Trial Outcomes & Findings for Phase 1 Safety, Pharmacokinetics And Pharmacodynamics Study Of Recombinant Factor VIIa Variant (813d) In Adult Subjects With Hemophilia (NCT NCT01439971)
NCT ID: NCT01439971
Last Updated: 2017-05-12
Results Overview
Supine blood pressure (BP) was measured with the participant's arm supported at the level of the heart, and recorded to the nearest millimeters of mercury (mmHg) after 5 minutes of rest. The same arm (preferably the dominant arm) was to be used throughout the study.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
29 participants
Primary outcome timeframe
Baseline, Day 2, Day 3, and Day 15
Results posted on
2017-05-12
Participant Flow
This was an open-label study to characterize the single dose pharmacokinetics (PK), pharmacodynamics, safety, and tolerability of 5 intravenous dose levels of PF-05280602 (0.5, 4.5, 9.0, 18.0 and 30.0 micrograms/kilogram \[mcg/kg\]).
Participant milestones
| Measure |
PF-05280602 0.5 mcg/kg
PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
|
PF-05280602 4.5 mcg/kg
PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 9.0 mcg/kg
PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 18.0 mcg/kg
PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 30.0 mcg/kg
PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
7
|
8
|
6
|
7
|
|
Overall Study
Received Treatment
|
1
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
1
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
0
|
1
|
Reasons for withdrawal
| Measure |
PF-05280602 0.5 mcg/kg
PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
|
PF-05280602 4.5 mcg/kg
PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 9.0 mcg/kg
PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 18.0 mcg/kg
PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 30.0 mcg/kg
PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
|---|---|---|---|---|---|
|
Overall Study
Required number in cohort dosed
|
0
|
1
|
2
|
0
|
1
|
Baseline Characteristics
Phase 1 Safety, Pharmacokinetics And Pharmacodynamics Study Of Recombinant Factor VIIa Variant (813d) In Adult Subjects With Hemophilia
Baseline characteristics by cohort
| Measure |
PF-05280602 0.5 mcg/kg
n=1 Participants
PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
|
PF-05280602 4.5 mcg/kg
n=6 Participants
PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 9.0 mcg/kg
n=6 Participants
PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 18.0 mcg/kg
n=6 Participants
PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 30.0 mcg/kg
n=6 Participants
PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
59.0 years
STANDARD_DEVIATION NA • n=5 Participants
|
32.7 years
STANDARD_DEVIATION 13.4 • n=7 Participants
|
38.5 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
32.8 years
STANDARD_DEVIATION 12.3 • n=4 Participants
|
41.0 years
STANDARD_DEVIATION 15.7 • n=21 Participants
|
37.2 years
STANDARD_DEVIATION 13.6 • n=8 Participants
|
|
Sex: Female, Male
FEMALE
|
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=8 Participants
|
|
Sex: Female, Male
MALE
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
25 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 2, Day 3, and Day 15Population: The safety population included all enrolled participants who received the study drug.
Supine blood pressure (BP) was measured with the participant's arm supported at the level of the heart, and recorded to the nearest millimeters of mercury (mmHg) after 5 minutes of rest. The same arm (preferably the dominant arm) was to be used throughout the study.
Outcome measures
| Measure |
PF-05280602 0.5 mcg/kg
n=1 Participants
PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
|
PF-05280602 4.5 mcg/kg
n=6 Participants
PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 9.0 mcg/kg
n=6 Participants
PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 18.0 mcg/kg
n=6 Participants
PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 30.0 mcg/kg
n=6 Participants
PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
|---|---|---|---|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Baseline
|
122.0 mmHg
Standard Deviation NA
As only 1 participant was analyzed, standard deviation was not calculated.
|
130.2 mmHg
Standard Deviation 7.14
|
120.2 mmHg
Standard Deviation 25.41
|
124.2 mmHg
Standard Deviation 7.68
|
125.5 mmHg
Standard Deviation 8.53
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Change at Day 2
|
0.0 mmHg
Standard Deviation NA
As only 1 participant was analyzed, standard deviation was not calculated.
|
-8.7 mmHg
Standard Deviation 8.24
|
-0.2 mmHg
Standard Deviation 14.41
|
-3.0 mmHg
Standard Deviation 6.51
|
-1.5 mmHg
Standard Deviation 5.58
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Change at Day 3
|
5.0 mmHg
Standard Deviation NA
As only 1 participant was analyzed, standard deviation was not calculated.
|
-7.0 mmHg
Standard Deviation 6.99
|
2.2 mmHg
Standard Deviation 19.30
|
-5.5 mmHg
Standard Deviation 7.66
|
0.0 mmHg
Standard Deviation 8.58
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Change at Day 15
|
-10.0 mmHg
Standard Deviation NA
As only 1 participant was analyzed, standard deviation was not calculated.
|
-5.5 mmHg
Standard Deviation 12.18
|
4.7 mmHg
Standard Deviation 18.00
|
-4.5 mmHg
Standard Deviation 14.92
|
1.8 mmHg
Standard Deviation 11.84
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Baseline
|
78.0 mmHg
Standard Deviation NA
As only 1 participant was analyzed, standard deviation was not calculated.
|
73.7 mmHg
Standard Deviation 6.35
|
70.5 mmHg
Standard Deviation 10.97
|
75.8 mmHg
Standard Deviation 4.67
|
77.0 mmHg
Standard Deviation 6.87
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Change at Day 2
|
2.0 mmHg
Standard Deviation NA
As only 1 participant was analyzed, standard deviation was not calculated.
|
-2.8 mmHg
Standard Deviation 6.43
|
2.7 mmHg
Standard Deviation 6.28
|
-0.8 mmHg
Standard Deviation 5.12
|
-3.3 mmHg
Standard Deviation 5.50
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Change at Day 3
|
-3.0 mmHg
Standard Deviation NA
As only 1 participant was analyzed, standard deviation was not calculated.
|
-6.5 mmHg
Standard Deviation 6.57
|
3.3 mmHg
Standard Deviation 6.56
|
-2.2 mmHg
Standard Deviation 8.11
|
4.3 mmHg
Standard Deviation 10.41
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Change at Day 15
|
-9.0 mmHg
Standard Deviation NA
As only 1 participant was analyzed, standard deviation was not calculated.
|
-3.5 mmHg
Standard Deviation 11.41
|
6.0 mmHg
Standard Deviation 13.11
|
-4.3 mmHg
Standard Deviation 11.15
|
-4.5 mmHg
Standard Deviation 5.65
|
PRIMARY outcome
Timeframe: Baseline, Day 2, Day 3, and Day 15Population: The safety population included all enrolled participants who received the study drug.
