Trial Outcomes & Findings for Safety and Pharmacokinetics of Single and Multiple Ascending Doses of 3K3A-APC in Healthy Adult Volunteers (NCT NCT01660230)
NCT ID: NCT01660230
Last Updated: 2018-02-05
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
64 participants
Primary outcome timeframe
Day 4 for single-dose cohorts
Results posted on
2018-02-05
Participant Flow
Participant milestones
| Measure |
6 µg/kg 3K3A-APC, Single-dose
Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
30 µg/kg 3K3A-APC, Single-dose
Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
90 µg/kg 3K3A-APC, Single-dose
Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
180 µg/kg 3K3A-APC, Single-dose
Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
360 µg/kg 3K3A-APC, Single-dose
Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
720 µg/kg 3K3A-APC, Single-dose
Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
540 µg/kg 3K3A-APC, Single-dose
Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
90 µg/kg 3K3A-APC, q12h for 5 Doses
Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water
|
180 µg/kg 3K3A-APC, q12h for 5 Doses
Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water
|
360 µg/kg 3K3A-APC, q12h for 5 Doses
Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water
|
540 µg/kg 3K3A-APC, q12h for 5 Doses
Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water
|
Matching Placebo, 0.9% NaCl in Water
Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
4
|
4
|
4
|
2
|
4
|
6
|
6
|
6
|
6
|
14
|
|
Overall Study
COMPLETED
|
4
|
4
|
4
|
4
|
4
|
2
|
4
|
6
|
6
|
6
|
6
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Pharmacokinetics of Single and Multiple Ascending Doses of 3K3A-APC in Healthy Adult Volunteers
Baseline characteristics by cohort
| Measure |
6 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
30 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
90 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
180 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
360 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
720 µg/kg 3K3A-APC, Single-dose
n=2 Participants
Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
540 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
90 µg/kg 3K3A-APC, q12h for 5 Doses
n=6 Participants
Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water
|
180 µg/kg 3K3A-APC, q12h for 5 Doses
n=6 Participants
Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water
|
360 µg/kg 3K3A-APC, q12h for 5 Doses
n=6 Participants
Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water
|
540 µg/kg 3K3A-APC, q12h for 5 Doses
n=6 Participants
Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water
|
Matching Placebo, 0.9% NaCl in Water
n=14 Participants
Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
27.25 years
STANDARD_DEVIATION 10.59 • n=5 Participants
|
28.50 years
STANDARD_DEVIATION 9.26 • n=7 Participants
|
23.75 years
STANDARD_DEVIATION 2.36 • n=5 Participants
|
24.00 years
STANDARD_DEVIATION 2.58 • n=4 Participants
|
28.25 years
STANDARD_DEVIATION 10.11 • n=21 Participants
|
36.00 years
STANDARD_DEVIATION 9.90 • n=10 Participants
|
23.75 years
STANDARD_DEVIATION 2.75 • n=115 Participants
|
27.00 years
STANDARD_DEVIATION 3.58 • n=6 Participants
|
24.50 years
STANDARD_DEVIATION 3.78 • n=6 Participants
|
27.50 years
STANDARD_DEVIATION 13.00 • n=64 Participants
|
25.67 years
STANDARD_DEVIATION 5.28 • n=17 Participants
|
29.14 years
STANDARD_DEVIATION 8.08 • n=21 Participants
|
27.03 years
STANDARD_DEVIATION 7.39 • n=22 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=64 Participants
|
4 Participants
n=17 Participants
|
8 Participants
n=21 Participants
|
30 Participants
n=22 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
4 Participants
n=64 Participants
|
2 Participants
n=17 Participants
|
6 Participants
n=21 Participants
|
34 Participants
n=22 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
1 Participants
n=17 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=22 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=64 Participants
|
5 Participants
n=17 Participants
|
13 Participants
n=21 Participants
|
61 Participants
n=22 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
|
Region of Enrollment
Austria
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
4 participants
n=4 Participants
|
4 participants
n=21 Participants
|
2 participants
n=10 Participants
|
4 participants
n=115 Participants
|
6 participants
n=6 Participants
|
6 participants
n=6 Participants
|
6 participants
n=64 Participants
|
6 participants
n=17 Participants
|
14 participants
n=21 Participants
|
64 participants
n=22 Participants
|
PRIMARY outcome
Timeframe: Day 4 for single-dose cohortsPopulation: All 'single-dose' subjects who received at least one dose of study treatment.
