Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ir-CPI in Healthy Male Subjects (NCT NCT04653766)
NCT ID: NCT04653766
Last Updated: 2023-02-23
Results Overview
These safety aPTT results were readily available to the PI for safety follow-up during and after the study drug administration. Safety aPTT was followed up "at the bedside" at regular time-points (as opposed to the PD biomarker aPTT, which was assessed by the central laboratory alongside the PK time-points). An aPTT ratio was calculated by dividing the aPTT value (in sec) of the specific time-point (aPTTt) by the baseline aPTT value (in sec) (aPTTbaseline) of the same participant (aPTT ratio = aPTTt/aPTTbaseline). The baseline time-point was considered as having an aPTT ratio of 1. Concerning the row titles, for example, Day 1 H02:00 corresponds to aPTT ratio results obtained on Day 1, 2 hours after the start of the infusion.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
At pre-dose (baseline), 2, 4, 6, 8, 12, 24, 48, 72 hours post-dose and at the discharge visit (Day 10 ± 2 days)
Results posted on
2023-02-23
Participant Flow
Participant milestones
| Measure |
Ir-CPI - Dose 1
6 participants received a single intravenous dose of 1.5 mg/kg of Ir-CPI during 6 hours
|
Ir-CPI - Dose 2
6 participants received a single intravenous dose of 3.0 mg/kg of Ir-CPI during 6 hours
|
Ir-CPI - Dose 3
6 participants received a single intravenous dose of 6.0 mg/kg of Ir-CPI during 6 hours
|
Ir-CPI - Dose 4
6 participants received a single intravenous dose of 9.0 mg/kg of Ir-CPI during 6 hours
|
Placebo
For each dose group, 2 additional participants received a single intravenous dose of placebo during 6 hours (8 in total).
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
8
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ir-CPI in Healthy Male Subjects
Baseline characteristics by cohort
| Measure |
Ir-CPI - Dose 1
n=6 Participants
Ir-CPI - Dose 1: 6 participants received a single intravenous dose of 1.5 mg/kg of Ir-CPI during 6 hours
|
Ir-CPI - Dose 2
n=6 Participants
Ir-CPI - Dose 2: 6 participants received a single intravenous dose of 3.0 mg/kg of Ir-CPI during 6 hours
|
Ir-CPI - Dose 3
n=6 Participants
Ir-CPI - Dose 3: 6 participants received a single intravenous dose of 6.0 mg/kg of Ir-CPI during 6 hours
|
Ir-CPI - Dose 4
n=6 Participants
Ir-CPI - Dose 4: 6 participants received a single intravenous dose of 9.0 mg/kg of Ir-CPI during 6 hours
|
Placebo
n=8 Participants
For each dose group, 2 additional participants received a single intravenous dose of placebo during 6 hours (8 in total).
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
32 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
36.0 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
35.2 years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
27.3 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
34.8 years
STANDARD_DEVIATION 10.0 • n=4 Participants
|
35.8 years
STANDARD_DEVIATION 11.4 • n=21 Participants
|
33.9 years
STANDARD_DEVIATION 10.6 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
32 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
32 Participants
n=8 Participants
|
|
Ethnicity (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=8 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=8 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=8 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=8 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
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
32 Participants
n=8 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=8 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=8 Participants
|
|
Region of Enrollment
Belgium
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
8 participants
n=21 Participants
|
32 participants
n=8 Participants
|
|
Height
|
178.8 cm
STANDARD_DEVIATION 4.4 • n=5 Participants
|
175.3 cm
STANDARD_DEVIATION 4.5 • n=7 Participants
|
177.2 cm
STANDARD_DEVIATION 4.9 • n=5 Participants
|
174.8 cm
STANDARD_DEVIATION 6.8 • n=4 Participants
|
179.5 cm
STANDARD_DEVIATION 6.9 • n=21 Participants
|
177.3 cm
STANDARD_DEVIATION 5.7 • n=8 Participants
|
|
Weight
|
78.43 kg
STANDARD_DEVIATION 4.28 • n=5 Participants
|
76.22 kg
STANDARD_DEVIATION 9.24 • n=7 Participants
|
77.25 kg
STANDARD_DEVIATION 6.34 • n=5 Participants
|
66.80 kg
STANDARD_DEVIATION 7.93 • n=4 Participants
|
72.96 kg
STANDARD_DEVIATION 6.99 • n=21 Participants
|
74.25 kg
STANDARD_DEVIATION 7.84 • n=8 Participants
|
|
Body Mass Index (BMI)
|
24.52 kg/m²
STANDARD_DEVIATION 0.95 • n=5 Participants
|
24.75 kg/m²
STANDARD_DEVIATION 2.47 • n=7 Participants
|
24.65 kg/m²
STANDARD_DEVIATION 2.32 • n=5 Participants
|
21.81 kg/m²
STANDARD_DEVIATION 1.63 • n=4 Participants
|
22.68 kg/m²
STANDARD_DEVIATION 2.23 • n=21 Participants
|
23.62 kg/m²
STANDARD_DEVIATION 2.24 • n=8 Participants
|
PRIMARY outcome
Timeframe: At pre-dose (baseline), 2, 4, 6, 8, 12, 24, 48, 72 hours post-dose and at the discharge visit (Day 10 ± 2 days)These safety aPTT results were readily available to the PI for safety follow-up during and after the study drug administration. Safety aPTT was followed up "at the bedside" at regular time-points (as opposed to the PD biomarker aPTT, which was assessed by the central laboratory alongside the PK time-points). An aPTT ratio was calculated by dividing the aPTT value (in sec) of the specific time-point (aPTTt) by the baseline aPTT value (in sec) (aPTTbaseline) of the same participant (aPTT ratio = aPTTt/aPTTbaseline). The baseline time-point was considered as having an aPTT ratio of 1. Concerning the row titles, for example, Day 1 H02:00 corresponds to aPTT ratio results obtained on Day 1, 2 hours after the start of the infusion.
Outcome measures
| Measure |
Ir-CPI - Dose 1
n=6 Participants
Ir-CPI - Dose 1: 6 participants received a single intravenous dose of 1.5 mg/kg of Ir-CPI during 6 hours
|
Ir-CPI - Dose 2
n=6 Participants
Ir-CPI - Dose 2: 6 participants received a single intravenous dose of 3.0 mg/kg of Ir-CPI during 6 hours
|
Ir-CPI - Dose 3
n=6 Participants
Ir-CPI - Dose 3: 6 participants received a single intravenous dose of 6.0 mg/kg of Ir-CPI during 6 hours
|
Ir-CPI - Dose 4
n=6 Participants
Ir-CPI - Dose 4: 6 participants received a single intravenous dose of 9.0 mg/kg of Ir-CPI during 6 hours
|
Placebo
n=8 Participants
Placebo: For each dose group, 2 additional participants received a single intravenous dose of placebo during 6 hours (8 in total).
|
|---|---|---|---|---|---|
|
Measurement of the Safety Lab Parameter Activated Partial Thromboplastin Time (aPTT)
Day 1 H00:00 (baseline)
|
1.000 aPTT ratio
Standard Deviation 0.000
|
1.000 aPTT ratio
Standard Deviation 0.000
|
1.000 aPTT ratio
Standard Deviation 0.000
|
1.000 aPTT ratio
Standard Deviation 0.000
|
1.000 aPTT ratio
Standard Deviation 0.000
|
|
Measurement of the Safety Lab Parameter Activated Partial Thromboplastin Time (aPTT)
Day 1 H02:00
|
1.600 aPTT ratio
Standard Deviation 0.080
|
1.978 aPTT ratio
Standard Deviation 0.068
|
2.405 aPTT ratio
Standard Deviation 0.214
|
2.627 aPTT ratio
Standard Deviation 0.126
|
0.986 aPTT ratio
Standard Deviation 0.088
|
|
Measurement of the Safety Lab Parameter Activated Partial Thromboplastin Time (aPTT)
Day 1 H04:00
|
1.768 aPTT ratio
Standard Deviation 0.123
|
2.262 aPTT ratio
Standard Deviation 0.085
|
2.628 aPTT ratio
Standard Deviation 0.260
|
2.875 aPTT ratio
Standard Deviation 0.129
|
0.981 aPTT ratio
Standard Deviation 0.077
|
|
Measurement of the Safety Lab Parameter Activated Partial Thromboplastin Time (aPTT)
Day 1 H06:00
|
1.860 aPTT ratio
Standard Deviation 0.103
|
2.313 aPTT ratio
Standard Deviation 0.060
|
2.775 aPTT ratio
Standard Deviation 0.269
|
2.993 aPTT ratio
Standard Deviation 0.196
|
0.994 aPTT ratio
Standard Deviation 0.086
|
|
Measurement of the Safety Lab Parameter Activated Partial Thromboplastin Time (aPTT)
Day 1 H08:00
|
1.520 aPTT ratio
Standard Deviation 0.100
|
1.832 aPTT ratio
Standard Deviation 0.072
|
2.135 aPTT ratio
Standard Deviation 0.208
|
2.367 aPTT ratio
Standard Deviation 0.096
|
0.960 aPTT ratio
Standard Deviation 0.091
|
|
Measurement of the Safety Lab Parameter Activated Partial Thromboplastin Time (aPTT)
Day 1 H12:00
|
1.308 aPTT ratio
Standard Deviation 0.070
|
1.600 aPTT ratio
Standard Deviation 0.102
|
1.848 aPTT ratio
Standard Deviation 0.075
|
2.077 aPTT ratio
Standard Deviation 0.046
|
0.970 aPTT ratio
Standard Deviation 0.075
|
|
Measurement of the Safety Lab Parameter Activated Partial Thromboplastin Time (aPTT)
Day 2 H24:00
|
1.162 aPTT ratio
Standard Deviation 0.056
|
1.352 aPTT ratio
Standard Deviation 0.122
|
1.627 aPTT ratio
Standard Deviation 0.114
|
1.725 aPTT ratio
Standard Deviation 0.056
|
0.973 aPTT ratio
Standard Deviation 0.077
|
|
Measurement of the Safety Lab Parameter Activated Partial Thromboplastin Time (aPTT)
Day 3 H48:00
|
1.033 aPTT ratio
Standard Deviation 0.041
|
1.123 aPTT ratio
Standard Deviation 0.132
|
1.313 aPTT ratio
Standard Deviation 0.063
|
1.377 aPTT ratio
Standard Deviation 0.064
|
0.983 aPTT ratio
Standard Deviation 0.108
|
|
Measurement of the Safety Lab Parameter Activated Partial Thromboplastin Time (aPTT)
Day 4 H72:00
|
1.020 aPTT ratio
Standard Deviation 0.036
|
1.083 aPTT ratio
Standard Deviation 0.056
|
1.143 aPTT ratio
Standard Deviation 0.067
|
1.182 aPTT ratio
Standard Deviation 0.046
|
0.974 aPTT ratio
Standard Deviation 0.071
|
|
Measurement of the Safety Lab Parameter Activated Partial Thromboplastin Time (aPTT)
Day 10 (discharge visit)
|
1.003 aPTT ratio
Standard Deviation 0.029
|
1.017 aPTT ratio
Standard Deviation 0.072
|
1.027 aPTT ratio
Standard Deviation 0.046
|
0.993 aPTT ratio
Standard Deviation 0.043
|
0.993 aPTT ratio
Standard Deviation 0.093
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 6.5, 7, 7.5, 8, 10, 12, 16, 24, 48, 72, 96, 144 hours (144 hours for Dose 4 only)Population: Pharmacokinetic set (PKS): all of the included participants who were administered a complete infusion of study drug without major protocol deviation affecting PK evaluation.
Outcome measures
| Measure |
Ir-CPI - Dose 1
n=6 Participants
Ir-CPI - Dose 1: 6 participants received a single intravenous dose of 1.5 mg/kg of Ir-CPI during 6 hours
|
Ir-CPI - Dose 2
n=6 Participants
Ir-CPI - Dose 2: 6 participants received a single intravenous dose of 3.0 mg/kg of Ir-CPI during 6 hours
|
Ir-CPI - Dose 3
n=6 Participants
Ir-CPI - Dose 3: 6 participants received a single intravenous dose of 6.0 mg/kg of Ir-CPI during 6 hours
|
Ir-CPI - Dose 4
n=6 Participants
Ir-CPI - Dose 4: 6 participants received a single intravenous dose of 9.0 mg/kg of Ir-CPI during 6 hours
|
Placebo
Placebo: For each dose group, 2 additional participants received a single intravenous dose of placebo during 6 hours (8 in total).
|
|---|---|---|---|---|---|
|
Measurement of the Maximum Plasma Concentration (Cmax) of Ir-CPI
|
958.8 ng/mL
Standard Deviation 98.6
|
2013.2 ng/mL
Standard Deviation 228.2
|
3752.5 ng/mL
Standard Deviation 422.3
|
6288.3 ng/mL
Standard Deviation 757
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 6.5, 7, 7.5, 8, 10, 12, 16, 24, 48, 72, 96, 144 hours (144 hours for Dose 4 only)Population: Pharmacokinetic set (PKS): all of the included participants who were administered a complete infusion of study drug without major protocol deviation affecting PK evaluation.
Outcome measures
| Measure |
Ir-CPI - Dose 1
n=6 Participants
Ir-CPI - Dose 1: 6 participants received a single intravenous dose of 1.5 mg/kg of Ir-CPI during 6 hours
|
Ir-CPI - Dose 2
n=6 Participants
Ir-CPI - Dose 2: 6 participants received a single intravenous dose of 3.0 mg/kg of Ir-CPI during 6 hours
|
Ir-CPI - Dose 3
n=6 Participants
Ir-CPI - Dose 3: 6 participants received a single intravenous dose of 6.0 mg/kg of Ir-CPI during 6 hours
|
Ir-CPI - Dose 4
n=6 Participants
Ir-CPI - Dose 4: 6 participants received a single intravenous dose of 9.0 mg/kg of Ir-CPI during 6 hours
|
Placebo
Placebo: For each dose group, 2 additional participants received a single intravenous dose of placebo during 6 hours (8 in total).
|
|---|---|---|---|---|---|
|
Measurement of the Time to Reach Maximum Plasma Concentration (Tmax) of Ir-CPI
|
6 hours
Standard Deviation 0
|
6 hours
Standard Deviation 0
|
6 hours
Standard Deviation 0
|
6 hours
Standard Deviation 0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 6.5, 7, 7.5, 8, 10, 12, 16, 24, 48, 72, 96, 144 hours (144 hours for Dose 4 only)Population: Pharmacokinetic set (PKS): all of the included participants who were administered a complete infusion of study drug without major protocol deviation affecting PK evaluation.
Outcome measures
| Measure |
Ir-CPI - Dose 1
n=6 Participants
Ir-CPI - Dose 1: 6 participants received a single intravenous dose of 1.5 mg/kg of Ir-CPI during 6 hours
|
Ir-CPI - Dose 2
n=6 Participants
Ir-CPI - Dose 2: 6 participants received a single intravenous dose of 3.0 mg/kg of Ir-CPI during 6 hours
|
Ir-CPI - Dose 3
n=6 Participants
Ir-CPI - Dose 3: 6 participants received a single intravenous dose of 6.0 mg/kg of Ir-CPI during 6 hours
|
Ir-CPI - Dose 4
n=6 Participants
Ir-CPI - Dose 4: 6 participants received a single intravenous dose of 9.0 mg/kg of Ir-CPI during 6 hours
|
Placebo
Placebo: For each dose group, 2 additional participants received a single intravenous dose of placebo during 6 hours (8 in total).
|
|---|---|---|---|---|---|
|
Measurement of the Area Under the Plasma Concentration-time Curve From Time Zero to 6h (AUC0-6) and From Time Zero to Time of Infinity (AUCinf)
AUC0-6h
|
3648.0 h*ng/mL
Standard Deviation 250.7
|
7915.5 h*ng/mL
Standard Deviation 1210.2
|
15184.7 h*ng/mL
Standard Deviation 1863.9
|
24683.2 h*ng/mL
Standard Deviation 5069.5
|
—
|
|
Measurement of the Area Under the Plasma Concentration-time Curve From Time Zero to 6h (AUC0-6) and From Time Zero to Time of Infinity (AUCinf)
AUC0-inf
|
13446.3 h*ng/mL
Standard Deviation 1208.2
|
26573.3 h*ng/mL
Standard Deviation 2037.3
|
53541.5 h*ng/mL
Standard Deviation 3832.6
|
104509.8 h*ng/mL
Standard Deviation 10124.8
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (baseline), 0.5, 1, 1.5, 2, 4, 6, 6.5, 7, 7.5, 8, 10, 12, 16, 24, 48, 72, 96 hours post-dose and at the discharge visit (Day 10 ± 2 days)Population: This analysis was performed on the Pharmacodyamic Set (PDS): all of the included participants who completed the study without any protocol deviation affecting PD evaluation and with at least one available post-baseline PD data point.
The activated partial thromboplastin time (aPTT) is used as a pharmacodynamic marker. No data were available for the Ir-CPI 1.5 mg/kg group because the results were not usable due to plasma preparation and method repeatability problems. An aPTT ratio was calculated by dividing the aPTT value (in sec) of the specific time-point (aPTTt) by the baseline aPTT value (in sec) (aPTTbaseline) of the same participant (aPTT ratio = aPTTt/aPTTbaseline). The baseline time-point (Day 1 H00:00) was considered as having an aPTT ratio of 1. Concerning the row titles, for example, Day 1 H02:00 corresponds to aPTT ratio results obtained on Day 1, 2 hours after the start of the infusion.
Outcome measures
| Measure |
Ir-CPI - Dose 1
n=6 Participants
Ir-CPI - Dose 1: 6 participants received a single intravenous dose of 1.5 mg/kg of Ir-CPI during 6 hours
|
Ir-CPI - Dose 2
n=6 Participants
Ir-CPI - Dose 2: 6 participants received a single intravenous dose of 3.0 mg/kg of Ir-CPI during 6 hours
|
Ir-CPI - Dose 3
n=6 Participants
Ir-CPI - Dose 3: 6 participants received a single intravenous dose of 6.0 mg/kg of Ir-CPI during 6 hours
|
Ir-CPI - Dose 4
n=8 Participants
Ir-CPI - Dose 4: 6 participants received a single intravenous dose of 9.0 mg/kg of Ir-CPI during 6 hours
|
Placebo
Placebo: For each dose group, 2 additional participants received a single intravenous dose of placebo during 6 hours (8 in total).
|
|---|---|---|---|---|---|
|
Measurement of the Effect of Ir-CPI on the Activated Partial Thromboplastin Time (aPTT)
Day 1 H00:00 (baseline)
|
1.000 aPTT ratio
Standard Deviation 0.000
|
1.000 aPTT ratio
Standard Deviation 0.000
|
1.000 aPTT ratio
Standard Deviation 0.000
|
1.000 aPTT ratio
Standard Deviation 0.000
|
—
|
|
Measurement of the Effect of Ir-CPI on the Activated Partial Thromboplastin Time (aPTT)
Day 1 H00:30
|
1.535 aPTT ratio
Standard Deviation 0.093
|
1.825 aPTT ratio
Standard Deviation 0.133
|
2.218 aPTT ratio
Standard Deviation 0.358
|
0.982 aPTT ratio
Standard Deviation 0.115
|
—
|
|
Measurement of the Effect of Ir-CPI on the Activated Partial Thromboplastin Time (aPTT)
Day 1 H01:00
|
1.707 aPTT ratio
Standard Deviation 0.073
|
2.085 aPTT ratio
Standard Deviation 0.131
|
2.397 aPTT ratio
Standard Deviation 0.296
|
0.962 aPTT ratio
Standard Deviation 0.097
|
—
|
|
Measurement of the Effect of Ir-CPI on the Activated Partial Thromboplastin Time (aPTT)
Day 1 H01:30
|
1.827 aPTT ratio
Standard Deviation 0.091
|
2.225 aPTT ratio
Standard Deviation 0.122
|
2.533 aPTT ratio
Standard Deviation 0.185
|
0.982 aPTT ratio
Standard Deviation 0.102
|
—
|
|
Measurement of the Effect of Ir-CPI on the Activated Partial Thromboplastin Time (aPTT)
Day 1 H02:00
|
1.915 aPTT ratio
Standard Deviation 0.079
|
2.367 aPTT ratio
Standard Deviation 0.143
|
2.692 aPTT ratio
Standard Deviation 0.214
|
0.972 aPTT ratio
Standard Deviation 0.094
|
—
|
|
Measurement of the Effect of Ir-CPI on the Activated Partial Thromboplastin Time (aPTT)
Day 1 H04:00
|
2.148 aPTT ratio
Standard Deviation 0.141
|
2.583 aPTT ratio
Standard Deviation 0.218
|
2.822 aPTT ratio
Standard Deviation 0.096
|
0.970 aPTT ratio
Standard Deviation 0.094
|
—
|
|
Measurement of the Effect of Ir-CPI on the Activated Partial Thromboplastin Time (aPTT)
Day 1 H06:00
|
2.207 aPTT ratio
Standard Deviation 0.119
|
2.652 aPTT ratio
Standard Deviation 0.260
|
3.050 aPTT ratio
Standard Deviation 0.189
|
0.973 aPTT ratio
Standard Deviation 0.116
|
—
|
|
Measurement of the Effect of Ir-CPI on the Activated Partial Thromboplastin Time (aPTT)
Day 1 H06:30
|
2.045 aPTT ratio
Standard Deviation 0.109
|
2.442 aPTT ratio
Standard Deviation 0.222
|
2.798 aPTT ratio
Standard Deviation 0.184
|
0.982 aPTT ratio
Standard Deviation 0.109
|
—
|
|
Measurement of the Effect of Ir-CPI on the Activated Partial Thromboplastin Time (aPTT)
Day 1 H07:00
|
1.917 aPTT ratio
Standard Deviation 0.105
|
2.240 aPTT ratio
Standard Deviation 0.154
|
2.558 aPTT ratio
Standard Deviation 0.113
|
0.972 aPTT ratio
Standard Deviation 0.101
|
—
|
|
Measurement of the Effect of Ir-CPI on the Activated Partial Thromboplastin Time (aPTT)
Day 1 H07:30
|
1.842 aPTT ratio
Standard Deviation 0.093
|
2.103 aPTT ratio
Standard Deviation 0.131
|
2.402 aPTT ratio
Standard Deviation 0.206
|
0.950 aPTT ratio
Standard Deviation 0.121
|
—
|
|
Measurement of the Effect of Ir-CPI on the Activated Partial Thromboplastin Time (aPTT)
Day 1 H08:00
|
1.775 aPTT ratio
Standard Deviation 0.097
|
2.098 aPTT ratio
Standard Deviation 0.161
|
1.098 aPTT ratio
Standard Deviation 0.161
|
0.945 aPTT ratio
Standard Deviation 0.102
|
—
|
|
Measurement of the Effect of Ir-CPI on the Activated Partial Thromboplastin Time (aPTT)
Day 1 H10:00
|
1.638 aPTT ratio
Standard Deviation 0.113
|
1.942 aPTT ratio
Standard Deviation 0.154
|
2.230 aPTT ratio
Standard Deviation 0.108
|
0.922 aPTT ratio
Standard Deviation 0.117
|
—
|
|
Measurement of the Effect of Ir-CPI on the Activated Partial Thromboplastin Time (aPTT)
Day 1 H12:00
|
1.540 aPTT ratio
Standard Deviation 0.120
|
1.842 aPTT ratio
Standard Deviation 0.119
|
2.137 aPTT ratio
Standard Deviation 0.116
|
0.952 aPTT ratio
Standard Deviation 0.106
|
—
|
|
Measurement of the Effect of Ir-CPI on the Activated Partial Thromboplastin Time (aPTT)
Day 1 H16:00
|
1.428 aPTT ratio
Standard Deviation 0.115
|
1.705 aPTT ratio
Standard Deviation 0.102
|
1.947 aPTT ratio
Standard Deviation 0.096
|
0.987 aPTT ratio
Standard Deviation 0.075
|
—
|
|
Measurement of the Effect of Ir-CPI on the Activated Partial Thromboplastin Time (aPTT)
Day 2 H24:00
|
1.312 aPTT ratio
Standard Deviation 0.151
|
1.585 aPTT ratio
Standard Deviation 0.107
|
1.718 aPTT ratio
Standard Deviation 0.116
|
0.965 aPTT ratio
Standard Deviation 0.103
|
—
|
|
Measurement of the Effect of Ir-CPI on the Activated Partial Thromboplastin Time (aPTT)
Day 3 H48:00
|
1.125 aPTT ratio
Standard Deviation 0.109
|
1.277 aPTT ratio
Standard Deviation 0.106
|
1.390 aPTT ratio
Standard Deviation 0.064
|
0.945 aPTT ratio
Standard Deviation 0.117
|
—
|
|
Measurement of the Effect of Ir-CPI on the Activated Partial Thromboplastin Time (aPTT)
Day 4 H72:00
|
1.025 aPTT ratio
Standard Deviation 0.107
|
1.113 aPTT ratio
Standard Deviation 0.118
|
1.172 aPTT ratio
Standard Deviation 0.053
|
0.988 aPTT ratio
Standard Deviation 0.133
|
—
|
|
Measurement of the Effect of Ir-CPI on the Activated Partial Thromboplastin Time (aPTT)
Day 5 H96:00
|
0.990 aPTT ratio
Standard Deviation 0.094
|
1.037 aPTT ratio
Standard Deviation 0.088
|
1.062 aPTT ratio
Standard Deviation 0.049
|
0.942 aPTT ratio
Standard Deviation 0.098
|
—
|
|
Measurement of the Effect of Ir-CPI on the Activated Partial Thromboplastin Time (aPTT)
Day 10 (discharge visit)
|
0.972 aPTT ratio
Standard Deviation 0.078
|
0.967 aPTT ratio
Standard Deviation 0.072
|
0.978 aPTT ratio
Standard Deviation 0.067
|
0.985 aPTT ratio
Standard Deviation 0.128
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (baseline), 0.5, 1, 1.5, 2, 4, 6, 6.5, 7, 7.5, 8, 10, 12, 16, 24, 48, 72, 96 hours post-dose and at the discharge visit (Day 10 ± 2 days)Population: This analysis was performed on the Pharmacodyamic Set (PDS): all of the included participants who completed the study without any protocol deviation affecting PD evaluation and with at least one available post-baseline PD data point.
The method is a clotting assay where all the clotting factors are present (constant and in excess, brought by the deficient plasma), excepted for FXI, which is brought by the diluted tested plasma, and clotting is triggered with cephalin, activator and calcium (aPTT). FXI is the limiting factor and clotting time is inversely proportional to the concentration of FXI. There is an inverse linear relationship between the percentage of FXI activity and the corresponding clotting time. Central laboratory normal ranges for Factor XI activity are between 65 and 150 %. Concerning the row titles, for example, Day 1 H02:00 corresponds to the percentage of FXI activity obtained on Day 1, 2 hours after the start of the infusion.
Outcome measures
| Measure |
Ir-CPI - Dose 1
n=6 Participants
Ir-CPI - Dose 1: 6 participants received a single intravenous dose of 1.5 mg/kg of Ir-CPI during 6 hours
|
Ir-CPI - Dose 2
n=6 Participants
Ir-CPI - Dose 2: 6 participants received a single intravenous dose of 3.0 mg/kg of Ir-CPI during 6 hours
|
Ir-CPI - Dose 3
n=6 Participants
Ir-CPI - Dose 3: 6 participants received a single intravenous dose of 6.0 mg/kg of Ir-CPI during 6 hours
|
Ir-CPI - Dose 4
n=6 Participants
Ir-CPI - Dose 4: 6 participants received a single intravenous dose of 9.0 mg/kg of Ir-CPI during 6 hours
|
Placebo
n=8 Participants
Placebo: For each dose group, 2 additional participants received a single intravenous dose of placebo during 6 hours (8 in total).
|
|---|---|---|---|---|---|
|
Measurement of the Effect of Ir-CPI on Factor XI Activity
Day 4 H72:00
|
136.8 Percentage of Factor XI activity
Standard Deviation 81.0
|
104.5 Percentage of Factor XI activity
Standard Deviation 20.9
|
92.8 Percentage of Factor XI activity
Standard Deviation 6.9
|
86.7 Percentage of Factor XI activity
Standard Deviation 17.3
|
105.5 Percentage of Factor XI activity
Standard Deviation 7.8
|
|
Measurement of the Effect of Ir-CPI on Factor XI Activity
Day 5 H96:00
|
110.8 Percentage of Factor XI activity
Standard Deviation 23.0
|
105.5 Percentage of Factor XI activity
Standard Deviation 24.2
|
90.0 Percentage of Factor XI activity
Standard Deviation 11.0
|
97.2 Percentage of Factor XI activity
Standard Deviation 19.1
|
107.4 Percentage of Factor XI activity
Standard Deviation 14.0
|
|
Measurement of the Effect of Ir-CPI on Factor XI Activity
Day 10 (discharge visit)
|
111.3 Percentage of Factor XI activity
Standard Deviation 28.6
|
107.7 Percentage of Factor XI activity
Standard Deviation 17.9
|
93.2 Percentage of Factor XI activity
Standard Deviation 9.3
|
99.3 Percentage of Factor XI activity
Standard Deviation 16.8
|
103.4 Percentage of Factor XI activity
Standard Deviation 11.7
|
|
Measurement of the Effect of Ir-CPI on Factor XI Activity
Day 1 H00:00 (baseline)
|
112.3 Percentage of Factor XI activity
Standard Deviation 23.9
|
103.7 Percentage of Factor XI activity
Standard Deviation 22.2
|
89.2 Percentage of Factor XI activity
Standard Deviation 9.8
|
94.5 Percentage of Factor XI activity
Standard Deviation 8.4
|
95.9 Percentage of Factor XI activity
Standard Deviation 12.4
|
|
Measurement of the Effect of Ir-CPI on Factor XI Activity
Day 1 H00:30
|
98.7 Percentage of Factor XI activity
Standard Deviation 20.1
|
85.5 Percentage of Factor XI activity
Standard Deviation 15.6
|
61.8 Percentage of Factor XI activity
Standard Deviation 8.3
|
58.8 Percentage of Factor XI activity
Standard Deviation 8.1
|
99.5 Percentage of Factor XI activity
Standard Deviation 10.2
|
|
Measurement of the Effect of Ir-CPI on Factor XI Activity
Day 1 H01:00
|
94.8 Percentage of Factor XI activity
Standard Deviation 23.4
|
79.5 Percentage of Factor XI activity
Standard Deviation 14.3
|
53.3 Percentage of Factor XI activity
Standard Deviation 7.1
|
54.7 Percentage of Factor XI activity
Standard Deviation 7.6
|
104.8 Percentage of Factor XI activity
Standard Deviation 12.2
|
|
Measurement of the Effect of Ir-CPI on Factor XI Activity
Day 1 H01:30
|
98.0 Percentage of Factor XI activity
Standard Deviation 18.2
|
73.3 Percentage of Factor XI activity
Standard Deviation 11.3
|
49.8 Percentage of Factor XI activity
Standard Deviation 6.3
|
50.0 Percentage of Factor XI activity
Standard Deviation 7.6
|
99.3 Percentage of Factor XI activity
Standard Deviation 14.2
|
|
Measurement of the Effect of Ir-CPI on Factor XI Activity
Day 1 H02:00
|
91.5 Percentage of Factor XI activity
Standard Deviation 19.1
|
70.8 Percentage of Factor XI activity
Standard Deviation 12.8
|
46.2 Percentage of Factor XI activity
Standard Deviation 6.0
|
47.2 Percentage of Factor XI activity
Standard Deviation 7.2
|
100.1 Percentage of Factor XI activity
Standard Deviation 10.8
|
|
Measurement of the Effect of Ir-CPI on Factor XI Activity
Day 1 H04:00
|
88.8 Percentage of Factor XI activity
Standard Deviation 19.1
|
64.0 Percentage of Factor XI activity
Standard Deviation 10.8
|
42.5 Percentage of Factor XI activity
Standard Deviation 5.5
|
41.7 Percentage of Factor XI activity
Standard Deviation 4.1
|
106.6 Percentage of Factor XI activity
Standard Deviation 13.8
|
|
Measurement of the Effect of Ir-CPI on Factor XI Activity
Day 1 H06:00
|
85.5 Percentage of Factor XI activity
Standard Deviation 16.5
|
61.7 Percentage of Factor XI activity
Standard Deviation 12.3
|
41.3 Percentage of Factor XI activity
Standard Deviation 3.3
|
40.5 Percentage of Factor XI activity
Standard Deviation 5.5
|
106.6 Percentage of Factor XI activity
Standard Deviation 12.7
|
|
Measurement of the Effect of Ir-CPI on Factor XI Activity
Day 1 H06:30
|
88.7 Percentage of Factor XI activity
Standard Deviation 19.5
|
67.7 Percentage of Factor XI activity
Standard Deviation 10.8
|
49.5 Percentage of Factor XI activity
Standard Deviation 6.7
|
45.3 Percentage of Factor XI activity
Standard Deviation 7.0
|
104.9 Percentage of Factor XI activity
Standard Deviation 13.0
|
|
Measurement of the Effect of Ir-CPI on Factor XI Activity
Day 1 H07:00
|
91.3 Percentage of Factor XI activity
Standard Deviation 25.9
|
70.7 Percentage of Factor XI activity
Standard Deviation 13.9
|
49.2 Percentage of Factor XI activity
Standard Deviation 4.4
|
47.0 Percentage of Factor XI activity
Standard Deviation 8.4
|
101.6 Percentage of Factor XI activity
Standard Deviation 10.9
|
|
Measurement of the Effect of Ir-CPI on Factor XI Activity
Day 1 H07:30
|
91.7 Percentage of Factor XI activity
Standard Deviation 23.9
|
74.5 Percentage of Factor XI activity
Standard Deviation 11.7
|
51.0 Percentage of Factor XI activity
Standard Deviation 5.6
|
47.8 Percentage of Factor XI activity
Standard Deviation 8.0
|
100.5 Percentage of Factor XI activity
Standard Deviation 14.5
|
|
Measurement of the Effect of Ir-CPI on Factor XI Activity
Day 1 H08:00
|
92.8 Percentage of Factor XI activity
Standard Deviation 20.8
|
73.8 Percentage of Factor XI activity
Standard Deviation 12.0
|
54.8 Percentage of Factor XI activity
Standard Deviation 4.3
|
50.7 Percentage of Factor XI activity
Standard Deviation 9.1
|
106.4 Percentage of Factor XI activity
Standard Deviation 15.4
|
|
Measurement of the Effect of Ir-CPI on Factor XI Activity
Day 1 H10:00
|
99.3 Percentage of Factor XI activity
Standard Deviation 28.1
|
83.2 Percentage of Factor XI activity
Standard Deviation 14.5
|
61.0 Percentage of Factor XI activity
Standard Deviation 6.9
|
56.7 Percentage of Factor XI activity
Standard Deviation 11.2
|
106.4 Percentage of Factor XI activity
Standard Deviation 14.9
|
|
Measurement of the Effect of Ir-CPI on Factor XI Activity
Day 1 H12:00
|
102.7 Percentage of Factor XI activity
Standard Deviation 25.0
|
87.0 Percentage of Factor XI activity
Standard Deviation 16.1
|
61.5 Percentage of Factor XI activity
Standard Deviation 7.1
|
59.5 Percentage of Factor XI activity
Standard Deviation 9.7
|
101.0 Percentage of Factor XI activity
Standard Deviation 11.5
|
|
Measurement of the Effect of Ir-CPI on Factor XI Activity
Day 1 H16:00
|
101.8 Percentage of Factor XI activity
Standard Deviation 25.7
|
89.0 Percentage of Factor XI activity
Standard Deviation 15.2
|
65.3 Percentage of Factor XI activity
Standard Deviation 8.0
|
63.5 Percentage of Factor XI activity
Standard Deviation 11.0
|
98.4 Percentage of Factor XI activity
Standard Deviation 11.1
|
|
Measurement of the Effect of Ir-CPI on Factor XI Activity
Day 2 H24:00
|
116.0 Percentage of Factor XI activity
Standard Deviation 35.8
|
92.7 Percentage of Factor XI activity
Standard Deviation 15.8
|
73.2 Percentage of Factor XI activity
Standard Deviation 9.9
|
71.2 Percentage of Factor XI activity
Standard Deviation 11.3
|
104.8 Percentage of Factor XI activity
Standard Deviation 8.5
|
|
Measurement of the Effect of Ir-CPI on Factor XI Activity
Day 3 H48:00
|
117.8 Percentage of Factor XI activity
Standard Deviation 21.9
|
104.7 Percentage of Factor XI activity
Standard Deviation 24.8
|
85.8 Percentage of Factor XI activity
Standard Deviation 13.8
|
81.5 Percentage of Factor XI activity
Standard Deviation 12.7
|
104.0 Percentage of Factor XI activity
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: Pre-dose (baseline), 0.5, 1, 1.5, 2, 4, 6, 6.5, 7, 7.5, 8, 10, 12, 16, 24, 48, 72, 96 hours post-dose and at the discharge visit (Day 10 ± 2 days)Population: This analysis was performed on the Pharmacodyamic Set (PDS): all of the included participants who completed the study without any protocol deviation affecting PD evaluation and with at least one available post-baseline PD data point.
The method is a clotting assay where all the clotting factors are present (constant and in excess, brought by the deficient plasma), excepted for FXII, which is brought by the diluted tested plasma, and clotting is triggered with cephalin, activator and calcium (aPTT). FXII is the limiting factor and clotting time is inversely proportional to the concentration of FXII. There is an inverse linear relationship between the percentage of FXII activity and the corresponding clotting time. Central laboratory normal ranges for Factor XII activity are between 50 and 150 %. Concerning the row titles, for example, Day 1 H02:00 corresponds to the percentage of FXII activity obtained on Day 1, 2 hours after the start of the infusion.
Outcome measures
| Measure |
Ir-CPI - Dose 1
n=6 Participants
Ir-CPI - Dose 1: 6 participants received a single intravenous dose of 1.5 mg/kg of Ir-CPI during 6 hours
|
Ir-CPI - Dose 2
n=6 Participants
Ir-CPI - Dose 2: 6 participants received a single intravenous dose of 3.0 mg/kg of Ir-CPI during 6 hours
|
Ir-CPI - Dose 3
n=6 Participants
Ir-CPI - Dose 3: 6 participants received a single intravenous dose of 6.0 mg/kg of Ir-CPI during 6 hours
|
Ir-CPI - Dose 4
n=6 Participants
Ir-CPI - Dose 4: 6 participants received a single intravenous dose of 9.0 mg/kg of Ir-CPI during 6 hours
|
Placebo
n=8 Participants
Placebo: For each dose group, 2 additional participants received a single intravenous dose of placebo during 6 hours (8 in total).
|
|---|---|---|---|---|---|
|
Measurement of the Effect of Ir-CPI on Factor XII Activity
Day 1 H00:00 (baseline)
|
105.0 Percentage of Factor XII activity
Standard Deviation 24.9
|
94.8 Percentage of Factor XII activity
Standard Deviation 20.8
|
101.5 Percentage of Factor XII activity
Standard Deviation 36.9
|
100.0 Percentage of Factor XII activity
Standard Deviation 15.9
|
111.0 Percentage of Factor XII activity
Standard Deviation 28.3
|
|
Measurement of the Effect of Ir-CPI on Factor XII Activity
Day 1 H00:30
|
93.0 Percentage of Factor XII activity
Standard Deviation 12.8
|
68.8 Percentage of Factor XII activity
Standard Deviation 18.7
|
60.8 Percentage of Factor XII activity
Standard Deviation 26.1
|
42.3 Percentage of Factor XII activity
Standard Deviation 9.7
|
114.0 Percentage of Factor XII activity
Standard Deviation 29.6
|
|
Measurement of the Effect of Ir-CPI on Factor XII Activity
Day 1 H01:00
|
83.5 Percentage of Factor XII activity
Standard Deviation 21.2
|
62.2 Percentage of Factor XII activity
Standard Deviation 17.7
|
45.8 Percentage of Factor XII activity
Standard Deviation 21.7
|
35.0 Percentage of Factor XII activity
Standard Deviation 5.3
|
119.1 Percentage of Factor XII activity
Standard Deviation 20.4
|
|
Measurement of the Effect of Ir-CPI on Factor XII Activity
Day 1 H01:30
|
82.7 Percentage of Factor XII activity
Standard Deviation 23.6
|
53.3 Percentage of Factor XII activity
Standard Deviation 15.0
|
43.8 Percentage of Factor XII activity
Standard Deviation 22.6
|
29.3 Percentage of Factor XII activity
Standard Deviation 5.3
|
111.4 Percentage of Factor XII activity
Standard Deviation 25.6
|
|
Measurement of the Effect of Ir-CPI on Factor XII Activity
Day 1 H02:00
|
76.0 Percentage of Factor XII activity
Standard Deviation 16.3
|
49.3 Percentage of Factor XII activity
Standard Deviation 12.5
|
32.7 Percentage of Factor XII activity
Standard Deviation 13.7
|
26.3 Percentage of Factor XII activity
Standard Deviation 5.0
|
113.5 Percentage of Factor XII activity
Standard Deviation 26.7
|
|
Measurement of the Effect of Ir-CPI on Factor XII Activity
Day 1 H04:00
|
68.5 Percentage of Factor XII activity
Standard Deviation 16.4
|
40.5 Percentage of Factor XII activity
Standard Deviation 10.6
|
27.5 Percentage of Factor XII activity
Standard Deviation 12.8
|
24.8 Percentage of Factor XII activity
Standard Deviation 4.6
|
117.0 Percentage of Factor XII activity
Standard Deviation 29.1
|
|
Measurement of the Effect of Ir-CPI on Factor XII Activity
Day 1 H06:00
|
64.8 Percentage of Factor XII activity
Standard Deviation 12.8
|
38.2 Percentage of Factor XII activity
Standard Deviation 5.7
|
26.7 Percentage of Factor XII activity
Standard Deviation 11.9
|
24.2 Percentage of Factor XII activity
Standard Deviation 7.4
|
116.4 Percentage of Factor XII activity
Standard Deviation 26.3
|
|
Measurement of the Effect of Ir-CPI on Factor XII Activity
Day 1 H06:30
|
69.5 Percentage of Factor XII activity
Standard Deviation 16.8
|
45.8 Percentage of Factor XII activity
Standard Deviation 11.8
|
33.3 Percentage of Factor XII activity
Standard Deviation 13.6
|
25.8 Percentage of Factor XII activity
Standard Deviation 5.9
|
116.3 Percentage of Factor XII activity
Standard Deviation 25.2
|
|
Measurement of the Effect of Ir-CPI on Factor XII Activity
Day 1 H07:00
|
75.0 Percentage of Factor XII activity
Standard Deviation 21.1
|
47.0 Percentage of Factor XII activity
Standard Deviation 11.0
|
35.8 Percentage of Factor XII activity
Standard Deviation 14.7
|
29.8 Percentage of Factor XII activity
Standard Deviation 8.2
|
116.8 Percentage of Factor XII activity
Standard Deviation 29.2
|
|
Measurement of the Effect of Ir-CPI on Factor XII Activity
Day 1 H07:30
|
75.2 Percentage of Factor XII activity
Standard Deviation 18.2
|
53.3 Percentage of Factor XII activity
Standard Deviation 14.4
|
39.0 Percentage of Factor XII activity
Standard Deviation 17.1
|
31.2 Percentage of Factor XII activity
Standard Deviation 8.1
|
115.9 Percentage of Factor XII activity
Standard Deviation 25.5
|
|
Measurement of the Effect of Ir-CPI on Factor XII Activity
Day 1 H08:00
|
77.7 Percentage of Factor XII activity
Standard Deviation 20.2
|
54.7 Percentage of Factor XII activity
Standard Deviation 12.1
|
44.3 Percentage of Factor XII activity
Standard Deviation 18.3
|
34.0 Percentage of Factor XII activity
Standard Deviation 7.6
|
117.4 Percentage of Factor XII activity
Standard Deviation 26.7
|
|
Measurement of the Effect of Ir-CPI on Factor XII Activity
Day 1 H10:00
|
90.3 Percentage of Factor XII activity
Standard Deviation 22.9
|
65.5 Percentage of Factor XII activity
Standard Deviation 15.7
|
54.2 Percentage of Factor XII activity
Standard Deviation 21.7
|
40.5 Percentage of Factor XII activity
Standard Deviation 8.8
|
118.3 Percentage of Factor XII activity
Standard Deviation 24.3
|
|
Measurement of the Effect of Ir-CPI on Factor XII Activity
Day 1 H12:00
|
91.3 Percentage of Factor XII activity
Standard Deviation 21.6
|
71.3 Percentage of Factor XII activity
Standard Deviation 14.5
|
58.5 Percentage of Factor XII activity
Standard Deviation 23.8
|
42.3 Percentage of Factor XII activity
Standard Deviation 9.7
|
113.6 Percentage of Factor XII activity
Standard Deviation 27.4
|
|
Measurement of the Effect of Ir-CPI on Factor XII Activity
Day 1 H16:00
|
89.7 Percentage of Factor XII activity
Standard Deviation 23.0
|
73.8 Percentage of Factor XII activity
Standard Deviation 18.6
|
61.0 Percentage of Factor XII activity
Standard Deviation 24.2
|
49.8 Percentage of Factor XII activity
Standard Deviation 11.7
|
112.8 Percentage of Factor XII activity
Standard Deviation 29.0
|
|
Measurement of the Effect of Ir-CPI on Factor XII Activity
Day 2 H24:00
|
104.8 Percentage of Factor XII activity
Standard Deviation 25.9
|
80.3 Percentage of Factor XII activity
Standard Deviation 16.4
|
78.8 Percentage of Factor XII activity
Standard Deviation 31.3
|
59.3 Percentage of Factor XII activity
Standard Deviation 14.6
|
116.5 Percentage of Factor XII activity
Standard Deviation 27.0
|
|
Measurement of the Effect of Ir-CPI on Factor XII Activity
Day 3 H48:00
|
128.7 Percentage of Factor XII activity
Standard Deviation 27.6
|
96.7 Percentage of Factor XII activity
Standard Deviation 15.4
|
92.0 Percentage of Factor XII activity
Standard Deviation 35.8
|
79.7 Percentage of Factor XII activity
Standard Deviation 21.0
|
118.1 Percentage of Factor XII activity
Standard Deviation 28.6
|
|
Measurement of the Effect of Ir-CPI on Factor XII Activity
Day 4 H72:00
|
121.5 Percentage of Factor XII activity
Standard Deviation 29.2
|
98.3 Percentage of Factor XII activity
Standard Deviation 15.9
|
112.0 Percentage of Factor XII activity
Standard Deviation 13.3
|
89.5 Percentage of Factor XII activity
Standard Deviation 24.2
|
120.4 Percentage of Factor XII activity
Standard Deviation 29.6
|
|
Measurement of the Effect of Ir-CPI on Factor XII Activity
Day 5 H96:00
|
123.5 Percentage of Factor XII activity
Standard Deviation 27.3
|
100.5 Percentage of Factor XII activity
Standard Deviation 17.4
|
102.5 Percentage of Factor XII activity
Standard Deviation 36.5
|
100.2 Percentage of Factor XII activity
Standard Deviation 23.8
|
121.6 Percentage of Factor XII activity
Standard Deviation 29.3
|
|
Measurement of the Effect of Ir-CPI on Factor XII Activity
Day 10 (discharge visit)
|
122.0 Percentage of Factor XII activity
Standard Deviation 26.9
|
102.2 Percentage of Factor XII activity
Standard Deviation 20.2
|
104.0 Percentage of Factor XII activity
Standard Deviation 35.3
|
107.2 Percentage of Factor XII activity
Standard Deviation 23.8
|
114.3 Percentage of Factor XII activity
Standard Deviation 27.5
|
Adverse Events
Ir-CPI - Dose 1
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Ir-CPI - Dose 2
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Ir-CPI - Dose 3
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Ir-CPI - Dose 4
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ir-CPI - Dose 1
n=6 participants at risk
6 participants received a single intravenous dose of 1.5 mg/kg of Ir-CPI during 6 hours
|
Ir-CPI - Dose 2
n=6 participants at risk
6 participants received a single intravenous dose of 3.0 mg/kg of Ir-CPI during 6 hours
|
Ir-CPI - Dose 3
n=6 participants at risk
6 participants received a single intravenous dose of 6.0 mg/kg of Ir-CPI during 6 hours
|
Ir-CPI - Dose 4
n=6 participants at risk
6 participants received a single intravenous dose of 9.0 mg/kg of Ir-CPI during 6 hours
|
Placebo
n=8 participants at risk
For each dose group, 2 additional participants received a single intravenous dose of placebo during 6 hours (8 in total).
|
|---|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
16.7%
1/6 • Number of events 1 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/8 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis acute
|
16.7%
1/6 • Number of events 1 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/8 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
Other adverse events
| Measure |
Ir-CPI - Dose 1
n=6 participants at risk
6 participants received a single intravenous dose of 1.5 mg/kg of Ir-CPI during 6 hours
|
Ir-CPI - Dose 2
n=6 participants at risk
6 participants received a single intravenous dose of 3.0 mg/kg of Ir-CPI during 6 hours
|
Ir-CPI - Dose 3
n=6 participants at risk
6 participants received a single intravenous dose of 6.0 mg/kg of Ir-CPI during 6 hours
|
Ir-CPI - Dose 4
n=6 participants at risk
6 participants received a single intravenous dose of 9.0 mg/kg of Ir-CPI during 6 hours
|
Placebo
n=8 participants at risk
For each dose group, 2 additional participants received a single intravenous dose of placebo during 6 hours (8 in total).
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
16.7%
1/6 • Number of events 1 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
16.7%
1/6 • Number of events 1 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/8 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Number of events 1 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
16.7%
1/6 • Number of events 1 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/8 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
16.7%
1/6 • Number of events 1 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/8 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
|
General disorders
Catheter site haematoma
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
12.5%
1/8 • Number of events 2 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
|
General disorders
Fatigue
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
16.7%
1/6 • Number of events 1 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/8 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
16.7%
1/6 • Number of events 3 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
16.7%
1/6 • Number of events 2 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
50.0%
3/6 • Number of events 3 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
12.5%
1/8 • Number of events 2 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
12.5%
1/8 • Number of events 1 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
|
Infections and infestations
Appendicitis
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
16.7%
1/6 • Number of events 1 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/8 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
16.7%
1/6 • Number of events 1 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/8 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
|
Infections and infestations
Fungal infection
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
16.7%
1/6 • Number of events 1 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/8 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
|
Infections and infestations
Influenza
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
16.7%
1/6 • Number of events 1 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/8 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
|
Infections and infestations
Laryngitis
|
16.7%
1/6 • Number of events 1 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/8 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
33.3%
2/6 • Number of events 2 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/8 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
16.7%
1/6 • Number of events 1 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/8 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
16.7%
1/6 • Number of events 1 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/8 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
16.7%
1/6 • Number of events 1 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/8 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
12.5%
1/8 • Number of events 1 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
16.7%
1/6 • Number of events 1 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/8 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
|
Injury, poisoning and procedural complications
Ligament injury
|
16.7%
1/6 • Number of events 1 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/8 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
|
Investigations
Fibrin D dimer increased
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
16.7%
1/6 • Number of events 2 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
12.5%
1/8 • Number of events 1 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
16.7%
1/6 • Number of events 1 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/8 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
16.7%
1/6 • Number of events 1 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/8 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
16.7%
1/6 • Number of events 1 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
12.5%
1/8 • Number of events 1 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
16.7%
1/6 • Number of events 1 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
50.0%
3/6 • Number of events 7 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
50.0%
3/6 • Number of events 6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
12.5%
1/8 • Number of events 1 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
1/6 • Number of events 1 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
16.7%
1/6 • Number of events 1 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/8 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
16.7%
1/6 • Number of events 1 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
25.0%
2/8 • Number of events 2 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
|
Surgical and medical procedures
Sebaceous cyst excision
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
16.7%
1/6 • Number of events 1 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/8 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
|
Surgical and medical procedures
Varicose vein operation
|
16.7%
1/6 • Number of events 1 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/8 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
|
Vascular disorders
Haematoma
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
16.7%
1/6 • Number of events 1 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/6 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
0.00%
0/8 • From screening visit through last extra-ambulatory visit [Day 90 or Day 180 (in case of anti-drug antibodies at Day 90)]
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER