Trial Outcomes & Findings for Safety and Tolerability Study of Xisomab 3G3 in Healthy Adult Subjects (NCT NCT03097341)
NCT ID: NCT03097341
Last Updated: 2019-06-05
Results Overview
TEAEs will be determined by physical examination that will include assessment of skin, head, ears, eyes, nose, throat, respiratory system, cardiovascular system, gastrointestinal system, neurological condition, blood and lymphatic systems, and the musculoskeletal system.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
21 participants
Primary outcome timeframe
From Subject Check-In through Follow up. Follow up was performed 7 days after Day 29. If the aPTT was not +/- 10% baseline or within normal range, subject was monitored weekly until baseline reached and follow up then occured 7 days after.
Results posted on
2019-06-05
Participant Flow
A total of 105 participants were screened for the study, of which 84 did not meet eligibility criteria or declined to participate. The remaining 21 participants were randomized into the study, with each dose level occurring in sequential order.
Participant milestones
| Measure |
Xisomab 3G3- Dose 1
Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 2
Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 3
Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 4
Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3.
|
Placebo
Participants received a single intravenous dose of placebo.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
4
|
4
|
5
|
|
Overall Study
COMPLETED
|
4
|
4
|
4
|
4
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Tolerability Study of Xisomab 3G3 in Healthy Adult Subjects
Baseline characteristics by cohort
| Measure |
Xisomab 3G3- Dose 1
n=4 Participants
Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 2
n=4 Participants
Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 3
n=4 Participants
Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 4
n=4 Participants
Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3.
|
Placebo
n=5 Participants
Participants received a single intravenous dose of placebo.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
42.3 years
n=5 Participants
|
33.0 years
n=7 Participants
|
32.0 years
n=5 Participants
|
42.0 years
n=4 Participants
|
32.2 years
n=21 Participants
|
36.1 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
17 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=10 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=10 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
|
|
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
|
|
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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
19 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 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
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
4 participants
n=4 Participants
|
5 participants
n=21 Participants
|
21 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: From Subject Check-In through Follow up. Follow up was performed 7 days after Day 29. If the aPTT was not +/- 10% baseline or within normal range, subject was monitored weekly until baseline reached and follow up then occured 7 days after.Population: Subjects who received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
TEAEs will be determined by physical examination that will include assessment of skin, head, ears, eyes, nose, throat, respiratory system, cardiovascular system, gastrointestinal system, neurological condition, blood and lymphatic systems, and the musculoskeletal system.
Outcome measures
| Measure |
Xisomab 3G3- Dose 1
n=4 Participants
Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 2
n=4 Participants
Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 3
n=4 Participants
Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 4
n=4 Participants
Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3.
|
Placebo
n=5 Participants
Participants received a single intravenous dose of placebo.
|
|---|---|---|---|---|---|
|
The Number of Subjects With Treatment-related Adverse Events (TEAEs) Will be Summarized Using Frequency Counts.
|
1 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: From subject Check-In through Follow up. Follow up was performed 7 days after Day 29. If the aPTT was not +/- 10% baseline or within normal range, subject was monitored weekly until baseline reached and follow up then occured 7 days after.Population: Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Vital sign measurements (body temperature, respiratory rate, blood pressure, and heart rate)
Outcome measures
| Measure |
Xisomab 3G3- Dose 1
n=4 Participants
Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 2
n=4 Participants
Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 3
n=4 Participants
Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 4
n=4 Participants
Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3.
|
Placebo
n=5 Participants
Participants received a single intravenous dose of placebo.
|
|---|---|---|---|---|---|
|
The Number of Subjects With Abnormal Vital Signs That Are Related to Treatment Will be Summarized Using Frequency Counts..
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From subject Check-In through Follow up. Follow up was performed 7 days after Day 29. If the aPTT was not +/- 10% baseline or within normal range, subject was monitored weekly until baseline reached and follow up then occured 7 days after.Population: Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
12-lead electrocardiogram measurement
Outcome measures
| Measure |
Xisomab 3G3- Dose 1
n=4 Participants
Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 2
n=4 Participants
Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 3
n=4 Participants
Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 4
n=4 Participants
Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3.
|
Placebo
n=4 Participants
Participants received a single intravenous dose of placebo.
|
|---|---|---|---|---|---|
|
The Number of Subjects With Abnormal Electrocardiogram That is Related to Treatment Will be Summarized Using Frequency Counts..
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Study Day 1 through Follow up. Follow up was performed 7 days after Day 29. If the aPTT was not +/- 10% baseline or within normal range, subject was monitored weekly until baseline reached and follow up then occured 7 days after.Population: Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Injection site reaction (pain, tenderness, erythema/ redness, and induration/ swelling)
Outcome measures
| Measure |
Xisomab 3G3- Dose 1
n=4 Participants
Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 2
n=4 Participants
Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 3
n=4 Participants
Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 4
n=4 Participants
Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3.
|
Placebo
n=5 Participants
Participants received a single intravenous dose of placebo.
|
|---|---|---|---|---|---|
|
The Number of Subjects With Abnormal Injection Site Reaction That Are Related to Treatment Will be Summarized Using Frequency Counts..
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From subject Check-In through Follow up. Follow up was performed 7 days after Day 29. If the aPTT was not +/- 10% baseline or within normal range, subject was monitored weekly until baseline reached and follow up then occured 7 days after.Population: Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Clinical laboratory tests include serum chemistry, hematology, coagulation parameters (aPTT, PT, and bleeding time), and urinalysis
Outcome measures
| Measure |
Xisomab 3G3- Dose 1
n=4 Participants
Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 2
n=4 Participants
Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 3
n=4 Participants
Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 4
n=4 Participants
Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3.
|
Placebo
n=5 Participants
Participants received a single intravenous dose of placebo.
|
|---|---|---|---|---|---|
|
The Number of Subjects With Abnormal Laboratory Values and/ or Adverse Events That Are Related to Treatment Will be Summarized Using Frequency Counts..
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Study Day 1 through Follow up. Follow up was performed 7 days after Day 29. If the aPTT was not +/- 10% baseline or within normal range, subject was monitored weekly until baseline reached and follow up then occured 7 days after.Population: Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Immunogenicity measured by the presence of plasma anti-drug antibodies
Outcome measures
| Measure |
Xisomab 3G3- Dose 1
n=4 Participants
Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 2
n=4 Participants
Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 3
n=4 Participants
Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 4
n=4 Participants
Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3.
|
Placebo
n=5 Participants
Participants received a single intravenous dose of placebo.
|
|---|---|---|---|---|---|
|
The Number of Subjects That Develop Treatment-related Immunogenicity Will be Summarized Using Frequency Counts.
Day 15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Subjects That Develop Treatment-related Immunogenicity Will be Summarized Using Frequency Counts.
Pre-dose (baseline)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Subjects That Develop Treatment-related Immunogenicity Will be Summarized Using Frequency Counts.
Day 29 or follow up
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-dose (0.5h prior to dose), 0.083, 0.25, 0.5, 1,3,8,24,72,120, 168, 216, 336, 504, 672h after dosing as well as follow up (7 days after aPTT returned back to baseline).Population: All subjects who were enrolled in, received the active treatment, completed the study, and had an evaluable PK profile were included in the PK analysis.
Maximum plasma concentration of xisomab 3G3 was estimated based on plasma xisomab 3G3 concentrations. Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.
Outcome measures
| Measure |
Xisomab 3G3- Dose 1
n=3 Participants
Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 2
n=4 Participants
Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 3
n=4 Participants
Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 4
n=4 Participants
Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3.
|
Placebo
Participants received a single intravenous dose of placebo.
|
|---|---|---|---|---|---|
|
The Maximum Plasma Concentration (Cmax) of Xisomab 3G3 After a Single Injection Will be Measured in Each Subject.
|
122.7 nanograms/milliliter
Geometric Coefficient of Variation 23.3
|
11210 nanograms/milliliter
Geometric Coefficient of Variation 9.1
|
42510 nanograms/milliliter
Geometric Coefficient of Variation 12.3
|
127200 nanograms/milliliter
Geometric Coefficient of Variation 2.6
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0.5h prior to dose), 0.083, 0.25, 0.5, 1,3,8,24,72,120, 168, 216, 336, 504, 672h after dosing as well as follow up (7 days after aPTT returned back to baseline).Population: All subjects who were enrolled in, received the active treatment, completed the study, and had an evaluable PK profile were included in the PK analysis.
The time to reach maximum plasma concentrations of xisomab 3G3 after a single injection was estimated based on plasma xisomab 3G3 concentrations. Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.
Outcome measures
| Measure |
Xisomab 3G3- Dose 1
n=3 Participants
Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 2
n=4 Participants
Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 3
n=4 Participants
Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 4
n=4 Participants
Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3.
|
Placebo
Participants received a single intravenous dose of placebo.
|
|---|---|---|---|---|---|
|
The Time to Reach Maximum Plasma Concentrations of Xisomab 3G3 (Tmax) After a Single Injection Will be Measured in Each Subject.
|
0.084 hours
Interval 0.08 to 0.09
|
0.649 hours
Interval 0.26 to 3.02
|
0.088 hours
Interval 0.08 to 0.25
|
0.387 hours
Interval 0.26 to 3.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0.5h prior to dose), 0.083, 0.25, 0.5, 1,3,8,24,72,120, 168, 216, 336, 504, 672h after dosing as well as follow up (7 days after aPTT returned back to baseline).Population: All subjects who were enrolled in, received the active treatment, completed the study, and had an evaluable PK profile were included in the PK analysis.
The area under the plasma concentration-time curve from time 0 to the last measurable non-zero concentration was estimated based on plasma xisomab 3G3 concentrations. Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.
Outcome measures
| Measure |
Xisomab 3G3- Dose 1
n=3 Participants
Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 2
n=4 Participants
Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 3
n=4 Participants
Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 4
n=4 Participants
Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3.
|
Placebo
Participants received a single intravenous dose of placebo.
|
|---|---|---|---|---|---|
|
The Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Non-zero Concentration (AUC0-t), as Calculated by the Linear Trapezoidal Method, After a Single Injection of Xisomab 3G3 Will be Calculated for Each Subject.
|
57.0 nanograms*hour/milliliter
Standard Deviation 46.5
|
361800 nanograms*hour/milliliter
Standard Deviation 21.9
|
5540000 nanograms*hour/milliliter
Standard Deviation 23.9
|
28120000 nanograms*hour/milliliter
Standard Deviation 11.8
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0.5h prior to dose), 0.083, 0.25, 0.5, 1,3,8,24,72,120, 168, 216, 336, 504, 672h after dosing as well as follow up (7 days after aPTT returned back to baseline).Population: All subjects who were enrolled in, received the active treatment, completed the study, and had an evaluable PK profile were included in the PK analysis.
The area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) is calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant. Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.
Outcome measures
| Measure |
Xisomab 3G3- Dose 1
n=1 Participants
Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 2
n=4 Participants
Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 3
n=4 Participants
Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 4
n=4 Participants
Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3.
|
Placebo
Participants received a single intravenous dose of placebo.
|
|---|---|---|---|---|---|
|
The Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) After a Single Injection of Xisomab 3G3 Will be Calculated for Each Subject.
|
184.7 nanogram*hour/milliliter
|
363700 nanogram*hour/milliliter
Standard Deviation 21.8
|
5550000 nanogram*hour/milliliter
Standard Deviation 24.0
|
28140000 nanogram*hour/milliliter
Standard Deviation 11.8
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0.5h prior to dose), 0.083, 0.25, 0.5, 1,3,8,24,72,120, 168, 216, 336, 504, 672h after dosing as well as follow up (7 days after aPTT returned back to baseline).Population: All subjects who were enrolled in, received the active treatment, completed the study, and had an evaluable PK profile were included in the PK analysis.
The percent of AUC0-inf extrapolated (AUC%extrap) is calculated by (1-AUC0-t/AUC0-inf)\*100. Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.
Outcome measures
| Measure |
Xisomab 3G3- Dose 1
n=1 Participants
Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 2
n=4 Participants
Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 3
n=4 Participants
Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 4
n=4 Participants
Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3.
|
Placebo
Participants received a single intravenous dose of placebo.
|
|---|---|---|---|---|---|
|
The Percent of AUC0-inf Extrapolated (AUC%Extrap) After a Single Injection of Xisomab 3G3 Will be Calculated for Each Subject.
|
57.3 percentage of AUC0-inf
|
0.53 percentage of AUC0-inf
Standard Deviation 0.18
|
0.18 percentage of AUC0-inf
Standard Deviation 0.07
|
0.07 percentage of AUC0-inf
Standard Deviation 0.04
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0.5h prior to dose), 0.083, 0.25, 0.5, 1,3,8,24,72,120, 168, 216, 336, 504, 672h after dosing as well as follow up (7 days after aPTT returned back to baseline).Population: All subjects who were enrolled in, received the active treatment, completed the study, and had an evaluable PK profile were included in the PK analysis.
The apparent first order terminal elimination rate constant will be calculated from a semi-log plot of the plasma concentration versus time curve. The parameter will be calculated by linear least squares regression analysis using the maximum number of points in the terminal log linear phase (e.g., three or more non zero plasma concentrations). Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.
Outcome measures
| Measure |
Xisomab 3G3- Dose 1
n=1 Participants
Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 2
n=4 Participants
Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 3
n=4 Participants
Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 4
n=4 Participants
Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3.
|
Placebo
Participants received a single intravenous dose of placebo.
|
|---|---|---|---|---|---|
|
The Apparent First Order Terminal Elimination Rate Constant (Kel) of Xisomab 3G3 After a Single Intravenous Injection Will be Calculated for Each Subject.
|
0.522 1/hour
|
0.042 1/hour
Standard Deviation 0.0042
|
0.011 1/hour
Standard Deviation 0.0009
|
0.006 1/hour
Standard Deviation 0.0018
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0.5h prior to dose), 0.083, 0.25, 0.5, 1,3,8,24,72,120, 168, 216, 336, 504, 672h after dosing as well as follow up (7 days after aPTT returned back to baseline).Population: All subjects who were enrolled in, received the active treatment, completed the study, and had an evaluable PK profile were included in the PK analysis.
The apparent first order terminal elimination half-life will be calculated as 0.693/Kel. Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.
Outcome measures
| Measure |
Xisomab 3G3- Dose 1
n=1 Participants
Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 2
n=4 Participants
Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 3
n=4 Participants
Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 4
n=4 Participants
Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3.
|
Placebo
Participants received a single intravenous dose of placebo.
|
|---|---|---|---|---|---|
|
The Apparent First Order Terminal Elimination Half-life (T1/2) of Xisomab 3G3 After a Single Intravenous Injection Will be Calculated for Each Subject.
|
1.33 hours
|
16.64 hours
Standard Deviation 1.56
|
60.63 hours
Standard Deviation 4.45
|
121.49 hours
Standard Deviation 40.69
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0.5h prior to dose), 0.083, 0.25, 0.5, 1,3,8,24,72,120, 168, 216, 336, 504, 672h after dosing as well as follow up (7 days after aPTT returned back to baseline).Population: All subjects who were enrolled in, received the active treatment, completed the study, and had an evaluable PK profile were included in the PK analysis.
The apparent total plasma clearance will be calculated as \[Dose/AUC0-inf\]. Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.
Outcome measures
| Measure |
Xisomab 3G3- Dose 1
n=1 Participants
Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 2
n=4 Participants
Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 3
n=4 Participants
Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 4
n=4 Participants
Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3.
|
Placebo
Participants received a single intravenous dose of placebo.
|
|---|---|---|---|---|---|
|
The Apparent Total Plasma Clearance (CL) of Xisomab 3G3 After a Single Intravenous Injection Will be Calculated for Each Subject.
|
37.46 Liters/hour
|
0.094 Liters/hour
Standard Deviation 0.018
|
0.026 Liters/hour
Standard Deviation 0.003
|
0.014 Liters/hour
Standard Deviation 0.003
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0.5h prior to dose), 0.083, 0.25, 0.5, 1,3,8,24,72,120, 168, 216, 336, 504, 672h after dosing as well as follow up (7 days after aPTT returned back to baseline).Population: All subjects who were enrolled in, received the active treatment, completed the study, and had an evaluable PK profile were included in the PK analysis.
The total apparent volume of distribution (Vss) will be calculated as the mean residence time x clearance. Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.
Outcome measures
| Measure |
Xisomab 3G3- Dose 1
n=1 Participants
Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 2
n=4 Participants
Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 3
n=4 Participants
Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 4
n=4 Participants
Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3.
|
Placebo
Participants received a single intravenous dose of placebo.
|
|---|---|---|---|---|---|
|
The Total Apparent Volume of Distribution (Vss) of Xisomab 3G3 After a Single Intravenous Injection Will be Calculated for Each Subject.
|
69.11 Liters
|
2.52 Liters
Standard Deviation 0.59
|
3.72 Liters
Standard Deviation 0.42
|
4.31 Liters
Standard Deviation 0.75
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0.5h prior to dose), 1, 24,72, 168, 336, 504, 672h after dosing as well as follow up (7 days after day 29 or after aPTT returned back to baseline)..Population: All subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to treatment.
Activated partial thromboplastin time (aPTT) will be used as a surrogate pharmacodynamic marker.
Outcome measures
| Measure |
Xisomab 3G3- Dose 1
n=4 Participants
Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 2
n=4 Participants
Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 3
n=4 Participants
Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 4
n=4 Participants
Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3.
|
Placebo
n=5 Participants
Participants received a single intravenous dose of placebo.
|
|---|---|---|---|---|---|
|
The Effect of a Single Intravenous Dose of Xisomab 3G3 on the Activated Partial Thromboplastin Time (aPTT) in Healthy Adult Subjects Will be Measured.
Follow Up
|
26.8 seconds
Standard Deviation 1.5
|
27.3 seconds
Standard Deviation 1.7
|
28.3 seconds
Standard Deviation 1.5
|
28.0 seconds
Standard Deviation 2.2
|
29.2 seconds
Standard Deviation 1.3
|
|
The Effect of a Single Intravenous Dose of Xisomab 3G3 on the Activated Partial Thromboplastin Time (aPTT) in Healthy Adult Subjects Will be Measured.
pre-dose
|
27.0 seconds
Standard Deviation 1.8
|
26.5 seconds
Standard Deviation 1.3
|
26.3 seconds
Standard Deviation 2.6
|
27.5 seconds
Standard Deviation 1.7
|
29.4 seconds
Standard Deviation 1.7
|
|
The Effect of a Single Intravenous Dose of Xisomab 3G3 on the Activated Partial Thromboplastin Time (aPTT) in Healthy Adult Subjects Will be Measured.
Day 1, Hour 1
|
32.8 seconds
Standard Deviation 3.8
|
48.3 seconds
Standard Deviation 0.5
|
53.3 seconds
Standard Deviation 5.7
|
57.3 seconds
Standard Deviation 7.8
|
29.4 seconds
Standard Deviation 1.7
|
|
The Effect of a Single Intravenous Dose of Xisomab 3G3 on the Activated Partial Thromboplastin Time (aPTT) in Healthy Adult Subjects Will be Measured.
Day 2
|
29.0 seconds
Standard Deviation 2.3
|
50.5 seconds
Standard Deviation 5.8
|
52.5 seconds
Standard Deviation 4.8
|
55.8 seconds
Standard Deviation 6.9
|
28.8 seconds
Standard Deviation 2.0
|
|
The Effect of a Single Intravenous Dose of Xisomab 3G3 on the Activated Partial Thromboplastin Time (aPTT) in Healthy Adult Subjects Will be Measured.
Day 4
|
28.3 seconds
Standard Deviation 2.6
|
48.8 seconds
Standard Deviation 6.5
|
49.8 seconds
Standard Deviation 3.9
|
52.3 seconds
Standard Deviation 5.6
|
27.3 seconds
Standard Deviation 2.1
|
|
The Effect of a Single Intravenous Dose of Xisomab 3G3 on the Activated Partial Thromboplastin Time (aPTT) in Healthy Adult Subjects Will be Measured.
Day 8
|
27.3 seconds
Standard Deviation 2.1
|
30.5 seconds
Standard Deviation 3.9
|
47.3 seconds
Standard Deviation 2.2
|
49.8 seconds
Standard Deviation 5.3
|
28.6 seconds
Standard Deviation 1.1
|
|
The Effect of a Single Intravenous Dose of Xisomab 3G3 on the Activated Partial Thromboplastin Time (aPTT) in Healthy Adult Subjects Will be Measured.
Day 15
|
26.8 seconds
Standard Deviation 2.1
|
27.5 seconds
Standard Deviation 2.1
|
47.0 seconds
Standard Deviation 2.9
|
48.0 seconds
Standard Deviation 6.5
|
29.0 seconds
Standard Deviation 1.2
|
|
The Effect of a Single Intravenous Dose of Xisomab 3G3 on the Activated Partial Thromboplastin Time (aPTT) in Healthy Adult Subjects Will be Measured.
Day 22
|
26.5 seconds
Standard Deviation 2.4
|
27.5 seconds
Standard Deviation 2.6
|
39.5 seconds
Standard Deviation 6.6
|
48.3 seconds
Standard Deviation 6.3
|
28.8 seconds
Standard Deviation 0.8
|
|
The Effect of a Single Intravenous Dose of Xisomab 3G3 on the Activated Partial Thromboplastin Time (aPTT) in Healthy Adult Subjects Will be Measured.
Day 29
|
27.0 seconds
Standard Deviation 2.3
|
27.5 seconds
Standard Deviation 2.1
|
30.3 seconds
Standard Deviation 2.9
|
47.3 seconds
Standard Deviation 5.0
|
29.2 seconds
Standard Deviation 1.3
|
Adverse Events
Xisomab 3G3- Dose 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Xisomab 3G3- Dose 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Xisomab 3G3- Dose 3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Xisomab 3G3- Dose 4
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Xisomab 3G3- Dose 1
n=4 participants at risk
Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 2
n=4 participants at risk
Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 3
n=4 participants at risk
Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3.
|
Xisomab 3G3- Dose 4
n=4 participants at risk
Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3.
|
Placebo
n=5 participants at risk
Participants received a single intravenous dose of placebo.
|
|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
25.0%
1/4 • Number of events 1 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/5 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
25.0%
1/4 • Number of events 1 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/5 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
25.0%
1/4 • Number of events 1 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/5 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
|
General disorders
Injection site ecchymosis
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
25.0%
1/4 • Number of events 1 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/5 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
|
General disorders
Injection site pain
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
25.0%
1/4 • Number of events 1 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/5 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
|
Infections and infestations
Upper respiritory tract infection
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
25.0%
1/4 • Number of events 1 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/5 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
25.0%
1/4 • Number of events 1 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/5 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
|
Infections and infestations
Viral infection
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
25.0%
1/4 • Number of events 1 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/5 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
|
Respiratory, thoracic and mediastinal disorders
Oralpharangeal pain
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
25.0%
1/4 • Number of events 1 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/5 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
25.0%
1/4 • Number of events 1 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
25.0%
1/4 • Number of events 1 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/5 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
25.0%
1/4 • Number of events 1 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/5 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalized
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
25.0%
1/4 • Number of events 1 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/5 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
|
Skin and subcutaneous tissue disorders
Skin discoloration
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/4 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
25.0%
1/4 • Number of events 1 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
0.00%
0/5 • Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
|
Additional Information
Christina U. Lorentz, PhD, Senior Scientist and Project Manager
Aronora, Inc.
Phone: 503-964-0250
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Aronora shall retain title to and the right to publish all documentation, records, raw data, specimens or other work product generated in connection with this study. Such publications shall not be made by the PI or Celerion without the prior written consent of Aronora.
- Publication restrictions are in place
Restriction type: OTHER