB2452
|
Cohort 3: 1000 mg PB2452 (no Ticagrelor)
n=3 Participants
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
|
Cohort 1 to 3: Placebo
n=3 Participants
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 4: 1000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 5: 3000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 3000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 6: 9000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 9000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 4 to 6: Placebo
n=6 Participants
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 7: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 8 hours
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 8: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 12 hours
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 9: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=3 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 20 minutes
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 10: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 12 minutes
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 7 to 10: Placebo
n=7 Participants
Placebo - Sodium Chloride: single 8-hour to 16.5-hour IV infusion of placebo
|
All PB2452
n=78 Participants
All participants in any cohorts who received PB2452.
|
All Placebo
n=16 Participants
All participants in any cohorts who received placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Participants Experiencing Anti-drug Antibodies (ADAs)
Day -3
|
NA Participants
Cohorts 1-3 had baseline testing at Day -1 and Cohorts 4-10 had baseline testing at Day -3.
|
NA Participants
Cohorts 1-3 had baseline testing at Day -1 and Cohorts 4-10 had baseline testing at Day -3.
|
NA Participants
Cohorts 1-3 had baseline testing at Day -1 and Cohorts 4-10 had baseline testing at Day -3.
|
NA Participants
Cohorts 1-3 had baseline testing at Day -1 and Cohorts 4-10 had baseline testing at Day -3.
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
14 Participants
|
1 Participants
|
|
Participants Experiencing Anti-drug Antibodies (ADAs)
Day -1
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
NA Participants
Cohorts 1-3 had baseline testing at Day -1 and Cohorts 4-10 had baseline testing at Day -3.
|
NA Participants
Cohorts 1-3 had baseline testing at Day -1 and Cohorts 4-10 had baseline testing at Day -3.
|
NA Participants
Cohorts 1-3 had baseline testing at Day -1 and Cohorts 4-10 had baseline testing at Day -3.
|
NA Participants
Cohorts 1-3 had baseline testing at Day -1 and Cohorts 4-10 had baseline testing at Day -3.
|
NA Participants
Cohorts 1-3 had baseline testing at Day -1 and Cohorts 4-10 had baseline testing at Day -3.
|
NA Participants
Cohorts 1-3 had baseline testing at Day -1 and Cohorts 4-10 had baseline testing at Day -3.
|
NA Participants
Cohorts 1-3 had baseline testing at Day -1 and Cohorts 4-10 had baseline testing at Day -3.
|
NA Participants
Cohorts 1-3 had baseline testing at Day -1 and Cohorts 4-10 had baseline testing at Day -3.
|
NA Participants
Cohorts 1-3 had baseline testing at Day -1 and Cohorts 4-10 had baseline testing at Day -3.
|
1 Participants
|
1 Participants
|
|
Participants Experiencing Anti-drug Antibodies (ADAs)
Day 7
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
11 Participants
|
3 Participants
|
|
Participants Experiencing Anti-drug Antibodies (ADAs)
Day 28
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
21 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Before dosing and at 0.5, 1, 2, 3, 6, 12, 24, and 48 hours after PB2452 infusion and 5th ticagrelor dose.Population: Pharmacodynamic (PD) Population: all participants who received at least 1 dose of ticagrelor and had at least 1 measurable post dose light transmission aggregometry (LTA) value. PD samples were not collected for participants in Cohorts 1 to 3; therefore, they were not included in the PD Population.
Effectiveness Of Single Ascending Doses Of PB2452. IPA \[maximum (max)\] induced by 20 µM adenosine diphosphate (ADP) at each assessment point.
Outcome measures
| Measure |
Cohort 1: 100 mg PB2452 (no Ticagrelor)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 100 mg PB2452
|
Cohort 2: 300 mg PB2452 (no Ticagrelor)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 300 mg PB2452
|
Cohort 3: 1000 mg PB2452 (no Ticagrelor)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
|
Cohort 1 to 3: Placebo
n=6 Participants
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 4: 1000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 5: 3000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single 30-minute IV infusion of 3000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 6: 9000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single 30-minute IV infusion of 9000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 4 to 6: Placebo
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 7: 18000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 8 hours
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 8: 18000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 12 hours
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 9: 18000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 20 minutes
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 10: 18000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 12 minutes
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 7 to 10: Placebo
Placebo - Sodium Chloride: single 8-hour to 16.5-hour IV infusion of placebo
|
All PB2452
All participants in any cohorts who received PB2452.
|
All Placebo
All participants in any cohorts who received placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximal Percent of Baseline Platelet Aggregation (PA(Max)) in Cohorts 4-6
|
77.1 percentage
Standard Deviation 14.5
|
67.9 percentage
Standard Deviation 18.3
|
92.6 percentage
Standard Deviation 9.2
|
97.3 percentage
Standard Deviation 3.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Before dosing and at 0.5, 1, 2, 3, 6, 12, 24, and 48 hours after PB2452 infusion and 5th ticagrelor dose.Population: Pharmacodynamic (PD) Population: all participants who received at least 1 dose of ticagrelor and had at least 1 measurable post dose light transmission aggregometry (LTA) value. PD samples were not collected for participants in Cohorts 1 to 3; therefore, they were not included in the PD Population.
Effectiveness Of Single Ascending Doses Of PB2452. IPA \[final extent\] induced by 20 µM adenosine diphosphate (ADP) at each assessment point.
Outcome measures
| Measure |
Cohort 1: 100 mg PB2452 (no Ticagrelor)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 100 mg PB2452
|
Cohort 2: 300 mg PB2452 (no Ticagrelor)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 300 mg PB2452
|
Cohort 3: 1000 mg PB2452 (no Ticagrelor)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
|
Cohort 1 to 3: Placebo
n=6 Participants
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 4: 1000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 5: 3000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single 30-minute IV infusion of 3000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 6: 9000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single 30-minute IV infusion of 9000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 4 to 6: Placebo
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 7: 18000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 8 hours
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 8: 18000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 12 hours
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 9: 18000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 20 minutes
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 10: 18000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 12 minutes
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 7 to 10: Placebo
Placebo - Sodium Chloride: single 8-hour to 16.5-hour IV infusion of placebo
|
All PB2452
All participants in any cohorts who received PB2452.
|
All Placebo
All participants in any cohorts who received placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Final Extent Percent of Baseline Platelet Aggregation in Cohorts 4-6
|
66.5 percentage
Standard Deviation 30.3
|
58.4 percentage
Standard Deviation 27.0
|
90.6 percentage
Standard Deviation 9.7
|
94.6 percentage
Standard Deviation 9.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Before dosing and at 0.5, 1, 2, 3, 6, 12, 24, and 48 hours after PB2452 infusion and 5th ticagrelor dose. And at 1, 2, 6, and 12 hours after the Day 2 post-MEDI2452 (PB2452) 6th ticagrelor dose (Cohorts 8 and 9 Only).Population: PD Population: all participants who received at least 1 dose of ticagrelor and had at least 1 measurable post dose LTA value. PD samples were not collected for participants in Cohorts 1 to 3, therefore, they were not included in the PD Population.
Effectiveness Of Single Ascending Doses Of PB2452 - Inhibition of maximal platelet aggregation.
Outcome measures
| Measure |
Cohort 1: 100 mg PB2452 (no Ticagrelor)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 100 mg PB2452
|
Cohort 2: 300 mg PB2452 (no Ticagrelor)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 300 mg PB2452
|
Cohort 3: 1000 mg PB2452 (no Ticagrelor)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
|
Cohort 1 to 3: Placebo
n=6 Participants
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 4: 1000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 5: 3000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single 30-minute IV infusion of 3000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 6: 9000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single 30-minute IV infusion of 9000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 4 to 6: Placebo
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 7: 18000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 8 hours
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 8: 18000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 12 hours
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 9: 18000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 20 minutes
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 10: 18000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 12 minutes
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 7 to 10: Placebo
Placebo - Sodium Chloride: single 8-hour to 16.5-hour IV infusion of placebo
|
All PB2452
All participants in any cohorts who received PB2452.
|
All Placebo
All participants in any cohorts who received placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximal Actual Platelet Aggregation (APA(Max)) (Cohorts 4-6)
|
61.7 percentage
Standard Deviation 13.3
|
59.5 percentage
Standard Deviation 15.1
|
77.5 percentage
Standard Deviation 8.4
|
83.7 percentage
Standard Deviation 13.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Before dosing and at 0.5, 1, 2, 3, 6, 12, 24, and 48 hours after PB2452 infusion and 5th ticagrelor dose.Population: PD Population: all participants who received at least 1 dose of ticagrelor and had at least 1 measurable post dose LTA value. PD samples were not collected for participants in Cohorts 1 to 3, therefore, they were not included in the PD Population.
Effectiveness Of Single Ascending Doses Of PB2452 - Time to IPAmax.
Outcome measures
| Measure |
Cohort 1: 100 mg PB2452 (no Ticagrelor)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 100 mg PB2452
|
Cohort 2: 300 mg PB2452 (no Ticagrelor)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 300 mg PB2452
|
Cohort 3: 1000 mg PB2452 (no Ticagrelor)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
|
Cohort 1 to 3: Placebo
n=6 Participants
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 4: 1000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 5: 3000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single 30-minute IV infusion of 3000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 6: 9000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single 30-minute IV infusion of 9000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 4 to 6: Placebo
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 7: 18000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 8 hours
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 8: 18000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 12 hours
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 9: 18000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 20 minutes
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 10: 18000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 12 minutes
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 7 to 10: Placebo
Placebo - Sodium Chloride: single 8-hour to 16.5-hour IV infusion of placebo
|
All PB2452
All participants in any cohorts who received PB2452.
|
All Placebo
All participants in any cohorts who received placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Platelet Aggregation (TPA(Max)) (Cohorts 4-6)
|
48.00 hours
Interval 48.0 to 48.0
|
48.00 hours
Interval 48.0 to 48.1
|
0.51 hours
Interval 0.5 to 1.0
|
0.82 hours
Interval 0.5 to 2.12
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Before dosing and at 5 min, 0.25, 0.5, 1, 2, 3, 6, 8, 10, 12, 16, 20, 24, and 48 hours after PB2452 infusion and 5th ticagrelor dose. And at 1, 2, 6, and 12 hours after the Day 2 post-MEDI2452 (PB2452) 6th ticagrelor dose.Population: PD Population: all participants who received at least 1 dose of ticagrelor and had at least 1 measurable post dose LTA value.
Effectiveness Of Single Ascending Doses Of PB2452 - IPA (max) induced by 20 µM ADP at each assessment point.
Outcome measures
| Measure |
Cohort 1: 100 mg PB2452 (no Ticagrelor)
n=7 Participants
PB2452 Infusion: single 30-minute IV infusion of 100 mg PB2452
|
Cohort 2: 300 mg PB2452 (no Ticagrelor)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 300 mg PB2452
|
Cohort 3: 1000 mg PB2452 (no Ticagrelor)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
|
Cohort 1 to 3: Placebo
n=3 Participants
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 4: 1000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 5: 3000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single 30-minute IV infusion of 3000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 6: 9000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single 30-minute IV infusion of 9000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 4 to 6: Placebo
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 7: 18000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 8 hours
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 8: 18000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 12 hours
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 9: 18000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 20 minutes
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 10: 18000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 12 minutes
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 7 to 10: Placebo
Placebo - Sodium Chloride: single 8-hour to 16.5-hour IV infusion of placebo
|
All PB2452
All participants in any cohorts who received PB2452.
|
All Placebo
All participants in any cohorts who received placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximal Percent of Baseline Platelet Aggregation (PA(Max)) (Cohorts 7-10)
|
62.2 percentage
Standard Deviation 20.1
|
98.9 percentage
Standard Deviation 2.8
|
98.6 percentage
Standard Deviation 3.0
|
100.0 percentage
Standard Deviation 0
|
98.7 percentage
Standard Deviation 2.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Before dosing and at 5 min, 0.25, 0.5, 1, 2, 3, 6, 8, 10, 12, 16, 20, 24, and 48 hours after PB2452 infusion and 5th ticagrelor dose. And at 1, 2, 6, and 12 hours after the Day 2 post-MEDI2452 (PB2452) 6th ticagrelor dose.Population: PD Population: all participants who received at least 1 dose of ticagrelor and had at least 1 measurable post dose LTA value.
Effectiveness Of Single Ascending Doses Of PB2452 - IPA (max) induced by 20 µM ADP at each assessment point.
Outcome measures
| Measure |
Cohort 1: 100 mg PB2452 (no Ticagrelor)
n=7 Participants
PB2452 Infusion: single 30-minute IV infusion of 100 mg PB2452
|
Cohort 2: 300 mg PB2452 (no Ticagrelor)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 300 mg PB2452
|
Cohort 3: 1000 mg PB2452 (no Ticagrelor)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
|
Cohort 1 to 3: Placebo
n=3 Participants
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 4: 1000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 5: 3000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single 30-minute IV infusion of 3000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 6: 9000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single 30-minute IV infusion of 9000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 4 to 6: Placebo
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 7: 18000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 8 hours
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 8: 18000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 12 hours
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 9: 18000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 20 minutes
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 10: 18000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 12 minutes
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 7 to 10: Placebo
Placebo - Sodium Chloride: single 8-hour to 16.5-hour IV infusion of placebo
|
All PB2452
All participants in any cohorts who received PB2452.
|
All Placebo
All participants in any cohorts who received placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Final Extent Percent of Baseline Platelet Aggregation (Cohorts 7-10)
|
51.5 percentage
Standard Deviation 26.4
|
96.1 percentage
Standard Deviation 9.6
|
98.2 percentage
Standard Deviation 3.4
|
100.0 percentage
Standard Deviation 0
|
97.3 percentage
Standard Deviation 4.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Before dosing and at 5 min, 0.25, 0.5, 1, 2, 3, 6, 8, 10, 12, 16, 20, 24, and 48 hours after PB2452 infusion and 5th ticagrelor dose. And at 1, 2, 6, and 12 hours after the Day 2 post-MEDI2452 (PB2452) 6th ticagrelor dosePopulation: PD Population: all participants who received at least 1 dose of ticagrelor and had at least 1 measurable post dose LTA value.
Effectiveness Of Single Ascending Doses Of PB2452 - Inhibition of maximal platelet aggregation.
Outcome measures
| Measure |
Cohort 1: 100 mg PB2452 (no Ticagrelor)
n=7 Participants
PB2452 Infusion: single 30-minute IV infusion of 100 mg PB2452
|
Cohort 2: 300 mg PB2452 (no Ticagrelor)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 300 mg PB2452
|
Cohort 3: 1000 mg PB2452 (no Ticagrelor)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
|
Cohort 1 to 3: Placebo
n=3 Participants
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 4: 1000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 5: 3000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single 30-minute IV infusion of 3000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 6: 9000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single 30-minute IV infusion of 9000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 4 to 6: Placebo
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 7: 18000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 8 hours
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 8: 18000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 12 hours
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 9: 18000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 20 minutes
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 10: 18000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 12 minutes
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 7 to 10: Placebo
Placebo - Sodium Chloride: single 8-hour to 16.5-hour IV infusion of placebo
|
All PB2452
All participants in any cohorts who received PB2452.
|
All Placebo
All participants in any cohorts who received placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximal Actual Platelet Aggregation (APA(Max)) (Cohorts 7-10)
|
51.9 percentage
Standard Deviation 17.8
|
84.8 percentage
Standard Deviation 9.3
|
86.0 percentage
Standard Deviation 5.7
|
94.7 percentage
Standard Deviation 1.2
|
86.0 percentage
Standard Deviation 2.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Before dosing and at 5 min, 0.25, 0.5, 1, 2, 3, 6, 8, 10, 12, 16, 20, 24, and 48 hours after PB2452 infusion and 5th ticagrelor dose. And at 1, 2, 6, and 12 hours after the Day 2 post-MEDI2452 (PB2452) 6th ticagrelor dose.Population: PD Population: all participants who received at least 1 dose of ticagrelor and had at least 1 measurable post dose LTA value.
Effectiveness Of Single Ascending Doses Of PB2452 - Time to IPAmax
Outcome measures
| Measure |
Cohort 1: 100 mg PB2452 (no Ticagrelor)
n=7 Participants
PB2452 Infusion: single 30-minute IV infusion of 100 mg PB2452
|
Cohort 2: 300 mg PB2452 (no Ticagrelor)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 300 mg PB2452
|
Cohort 3: 1000 mg PB2452 (no Ticagrelor)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
|
Cohort 1 to 3: Placebo
n=3 Participants
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 4: 1000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 Participants
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 5: 3000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single 30-minute IV infusion of 3000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 6: 9000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single 30-minute IV infusion of 9000 mg PB2452
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 4 to 6: Placebo
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 7: 18000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 8 hours
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 8: 18000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 12 hours
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 9: 18000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 20 minutes
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 10: 18000 mg PB2452 (Ticagrelor Pre-Trx)
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 12 minutes
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 7 to 10: Placebo
Placebo - Sodium Chloride: single 8-hour to 16.5-hour IV infusion of placebo
|
All PB2452
All participants in any cohorts who received PB2452.
|
All Placebo
All participants in any cohorts who received placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Platelet Aggregation (TPA(Max))(Cohorts 7-10)
|
48.00 hours
Interval 3.0 to 48.05
|
6.00 hours
Interval 2.0 to 16.0
|
5.50 hours
Interval 0.53 to 16.0
|
6.00 hours
Interval 1.02 to 8.0
|
1.25 hours
Interval 0.25 to 48.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort 3: 1000 mg PB2452 (no Ticagrelor)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 1 to 3: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 4: 1000 mg PB2452 (Ticagrelor Pre-Trx)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 5: 3000 mg PB2452 (Ticagrelor Pre-Trx)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 6: 9000 mg PB2452 (Ticagrelor Pre-Trx)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 4 to 6: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 7: 18000 mg PB2452 (Ticagrelor Pre-Trx)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 8: 18000 mg PB2452 (Ticagrelor Pre-Trx)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 9: 18000 mg PB2452 (Ticagrelor Pre-Trx)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 10: 18000 mg PB2452 (Ticagrelor Pre-Trx)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 7 to 10: Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
All PB2452
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
All Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 1: 100 mg PB2452 (no Ticagrelor)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2: 300 mg PB2452 (no Ticagrelor)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 3: 1000 mg PB2452 (no Ticagrelor)
n=3 participants at risk
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
|
Cohort 1 to 3: Placebo
n=3 participants at risk
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 4: 1000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 participants at risk
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452 Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 5: 3000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 participants at risk
PB2452 Infusion: single 30-minute IV infusion of 3000 mg PB2452 Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 6: 9000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 participants at risk
PB2452 Infusion: single 30-minute IV infusion of 9000 mg PB2452 Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 4 to 6: Placebo
n=6 participants at risk
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 7: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 participants at risk
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 8 hours Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 8: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 participants at risk
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 12 hours Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 9: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=3 participants at risk
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 20 minutes Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 10: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 participants at risk
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 12 minutes Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 7 to 10: Placebo
n=7 participants at risk
Placebo - Sodium Chloride: single 8-hour to 16.5-hour IV infusion of placebo
|
All PB2452
n=48 participants at risk
All participants in any cohorts who received PB2452.
|
All Placebo
n=16 participants at risk
All participants in any cohorts who received placebo.
|
Cohort 1: 100 mg PB2452 (no Ticagrelor)
n=3 participants at risk
PB2452 Infusion: single 30-minute IV infusion of 100 mg PB2452
|
Cohort 2: 300 mg PB2452 (no Ticagrelor)
n=3 participants at risk
PB2452 Infusion: single 30-minute IV infusion of 300 mg PB2452
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
16.7%
1/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/7 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
2.1%
1/48 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/16 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
16.7%
1/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/7 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
2.1%
1/48 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/16 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
Other adverse events
| Measure |
Cohort 3: 1000 mg PB2452 (no Ticagrelor)
n=3 participants at risk
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452
|
Cohort 1 to 3: Placebo
n=3 participants at risk
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 4: 1000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 participants at risk
PB2452 Infusion: single 30-minute IV infusion of 1000 mg PB2452 Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 5: 3000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 participants at risk
PB2452 Infusion: single 30-minute IV infusion of 3000 mg PB2452 Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 6: 9000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 participants at risk
PB2452 Infusion: single 30-minute IV infusion of 9000 mg PB2452 Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 4 to 6: Placebo
n=6 participants at risk
Placebo - Sodium Chloride: single 30-minute IV infusion of placebo
|
Cohort 7: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 participants at risk
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 8 hours Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 8: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 participants at risk
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 12 hours Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 9: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=3 participants at risk
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 20 minutes Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 10: 18000 mg PB2452 (Ticagrelor Pre-Trx)
n=6 participants at risk
PB2452 Infusion: single IV infusion of 18000 mg PB2452 for 16 hours and 12 minutes Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 180 mg + 90 mg BID for 5 doses prior to administration of a single IV dose of PB2452
|
Cohort 7 to 10: Placebo
n=7 participants at risk
Placebo - Sodium Chloride: single 8-hour to 16.5-hour IV infusion of placebo
|
All PB2452
n=48 participants at risk
All participants in any cohorts who received PB2452.
|
All Placebo
n=16 participants at risk
All participants in any cohorts who received placebo.
|
Cohort 1: 100 mg PB2452 (no Ticagrelor)
n=3 participants at risk
PB2452 Infusion: single 30-minute IV infusion of 100 mg PB2452
|
Cohort 2: 300 mg PB2452 (no Ticagrelor)
n=3 participants at risk
PB2452 Infusion: single 30-minute IV infusion of 300 mg PB2452
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Eyelid irritation
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
16.7%
1/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/7 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/48 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
6.2%
1/16 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
16.7%
1/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/7 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
2.1%
1/48 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/16 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
|
General disorders
Infusion site bruising
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
33.3%
2/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
16.7%
1/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
16.7%
1/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/7 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
8.3%
4/48 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/16 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
|
General disorders
Medical device site reaction
|
33.3%
1/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
16.7%
1/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
16.7%
1/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/7 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
6.2%
3/48 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/16 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
|
General disorders
Infusion site extravasation
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
16.7%
1/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
33.3%
1/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/7 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
4.2%
2/48 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/16 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
33.3%
2/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/7 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
4.2%
2/48 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/16 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
|
General disorders
Infusion site reaction
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
16.7%
1/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/7 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
2.1%
1/48 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/16 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
16.7%
1/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/7 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
2.1%
1/48 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/16 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
16.7%
1/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/7 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
2.1%
1/48 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/16 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
16.7%
1/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/7 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
2.1%
1/48 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/16 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
16.7%
1/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/7 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
2.1%
1/48 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/16 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
16.7%
1/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/7 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/48 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
6.2%
1/16 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
16.7%
1/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/7 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
2.1%
1/48 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/16 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
16.7%
1/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/7 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
2.1%
1/48 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/16 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
16.7%
1/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/7 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
2.1%
1/48 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/16 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration Pneumonitis
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
16.7%
1/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/7 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
2.1%
1/48 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/16 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
|
Investigations
Blood urine present
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
16.7%
1/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/7 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
2.1%
1/48 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/16 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
33.3%
1/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/7 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/48 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
6.2%
1/16 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
16.7%
1/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/7 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
2.1%
1/48 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/16 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
16.7%
1/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/6 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/7 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
2.1%
1/48 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/16 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).
|
0.00%
0/3 • Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (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