Outcome measures
| Measure |
6 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
30 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
90 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
180 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
360 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
720 µg/kg 3K3A-APC, Single-dose
n=2 Participants
Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
540 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
Matching Placebo, 0.9% NaCl in Water
n=6 Participants
Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water
|
|---|---|---|---|---|---|---|---|---|
|
Adverse Events That Meet Dose-limiting Toxicity Criteria Specified in Protocol.
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Day 6 for multiple-dose cohortsPopulation: All 'multiple-dose' subjects who received at least one dose of study treatment.
Outcome measures
| Measure |
6 µg/kg 3K3A-APC, Single-dose
n=6 Participants
Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
30 µg/kg 3K3A-APC, Single-dose
n=6 Participants
Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
90 µg/kg 3K3A-APC, Single-dose
n=6 Participants
Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
180 µg/kg 3K3A-APC, Single-dose
n=6 Participants
Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
360 µg/kg 3K3A-APC, Single-dose
n=8 Participants
Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
720 µg/kg 3K3A-APC, Single-dose
Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
540 µg/kg 3K3A-APC, Single-dose
Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
Matching Placebo, 0.9% NaCl in Water
Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water
|
|---|---|---|---|---|---|---|---|---|
|
Adverse Events That Meet Dose-limiting Toxicity Criteria Specified in the Protocol.
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dosePopulation: All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.
Single-dose cohorts
Outcome measures
| Measure |
6 µg/kg 3K3A-APC, Single-dose
Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
30 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
90 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
180 µg/kg 3K3A-APC, Single-dose
n=3 Participants
Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
360 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
720 µg/kg 3K3A-APC, Single-dose
n=2 Participants
Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
540 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
Matching Placebo, 0.9% NaCl in Water
Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Non-compartmental Analysis
|
—
|
248 ng/mL
Standard Deviation 64.1
|
745 ng/mL
Standard Deviation 33.2
|
1423 ng/mL
Standard Deviation 131
|
3562 ng/mL
Standard Deviation 512
|
6115 ng/mL
Standard Deviation 522
|
4428 ng/mL
Standard Deviation 462
|
—
|
SECONDARY outcome
Timeframe: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dosePopulation: All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.
Single-dose cohorts
Outcome measures
| Measure |
6 µg/kg 3K3A-APC, Single-dose
Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
30 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
90 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
180 µg/kg 3K3A-APC, Single-dose
n=3 Participants
Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
360 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
720 µg/kg 3K3A-APC, Single-dose
n=2 Participants
Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
540 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
Matching Placebo, 0.9% NaCl in Water
Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water
|
|---|---|---|---|---|---|---|---|---|
|
Time at Which Cmax is Observed (Tmax) for 3K3A-APC by Non-compartmental Analysis
|
—
|
0.250 hour (from start of infusion)
Interval 0.25 to 0.25
|
0.250 hour (from start of infusion)
Interval 0.233 to 0.25
|
0.250 hour (from start of infusion)
Interval 0.25 to 0.333
|
0.333 hour (from start of infusion)
Interval 0.25 to 0.333
|
0.250 hour (from start of infusion)
Interval 0.25 to 0.25
|
0.250 hour (from start of infusion)
Interval 0.25 to 0.25
|
—
|
SECONDARY outcome
Timeframe: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dosePopulation: All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.
Single-dose cohorts
Outcome measures
| Measure |
6 µg/kg 3K3A-APC, Single-dose
Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
30 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
90 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
180 µg/kg 3K3A-APC, Single-dose
n=3 Participants
Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
360 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
720 µg/kg 3K3A-APC, Single-dose
n=2 Participants
Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
540 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
Matching Placebo, 0.9% NaCl in Water
Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 to the Final Time With a Concentration ≥ Limit of Quantitation [AUC(0-t)] for 3K3A-APC by Non-compartmental Analysis
|
—
|
85.8 h * ng/mL
Standard Deviation 33.9
|
327 h * ng/mL
Standard Deviation 31.2
|
615 h * ng/mL
Standard Deviation 101
|
1492 h * ng/mL
Standard Deviation 140
|
3025 h * ng/mL
Standard Deviation 174
|
2156 h * ng/mL
Standard Deviation 176
|
—
|
SECONDARY outcome
Timeframe: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dosePopulation: All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.
Single-dose cohorts
Outcome measures
| Measure |
6 µg/kg 3K3A-APC, Single-dose
Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
30 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
90 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
180 µg/kg 3K3A-APC, Single-dose
n=3 Participants
Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
360 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
720 µg/kg 3K3A-APC, Single-dose
n=2 Participants
Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
540 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
Matching Placebo, 0.9% NaCl in Water
Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Non-compartmental Analysis
|
—
|
114 h * ng/mL
Standard Deviation 31.9
|
374 h * ng/mL
Standard Deviation 31.8
|
664 h * ng/mL
Standard Deviation 112
|
1555 h * ng/mL
Standard Deviation 147
|
3087 h * ng/mL
Standard Deviation 178
|
2226 h * ng/mL
Standard Deviation 188
|
—
|
SECONDARY outcome
Timeframe: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dosePopulation: All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.
Single-dose cohorts
Outcome measures
| Measure |
6 µg/kg 3K3A-APC, Single-dose
Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
30 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
90 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
180 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
360 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
720 µg/kg 3K3A-APC, Single-dose
n=2 Participants
Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
540 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
Matching Placebo, 0.9% NaCl in Water
Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water
|
|---|---|---|---|---|---|---|---|---|
|
Elimination Rate Constant (λz) for 3K3A-APC by Non-compartmental Analysis
|
—
|
3.45 L/h
Standard Deviation 0.84
|
2.69 L/h
Standard Deviation 0.50
|
2.73 L/h
Standard Deviation 0.47
|
2.50 L/h
Standard Deviation 0.47
|
1.81 L/h
Standard Deviation 0.32
|
2.03 L/h
Standard Deviation 0.32
|
—
|
SECONDARY outcome
Timeframe: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dosePopulation: All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.
Single-dose cohorts
Outcome measures
| Measure |
6 µg/kg 3K3A-APC, Single-dose
Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
30 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
90 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
180 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
360 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
720 µg/kg 3K3A-APC, Single-dose
n=2 Participants
Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
540 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
Matching Placebo, 0.9% NaCl in Water
Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water
|
|---|---|---|---|---|---|---|---|---|
|
Half-life (t1/2) of 3K3A-APC by Non-compartmental Analysis
|
—
|
0.208 h
Standard Deviation 0.041
|
0.263 h
Standard Deviation 0.043
|
0.259 h
Standard Deviation 0.045
|
0.285 h
Standard Deviation 0.054
|
0.388 h
Standard Deviation 0.069
|
0.347 h
Standard Deviation 0.049
|
—
|
SECONDARY outcome
Timeframe: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dosePopulation: All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.
Single-dose cohorts
Outcome measures
| Measure |
6 µg/kg 3K3A-APC, Single-dose
Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
30 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
90 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
180 µg/kg 3K3A-APC, Single-dose
n=3 Participants
Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
360 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
720 µg/kg 3K3A-APC, Single-dose
n=2 Participants
Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
540 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
Matching Placebo, 0.9% NaCl in Water
Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water
|
|---|---|---|---|---|---|---|---|---|
|
Total Clearance (CL) of 3K3A-APC by Non-compartmental Analysis
|
—
|
18,556 mL/h
Standard Deviation 4,538
|
18,328 mL/h
Standard Deviation 1,686
|
16,883 mL/h
Standard Deviation 573
|
18,036 mL/h
Standard Deviation 1,558
|
12,081 mL/h
Standard Deviation 535
|
17,285 mL/h
Standard Deviation 1,546
|
—
|
SECONDARY outcome
Timeframe: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dosePopulation: All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.
Single-dose cohorts
Outcome measures
| Measure |
6 µg/kg 3K3A-APC, Single-dose
Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
30 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
90 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
180 µg/kg 3K3A-APC, Single-dose
n=3 Participants
Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
360 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
720 µg/kg 3K3A-APC, Single-dose
n=2 Participants
Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
540 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
Matching Placebo, 0.9% NaCl in Water
Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water
|
|---|---|---|---|---|---|---|---|---|
|
Volume of Distribution (Vz) of 3K3A-APC by Non-compartmental Analysis
|
—
|
5,494 mL
Standard Deviation 1,501
|
6,934 mL
Standard Deviation 1,173
|
6,727 mL
Standard Deviation 944
|
7,412 mL
Standard Deviation 1,473
|
6,744 mL
Standard Deviation 911
|
8,674 mL
Standard Deviation 1,655
|
—
|
SECONDARY outcome
Timeframe: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dosePopulation: All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.
Single-dose cohorts
Outcome measures
| Measure |
6 µg/kg 3K3A-APC, Single-dose
Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
30 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
90 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
180 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
360 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
720 µg/kg 3K3A-APC, Single-dose
n=2 Participants
Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
540 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
Matching Placebo, 0.9% NaCl in Water
Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Compartmental Analysis
|
—
|
249 ng/mL
Standard Deviation 59.2
|
741 ng/mL
Standard Deviation 50.2
|
1300 ng/mL
Standard Deviation 111
|
3374 ng/mL
Standard Deviation 490
|
5715 ng/mL
Standard Deviation 306
|
4489 ng/mL
Standard Deviation 654
|
—
|
SECONDARY outcome
Timeframe: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dosePopulation: All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.
Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.
Outcome measures
| Measure |
6 µg/kg 3K3A-APC, Single-dose
Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
30 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
90 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
180 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
360 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
720 µg/kg 3K3A-APC, Single-dose
n=2 Participants
Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
540 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
Matching Placebo, 0.9% NaCl in Water
Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Compartmental Analysis
|
—
|
123 h * ng/mL
Standard Deviation 32.0
|
381 h * ng/mL
Standard Deviation 29.6
|
623 h * ng/mL
Standard Deviation 131
|
1615 h * ng/mL
Standard Deviation 142
|
3195 h * ng/mL
Standard Deviation 263
|
2309 h * ng/mL
Standard Deviation 191
|
—
|
SECONDARY outcome
Timeframe: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dosePopulation: All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.
Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.
Outcome measures
| Measure |
6 µg/kg 3K3A-APC, Single-dose
Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
30 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
90 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
180 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
360 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
720 µg/kg 3K3A-APC, Single-dose
n=2 Participants
Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
540 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
Matching Placebo, 0.9% NaCl in Water
Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water
|
|---|---|---|---|---|---|---|---|---|
|
Elimination Rate Constant (λz) for 3K3A-APC by Compartmental Analysis
|
—
|
2.85 L/h
Standard Deviation 0.30
|
2.69 L/h
Standard Deviation 0.49
|
3.08 L/h
Standard Deviation 0.65
|
2.96 L/h
Standard Deviation 0.33
|
2.40 L/h
Standard Deviation 0.44
|
2.68 L/h
Standard Deviation 0.49
|
—
|
SECONDARY outcome
Timeframe: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dosePopulation: All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.
Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.
Outcome measures
| Measure |
6 µg/kg 3K3A-APC, Single-dose
Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
30 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
90 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
180 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
360 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
720 µg/kg 3K3A-APC, Single-dose
n=2 Participants
Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
540 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
Matching Placebo, 0.9% NaCl in Water
Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water
|
|---|---|---|---|---|---|---|---|---|
|
Half-life (t1/2) of 3K3A-APC by Compartmental Analysis
|
—
|
0.246 h
Standard Deviation 0.027
|
0.263 h
Standard Deviation 0.043
|
0.232 h
Standard Deviation 0.046
|
0.237 h
Standard Deviation 0.029
|
0.294 h
Standard Deviation 0.054
|
0.264 h
Standard Deviation 0.041
|
—
|
SECONDARY outcome
Timeframe: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dosePopulation: All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.
Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.
Outcome measures
| Measure |
6 µg/kg 3K3A-APC, Single-dose
Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
30 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
90 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
180 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
360 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
720 µg/kg 3K3A-APC, Single-dose
n=2 Participants
Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
540 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
Matching Placebo, 0.9% NaCl in Water
Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water
|
|---|---|---|---|---|---|---|---|---|
|
Total Clearance (CL) of 3K3A-APC by Compartmental Analysis
|
—
|
17,017 mL/h
Standard Deviation 4,163
|
18,016 mL/h
Standard Deviation 1,695
|
17,981 mL/h
Standard Deviation 2,321
|
17,372 mL/h
Standard Deviation 1,700
|
11,693 mL/h
Standard Deviation 807
|
16,665 mL/h
Standard Deviation 1,555
|
—
|
SECONDARY outcome
Timeframe: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dosePopulation: All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.
Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.
Outcome measures
| Measure |
6 µg/kg 3K3A-APC, Single-dose
Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
30 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
90 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
180 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
360 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
720 µg/kg 3K3A-APC, Single-dose
n=2 Participants
Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
540 µg/kg 3K3A-APC, Single-dose
n=4 Participants
Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
Matching Placebo, 0.9% NaCl in Water
Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water
|
|---|---|---|---|---|---|---|---|---|
|
Volume of Distribution (V) of 3K3A-APC by Compartmental Analysis
|
—
|
5967 mL
Standard Deviation 1236
|
6831 mL
Standard Deviation 1231
|
5931 mL
Standard Deviation 726
|
5970 mL
Standard Deviation 1194
|
4922 mL
Standard Deviation 574
|
6359 mL
Standard Deviation 1277
|
—
|
SECONDARY outcome
Timeframe: 0, 20 minutes and 1 hour post for doses 1 and 5Population: All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.
Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.
Outcome measures
| Measure |
6 µg/kg 3K3A-APC, Single-dose
n=6 Participants
Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
30 µg/kg 3K3A-APC, Single-dose
n=6 Participants
Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
90 µg/kg 3K3A-APC, Single-dose
n=6 Participants
Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
180 µg/kg 3K3A-APC, Single-dose
n=6 Participants
Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
360 µg/kg 3K3A-APC, Single-dose
Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
720 µg/kg 3K3A-APC, Single-dose
Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
540 µg/kg 3K3A-APC, Single-dose
Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
Matching Placebo, 0.9% NaCl in Water
Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Compartmental Analysis
|
810 ng/mL
Standard Deviation 118
|
1447 ng/mL
Standard Deviation 135
|
2990 ng/mL
Standard Deviation 608
|
5577 ng/mL
Standard Deviation 1134
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 20 minutes and 1 hour post for doses 1 and 5Population: All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.
Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.
Outcome measures
| Measure |
6 µg/kg 3K3A-APC, Single-dose
n=6 Participants
Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
30 µg/kg 3K3A-APC, Single-dose
n=6 Participants
Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
90 µg/kg 3K3A-APC, Single-dose
n=6 Participants
Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
180 µg/kg 3K3A-APC, Single-dose
n=6 Participants
Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
360 µg/kg 3K3A-APC, Single-dose
Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
720 µg/kg 3K3A-APC, Single-dose
Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
540 µg/kg 3K3A-APC, Single-dose
Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
Matching Placebo, 0.9% NaCl in Water
Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Compartmental Analysis
|
370 h * ng/mL
Standard Deviation 145
|
794 h * ng/mL
Standard Deviation 148
|
1634 h * ng/mL
Standard Deviation 365
|
2750 h * ng/mL
Standard Deviation 512
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 20 minutes and 1 hour post for doses 1 and 5Population: All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.
Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.
Outcome measures
| Measure |
6 µg/kg 3K3A-APC, Single-dose
n=6 Participants
Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
30 µg/kg 3K3A-APC, Single-dose
n=6 Participants
Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
90 µg/kg 3K3A-APC, Single-dose
n=6 Participants
Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
180 µg/kg 3K3A-APC, Single-dose
n=6 Participants
Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
360 µg/kg 3K3A-APC, Single-dose
Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
720 µg/kg 3K3A-APC, Single-dose
Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
540 µg/kg 3K3A-APC, Single-dose
Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
Matching Placebo, 0.9% NaCl in Water
Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water
|
|---|---|---|---|---|---|---|---|---|
|
Elimination Rate Constant (λz) for 3K3A-APC by Compartmental Analysis
|
3.87 L/h
Standard Deviation 1.58
|
2.50 L/h
Standard Deviation 0.46
|
2.47 L/h
Standard Deviation 0.20
|
2.83 L/h
Standard Deviation 0.25
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 20 minutes and 1 hour post for doses 1 and 5Population: All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.
Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.
Outcome measures
| Measure |
6 µg/kg 3K3A-APC, Single-dose
n=6 Participants
Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
30 µg/kg 3K3A-APC, Single-dose
n=6 Participants
Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
90 µg/kg 3K3A-APC, Single-dose
n=6 Participants
Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
180 µg/kg 3K3A-APC, Single-dose
n=6 Participants
Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
360 µg/kg 3K3A-APC, Single-dose
Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
720 µg/kg 3K3A-APC, Single-dose
Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
540 µg/kg 3K3A-APC, Single-dose
Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
Matching Placebo, 0.9% NaCl in Water
Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water
|
|---|---|---|---|---|---|---|---|---|
|
Half-life (t1/2) of 3K3A-APC by Compartmental Analysis
|
0.211 h
Standard Deviation 0.097
|
0.284 h
Standard Deviation 0.044
|
0.282 h
Standard Deviation 0.022
|
0.247 h
Standard Deviation 0.022
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 20 minutes and 1 hour post for doses 1 and 5Population: All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.
Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.
Outcome measures
| Measure |
6 µg/kg 3K3A-APC, Single-dose
n=6 Participants
Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
30 µg/kg 3K3A-APC, Single-dose
n=6 Participants
Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
90 µg/kg 3K3A-APC, Single-dose
n=6 Participants
Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
180 µg/kg 3K3A-APC, Single-dose
n=6 Participants
Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
360 µg/kg 3K3A-APC, Single-dose
Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
720 µg/kg 3K3A-APC, Single-dose
Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
540 µg/kg 3K3A-APC, Single-dose
Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
Matching Placebo, 0.9% NaCl in Water
Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water
|
|---|---|---|---|---|---|---|---|---|
|
Total Clearance (CL) of 3K3A-APC by Compartmental Analysis
|
18,701 mL/h
Standard Deviation 4,797
|
17,177 mL/h
Standard Deviation 2,593
|
14,231 mL/h
Standard Deviation 2,536
|
13,647 mL/h
Standard Deviation 1,584
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 20 minutes and 1 hour post for doses 1 and 5Population: All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.
Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.
Outcome measures
| Measure |
6 µg/kg 3K3A-APC, Single-dose
n=6 Participants
Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
30 µg/kg 3K3A-APC, Single-dose
n=6 Participants
Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
90 µg/kg 3K3A-APC, Single-dose
n=6 Participants
Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
180 µg/kg 3K3A-APC, Single-dose
n=6 Participants
Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
360 µg/kg 3K3A-APC, Single-dose
Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
720 µg/kg 3K3A-APC, Single-dose
Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
540 µg/kg 3K3A-APC, Single-dose
Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
Matching Placebo, 0.9% NaCl in Water
Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water
|
|---|---|---|---|---|---|---|---|---|
|
Volume of Distribution (V) of 3K3A-APC by Compartmental Analysis
|
5151 mL
Standard Deviation 982
|
6971 mL
Standard Deviation 1169
|
5732 mL
Standard Deviation 645
|
4873 mL
Standard Deviation 828
|
—
|
—
|
—
|
—
|
Adverse Events
6 µg/kg 3K3A-APC, Single-dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
30 µg/kg 3K3A-APC, Single-dose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
90 µg/kg 3K3A-APC, Single-dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
180 µg/kg 3K3A-APC, Single-dose
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
360 µg/kg 3K3A-APC, Single-dose
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
720 µg/kg 3K3A-APC, Single-dose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
540 µg/kg 3K3A-APC, Single-dose
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
90 µg/kg 3K3A-APC, q12h for 5 Doses
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
180 µg/kg 3K3A-APC, q12h for 5 Doses
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
360 µg/kg 3K3A-APC, q12h for 5 Doses
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
540 µg/kg 3K3A-APC, q12h for 5 Doses
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Matching Placebo, 0.9% NaCl in Water
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
6 µg/kg 3K3A-APC, Single-dose
n=4 participants at risk
Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
30 µg/kg 3K3A-APC, Single-dose
n=4 participants at risk
Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
90 µg/kg 3K3A-APC, Single-dose
n=4 participants at risk
Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
180 µg/kg 3K3A-APC, Single-dose
n=4 participants at risk
Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
360 µg/kg 3K3A-APC, Single-dose
n=4 participants at risk
Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
720 µg/kg 3K3A-APC, Single-dose
n=2 participants at risk
Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
540 µg/kg 3K3A-APC, Single-dose
n=4 participants at risk
Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water
|
90 µg/kg 3K3A-APC, q12h for 5 Doses
n=6 participants at risk
Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water
|
180 µg/kg 3K3A-APC, q12h for 5 Doses
n=6 participants at risk
Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water
|
360 µg/kg 3K3A-APC, q12h for 5 Doses
n=6 participants at risk
Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water
|
540 µg/kg 3K3A-APC, q12h for 5 Doses
n=6 participants at risk
Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water
|
Matching Placebo, 0.9% NaCl in Water
n=14 participants at risk
Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
25.0%
1/4 • Number of events 1 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
50.0%
2/4 • Number of events 2 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
100.0%
2/2 • Number of events 3 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
100.0%
4/4 • Number of events 4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
83.3%
5/6 • Number of events 12 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
33.3%
2/6 • Number of events 10 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
100.0%
6/6 • Number of events 27 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
83.3%
5/6 • Number of events 17 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
7.1%
1/14 • Number of events 2 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/2 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
7.1%
1/14 • Number of events 1 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
|
Nervous system disorders
Vertigo
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
50.0%
1/2 • Number of events 1 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/14 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
25.0%
1/4 • Number of events 1 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/2 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
16.7%
1/6 • Number of events 2 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
16.7%
1/6 • Number of events 1 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
16.7%
1/6 • Number of events 3 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
21.4%
3/14 • Number of events 5 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
|
Vascular disorders
Migraine
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/2 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
16.7%
1/6 • Number of events 1 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/14 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
25.0%
1/4 • Number of events 1 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
50.0%
1/2 • Number of events 1 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
16.7%
1/6 • Number of events 1 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
16.7%
1/6 • Number of events 1 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
7.1%
1/14 • Number of events 1 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
25.0%
1/4 • Number of events 1 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
50.0%
1/2 • Number of events 1 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/14 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/2 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
16.7%
1/6 • Number of events 1 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/14 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/2 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
7.1%
1/14 • Number of events 1 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/2 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
7.1%
1/14 • Number of events 1 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
|
General disorders
Fatigue
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/2 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
16.7%
1/6 • Number of events 1 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/14 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
|
General disorders
Hyperhidrosis
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
25.0%
1/4 • Number of events 1 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/2 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/14 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/2 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
16.7%
1/6 • Number of events 1 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/14 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
25.0%
1/4 • Number of events 1 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/2 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/14 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
|
Cardiac disorders
Sinus Bradycardia
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/2 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
7.1%
1/14 • Number of events 1 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/2 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/4 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
16.7%
1/6 • Number of events 1 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/6 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
0.00%
0/14 • AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60