Outcome measures
| Measure |
PF-05280602 0.5 mcg/kg
n=1 Participants
PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
|
PF-05280602 4.5 mcg/kg
n=6 Participants
PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 9.0 mcg/kg
n=6 Participants
PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 18.0 mcg/kg
n=6 Participants
PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 30.0 mcg/kg
n=6 Participants
PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
|---|---|---|---|---|---|
|
Change From Baseline in Body Weight
Baseline
|
72.7 kilograms (kg)
Standard Deviation NA
As only 1 participant was analyzed, standard deviation was not calculated.
|
75.0 kilograms (kg)
Standard Deviation 12.65
|
78.7 kilograms (kg)
Standard Deviation 10.73
|
78.0 kilograms (kg)
Standard Deviation 11.31
|
73.4 kilograms (kg)
Standard Deviation 6.88
|
|
Change From Baseline in Body Weight
Change at Day 2
|
-0.9 kilograms (kg)
Standard Deviation NA
As only 1 participant was analyzed, standard deviation was not calculated.
|
-1.0 kilograms (kg)
Standard Deviation 0.98
|
-0.6 kilograms (kg)
Standard Deviation 0.72
|
-0.8 kilograms (kg)
Standard Deviation 1.31
|
-0.4 kilograms (kg)
Standard Deviation 0.83
|
|
Change From Baseline in Body Weight
Change at Day 3
|
-0.8 kilograms (kg)
Standard Deviation NA
As only 1 participant was analyzed, standard deviation was not calculated.
|
-0.6 kilograms (kg)
Standard Deviation 0.85
|
-0.5 kilograms (kg)
Standard Deviation 0.60
|
-0.8 kilograms (kg)
Standard Deviation 1.39
|
-0.3 kilograms (kg)
Standard Deviation 0.56
|
|
Change From Baseline in Body Weight
Change at Day 15
|
-0.5 kilograms (kg)
Standard Deviation NA
As only 1 participant was analyzed, standard deviation was not calculated.
|
0.4 kilograms (kg)
Standard Deviation 1.09
|
0.6 kilograms (kg)
Standard Deviation 1.55
|
0.6 kilograms (kg)
Standard Deviation 1.26
|
0.2 kilograms (kg)
Standard Deviation 0.59
|
PRIMARY outcome
Timeframe: Baseline, Day 2, Day 3, and Day 15Population: The safety population included all enrolled participants who received the study drug.
Body temperature was measured by mouth (oral) or ear (tympanic). A temperature greater than 38.5 degree Celsius was considered a fever.
Outcome measures
| Measure |
PF-05280602 0.5 mcg/kg
n=1 Participants
PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
|
PF-05280602 4.5 mcg/kg
n=6 Participants
PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 9.0 mcg/kg
n=6 Participants
PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 18.0 mcg/kg
n=6 Participants
PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 30.0 mcg/kg
n=6 Participants
PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
|---|---|---|---|---|---|
|
Change From Baseline in Body Temperature
Baseline
|
36.1 degree Celcius
Standard Deviation NA
As only 1 participant was analyzed, standard deviation was not calculated.
|
36.5 degree Celcius
Standard Deviation 0.29
|
36.5 degree Celcius
Standard Deviation 0.34
|
36.6 degree Celcius
Standard Deviation 0.30
|
36.4 degree Celcius
Standard Deviation 0.43
|
|
Change From Baseline in Body Temperature
Change at Day 2
|
0.4 degree Celcius
Standard Deviation NA
As only 1 participant was analyzed, standard deviation was not calculated.
|
-0.4 degree Celcius
Standard Deviation 0.62
|
-0.1 degree Celcius
Standard Deviation 0.30
|
0.1 degree Celcius
Standard Deviation 0.34
|
0.2 degree Celcius
Standard Deviation 0.29
|
|
Change From Baseline in Body Temperature
Change at Day 3
|
0.3 degree Celcius
Standard Deviation NA
As only 1 participant was analyzed, standard deviation was not calculated.
|
-0.2 degree Celcius
Standard Deviation 0.60
|
0.1 degree Celcius
Standard Deviation 0.15
|
-0.0 degree Celcius
Standard Deviation 0.41
|
0.2 degree Celcius
Standard Deviation 0.13
|
|
Change From Baseline in Body Temperature
Change at Day 15
|
0.3 degree Celcius
Standard Deviation NA
As only 1 participant was analyzed, standard deviation was not calculated.
|
0.1 degree Celcius
Standard Deviation 0.39
|
0.1 degree Celcius
Standard Deviation 0.36
|
0.1 degree Celcius
Standard Deviation 0.24
|
0.2 degree Celcius
Standard Deviation 0.60
|
PRIMARY outcome
Timeframe: Baseline, Day 2, Day 3, and Day 15Population: The safety population included all enrolled participants who received the study drug.
Respiration rate measured as respirations per minute (resp/min).
Outcome measures
| Measure |
PF-05280602 0.5 mcg/kg
n=1 Participants
PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
|
PF-05280602 4.5 mcg/kg
n=6 Participants
PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 9.0 mcg/kg
n=6 Participants
PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 18.0 mcg/kg
n=6 Participants
PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 30.0 mcg/kg
n=6 Participants
PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
|---|---|---|---|---|---|
|
Change From Baseline in Respiration Rate
Baseline
|
12.0 resp/min
Standard Deviation NA
As only 1 participant was analyzed, standard deviation was not calculated.
|
15.0 resp/min
Standard Deviation 2.76
|
15.2 resp/min
Standard Deviation 2.04
|
15.7 resp/min
Standard Deviation 1.97
|
16.0 resp/min
Standard Deviation 2.83
|
|
Change From Baseline in Respiration Rate
Change at Day 2
|
0.0 resp/min
Standard Deviation NA
As only 1 participant was analyzed, standard deviation was not calculated.
|
0.5 resp/min
Standard Deviation 1.76
|
0.3 resp/min
Standard Deviation 3.50
|
2.2 resp/min
Standard Deviation 2.56
|
0.5 resp/min
Standard Deviation 1.22
|
|
Change From Baseline in Respiration Rate
Change at Day 3
|
0.0 resp/min
Standard Deviation NA
As only 1 participant was analyzed, standard deviation was not calculated.
|
0.2 resp/min
Standard Deviation 3.37
|
0.3 resp/min
Standard Deviation 3.50
|
1.7 resp/min
Standard Deviation 1.63
|
0.2 resp/min
Standard Deviation 2.23
|
|
Change From Baseline in Respiration Rate
Change at Day 15
|
2.0 resp/min
Standard Deviation NA
As only 1 participant was analyzed, standard deviation was not calculated.
|
0.7 resp/min
Standard Deviation 4.32
|
-0.2 resp/min
Standard Deviation 2.14
|
1.2 resp/min
Standard Deviation 3.49
|
-0.3 resp/min
Standard Deviation 1.97
|
PRIMARY outcome
Timeframe: Baseline, Day 2, Day 3, and Day 15Population: The safety population included all enrolled participants who received the study drug.
Change from baseline is the vital sign value at Day 2, Day 3, and Day 15 minus vital sign value at baseline.
Outcome measures
| Measure |
PF-05280602 0.5 mcg/kg
n=1 Participants
PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
|
PF-05280602 4.5 mcg/kg
n=6 Participants
PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 9.0 mcg/kg
n=6 Participants
PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 18.0 mcg/kg
n=6 Participants
PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 30.0 mcg/kg
n=6 Participants
PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
|---|---|---|---|---|---|
|
Change From Baseline in Supine Pulse Rate
Baseline
|
62.0 beats per minute (bpm)
Standard Deviation NA
As only 1 participant was analyzed, standard deviation was not calculated.
|
64.8 beats per minute (bpm)
Standard Deviation 6.21
|
69.3 beats per minute (bpm)
Standard Deviation 10.65
|
60.7 beats per minute (bpm)
Standard Deviation 10.69
|
66.5 beats per minute (bpm)
Standard Deviation 8.22
|
|
Change From Baseline in Supine Pulse Rate
Change at Day 2
|
1.0 beats per minute (bpm)
Standard Deviation NA
As only 1 participant was analyzed, standard deviation was not calculated.
|
-1.3 beats per minute (bpm)
Standard Deviation 3.56
|
3.7 beats per minute (bpm)
Standard Deviation 6.89
|
8.8 beats per minute (bpm)
Standard Deviation 7.88
|
2.0 beats per minute (bpm)
Standard Deviation 5.69
|
|
Change From Baseline in Supine Pulse Rate
Change at Day 3
|
0.0 beats per minute (bpm)
Standard Deviation NA
As only 1 participant was analyzed, standard deviation was not calculated.
|
1.3 beats per minute (bpm)
Standard Deviation 6.80
|
2.5 beats per minute (bpm)
Standard Deviation 7.89
|
10.7 beats per minute (bpm)
Standard Deviation 5.65
|
3.3 beats per minute (bpm)
Standard Deviation 3.56
|
|
Change From Baseline in Supine Pulse Rate
Change at Day 15
|
2.0 beats per minute (bpm)
Standard Deviation NA
As only 1 participant was analyzed, standard deviation was not calculated.
|
8.3 beats per minute (bpm)
Standard Deviation 12.68
|
4.5 beats per minute (bpm)
Standard Deviation 12.68
|
10.2 beats per minute (bpm)
Standard Deviation 12.22
|
3.0 beats per minute (bpm)
Standard Deviation 5.33
|
PRIMARY outcome
Timeframe: Baseline (Day 0), Day 1, Day 2, Day 3, Day 15Population: The safety population included all enrolled participants who received the study drug.
Physical examinations were conducted by a physician, trained physician's assistant, or nurse practitioner. A complete physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, genitourinary, gastrointestinal, musculoskeletal, and neurological systems. The limited or abbreviated physical examination focused on general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms.
Outcome measures
| Measure |
PF-05280602 0.5 mcg/kg
n=1 Participants
PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
|
PF-05280602 4.5 mcg/kg
n=6 Participants
PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 9.0 mcg/kg
n=6 Participants
PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 18.0 mcg/kg
n=6 Participants
PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 30.0 mcg/kg
n=6 Participants
PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Changes Since Previous Physical Examination
Baseline
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Changes Since Previous Physical Examination
Day 1
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Changes Since Previous Physical Examination
Day 2
|
NA participants
No participants were analyzed at Day 2 in this arm.
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Changes Since Previous Physical Examination
Day 3
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Changes Since Previous Physical Examination
Day 15
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline through Day 15Population: The safety population included all enrolled participants who received the study drug.
ECG findings of potential clinical concern were: PR interval greater than or equal to (\>=)300 milliseconds (msec), \>=25% increase from baseline for baseline values \>200 msec, \>=50% increase from baseline for baseline values less than or equal to (\<=)200 msec; QRS complex \>=140 msec or \>=50% increase from baseline; QTcF interval (Fridericia's correction) \>=450 msec or \>=30 msec increase from baseline.
Outcome measures
| Measure |
PF-05280602 0.5 mcg/kg
n=1 Participants
PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
|
PF-05280602 4.5 mcg/kg
n=6 Participants
PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 9.0 mcg/kg
n=6 Participants
PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 18.0 mcg/kg
n=6 Participants
PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 30.0 mcg/kg
n=6 Participants
PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
PR Interval >=300 msec
|
0 participants
NA
|
0 participants
7.14
|
0 participants
25.41
|
0 participants
7.68
|
0 participants
8.53
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
QRS Complex >=140 msec
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
QTcF Interval >=450 msec
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
PR Interval >=25/50% Increase From Baseline
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
QRS Complex >=50% Increase From Baseline
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
QTcF Interval 30-<60 msec Increase From Baseline
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
QTcF Interval >=60 msec Increase From Baseline
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline through Day 60Population: The safety population included all enrolled participants who received the study drug.
An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 15 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.
Outcome measures
| Measure |
PF-05280602 0.5 mcg/kg
n=1 Participants
PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
|
PF-05280602 4.5 mcg/kg
n=6 Participants
PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 9.0 mcg/kg
n=6 Participants
PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 18.0 mcg/kg
n=6 Participants
PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 30.0 mcg/kg
n=6 Participants
PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs (Except Hemophilia AEs)
AEs
|
1 participants
|
4 participants
|
4 participants
|
3 participants
|
2 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs (Except Hemophilia AEs)
SAEs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs (Except Hemophilia AEs)
Withdrawals Due to AEs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline through Day 60Population: The safety population included all enrolled participants who received the study drug.
Hemophilia AEs included spontaneous (no known contributing factor) and traumatic (known or presumed contributing factor/reason) bleeding episodes.
Outcome measures
| Measure |
PF-05280602 0.5 mcg/kg
n=1 Participants
PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
|
PF-05280602 4.5 mcg/kg
n=6 Participants
PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 9.0 mcg/kg
n=6 Participants
PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 18.0 mcg/kg
n=6 Participants
PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 30.0 mcg/kg
n=6 Participants
PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Hemophilia AEs and Withdrawals Due to Hemophilia AEs
Hemophilia AEs
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
2 participants
|
|
Number of Participants With Treatment-Emergent Hemophilia AEs and Withdrawals Due to Hemophilia AEs
Hemophilia SAEs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Hemophilia AEs and Withdrawals Due to Hemophilia AEs
Withdrawals Due to Hemophilia AEs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline through Day 60Population: The safety population included all enrolled participants who received the study drug.
AE severity were graded as mild, moderate, or severe. Mild severity AEs do not interfere with the participant's usual function. Moderate AEs interfere to some extent with the participant's usual function. Severe AEs interfere significantly with the participant's usual function.
Outcome measures
| Measure |
PF-05280602 0.5 mcg/kg
n=1 Participants
PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
|
PF-05280602 4.5 mcg/kg
n=6 Participants
PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 9.0 mcg/kg
n=6 Participants
PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 18.0 mcg/kg
n=6 Participants
PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 30.0 mcg/kg
n=6 Participants
PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
|---|---|---|---|---|---|
|
Number of Treatment-Emergent AEs and SAEs by Severity (Except Hemophilia AEs)
Mild AEs
|
2 adverse events
|
6 adverse events
|
5 adverse events
|
7 adverse events
|
1 adverse events
|
|
Number of Treatment-Emergent AEs and SAEs by Severity (Except Hemophilia AEs)
Severe AEs
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Treatment-Emergent AEs and SAEs by Severity (Except Hemophilia AEs)
Moderate AEs
|
1 adverse events
|
1 adverse events
|
5 adverse events
|
2 adverse events
|
1 adverse events
|
PRIMARY outcome
Timeframe: Baseline through Day 60Population: The safety population included all enrolled participants who received the study drug.
Mild severity AEs do not interfere with the participant's usual function. Moderate AEs interfere to some extent with the participant's usual function. Severe AEs interfere significantly with the participant's usual function.
Outcome measures
| Measure |
PF-05280602 0.5 mcg/kg
n=1 Participants
PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
|
PF-05280602 4.5 mcg/kg
n=6 Participants
PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 9.0 mcg/kg
n=6 Participants
PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 18.0 mcg/kg
n=6 Participants
PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 30.0 mcg/kg
n=6 Participants
PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
|---|---|---|---|---|---|
|
Number of Treatment-Emergent Hemophilia AEs by Severity
Mild Hemophilia AEs
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Treatment-Emergent Hemophilia AEs by Severity
Moderate Hemophilia AEs
|
1 adverse events
|
1 adverse events
|
2 adverse events
|
1 adverse events
|
2 adverse events
|
|
Number of Treatment-Emergent Hemophilia AEs by Severity
Severe Hemophilia AEs
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
PRIMARY outcome
Timeframe: Baseline through Day 15Population: The safety population included all enrolled participants who received the study drug.
Troponin-T is a cardiac marker for the evaluation of possible cardiovascular injury. Troponin-T levels of potential clinical concern are values \>1.5 times the upper limit of normal (1.5X ULN) or \>=2.5X ULN.
Outcome measures
| Measure |
PF-05280602 0.5 mcg/kg
n=1 Participants
PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
|
PF-05280602 4.5 mcg/kg
n=6 Participants
PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 9.0 mcg/kg
n=6 Participants
PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 18.0 mcg/kg
n=6 Participants
PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 30.0 mcg/kg
n=6 Participants
PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Abnormal Troponin-T Levels by Magnitude
<1X lower limit of normal (LLN)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Abnormal Troponin-T Levels by Magnitude
>1X ULN
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Abnormal Troponin-T Levels by Magnitude
>1.5X ULN
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Abnormal Troponin-T Levels by Magnitude
>=2.5X ULN
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline through Day 3Population: The safety population included all enrolled participants who received the study drug.
ATIII is a protein in the blood that blocks abnormal blood clots from forming. Low levels of ATIII can cause abnormal blood clots. ATIII levels of potential clinical concern are values \<1X LLN and \>1X ULN.
Outcome measures
| Measure |
PF-05280602 0.5 mcg/kg
n=1 Participants
PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
|
PF-05280602 4.5 mcg/kg
n=6 Participants
PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 9.0 mcg/kg
n=6 Participants
PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 18.0 mcg/kg
n=6 Participants
PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 30.0 mcg/kg
n=6 Participants
PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Abnormal Anti-Thrombin III (ATIII) Levels by Magnitude
>1X ULN
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Abnormal Anti-Thrombin III (ATIII) Levels by Magnitude
<1X LLN
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
PRIMARY outcome
Timeframe: Baseline through Day 3Population: The safety population included all enrolled participants who received the study drug.
TFPI is a polypeptide that can regulate blood coagulation. TFPI levels of potential clinical concern are values \<1X LLN and \>1X ULN.
Outcome measures
| Measure |
PF-05280602 0.5 mcg/kg
n=1 Participants
PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
|
PF-05280602 4.5 mcg/kg
n=6 Participants
PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 9.0 mcg/kg
n=6 Participants
PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 18.0 mcg/kg
n=6 Participants
PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 30.0 mcg/kg
n=6 Participants
PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Abnormal Tissue Factor Pathway Inhibitor (TFPI) Levels by Magnitude
<1X LLN
|
0 participants
|
1 participants
|
2 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Abnormal Tissue Factor Pathway Inhibitor (TFPI) Levels by Magnitude
>1X ULN
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Baseline through Day 15Population: The safety population included all enrolled participants who received the study drug.
The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell \[RBC\] count, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes); chemistry (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], alkaline phosphatase, creatinine, blood urea nitrogen \[BUN\], glucose, uric acid, sodium, potassium, chloride, bicarbonate, calcium, albumin, total protein, creatine kinase); urinalysis (urine white blood cell \[WBC\], urine RBC); other (troponin T).
Outcome measures
| Measure |
PF-05280602 0.5 mcg/kg
n=1 Participants
PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
|
PF-05280602 4.5 mcg/kg
n=6 Participants
PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 9.0 mcg/kg
n=6 Participants
PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 18.0 mcg/kg
n=6 Participants
PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 30.0 mcg/kg
n=6 Participants
PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Laboratory Test Abnormalities (Normal Baseline)
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
2 participants
|
PRIMARY outcome
Timeframe: Baseline through Day 15Population: The safety population included all enrolled participants who received the study drug.
Clinically significant findings for stopping rules are: hemoglobin \<8 grams/deciliter (g/dL) or \>20% decrease from normal baseline; WBC \>20,000 cells/mm\^3 or \<1,500 decrease with normal baseline; platelets \<100,000/mm\^3 or \>33% decrease from baseline; total bilirubin \>1.5X ULN; AST or ALT \>2.5X ULN; alkaline phosphatase \>3X ULN; creatinine \>1.5X baseline; BUN \>31.0 mg/dL; glucose \<0.6 or \>1.5X reference range; uric acid \> ULN; sodium \>150 or \<130 mEq/L; potassium \>5.5 or \<3.0 mEq/L; calcium \>11.5 or \<8.0 mg/dL; albumin \<2.0 g/L; total protein \<5.0 g/L; positive D-dimer at Day 15; PT prolonged by 3 seconds above baseline; ATIII \< LLN and \>20% decrease from baseline; troponin-T values above the reference range; fibrinogen \<0.75X LLN or \>25% decrease from baseline.
Outcome measures
| Measure |
PF-05280602 0.5 mcg/kg
n=1 Participants
PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
|
PF-05280602 4.5 mcg/kg
n=6 Participants
PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 9.0 mcg/kg
n=6 Participants
PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 18.0 mcg/kg
n=6 Participants
PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 30.0 mcg/kg
n=6 Participants
PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria
Hemoglobin
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria
Platelets
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria
WBC
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria
Prothrombin Time
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria
Total Bilirubin
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria
Total Protein
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria
Albumin
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria
AST
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria
ALT
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria
Alkaline Phosphatase
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria
BUN
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria
Creatinine
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria
Uric Acid
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria
Sodium
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria
Potassium
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria
Calcium
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria
Troponin-T
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria
Anti-Thrombin III
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria
D-Dimer
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria
Glucose
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria
Fibrinogen
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Baseline through Day 60Population: The immunogenicity parameter population included enrolled and treated participants with at least 1 post-treatment anti-PF-05280602 antibody (ADA), PF-05280602 inhibitor, or Factor VII activity level determination.
Assays for the determination of a positive immune response was performed. An antibody immune response was defined as a confirmed post-treatment positive ELISA result in combination with a negative baseline sample ELISA result. Positive antibody immune responses to PF-05280602 by ELISA was evaluated for cross reactivity to NovoSeven RT and to Factor VII.
Outcome measures
| Measure |
PF-05280602 0.5 mcg/kg
n=1 Participants
PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
|
PF-05280602 4.5 mcg/kg
n=6 Participants
PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 9.0 mcg/kg
n=6 Participants
PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 18.0 mcg/kg
n=6 Participants
PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 30.0 mcg/kg
n=6 Participants
PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Positive Immune Response (Anti-Drug Antibodies [ADA], PF-05280602 Inhibitor, Factor VIIa Inhibitor, Factor VII Inhibitor, and Depletion of Factor VII Activity)
ADA
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Positive Immune Response (Anti-Drug Antibodies [ADA], PF-05280602 Inhibitor, Factor VIIa Inhibitor, Factor VII Inhibitor, and Depletion of Factor VII Activity)
PF-05280602 Inhibitor
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Positive Immune Response (Anti-Drug Antibodies [ADA], PF-05280602 Inhibitor, Factor VIIa Inhibitor, Factor VII Inhibitor, and Depletion of Factor VII Activity)
Factor VII Inhibitor
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Positive Immune Response (Anti-Drug Antibodies [ADA], PF-05280602 Inhibitor, Factor VIIa Inhibitor, Factor VII Inhibitor, and Depletion of Factor VII Activity)
Depletion of Factor VII Activity
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Positive Immune Response (Anti-Drug Antibodies [ADA], PF-05280602 Inhibitor, Factor VIIa Inhibitor, Factor VII Inhibitor, and Depletion of Factor VII Activity)
Factor VIIa Inhibitor
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)Population: The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.
Outcome measures
| Measure |
PF-05280602 0.5 mcg/kg
n=1 Participants
PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
|
PF-05280602 4.5 mcg/kg
n=6 Participants
PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 9.0 mcg/kg
n=6 Participants
PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 18.0 mcg/kg
n=6 Participants
PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 30.0 mcg/kg
n=6 Participants
PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
1.68 ng/mL
Geometric Coefficient of Variation NA
As only 1 participant was analyzed, geometric coefficient of variation was not calculated.
|
84.78 ng/mL
Geometric Coefficient of Variation 20
|
183.1 ng/mL
Geometric Coefficient of Variation 28
|
496.2 ng/mL
Geometric Coefficient of Variation 14
|
814.8 ng/mL
Geometric Coefficient of Variation 23
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)Population: The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Outcome measures
| Measure |
PF-05280602 0.5 mcg/kg
n=1 Participants
PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
|
PF-05280602 4.5 mcg/kg
n=6 Participants
PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 9.0 mcg/kg
n=6 Participants
PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 18.0 mcg/kg
n=6 Participants
PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 30.0 mcg/kg
n=6 Participants
PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
|
3.82 ng*hr/mL
Geometric Coefficient of Variation NA
As only 1 participant was analyzed, geometric coefficient of variation was not calculated.
|
300.7 ng*hr/mL
Geometric Coefficient of Variation 15
|
638.9 ng*hr/mL
Geometric Coefficient of Variation 21
|
1557 ng*hr/mL
Geometric Coefficient of Variation 19
|
2788 ng*hr/mL
Geometric Coefficient of Variation 31
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)Population: The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.
t1/2 is the time measured for the plasma concentration to decrease by one half.
Outcome measures
| Measure |
PF-05280602 0.5 mcg/kg
n=1 Participants
PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
|
PF-05280602 4.5 mcg/kg
n=6 Participants
PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 9.0 mcg/kg
n=6 Participants
PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 18.0 mcg/kg
n=6 Participants
PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 30.0 mcg/kg
n=6 Participants
PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
|---|---|---|---|---|---|
|
Terminal Elimination Half-Life (t1/2)
|
NA hour
Standard Deviation NA
Due to low PF-05280602 levels, terminal phase was not well characterized.
|
3.533 hour
Standard Deviation 0.560
|
3.637 hour
Standard Deviation 0.803
|
3.303 hour
Standard Deviation 0.638
|
3.580 hour
Standard Deviation 0.564
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)Population: The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.
IncRec is the maximum rise in plasma concentration per administered dose.
Outcome measures
| Measure |
PF-05280602 0.5 mcg/kg
n=1 Participants
PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
|
PF-05280602 4.5 mcg/kg
n=6 Participants
PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 9.0 mcg/kg
n=6 Participants
PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 18.0 mcg/kg
n=6 Participants
PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 30.0 mcg/kg
n=6 Participants
PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
|---|---|---|---|---|---|
|
Incremental Recovery (IncRec)
|
3.48 ng/mL/mcg/kg
Geometric Coefficient of Variation NA
As only 1 participant was analyzed, geometric coefficient of variation was not calculated.
|
18.49 ng/mL/mcg/kg
Geometric Coefficient of Variation 20
|
20.06 ng/mL/mcg/kg
Geometric Coefficient of Variation 28
|
27.67 ng/mL/mcg/kg
Geometric Coefficient of Variation 16
|
26.87 ng/mL/mcg/kg
Geometric Coefficient of Variation 24
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)Population: The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.
AUCinf is area under the plasma concentration-time curve from time 0 extrapolated to infinite time.
Outcome measures
| Measure |
PF-05280602 0.5 mcg/kg
n=1 Participants
PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
|
PF-05280602 4.5 mcg/kg
n=6 Participants
PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 9.0 mcg/kg
n=6 Participants
PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 18.0 mcg/kg
n=6 Participants
PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 30.0 mcg/kg
n=6 Participants
PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Due to low PF-05280602 levels, terminal phase was not well characterized.
|
300.7 ng*hr/mL
Geometric Coefficient of Variation 15
|
638.9 ng*hr/mL
Geometric Coefficient of Variation 21
|
1557 ng*hr/mL
Geometric Coefficient of Variation 19
|
2788 ng*hr/mL
Geometric Coefficient of Variation 31
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)Population: The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.
MRT is AUMCinf/AUCinf, where AUMC is the area under the first moment curve.
Outcome measures
| Measure |
PF-05280602 0.5 mcg/kg
n=1 Participants
PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
|
PF-05280602 4.5 mcg/kg
n=6 Participants
PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 9.0 mcg/kg
n=6 Participants
PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 18.0 mcg/kg
n=6 Participants
PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 30.0 mcg/kg
n=6 Participants
PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
|---|---|---|---|---|---|
|
Mean Residence Time (MRT)
|
NA hours
Standard Deviation NA
Due to low PF-05280602 levels, terminal phase was not well characterized.
|
7.948 hours
Standard Deviation 1.786
|
5.697 hours
Standard Deviation 0.727
|
4.963 hours
Standard Deviation 0.741
|
5.087 hours
Standard Deviation 0.649
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)Population: The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
Outcome measures
| Measure |
PF-05280602 0.5 mcg/kg
n=1 Participants
PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
|
PF-05280602 4.5 mcg/kg
n=6 Participants
PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 9.0 mcg/kg
n=6 Participants
PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 18.0 mcg/kg
n=6 Participants
PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 30.0 mcg/kg
n=6 Participants
PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
|---|---|---|---|---|---|
|
Volume of Distribution at Steady State (Vss)
|
NA L/kg
Geometric Coefficient of Variation NA
Due to low PF-05280602 levels, terminal phase was not well characterized.
|
0.1168 L/kg
Geometric Coefficient of Variation 35
|
0.08060 L/kg
Geometric Coefficient of Variation 24
|
0.05651 L/kg
Geometric Coefficient of Variation 21
|
0.05494 L/kg
Geometric Coefficient of Variation 32
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)Population: The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). Clearance obtained after intravenous infusion dose is influenced by the fraction of the dose absorbed.
Outcome measures
| Measure |
PF-05280602 0.5 mcg/kg
n=1 Participants
PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
|
PF-05280602 4.5 mcg/kg
n=6 Participants
PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 9.0 mcg/kg
n=6 Participants
PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 18.0 mcg/kg
n=6 Participants
PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 30.0 mcg/kg
n=6 Participants
PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
|---|---|---|---|---|---|
|
Clearance (CL)
|
NA L/hr/kg
Geometric Coefficient of Variation NA
Due to low PF-05280602 levels, terminal phase was not well characterized.
|
0.01502 L/hr/kg
Geometric Coefficient of Variation 15
|
0.01423 L/hr/kg
Geometric Coefficient of Variation 21
|
0.01149 L/hr/kg
Geometric Coefficient of Variation 20
|
0.01089 L/hr/kg
Geometric Coefficient of Variation 31
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)Population: The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.
Outcome measures
| Measure |
PF-05280602 0.5 mcg/kg
n=1 Participants
PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
|
PF-05280602 4.5 mcg/kg
n=6 Participants
PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 9.0 mcg/kg
n=6 Participants
PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 18.0 mcg/kg
n=6 Participants
PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 30.0 mcg/kg
n=6 Participants
PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax)
|
0.167 hours
Full Range NA • Interval 0.167 to 0.167
|
0.167 hours
Full Range 15 • Interval 0.083 to 0.2
|
0.242 hours
Full Range 21 • Interval 0.117 to 0.367
|
0.142 hours
Full Range 20 • Interval 0.083 to 0.333
|
0.150 hours
Full Range 31 • Interval 0.083 to 0.333
|
SECONDARY outcome
Timeframe: Baseline through Day 15Population: The safety population included all enrolled participants who received the study drug.
PT measures how long it takes blood to clot. Maximum mean decrease from baseline at any time point was reported.
Outcome measures
| Measure |
PF-05280602 0.5 mcg/kg
n=1 Participants
PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
|
PF-05280602 4.5 mcg/kg
n=6 Participants
PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 9.0 mcg/kg
n=6 Participants
PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 18.0 mcg/kg
n=6 Participants
PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 30.0 mcg/kg
n=6 Participants
PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
|---|---|---|---|---|---|
|
Maximum Mean Decrease From Baseline in Prothrombin Time (PT)
|
-0.70 seconds
Standard Deviation NA
As only 1 participant was analyzed, standard deviation was not calculated.
|
-3.37 seconds
Standard Deviation 0.372
|
-3.80 seconds
Standard Deviation 0.629
|
-3.85 seconds
Standard Deviation 0.409
|
-4.45 seconds
Standard Deviation 0.493
|
SECONDARY outcome
Timeframe: Baseline through Day 15Population: The safety population included all enrolled participants who received the study drug.
aPTT is a blood test that characterizes blood coagulation. Maximum mean decrease from baseline at any time point was reported.
Outcome measures
| Measure |
PF-05280602 0.5 mcg/kg
n=1 Participants
PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
|
PF-05280602 4.5 mcg/kg
n=6 Participants
PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 9.0 mcg/kg
n=6 Participants
PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 18.0 mcg/kg
n=6 Participants
PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 30.0 mcg/kg
n=6 Participants
PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
|---|---|---|---|---|---|
|
Maximum Mean Decrease From Baseline in Activated Partial Thromboplastin Time (aPTT)
|
-1.30 seconds
Standard Deviation NA
As only 1 participant was analyzed, standard deviation was not calculated.
|
-17.93 seconds
Standard Deviation 8.944
|
-24.47 seconds
Standard Deviation 12.273
|
-43.02 seconds
Standard Deviation 16.541
|
-46.85 seconds
Standard Deviation 12.281
|
SECONDARY outcome
Timeframe: Baseline through Day 3Population: The safety population included all enrolled participants who received the study drug. The 'Number of Participants Analyzed' is the number of evaluable participants for this measure.
TAT complex is a parameter of coagulation and fibrinolysis. The normal reference range of values for TAT is 1 to 4.1 mcg/L. Elevated TAT concentrations may signify predisposition to thrombosis. Maximum mean increase from baseline at any time point was reported.
Outcome measures
| Measure |
PF-05280602 0.5 mcg/kg
n=1 Participants
PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
|
PF-05280602 4.5 mcg/kg
n=6 Participants
PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 9.0 mcg/kg
n=5 Participants
PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 18.0 mcg/kg
n=6 Participants
PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 30.0 mcg/kg
n=6 Participants
PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
|---|---|---|---|---|---|
|
Maximum Mean Increase From Baseline in Thrombin Anti-Thrombin (TAT) Complexes
|
3.70 mcg/L
Standard Deviation NA
As only 1 participant was analyzed, standard deviation was not calculated.
|
23.82 mcg/L
Standard Deviation 51.130
|
4.72 mcg/L
Standard Deviation 5.282
|
5.52 mcg/L
Standard Deviation 6.530
|
22.47 mcg/L
Standard Deviation 28.010
|
SECONDARY outcome
Timeframe: Baseline through Day 3Population: The safety population included all enrolled participants who received the study drug. The 'Number of Participants Analyzed' is the number of evaluable participants for this measure.
Prothrombin fragment 1+2 is a coagulation factor, released when prothrombin is cleaved by activated Factor X. Elevated plasma levels of prothrombin fragment 1+2 indicate high risk of thrombosis. Maximum mean increase from baseline at any time point was reported.
Outcome measures
| Measure |
PF-05280602 0.5 mcg/kg
n=1 Participants
PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
|
PF-05280602 4.5 mcg/kg
n=6 Participants
PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 9.0 mcg/kg
n=5 Participants
PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 18.0 mcg/kg
n=6 Participants
PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 30.0 mcg/kg
n=6 Participants
PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
|---|---|---|---|---|---|
|
Maximum Mean Increase From Baseline in Prothrombin Fragments 1+2
|
38.0 picomoles per liter (pmol/L)
Standard Deviation NA
As only 1 participant was analyzed, standard deviation was not calculated.
|
31.8 picomoles per liter (pmol/L)
Standard Deviation 30.56
|
66.4 picomoles per liter (pmol/L)
Standard Deviation 84.73
|
76.7 picomoles per liter (pmol/L)
Standard Deviation 28.27
|
238.3 picomoles per liter (pmol/L)
Standard Deviation 162.22
|
SECONDARY outcome
Timeframe: Baseline through Day 15Population: The safety population included all enrolled participants who received the study drug.
D-dimer is an indicator of fibrin formation and its subsequent lysis and is a useful biomarker representing overall activation of blood coagulation. Maximum mean increase from baseline at any time point was reported.
Outcome measures
| Measure |
PF-05280602 0.5 mcg/kg
n=1 Participants
PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
|
PF-05280602 4.5 mcg/kg
n=6 Participants
PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 9.0 mcg/kg
n=6 Participants
PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 18.0 mcg/kg
n=6 Participants
PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 30.0 mcg/kg
n=6 Participants
PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
|---|---|---|---|---|---|
|
Maximum Mean Increase From Baseline in D-Dimers
|
240.0 ng/mL
Standard Deviation NA
As only 1 participant was analyzed, standard deviation was not calculated.
|
75.0 ng/mL
Standard Deviation 103.68
|
28.3 ng/mL
Standard Deviation 173.60
|
88.3 ng/mL
Standard Deviation 123.36
|
238.3 ng/mL
Standard Deviation 285.06
|
SECONDARY outcome
Timeframe: Baseline through Day 3Population: The safety population included all enrolled participants who received the study drug. The 'Number of Participants Analyzed' is the number of evaluable participants for this measure.
ETP was evaluated using a Thrombin Generation Assay (TGA), a validated automated ex-vivo assay that measures the ability of plasma to generate thrombin. Thrombin generation curves are generated and calculated using dedicated software. ETP is the area under the thrombin generation curve and represents the total amount of generated thrombin. Maximum mean increase from baseline at any time point was reported.
Outcome measures
| Measure |
PF-05280602 0.5 mcg/kg
n=1 Participants
PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
|
PF-05280602 4.5 mcg/kg
n=6 Participants
PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 9.0 mcg/kg
n=5 Participants
PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 18.0 mcg/kg
n=6 Participants
PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 30.0 mcg/kg
n=6 Participants
PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
|---|---|---|---|---|---|
|
Maximum Mean Increase From Baseline in Endogenous Thrombin Potential (ETP)
|
13.400 nanomolar*minute (nM*min)
Standard Deviation NA
As only 1 participant was analyzed, standard deviation was not calculated.
|
212.643 nanomolar*minute (nM*min)
Standard Deviation 77.3337
|
186.196 nanomolar*minute (nM*min)
Standard Deviation 147.6925
|
287.173 nanomolar*minute (nM*min)
Standard Deviation 421.1883
|
522.758 nanomolar*minute (nM*min)
Standard Deviation 94.0122
|
SECONDARY outcome
Timeframe: Baseline through Day 3Population: The safety population included all enrolled participants who received the study drug. The 'Number of Participants Analyzed' is the number of evaluable participants for this measure.
The lag time is defined as the time to reach one sixth of the peak height and is a measure of the initiation phase. It is equivalent to the clotting time. Maximum mean decrease from baseline at any time point was reported.
Outcome measures
| Measure |
PF-05280602 0.5 mcg/kg
n=1 Participants
PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
|
PF-05280602 4.5 mcg/kg
n=6 Participants
PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 9.0 mcg/kg
n=5 Participants
PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 18.0 mcg/kg
n=6 Participants
PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 30.0 mcg/kg
n=6 Participants
PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
|---|---|---|---|---|---|
|
Maximum Mean Decrease From Baseline in Thrombin Generation Lag Time
|
-0.540 minutes
Standard Deviation NA
As only 1 participant was analyzed, standard deviation was not calculated.
|
-6.235 minutes
Standard Deviation 5.7141
|
-7.088 minutes
Standard Deviation 7.9294
|
-13.400 minutes
Standard Deviation 14.6902
|
-2.425 minutes
Standard Deviation 0.9507
|
SECONDARY outcome
Timeframe: Baseline through Day 3Population: The safety population included all enrolled participants who received the study drug. The 'Number of Participants Analyzed' is the number of evaluable participants for this measure.
The peak height is defined as the maximum thrombin concentration produced. Maximum mean increase from baseline at any time point was reported.
Outcome measures
| Measure |
PF-05280602 0.5 mcg/kg
n=1 Participants
PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
|
PF-05280602 4.5 mcg/kg
n=6 Participants
PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 9.0 mcg/kg
n=5 Participants
PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 18.0 mcg/kg
n=6 Participants
PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 30.0 mcg/kg
n=6 Participants
PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
|---|---|---|---|---|---|
|
Maximum Mean Increase From Baseline in Peak Thrombin Generation
|
-0.620 Nanomolar (nM)
Standard Deviation NA
As only 1 participant was analyzed, standard deviation was not calculated.
|
17.982 Nanomolar (nM)
Standard Deviation 6.0924
|
16.568 Nanomolar (nM)
Standard Deviation 12.9124
|
23.362 Nanomolar (nM)
Standard Deviation 28.4618
|
49.130 Nanomolar (nM)
Standard Deviation 21.0371
|
Adverse Events
PF-05280602 0.5 mcg/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
PF-05280602 4.5 mcg/kg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
PF-05280602 9.0 mcg/kg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
PF-05280602 18.0 mcg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
PF-05280602 30.0 mcg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PF-05280602 0.5 mcg/kg
n=1 participants at risk
PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
|
PF-05280602 4.5 mcg/kg
n=6 participants at risk
PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 9.0 mcg/kg
n=6 participants at risk
PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 18.0 mcg/kg
n=6 participants at risk
PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
PF-05280602 30.0 mcg/kg
n=6 participants at risk
PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
|
|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/1 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
|
Eye disorders
Visual impairment
|
0.00%
0/1 • Baseline up to 28 days after last study drug administration (Day 60)
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
1/1 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
|
General disorders
Chills
|
0.00%
0/1 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
|
General disorders
Influenza like illness
|
0.00%
0/1 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
|
General disorders
Pain
|
0.00%
0/1 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
|
General disorders
Peripheral swelling
|
0.00%
0/1 • Baseline up to 28 days after last study drug administration (Day 60)
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
|
Infections and infestations
Nasopharyngitis
|
100.0%
1/1 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/1 • Baseline up to 28 days after last study drug administration (Day 60)
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
|
Investigations
Blood creatinine increased
|
0.00%
0/1 • Baseline up to 28 days after last study drug administration (Day 60)
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
|
Investigations
Blood glucose increased
|
0.00%
0/1 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
|
Investigations
Blood urea increased
|
0.00%
0/1 • Baseline up to 28 days after last study drug administration (Day 60)
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
100.0%
1/1 • Baseline up to 28 days after last study drug administration (Day 60)
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
100.0%
1/1 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/1 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
|
Musculoskeletal and connective tissue disorders
Muscle swelling
|
0.00%
0/1 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • Baseline up to 28 days after last study drug administration (Day 60)
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/1 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • Baseline up to 28 days after last study drug administration (Day 60)
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/1 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
100.0%
1/1 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
|
Vascular disorders
Haematoma
|
0.00%
0/1 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/1 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration (Day 60)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Catalyst Biosciences has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER