Trial Outcomes & Findings for Study to Determine the Safety, Tolerability and Pharmacokinetics of UV-4B Solution Administered Orally in Healthy Subjects (NCT NCT02061358)
NCT ID: NCT02061358
Last Updated: 2024-03-18
Results Overview
TEAEs are those AEs occurring only after administration of investigational product
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
64 participants
Primary outcome timeframe
From time of the first dose administration through Day 9 ± 1
Results posted on
2024-03-18
Participant Flow
This was a single center study performed in the United States. The study was completed with a total of 64 patients enrolled.
Each cohort was assigned 6 subjects who received the cohort's prescribed dose of UV-4B, along with 2 subjects in each cohort assigned to receive placebo.
Participant milestones
| Measure |
3 mg UV-4B
UV-4B 3 mg oral, single dose
|
10 mg UV-4B
UV-4B 10 mg oral, single dose
|
30 mg UV-4B
UV-4B 30 mg oral, single dose
|
90 mg UV-4B
UV-4B 90 mg oral, single dose
|
180 mg UV-4B
UV-4B 180 mg oral, single dose
|
360 mg UV-4B
UV-4B 360 mg oral, single dose
|
720 mg UV-4B
UV-4B 720 mg oral, single dose
|
1000 mg UV-4B
UV-4B 1000 mg oral, single dose
|
Placebo
Placebo oral, single dose
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
16
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Determine the Safety, Tolerability and Pharmacokinetics of UV-4B Solution Administered Orally in Healthy Subjects
Baseline characteristics by cohort
| Measure |
3 mg UV-4B
n=6 Participants
UV-4B 3 mg oral, single dose
|
10 mg UV-4B
n=6 Participants
UV-4B 10 mg oral, single dose
|
30 mg UV-4B
n=6 Participants
UV-4B 30 mg oral, single dose
|
90 mg UV-4B
n=6 Participants
UV-4B 90 mg oral, single dose
|
180 mg UV-4B
n=6 Participants
UV-4B 180 mg oral, single dose
|
360 mg UV-4B
n=6 Participants
UV-4B 360 mg oral, single dose
|
720 mg UV-4B
n=6 Participants
UV-4B 720 mg oral, single dose
|
1000 mg UV-4B
n=6 Participants
UV-4B 1000 mg oral, single dose
|
Placebo
n=16 Participants
Placebo oral, single dose
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
25 years
STANDARD_DEVIATION 5 • n=5 Participants
|
27 years
STANDARD_DEVIATION 8 • n=7 Participants
|
27 years
STANDARD_DEVIATION 4 • n=5 Participants
|
28 years
STANDARD_DEVIATION 9 • n=4 Participants
|
28 years
STANDARD_DEVIATION 9 • n=21 Participants
|
29 years
STANDARD_DEVIATION 9 • n=10 Participants
|
25 years
STANDARD_DEVIATION 9 • n=115 Participants
|
27 years
STANDARD_DEVIATION 8 • n=6 Participants
|
28 years
STANDARD_DEVIATION 8 • n=6 Participants
|
27 years
STANDARD_DEVIATION 7 • n=64 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
17 Participants
n=64 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
5 Participants
n=6 Participants
|
13 Participants
n=6 Participants
|
47 Participants
n=64 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
9 Participants
n=64 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
5 Participants
n=6 Participants
|
14 Participants
n=6 Participants
|
55 Participants
n=64 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
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
12 Participants
n=64 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
14 Participants
n=6 Participants
|
51 Participants
n=64 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Height
|
173.4 cm
STANDARD_DEVIATION 11.1 • n=5 Participants
|
171.8 cm
STANDARD_DEVIATION 12.3 • n=7 Participants
|
175.0 cm
STANDARD_DEVIATION 11.3 • n=5 Participants
|
175.2 cm
STANDARD_DEVIATION 3.8 • n=4 Participants
|
176.2 cm
STANDARD_DEVIATION 9.9 • n=21 Participants
|
174.8 cm
STANDARD_DEVIATION 8.9 • n=10 Participants
|
172.6 cm
STANDARD_DEVIATION 8.2 • n=115 Participants
|
173.5 cm
STANDARD_DEVIATION 3.2 • n=6 Participants
|
174.9 cm
STANDARD_DEVIATION 8.1 • n=6 Participants
|
174.25 cm
STANDARD_DEVIATION 8.39 • n=64 Participants
|
|
Weight
|
82.9 kg
STANDARD_DEVIATION 12.1 • n=5 Participants
|
79.6 kg
STANDARD_DEVIATION 13.8 • n=7 Participants
|
80.8 kg
STANDARD_DEVIATION 9.7 • n=5 Participants
|
75.9 kg
STANDARD_DEVIATION 8.3 • n=4 Participants
|
84.0 kg
STANDARD_DEVIATION 8.5 • n=21 Participants
|
80.1 kg
STANDARD_DEVIATION 10.5 • n=10 Participants
|
74.1 kg
STANDARD_DEVIATION 11 • n=115 Participants
|
75.0 kg
STANDARD_DEVIATION 5.5 • n=6 Participants
|
76.2 kg
STANDARD_DEVIATION 11.5 • n=6 Participants
|
78.36 kg
STANDARD_DEVIATION 10.4 • n=64 Participants
|
|
Body mass index
|
27.44 kg/m^2
STANDARD_DEVIATION 1.28 • n=5 Participants
|
26.88 kg/m^2
STANDARD_DEVIATION 2.6 • n=7 Participants
|
26.44 kg/m^2
STANDARD_DEVIATION 2.36 • n=5 Participants
|
24.76 kg/m^2
STANDARD_DEVIATION 2.71 • n=4 Participants
|
27.05 kg/m^2
STANDARD_DEVIATION 1.84 • n=21 Participants
|
26.13 kg/m^2
STANDARD_DEVIATION 2.07 • n=10 Participants
|
24.86 kg/m^2
STANDARD_DEVIATION 2.93 • n=115 Participants
|
24.93 kg/m^2
STANDARD_DEVIATION 1.6 • n=6 Participants
|
24.89 kg/m^2
STANDARD_DEVIATION 2.82 • n=6 Participants
|
25.77 kg/m^2
STANDARD_DEVIATION 2.47 • n=64 Participants
|
PRIMARY outcome
Timeframe: From time of the first dose administration through Day 9 ± 1Population: Safety Population: all subjects who received any investigational product, UV-4B or placebo
TEAEs are those AEs occurring only after administration of investigational product
Outcome measures
| Measure |
3 mg UV-4B
n=6 Participants
UV-4B 3 mg oral, single dose
|
10 mg UV-4B
n=6 Participants
UV-4B 10 mg oral, single dose
|
30 mg UV-4B
n=6 Participants
UV-4B 30 mg oral, single dose
|
90 mg UV-4B
n=6 Participants
UV-4B 90 mg oral, single dose
|
180 mg UV-4B
n=6 Participants
UV-4B 180 mg oral, single dose
|
360 mg UV-4B
n=6 Participants
UV-4B 360 mg oral, single dose
|
720 mg UV-4B
n=6 Participants
UV-4B 720 mg oral, single dose
|
1000 mg UV-4B
n=6 Participants
UV-4B 1000 mg oral, single dose
|
Placebo
n=16 Participants
Placebo oral, single dose
|
|---|---|---|---|---|---|---|---|---|---|
|
Subjects With Treatment-emergent Adverse Event (TEAEs) by Treatment Group
|
5 Subjects with at least 1 TEAE
|
6 Subjects with at least 1 TEAE
|
5 Subjects with at least 1 TEAE
|
5 Subjects with at least 1 TEAE
|
6 Subjects with at least 1 TEAE
|
5 Subjects with at least 1 TEAE
|
6 Subjects with at least 1 TEAE
|
5 Subjects with at least 1 TEAE
|
12 Subjects with at least 1 TEAE
|
PRIMARY outcome
Timeframe: From time of the first dose administration through Day 9 ± 1Population: Safety Population: all subjects who received any investigational product, UV-4B or placebo
Subjects with AEs considered serious by the investigator
Outcome measures
| Measure |
3 mg UV-4B
n=6 Participants
UV-4B 3 mg oral, single dose
|
10 mg UV-4B
n=6 Participants
UV-4B 10 mg oral, single dose
|
30 mg UV-4B
n=6 Participants
UV-4B 30 mg oral, single dose
|
90 mg UV-4B
n=6 Participants
UV-4B 90 mg oral, single dose
|
180 mg UV-4B
n=6 Participants
UV-4B 180 mg oral, single dose
|
360 mg UV-4B
n=6 Participants
UV-4B 360 mg oral, single dose
|
720 mg UV-4B
n=6 Participants
UV-4B 720 mg oral, single dose
|
1000 mg UV-4B
n=6 Participants
UV-4B 1000 mg oral, single dose
|
Placebo
n=16 Participants
Placebo oral, single dose
|
|---|---|---|---|---|---|---|---|---|---|
|
Subjects With Serious Adverse Event (SAEs) by Treatment Group
|
0 Subjects with at least 1 SAE
|
0 Subjects with at least 1 SAE
|
0 Subjects with at least 1 SAE
|
0 Subjects with at least 1 SAE
|
0 Subjects with at least 1 SAE
|
0 Subjects with at least 1 SAE
|
0 Subjects with at least 1 SAE
|
0 Subjects with at least 1 SAE
|
0 Subjects with at least 1 SAE
|
PRIMARY outcome
Timeframe: From time of the first dose administration through Day 9 ± 1Population: Safety Population: all subjects who received any investigational product, UV-4B or placebo
Number of subjects in a treatment group, who had a vital sign value of toxicity Grade 1 or higher: supine and standing systolic blood pressure (BP), supine and standing diastolic BP, supine and standing pulse rate, respiratory rate, and temperature
Outcome measures
| Measure |
3 mg UV-4B
n=6 Participants
UV-4B 3 mg oral, single dose
|
10 mg UV-4B
n=6 Participants
UV-4B 10 mg oral, single dose
|
30 mg UV-4B
n=6 Participants
UV-4B 30 mg oral, single dose
|
90 mg UV-4B
n=6 Participants
UV-4B 90 mg oral, single dose
|
180 mg UV-4B
n=6 Participants
UV-4B 180 mg oral, single dose
|
360 mg UV-4B
n=6 Participants
UV-4B 360 mg oral, single dose
|
720 mg UV-4B
n=6 Participants
UV-4B 720 mg oral, single dose
|
1000 mg UV-4B
n=6 Participants
UV-4B 1000 mg oral, single dose
|
Placebo
n=16 Participants
Placebo oral, single dose
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population)
Subjects with any Grade 1 or higher
|
6 Participants
|
6 Participants
|
5 Participants
|
5 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
|
Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population)
Supine pulse ≤ 50 bpm, baseline ≤ 60 bpm
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
|
Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population)
Standing pulse ≤ 54 bpm, baseline > 60 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population)
Standing pulse ≥ 101 bpm
|
6 Participants
|
6 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
6 Participants
|
4 Participants
|
9 Participants
|
|
Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population)
Supine pulse ≥ 101 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population)
Standing pulse ≤ 50 bpm, baseline ≤ 60 bpm)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population)
Respiratory rate ≥ 17 breaths/min
|
3 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
|
Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population)
Temperature ≥ 100.4 ⁰F (38.0 ⁰C)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population)
Supine systolic BP ≤ 89 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population)
Supine systolic BP ≥ 141 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population)
Standing systolic BP ≤ 89 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population)
Standing systolic BP ≥ 141 mmHg
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population)
Supine diastolic BP ≥ 91 mmHg
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population)
Standing diastolic BP ≥ 91 mmHg
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population)
Supine pulse ≤ 54 bpm, baseline > 60 bpm
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From time of the first dose administration through Day 9 ± 1Population: Safety Population: all subjects who received any investigational product, UV-4B or placebo
Number of subjects in a treatment group with outlier ECG findings: QTcF (Fridericia's), PR, and QRS intervals
Outcome measures
| Measure |
3 mg UV-4B
n=6 Participants
UV-4B 3 mg oral, single dose
|
10 mg UV-4B
n=6 Participants
UV-4B 10 mg oral, single dose
|
30 mg UV-4B
n=6 Participants
UV-4B 30 mg oral, single dose
|
90 mg UV-4B
n=6 Participants
UV-4B 90 mg oral, single dose
|
180 mg UV-4B
n=6 Participants
UV-4B 180 mg oral, single dose
|
360 mg UV-4B
n=6 Participants
UV-4B 360 mg oral, single dose
|
720 mg UV-4B
n=6 Participants
UV-4B 720 mg oral, single dose
|
1000 mg UV-4B
n=6 Participants
UV-4B 1000 mg oral, single dose
|
Placebo
n=16 Participants
Placebo oral, single dose
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group
Subjects with an outlier value
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group
QTcF > 450 ms (males) or > 470 ms (females)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group
QTcF > 500 ms
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group
QTcF increase from baseline > 30 ms or ≤ 60 ms
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group
QTcF increase from baseline > 220 ms
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group
PR > 220 ms
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group
QRS > 120 ms
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Day 9 ± 1Population: Safety Population: all subjects who received any investigational product, UV-4B or placebo
Number of subjects with Grade 1 toxicity or higher for hematology, coagulation, chemistry and urinalysis analytes. ULN=upper limit of normal; WBC=white blood cell count.
Outcome measures
| Measure |
3 mg UV-4B
n=6 Participants
UV-4B 3 mg oral, single dose
|
10 mg UV-4B
n=6 Participants
UV-4B 10 mg oral, single dose
|
30 mg UV-4B
n=6 Participants
UV-4B 30 mg oral, single dose
|
90 mg UV-4B
n=6 Participants
UV-4B 90 mg oral, single dose
|
180 mg UV-4B
n=6 Participants
UV-4B 180 mg oral, single dose
|
360 mg UV-4B
n=6 Participants
UV-4B 360 mg oral, single dose
|
720 mg UV-4B
n=6 Participants
UV-4B 720 mg oral, single dose
|
1000 mg UV-4B
n=6 Participants
UV-4B 1000 mg oral, single dose
|
Placebo
n=16 Participants
Placebo oral, single dose
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group
Prothrombin time ≥ 1 * ULN
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group
Activated partial thromboplastin time ≥ 1 * ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group
Bilirubin ≥ 1.1 * ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group
Phosphorous ≤ 2.5 mg/dL
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group
Potassium ≤ 3.5 or ≥ 5.3 mEq/L
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group
Sodium ≤ 134 or ≥ 148 mEq/L
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group
Total protein ≤ 5.9 g/dL
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group
Creatinine ≥ 1.5 mg/dL
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group
Glucose ≤ 69 or ≥100 (fasting)/111 (random) mg/dL
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group
Creatine phosphokinase ≥ 2 * ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group
Amylase ≥ 1.5 * ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group
Urine protein trace or more
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group
Urine red blood cell count ≥ 1 rbc/hpf
|
2 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
3 Participants
|
10 Participants
|
|
Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group
Hemoglobin ≤ 11.5 (♀), 13.5 (♂) g/dL or any ↓
|
3 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
14 Participants
|
|
Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group
WBC ≥ 10,800 or ≤ 3,500 cell/mm^3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group
Neutrophils ≤ 2,000 cell/mm^3
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group
Lymphocytes ≤ 1,000 cell/mm^3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group
Eosinophils ≥ 650 cell/mm^3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group
Alkaline phosphatase ≥ 2 * ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group
Alanine aminotransferase ≥ 1.1 * ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group
Aspartate aminotransferase ≥ 1.1 * ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group
Calcium ≤ 8.8 or ≥ 10.6 mg/dL
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group
Magnesium ≤ 1.7 mg/dL
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group
Albumin ≤ 3.3 g/dL
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group
Blood urea nitrogen ≥ 21 mg/dL
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group
Lipase ≥ 1.5 * ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group
Urine glucose trace or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)Population: The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.
Cmax is the maximum plasma concentration, obtained directly from the observed concentration versus time data.
Outcome measures
| Measure |
3 mg UV-4B
n=6 Participants
UV-4B 3 mg oral, single dose
|
10 mg UV-4B
n=6 Participants
UV-4B 10 mg oral, single dose
|
30 mg UV-4B
n=6 Participants
UV-4B 30 mg oral, single dose
|
90 mg UV-4B
n=6 Participants
UV-4B 90 mg oral, single dose
|
180 mg UV-4B
n=6 Participants
UV-4B 180 mg oral, single dose
|
360 mg UV-4B
n=6 Participants
UV-4B 360 mg oral, single dose
|
720 mg UV-4B
n=6 Participants
UV-4B 720 mg oral, single dose
|
1000 mg UV-4B
n=6 Participants
UV-4B 1000 mg oral, single dose
|
Placebo
Placebo oral, single dose
|
|---|---|---|---|---|---|---|---|---|---|
|
Cmax by Treatment Group: UV-4
|
22.1 ng/mL
Geometric Coefficient of Variation 15.4
|
82.6 ng/mL
Geometric Coefficient of Variation 24.2
|
289 ng/mL
Geometric Coefficient of Variation 17.5
|
900 ng/mL
Geometric Coefficient of Variation 35.3
|
2060 ng/mL
Geometric Coefficient of Variation 33.6
|
4490 ng/mL
Geometric Coefficient of Variation 20.0
|
9760 ng/mL
Geometric Coefficient of Variation 20.0
|
13000 ng/mL
Geometric Coefficient of Variation 15.6
|
—
|
SECONDARY outcome
Timeframe: Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)Population: The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.
Tmax is the time of maximum concentration observed directly from the observed concentration versus time data.
Outcome measures
| Measure |
3 mg UV-4B
n=6 Participants
UV-4B 3 mg oral, single dose
|
10 mg UV-4B
n=6 Participants
UV-4B 10 mg oral, single dose
|
30 mg UV-4B
n=6 Participants
UV-4B 30 mg oral, single dose
|
90 mg UV-4B
n=6 Participants
UV-4B 90 mg oral, single dose
|
180 mg UV-4B
n=6 Participants
UV-4B 180 mg oral, single dose
|
360 mg UV-4B
n=6 Participants
UV-4B 360 mg oral, single dose
|
720 mg UV-4B
n=6 Participants
UV-4B 720 mg oral, single dose
|
1000 mg UV-4B
n=6 Participants
UV-4B 1000 mg oral, single dose
|
Placebo
Placebo oral, single dose
|
|---|---|---|---|---|---|---|---|---|---|
|
Tmax by Treatment Group: UV-4
|
0.50 hours
Interval 0.5 to 1.0
|
1.00 hours
Interval 0.5 to 1.5
|
0.50 hours
Interval 0.5 to 1.0
|
0.50 hours
Interval 0.5 to 1.52
|
0.75 hours
Interval 0.5 to 1.0
|
0.50 hours
Interval 0.5 to 1.0
|
0.75 hours
Interval 0.5 to 1.0
|
1.00 hours
Interval 0.5 to 1.5
|
—
|
SECONDARY outcome
Timeframe: Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)Population: The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.
AUC(0-last) is the area under the concentration-time curve from time zero (pre-dose) to time of last quantifiable concentration, calculated by linear up/log down trapezoidal summation.
Outcome measures
| Measure |
3 mg UV-4B
n=6 Participants
UV-4B 3 mg oral, single dose
|
10 mg UV-4B
n=6 Participants
UV-4B 10 mg oral, single dose
|
30 mg UV-4B
n=6 Participants
UV-4B 30 mg oral, single dose
|
90 mg UV-4B
n=6 Participants
UV-4B 90 mg oral, single dose
|
180 mg UV-4B
n=6 Participants
UV-4B 180 mg oral, single dose
|
360 mg UV-4B
n=6 Participants
UV-4B 360 mg oral, single dose
|
720 mg UV-4B
n=6 Participants
UV-4B 720 mg oral, single dose
|
1000 mg UV-4B
n=6 Participants
UV-4B 1000 mg oral, single dose
|
Placebo
Placebo oral, single dose
|
|---|---|---|---|---|---|---|---|---|---|
|
AUC(0-last) by Treatment Group: UV-4
|
82.1 ng * h/mL
Geometric Coefficient of Variation 18.8
|
406 ng * h/mL
Geometric Coefficient of Variation 24.7
|
1230 ng * h/mL
Geometric Coefficient of Variation 10.9
|
3640 ng * h/mL
Geometric Coefficient of Variation 12.7
|
7050 ng * h/mL
Geometric Coefficient of Variation 8.3
|
13600 ng * h/mL
Geometric Coefficient of Variation 14.6
|
32700 ng * h/mL
Geometric Coefficient of Variation 10.9
|
42700 ng * h/mL
Geometric Coefficient of Variation 13.2
|
—
|
SECONDARY outcome
Timeframe: Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)Population: The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B. Subjects in this population were used for all PK summaries.
AUC(0-inf) is the area under the concentration-time curve in the sample from pre-dose extrapolated to infinite time, calculated by linear up/log down trapezoidal summation and extrapolated to infinity by addition of the last quantifiable concentration divided by the apparent terminal rate constant: AUC(0-last) - C(last)/λ(z).
Outcome measures
| Measure |
3 mg UV-4B
n=6 Participants
UV-4B 3 mg oral, single dose
|
10 mg UV-4B
n=6 Participants
UV-4B 10 mg oral, single dose
|
30 mg UV-4B
n=6 Participants
UV-4B 30 mg oral, single dose
|
90 mg UV-4B
n=6 Participants
UV-4B 90 mg oral, single dose
|
180 mg UV-4B
n=6 Participants
UV-4B 180 mg oral, single dose
|
360 mg UV-4B
n=6 Participants
UV-4B 360 mg oral, single dose
|
720 mg UV-4B
n=6 Participants
UV-4B 720 mg oral, single dose
|
1000 mg UV-4B
n=6 Participants
UV-4B 1000 mg oral, single dose
|
Placebo
Placebo oral, single dose
|
|---|---|---|---|---|---|---|---|---|---|
|
AUC(0-inf) by Treatment Group: UV-4
|
94.6 ng * h/mL
Geometric Coefficient of Variation 16.3
|
420 ng * h/mL
Geometric Coefficient of Variation 24.2
|
1260 ng * h/mL
Geometric Coefficient of Variation 10.2
|
3700 ng * h/mL
Geometric Coefficient of Variation 13.3
|
7090 ng * h/mL
Geometric Coefficient of Variation 8.2
|
13700 ng * h/mL
Geometric Coefficient of Variation 14.6
|
32800 ng * h/mL
Geometric Coefficient of Variation 10.9
|
42800 ng * h/mL
Geometric Coefficient of Variation 13.3
|
—
|
SECONDARY outcome
Timeframe: Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)Population: The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.
CL/F is the apparent systematic clearance, calculated as dose (free-base equivalent) divided by AUC(0-inf).
Outcome measures
| Measure |
3 mg UV-4B
n=6 Participants
UV-4B 3 mg oral, single dose
|
10 mg UV-4B
n=6 Participants
UV-4B 10 mg oral, single dose
|
30 mg UV-4B
n=6 Participants
UV-4B 30 mg oral, single dose
|
90 mg UV-4B
n=6 Participants
UV-4B 90 mg oral, single dose
|
180 mg UV-4B
n=6 Participants
UV-4B 180 mg oral, single dose
|
360 mg UV-4B
n=6 Participants
UV-4B 360 mg oral, single dose
|
720 mg UV-4B
n=6 Participants
UV-4B 720 mg oral, single dose
|
1000 mg UV-4B
n=6 Participants
UV-4B 1000 mg oral, single dose
|
Placebo
Placebo oral, single dose
|
|---|---|---|---|---|---|---|---|---|---|
|
CL/F by Treatment Group: UV-4
|
31.7 L/h
Geometric Coefficient of Variation 16.3
|
23.8 L/h
Geometric Coefficient of Variation 24.1
|
23.9 L/h
Geometric Coefficient of Variation 10.5
|
24.3 L/h
Geometric Coefficient of Variation 13.5
|
25.4 L/h
Geometric Coefficient of Variation 8.2
|
26.3 L/h
Geometric Coefficient of Variation 14.7
|
22.0 L/h
Geometric Coefficient of Variation 11.0
|
23.4 L/h
Geometric Coefficient of Variation 13.3
|
—
|
SECONDARY outcome
Timeframe: Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)Population: The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.
Vz/F is the apparent volume of distribution of UV-4 based on the terminal phase, calculated as dose (free-base equivalent) divided by \[λ(z) × AUC(0-inf)\].
Outcome measures
| Measure |
3 mg UV-4B
n=6 Participants
UV-4B 3 mg oral, single dose
|
10 mg UV-4B
n=6 Participants
UV-4B 10 mg oral, single dose
|
30 mg UV-4B
n=6 Participants
UV-4B 30 mg oral, single dose
|
90 mg UV-4B
n=6 Participants
UV-4B 90 mg oral, single dose
|
180 mg UV-4B
n=6 Participants
UV-4B 180 mg oral, single dose
|
360 mg UV-4B
n=6 Participants
UV-4B 360 mg oral, single dose
|
720 mg UV-4B
n=6 Participants
UV-4B 720 mg oral, single dose
|
1000 mg UV-4B
n=6 Participants
UV-4B 1000 mg oral, single dose
|
Placebo
Placebo oral, single dose
|
|---|---|---|---|---|---|---|---|---|---|
|
Vz/F by Treatment Group: UV-4
|
470 L
Geometric Coefficient of Variation 32.8
|
409 L
Geometric Coefficient of Variation 30.6
|
344 L
Geometric Coefficient of Variation 16.7
|
358 L
Geometric Coefficient of Variation 21.5
|
317 L
Geometric Coefficient of Variation 17.2
|
308 L
Geometric Coefficient of Variation 11.9
|
259 L
Geometric Coefficient of Variation 10.3
|
290 L
Geometric Coefficient of Variation 27.3
|
—
|
SECONDARY outcome
Timeframe: Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)Population: The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.
t(1/2) is the apparent terminal half-life, determined as ln(2)/λ(z).
Outcome measures
| Measure |
3 mg UV-4B
n=6 Participants
UV-4B 3 mg oral, single dose
|
10 mg UV-4B
n=6 Participants
UV-4B 10 mg oral, single dose
|
30 mg UV-4B
n=6 Participants
UV-4B 30 mg oral, single dose
|
90 mg UV-4B
n=6 Participants
UV-4B 90 mg oral, single dose
|
180 mg UV-4B
n=6 Participants
UV-4B 180 mg oral, single dose
|
360 mg UV-4B
n=6 Participants
UV-4B 360 mg oral, single dose
|
720 mg UV-4B
n=6 Participants
UV-4B 720 mg oral, single dose
|
1000 mg UV-4B
n=6 Participants
UV-4B 1000 mg oral, single dose
|
Placebo
Placebo oral, single dose
|
|---|---|---|---|---|---|---|---|---|---|
|
t(1/2) by Treatment Group: UV-4
|
9.11 hours
Interval 7.75 to 16.3
|
11.6 hours
Interval 10.6 to 13.7
|
9.98 hours
Interval 8.75 to 10.8
|
9.56 hours
Interval 8.52 to 16.0
|
8.52 hours
Interval 7.65 to 10.3
|
8.14 hours
Interval 7.06 to 9.08
|
8.03 hours
Interval 7.66 to 9.23
|
7.95 hours
Interval 6.6 to 13.4
|
—
|
SECONDARY outcome
Timeframe: Pooled urine samples were collected at predose (-12 to 0 hour), and from 0 to 6, 6 to 12, 12 to 24, and 24 to 48 hours postdosePopulation: The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B. Subjects in this population were used for all PK summaries.
Ae is the by-interval and cumulative amounts of UV-4 drug excreted in urine. Intervals were 0 to 6, 6 to 12, 12 to 24, and 24 to 48 hours postdose. Ae by-interval amounts were calculated as the product of urine volume and urine concentration. Ae(0-last) is the cumulative amount of UV-4 drug excreted in urine over the entire collection period, 48 hours. Cumulative amounts were calculated as the summation of the amounts excreted in collection intervals.
Outcome measures
| Measure |
3 mg UV-4B
n=6 Participants
UV-4B 3 mg oral, single dose
|
10 mg UV-4B
n=6 Participants
UV-4B 10 mg oral, single dose
|
30 mg UV-4B
n=6 Participants
UV-4B 30 mg oral, single dose
|
90 mg UV-4B
n=6 Participants
UV-4B 90 mg oral, single dose
|
180 mg UV-4B
n=6 Participants
UV-4B 180 mg oral, single dose
|
360 mg UV-4B
n=6 Participants
UV-4B 360 mg oral, single dose
|
720 mg UV-4B
n=6 Participants
UV-4B 720 mg oral, single dose
|
1000 mg UV-4B
n=6 Participants
UV-4B 1000 mg oral, single dose
|
Placebo
Placebo oral, single dose
|
|---|---|---|---|---|---|---|---|---|---|
|
Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group
Ae(6-12)
|
0.215 mg
Standard Deviation 0.0496
|
0.859 mg
Standard Deviation 0.112
|
2.45 mg
Standard Deviation 0.145
|
6.05 mg
Standard Deviation 2.55
|
12.1 mg
Standard Deviation 1.48
|
19.1 mg
Standard Deviation 7.00
|
42.5 mg
Standard Deviation 6.00
|
53.7 mg
Standard Deviation 15.2
|
—
|
|
Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group
Ae(12-24)
|
0.202 mg
Standard Deviation 0.0543
|
0.608 mg
Standard Deviation 0.0888
|
1.61 mg
Standard Deviation 0.363
|
3.89 mg
Standard Deviation 0.799
|
6.06 mg
Standard Deviation 2.40
|
7.09 mg
Standard Deviation 1.90
|
11.7 mg
Standard Deviation 1.60
|
16.4 mg
Standard Deviation 5.32
|
—
|
|
Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group
Ae(24-48)
|
0.170 mg
Standard Deviation 0.0416
|
0.503 mg
Standard Deviation 0.0655
|
0.887 mg
Standard Deviation 0.200
|
1.61 mg
Standard Deviation 0.474
|
2.43 mg
Standard Deviation 1.03
|
2.83 mg
Standard Deviation 0.672
|
4.09 mg
Standard Deviation 1.24
|
5.21 mg
Standard Deviation 1.41
|
—
|
|
Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group
Ae(0-12)
|
0.822 mg
Standard Deviation 0.177
|
3.53 mg
Standard Deviation 0.428
|
13.0 mg
Standard Deviation 1.31
|
44.1 mg
Standard Deviation 3.83
|
89.6 mg
Standard Deviation 3.76
|
178 mg
Standard Deviation 18.7
|
355 mg
Standard Deviation 34.6
|
498 mg
Standard Deviation 65.6
|
—
|
|
Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group
Ae(0-6)
|
0.607 mg
Standard Deviation 0.145
|
2.67 mg
Standard Deviation 0.386
|
10.6 mg
Standard Deviation 1.18
|
38.1 mg
Standard Deviation 3.83
|
77.5 mg
Standard Deviation 3.49
|
159 mg
Standard Deviation 24.3
|
301 mg
Standard Deviation 36.3
|
428 mg
Standard Deviation 64.5
|
—
|
|
Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group
Ae(0-24)
|
1.02 mg
Standard Deviation 0.197
|
4.13 mg
Standard Deviation 0.515
|
14.6 mg
Standard Deviation 1.13
|
48.0 mg
Standard Deviation 3.75
|
95.7 mg
Standard Deviation 4.26
|
185 mg
Standard Deviation 17.9
|
355 mg
Standard Deviation 34.6
|
498 mg
Standard Deviation 65.6
|
—
|
|
Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group
Ae(0-last)
|
1.19 mg
Standard Deviation 0.200
|
4.64 mg
Standard Deviation 0.463
|
15.5 mg
Standard Deviation 0.982
|
49.6 mg
Standard Deviation 3.58
|
97.9 mg
Standard Deviation 4.86
|
188 mg
Standard Deviation 17.3
|
360 mg
Standard Deviation 34.7
|
504 mg
Standard Deviation 66.1
|
—
|
SECONDARY outcome
Timeframe: Pooled urine samples were collected at predose (-12 to 0 hour), and from 0 to 6, 6 to 12, 12 to 24, and 24 to 48 hours postdosePopulation: The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.
fe is the by-interval percentage of UV-4 drug excreted in urine. Intervals were 0 to 6, 6 to 12, 12 to 24, and 24 to 48 hours postdose. fe = Ae/(UV-4B dose x 100). fe(0-12), fe(0-24) and fe(0-last) are the cumulative percentages of UV-4 drug excreted in urine over 24 hours and the entire collection period, respectively.
Outcome measures
| Measure |
3 mg UV-4B
n=6 Participants
UV-4B 3 mg oral, single dose
|
10 mg UV-4B
n=6 Participants
UV-4B 10 mg oral, single dose
|
30 mg UV-4B
n=6 Participants
UV-4B 30 mg oral, single dose
|
90 mg UV-4B
n=6 Participants
UV-4B 90 mg oral, single dose
|
180 mg UV-4B
n=6 Participants
UV-4B 180 mg oral, single dose
|
360 mg UV-4B
n=6 Participants
UV-4B 360 mg oral, single dose
|
720 mg UV-4B
n=6 Participants
UV-4B 720 mg oral, single dose
|
1000 mg UV-4B
n=6 Participants
UV-4B 1000 mg oral, single dose
|
Placebo
Placebo oral, single dose
|
|---|---|---|---|---|---|---|---|---|---|
|
Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group
fe(0-12)
|
27.4 percentage of dose
Standard Deviation 5.93
|
35.3 percentage of dose
Standard Deviation 4.28
|
43.4 percentage of dose
Standard Deviation 4.28
|
49.0 percentage of dose
Standard Deviation 4.28
|
49.8 percentage of dose
Standard Deviation 2.08
|
49.5 percentage of dose
Standard Deviation 5.18
|
47.7 percentage of dose
Standard Deviation 4.86
|
48.2 percentage of dose
Standard Deviation 6.66
|
—
|
|
Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group
fe(0-6)
|
20.2 percentage of dose
Standard Deviation 4.81
|
26.7 percentage of dose
Standard Deviation 3.86
|
35.3 percentage of dose
Standard Deviation 3.84
|
42.2 percentage of dose
Standard Deviation 4.26
|
43.0 percentage of dose
Standard Deviation 1.96
|
44.2 percentage of dose
Standard Deviation 6.69
|
41.8 percentage of dose
Standard Deviation 5.04
|
42.8 percentage of dose
Standard Deviation 6.45
|
—
|
|
Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group
fe(6-12)
|
7.17 percentage of dose
Standard Deviation 1.65
|
8.59 percentage of dose
Standard Deviation 1.12
|
8.16 percentage of dose
Standard Deviation 0.480
|
6.72 percentage of dose
Standard Deviation 2.83
|
6.74 percentage of dose
Standard Deviation 0.820
|
5.32 percentage of dose
Standard Deviation 1.94
|
5.90 percentage of dose
Standard Deviation 0.833
|
5.37 percentage of dose
Standard Deviation 1.52
|
—
|
|
Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group
fe(12-24)
|
6.71 percentage of dose
Standard Deviation 1.82
|
6.08 percentage of dose
Standard Deviation 0.888
|
5.36 percentage of dose
Standard Deviation 1.21
|
4.32 percentage of dose
Standard Deviation 0.886
|
3.37 percentage of dose
Standard Deviation 1.34
|
1.97 percentage of dose
Standard Deviation 0.532
|
1.63 percentage of dose
Standard Deviation 0.221
|
1.64 percentage of dose
Standard Deviation 0.532
|
—
|
|
Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group
fe(24-48)
|
5.66 percentage of dose
Standard Deviation 1.39
|
5.03 percentage of dose
Standard Deviation 0.655
|
2.96 percentage of dose
Standard Deviation 0.664
|
1.79 percentage of dose
Standard Deviation 0.528
|
1.35 percentage of dose
Standard Deviation 0.572
|
0.787 percentage of dose
Standard Deviation 0.186
|
0.569 percentage of dose
Standard Deviation 0.172
|
0.521 percentage of dose
Standard Deviation 0.141
|
—
|
|
Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group
fe(0-24)
|
34.1 percentage of dose
Standard Deviation 6.57
|
41.3 percentage of dose
Standard Deviation 5.15
|
48.8 percentage of dose
Standard Deviation 3.72
|
53.3 percentage of dose
Standard Deviation 4.14
|
53.1 percentage of dose
Standard Deviation 2.37
|
51.5 percentage of dose
Standard Deviation 4.97
|
49.4 percentage of dose
Standard Deviation 4.81
|
49.8 percentage of dose
Standard Deviation 6.56
|
—
|
|
Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group
fe(0-last)
|
39.8 percentage of dose
Standard Deviation 6.66
|
46.4 percentage of dose
Standard Deviation 4.63
|
51.7 percentage of dose
Standard Deviation 3.27
|
55.1 percentage of dose
Standard Deviation 3.98
|
54.5 percentage of dose
Standard Deviation 2.76
|
52.3 percentage of dose
Standard Deviation 4.82
|
49.9 percentage of dose
Standard Deviation 4.84
|
50.4 percentage of dose
Standard Deviation 6.61
|
—
|
SECONDARY outcome
Timeframe: Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)Population: The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing.L/h
CLr is the renal clearance, calculated at Ae(0-last) divided by AUC(0-last).
Outcome measures
| Measure |
3 mg UV-4B
n=6 Participants
UV-4B 3 mg oral, single dose
|
10 mg UV-4B
n=6 Participants
UV-4B 10 mg oral, single dose
|
30 mg UV-4B
n=6 Participants
UV-4B 30 mg oral, single dose
|
90 mg UV-4B
n=6 Participants
UV-4B 90 mg oral, single dose
|
180 mg UV-4B
n=6 Participants
UV-4B 180 mg oral, single dose
|
360 mg UV-4B
n=6 Participants
UV-4B 360 mg oral, single dose
|
720 mg UV-4B
n=6 Participants
UV-4B 720 mg oral, single dose
|
1000 mg UV-4B
n=6 Participants
UV-4B 1000 mg oral, single dose
|
Placebo
Placebo oral, single dose
|
|---|---|---|---|---|---|---|---|---|---|
|
CLr by Treatment Group: UV-4
|
14.3 L/h
Geometric Coefficient of Variation 15.0
|
11.4 L/h
Geometric Coefficient of Variation 26.9
|
12.5 L/h
Geometric Coefficient of Variation 10.1
|
13.6 L/h
Geometric Coefficient of Variation 14.2
|
13.9 L/h
Geometric Coefficient of Variation 12.4
|
13.7 L/h
Geometric Coefficient of Variation 23.6
|
10.9 L/h
Geometric Coefficient of Variation 17.6
|
11.7 L/h
Geometric Coefficient of Variation 17.2
|
—
|
Adverse Events
3 mg UV-4B
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
10 mg UV-4B
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
30 mg UV-4B
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
90 mg UV-4B
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
180 mg UV-4B
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
360 mg UV-4B
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
720 mg UV-4B
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
1000 mg UV-4B
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
3 mg UV-4B
n=6 participants at risk
UV-4B 3 mg oral, single dose
|
10 mg UV-4B
n=6 participants at risk
UV-4B 10 mg oral, single dose
|
30 mg UV-4B
n=6 participants at risk
UV-4B 30 mg oral, single dose
|
90 mg UV-4B
n=6 participants at risk
UV-4B 90 mg oral, single dose
|
180 mg UV-4B
n=6 participants at risk
UV-4B 180 mg oral, single dose
|
360 mg UV-4B
n=6 participants at risk
UV-4B 360 mg oral, single dose
|
720 mg UV-4B
n=6 participants at risk
UV-4B 720 mg oral, single dose
|
1000 mg UV-4B
n=6 participants at risk
UV-4B 1000 mg oral, single dose
|
Placebo
n=16 participants at risk
Placebo oral, single dose
|
|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
6.2%
1/16 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/16 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/16 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/16 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 3 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
50.0%
3/6 • Number of events 3 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/16 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/16 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
General disorders
Local swelling
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/16 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/16 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/16 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Injury, poisoning and procedural complications
Chemical eye injury
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/16 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Investigations
APTT prolonged
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
50.0%
3/6 • Number of events 3 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
50.0%
3/6 • Number of events 3 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
6.2%
1/16 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Investigations
ALT increased
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/16 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Investigations
AST increased
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
6.2%
1/16 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Investigations
Blood calcium decreased
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/16 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
6.2%
1/16 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Investigations
Blood pressure decreased
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
6.2%
1/16 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Investigations
Blood urea increased
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
33.3%
2/6 • Number of events 2 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
25.0%
4/16 • Number of events 4 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
6.2%
1/16 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Investigations
Protein total decreased
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/16 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
33.3%
2/6 • Number of events 2 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/16 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Investigations
Respiratory rate increased
|
50.0%
3/6 • Number of events 3 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
66.7%
4/6 • Number of events 4 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
33.3%
2/6 • Number of events 2 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
12.5%
2/16 • Number of events 2 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Investigations
Heart rate decreased
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/16 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Investigations
Lipase increased
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/16 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
12.5%
2/16 • Number of events 2 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Investigations
WBC decreased
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
6.2%
1/16 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Investigations
WBC increased
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/16 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
33.3%
2/6 • Number of events 2 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
33.3%
2/6 • Number of events 2 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
50.0%
3/6 • Number of events 3 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
6.2%
1/16 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
6.2%
1/16 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Metabolism and nutrition disorders
Hypokaelemia
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
12.5%
2/16 • Number of events 2 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Metabolism and nutrition disorders
Hypomagnaesemia
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/16 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Metabolism and nutrition disorders
Hypophosphaetemia
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/16 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/16 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/16 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/16 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/16 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
6.2%
1/16 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/16 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
6.2%
1/16 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
6.2%
1/16 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Nervous system disorders
Tension headache
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
6.2%
1/16 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Cardiac disorders
Bradycardia
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
33.3%
2/6 • Number of events 3 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
33.3%
2/6 • Number of events 2 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
33.3%
2/6 • Number of events 2 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
6.2%
1/16 • Number of events 2 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
6.2%
1/16 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/16 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
33.3%
2/6 • Number of events 2 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
6.2%
1/16 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Renal and urinary disorders
Proteinuria
|
33.3%
2/6 • Number of events 2 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
33.3%
2/6 • Number of events 2 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
66.7%
4/6 • Number of events 4 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/16 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
33.3%
2/6 • Number of events 2 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
6.2%
1/16 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Vascular disorders
Hot flush
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/16 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
16.7%
1/6 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/16 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
0.00%
0/6 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
6.2%
1/16 • Number of events 1 • From time of the first dose administration through 9 ± 1 days after dosing
Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor will make the results of the study publicly available, including for purposes of national and international registration, publication, and information for medical and pharmaceutical professionals.
- Publication restrictions are in place
Restriction type: OTHER