Trial Outcomes & Findings for To Evaluate Safety, Pharmacokinetics and Pharmacodynamics of MEDI6012 in Subjects With Stable Coronary Artery Disease (NCT NCT02601560)
NCT ID: NCT02601560
Last Updated: 2018-03-19
Results Overview
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are the events between first dose of study drug and up to 57 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
Baseline (Day 1) up to Day 57
Results posted on
2018-03-19
Participant Flow
A total of 230 participants were screened in the study from 07-Dec-2015 to 13-Jan-2017 at 8 sites in the United States of America.
Out of 230 participants, 182 participants were considered screen failures. The remaining 48 participants were randomized to receive the study drug. The 1600 mg dose was omitted based on a greater than expected pharmacodynamics effects at lower doses.
Participant milestones
| Measure |
Placebo Intravenous (IV)
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 24 Milligram (mg) IV
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
|
MEDI6012 80 mg IV
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 240 mg IV
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
|
MEDI6012 800 mg IV
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
|
Placebo Subcutaneous (SC)
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 80 mg SC
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 600 mg SC
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
6
|
6
|
6
|
6
|
4
|
6
|
6
|
|
Overall Study
COMPLETED
|
8
|
6
|
6
|
6
|
6
|
4
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo Intravenous (IV)
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 24 Milligram (mg) IV
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
|
MEDI6012 80 mg IV
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 240 mg IV
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
|
MEDI6012 800 mg IV
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
|
Placebo Subcutaneous (SC)
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 80 mg SC
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 600 mg SC
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
To Evaluate Safety, Pharmacokinetics and Pharmacodynamics of MEDI6012 in Subjects With Stable Coronary Artery Disease
Baseline characteristics by cohort
| Measure |
Placebo Intravenous (IV)
n=8 Participants
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 24 Milligram (mg) IV
n=6 Participants
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
|
MEDI6012 80 mg IV
n=6 Participants
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 240 mg IV
n=6 Participants
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
|
MEDI6012 800 mg IV
n=6 Participants
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
|
Placebo Subcutaneous (SC)
n=4 Participants
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 80 mg SC
n=6 Participants
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 600 mg SC
n=6 Participants
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
62.8 Years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
59.8 Years
STANDARD_DEVIATION 7.0 • n=7 Participants
|
60.0 Years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
63.5 Years
STANDARD_DEVIATION 5.4 • n=4 Participants
|
65.8 Years
STANDARD_DEVIATION 8.2 • n=21 Participants
|
62.0 Years
STANDARD_DEVIATION 9.3 • n=10 Participants
|
71.3 Years
STANDARD_DEVIATION 3.4 • n=115 Participants
|
66.5 Years
STANDARD_DEVIATION 4.7 • n=6 Participants
|
64.0 Years
STANDARD_DEVIATION 6.9 • n=6 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
9 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
5 Participants
n=6 Participants
|
39 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) up to Day 57Population: As-treated Population: All participants who received any amount of study drug were included in this population.
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are the events between first dose of study drug and up to 57 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
Outcome measures
| Measure |
Placebo Intravenous (IV)
n=8 Participants
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 24 Milligram (mg) IV
n=6 Participants
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
|
MEDI6012 80 mg IV
n=6 Participants
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 240 mg IV
n=6 Participants
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
|
MEDI6012 800 mg IV
n=6 Participants
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
|
Placebo Subcutaneous (SC)
n=4 Participants
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 80 mg SC
n=6 Participants
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 600 mg SC
n=6 Participants
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
TEAEs
|
3 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
TESAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) up to Day 57Population: As-treated Population
TEAEs observed in participants with clinically significant ECG abnormalities were assessed. TEAEs are the events between first dose of study drug and up to 57 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
Outcome measures
| Measure |
Placebo Intravenous (IV)
n=8 Participants
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 24 Milligram (mg) IV
n=6 Participants
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
|
MEDI6012 80 mg IV
n=6 Participants
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 240 mg IV
n=6 Participants
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
|
MEDI6012 800 mg IV
n=6 Participants
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
|
Placebo Subcutaneous (SC)
n=4 Participants
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 80 mg SC
n=6 Participants
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 600 mg SC
n=6 Participants
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With TEAEs Related to Electrocardiogram (ECG) Evaluations
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) up to Day 57Population: As-treated Population
TEAEs observed in participants with clinically significant vital signs abnormalities were assessed. Vital signs parameters included blood pressure, respiration rate, pulse, pulse oximetry, and body temperature.
Outcome measures
| Measure |
Placebo Intravenous (IV)
n=8 Participants
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 24 Milligram (mg) IV
n=6 Participants
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
|
MEDI6012 80 mg IV
n=6 Participants
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 240 mg IV
n=6 Participants
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
|
MEDI6012 800 mg IV
n=6 Participants
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
|
Placebo Subcutaneous (SC)
n=4 Participants
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 80 mg SC
n=6 Participants
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 600 mg SC
n=6 Participants
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With TEAEs Related to Vital Sign Parameters
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) up to Day 57Population: As-treated Population
An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.
Outcome measures
| Measure |
Placebo Intravenous (IV)
n=8 Participants
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 24 Milligram (mg) IV
n=6 Participants
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
|
MEDI6012 80 mg IV
n=6 Participants
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 240 mg IV
n=6 Participants
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
|
MEDI6012 800 mg IV
n=6 Participants
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
|
Placebo Subcutaneous (SC)
n=4 Participants
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 80 mg SC
n=6 Participants
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 600 mg SC
n=6 Participants
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With TEAEs Related to Clinical Laboratory Evaluations
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion, 4 and 8 hrs post-dose Day 1 (IV cohorts only)Population: As-treated Population.
The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of HDL-C.
Outcome measures
| Measure |
Placebo Intravenous (IV)
n=8 Participants
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 24 Milligram (mg) IV
n=6 Participants
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
|
MEDI6012 80 mg IV
n=6 Participants
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 240 mg IV
n=6 Participants
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
|
MEDI6012 800 mg IV
n=6 Participants
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
|
Placebo Subcutaneous (SC)
n=4 Participants
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 80 mg SC
n=6 Participants
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 600 mg SC
n=6 Participants
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hours (Hrs) (AUC [0-96 Hrs]) for High-Density Lipoprotein-Cholesterol (HDL-C)
|
-49.1 milligrams per deciliter (mg/dL)
Standard Deviation 120.0
|
728.3 milligrams per deciliter (mg/dL)
Standard Deviation 334.2
|
1639.9 milligrams per deciliter (mg/dL)
Standard Deviation 631.7
|
3035.0 milligrams per deciliter (mg/dL)
Standard Deviation 439.1
|
5318.3 milligrams per deciliter (mg/dL)
Standard Deviation 1674.3
|
-113.5 milligrams per deciliter (mg/dL)
Standard Deviation 289.4
|
422.4 milligrams per deciliter (mg/dL)
Standard Deviation 395.7
|
2844.7 milligrams per deciliter (mg/dL)
Standard Deviation 1219.1
|
SECONDARY outcome
Timeframe: Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)Population: As-treated population
The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of total cholesterol.
Outcome measures
| Measure |
Placebo Intravenous (IV)
n=8 Participants
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 24 Milligram (mg) IV
n=6 Participants
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
|
MEDI6012 80 mg IV
n=6 Participants
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 240 mg IV
n=6 Participants
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
|
MEDI6012 800 mg IV
n=6 Participants
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
|
Placebo Subcutaneous (SC)
n=4 Participants
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 80 mg SC
n=6 Participants
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 600 mg SC
n=6 Participants
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Total Cholesterol
|
13.8 mg/dL
Standard Deviation 954.1
|
-164.9 mg/dL
Standard Deviation 1301.5
|
1925.7 mg/dL
Standard Deviation 913.3
|
3639.2 mg/dL
Standard Deviation 667.6
|
6990.3 mg/dL
Standard Deviation 1764.0
|
82.3 mg/dL
Standard Deviation 983.4
|
240.9 mg/dL
Standard Deviation 494.2
|
3156.8 mg/dL
Standard Deviation 1476.5
|
SECONDARY outcome
Timeframe: Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)Population: As-treated population
The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of free cholesterol.
Outcome measures
| Measure |
Placebo Intravenous (IV)
n=8 Participants
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 24 Milligram (mg) IV
n=6 Participants
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
|
MEDI6012 80 mg IV
n=6 Participants
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 240 mg IV
n=6 Participants
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
|
MEDI6012 800 mg IV
n=6 Participants
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
|
Placebo Subcutaneous (SC)
n=4 Participants
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 80 mg SC
n=6 Participants
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 600 mg SC
n=6 Participants
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Free Cholesterol
|
38.4 mg/dL
Standard Deviation 265.4
|
-197.7 mg/dL
Standard Deviation 338.2
|
38.9 mg/dL
Standard Deviation 346.8
|
110.0 mg/dL
Standard Deviation 133.9
|
434.6 mg/dL
Standard Deviation 541.7
|
172.5 mg/dL
Standard Deviation 76.6
|
-61.5 mg/dL
Standard Deviation 206.6
|
-205.4 mg/dL
Standard Deviation 324.5
|
SECONDARY outcome
Timeframe: Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)Population: As-treated population
The AUC(0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of cholesteryl ester.
Outcome measures
| Measure |
Placebo Intravenous (IV)
n=8 Participants
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 24 Milligram (mg) IV
n=6 Participants
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
|
MEDI6012 80 mg IV
n=6 Participants
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 240 mg IV
n=6 Participants
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
|
MEDI6012 800 mg IV
n=6 Participants
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
|
Placebo Subcutaneous (SC)
n=4 Participants
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 80 mg SC
n=6 Participants
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 600 mg SC
n=6 Participants
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Cholesteryl Ester
|
-24.6 mg/dL
Standard Deviation 776.0
|
32.8 mg/dL
Standard Deviation 992.6
|
1886.8 mg/dL
Standard Deviation 722.8
|
3529.2 mg/dL
Standard Deviation 628.3
|
6555.7 mg/dL
Standard Deviation 1674.0
|
-90.2 mg/dL
Standard Deviation 965.4
|
302.4 mg/dL
Standard Deviation 428.4
|
3362.3 mg/dL
Standard Deviation 1340.5
|
SECONDARY outcome
Timeframe: Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)Population: As-treated population
The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of high density lipoprotein cholesteryl ester.
Outcome measures
| Measure |
Placebo Intravenous (IV)
n=8 Participants
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 24 Milligram (mg) IV
n=6 Participants
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
|
MEDI6012 80 mg IV
n=6 Participants
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 240 mg IV
n=6 Participants
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
|
MEDI6012 800 mg IV
n=6 Participants
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
|
Placebo Subcutaneous (SC)
n=4 Participants
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 80 mg SC
n=6 Participants
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 600 mg SC
n=6 Participants
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for High-Density Lipoprotein Cholesteryl Ester
|
-50.3 mg/dL
Standard Deviation 108.9
|
668.4 mg/dL
Standard Deviation 263.3
|
1460.7 mg/dL
Standard Deviation 584.0
|
2778.0 mg/dL
Standard Deviation 416.7
|
4886.0 mg/dL
Standard Deviation 1459.7
|
-132.6 mg/dL
Standard Deviation 253.1
|
392.7 mg/dL
Standard Deviation 350.3
|
2672.5 mg/dL
Standard Deviation 1115.7
|
SECONDARY outcome
Timeframe: Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)Population: As-treated population
The AUC(0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of non-high density lipoprotein cholesterol.
Outcome measures
| Measure |
Placebo Intravenous (IV)
n=8 Participants
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 24 Milligram (mg) IV
n=6 Participants
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
|
MEDI6012 80 mg IV
n=6 Participants
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 240 mg IV
n=6 Participants
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
|
MEDI6012 800 mg IV
n=6 Participants
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
|
Placebo Subcutaneous (SC)
n=4 Participants
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 80 mg SC
n=6 Participants
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 600 mg SC
n=6 Participants
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Non-High Density Lipoprotein Cholesterol
|
63.0 mg/dL
Standard Deviation 906.4
|
-893.2 mg/dL
Standard Deviation 1316.0
|
285.8 mg/dL
Standard Deviation 1051.8
|
604.2 mg/dL
Standard Deviation 659.1
|
1672.0 mg/dL
Standard Deviation 1413.4
|
195.8 mg/dL
Standard Deviation 809.9
|
-181.5 mg/dL
Standard Deviation 385.1
|
312.2 mg/dL
Standard Deviation 642.4
|
SECONDARY outcome
Timeframe: Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)Population: As-treated population
The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of high density lipoprotein unesterified cholesterol.
Outcome measures
| Measure |
Placebo Intravenous (IV)
n=8 Participants
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 24 Milligram (mg) IV
n=6 Participants
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
|
MEDI6012 80 mg IV
n=6 Participants
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 240 mg IV
n=6 Participants
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
|
MEDI6012 800 mg IV
n=6 Participants
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
|
Placebo Subcutaneous (SC)
n=4 Participants
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 80 mg SC
n=6 Participants
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 600 mg SC
n=6 Participants
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for High-Density Lipoprotein Unesterified Cholesterol
|
1.2 mg/dL
Standard Deviation 38.0
|
59.9 mg/dL
Standard Deviation 78.9
|
179.2 mg/dL
Standard Deviation 116.5
|
248.4 mg/dL
Standard Deviation 37.6
|
417.1 mg/dL
Standard Deviation 256.1
|
19.1 mg/dL
Standard Deviation 46.6
|
29.7 mg/dL
Standard Deviation 77.5
|
172.2 mg/dL
Standard Deviation 156.6
|
SECONDARY outcome
Timeframe: Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)Population: As-treated population
The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of non-high density lipoprotein cholesteryl ester.
Outcome measures
| Measure |
Placebo Intravenous (IV)
n=8 Participants
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 24 Milligram (mg) IV
n=6 Participants
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
|
MEDI6012 80 mg IV
n=6 Participants
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 240 mg IV
n=6 Participants
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
|
MEDI6012 800 mg IV
n=6 Participants
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
|
Placebo Subcutaneous (SC)
n=4 Participants
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 80 mg SC
n=6 Participants
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 600 mg SC
n=6 Participants
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Non-High Density Lipoprotein Cholesteryl Ester
|
25.8 mg/dL
Standard Deviation 748.1
|
-635.6 mg/dL
Standard Deviation 984.0
|
426.1 mg/dL
Standard Deviation 723.0
|
741.6 mg/dL
Standard Deviation 590.5
|
1649.5 mg/dL
Standard Deviation 1007.5
|
42.4 mg/dL
Standard Deviation 791.6
|
-90.3 mg/dL
Standard Deviation 390.6
|
689.8 mg/dL
Standard Deviation 634.5
|
SECONDARY outcome
Timeframe: Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)Population: As-treated population
The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of non-high density lipoprotein unesterified cholesterol.
Outcome measures
| Measure |
Placebo Intravenous (IV)
n=8 Participants
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 24 Milligram (mg) IV
n=6 Participants
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
|
MEDI6012 80 mg IV
n=6 Participants
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 240 mg IV
n=6 Participants
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
|
MEDI6012 800 mg IV
n=6 Participants
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
|
Placebo Subcutaneous (SC)
n=4 Participants
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 80 mg SC
n=6 Participants
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 600 mg SC
n=6 Participants
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Non-High Density Lipoprotein Unesterified Cholesterol
|
37.2 mg/dL
Standard Deviation 241.2
|
-257.6 mg/dL
Standard Deviation 351.8
|
-140.3 mg/dL
Standard Deviation 354.7
|
-132.2 mg/dL
Standard Deviation 139.9
|
27.8 mg/dL
Standard Deviation 609.9
|
153.4 mg/dL
Standard Deviation 72.9
|
-91.2 mg/dL
Standard Deviation 155.2
|
-377.6 mg/dL
Standard Deviation 280.7
|
SECONDARY outcome
Timeframe: Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)Population: As-treated population
The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of low density lipoprotein cholesterol (direct).
Outcome measures
| Measure |
Placebo Intravenous (IV)
n=8 Participants
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 24 Milligram (mg) IV
n=6 Participants
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
|
MEDI6012 80 mg IV
n=6 Participants
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 240 mg IV
n=6 Participants
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
|
MEDI6012 800 mg IV
n=6 Participants
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
|
Placebo Subcutaneous (SC)
n=4 Participants
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 80 mg SC
n=6 Participants
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 600 mg SC
n=6 Participants
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Low Density Lipoprotein-Cholesterol (Direct)
|
182.1 mg/dL
Standard Deviation 600.9
|
-473.0 mg/dL
Standard Deviation 1096.4
|
83.2 mg/dL
Standard Deviation 762.0
|
987.2 mg/dL
Standard Deviation 453.8
|
1812.8 mg/dL
Standard Deviation 1081.8
|
-101.6 mg/dL
Standard Deviation 854.2
|
-61.7 mg/dL
Standard Deviation 438.1
|
996.1 mg/dL
Standard Deviation 803.5
|
SECONDARY outcome
Timeframe: Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)Population: As-treated population
The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of apolipoprotein B.
Outcome measures
| Measure |
Placebo Intravenous (IV)
n=8 Participants
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 24 Milligram (mg) IV
n=6 Participants
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
|
MEDI6012 80 mg IV
n=6 Participants
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 240 mg IV
n=6 Participants
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
|
MEDI6012 800 mg IV
n=6 Participants
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
|
Placebo Subcutaneous (SC)
n=4 Participants
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 80 mg SC
n=6 Participants
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 600 mg SC
n=6 Participants
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) Post Dose for Apolipoprotein B
|
220.7 mg/dL
Standard Deviation 524.7
|
-795.5 mg/dL
Standard Deviation 695.5
|
-636.7 mg/dL
Standard Deviation 682.6
|
-649.5 mg/dL
Standard Deviation 208.6
|
-537.1 mg/dL
Standard Deviation 706.2
|
97.4 mg/dL
Standard Deviation 483.2
|
-309.0 mg/dL
Standard Deviation 270.5
|
-219.0 mg/dL
Standard Deviation 630.7
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 29Population: As-treated population.
The change from baseline in serum concentration of pre beta 1-high density lipoprotein was estimated.
Outcome measures
| Measure |
Placebo Intravenous (IV)
n=8 Participants
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 24 Milligram (mg) IV
n=6 Participants
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
|
MEDI6012 80 mg IV
n=6 Participants
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 240 mg IV
n=6 Participants
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
|
MEDI6012 800 mg IV
n=6 Participants
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
|
Placebo Subcutaneous (SC)
n=4 Participants
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 80 mg SC
n=6 Participants
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 600 mg SC
n=6 Participants
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Serum Concentration of Pre Beta 1-High Density Lipoprotein at Day 29
Baseline (Day 1)
|
3.68 mg/dL
Standard Deviation 2.24
|
1.75 mg/dL
Standard Deviation 0.37
|
2.08 mg/dL
Standard Deviation 1.19
|
2.53 mg/dL
Standard Deviation 1.80
|
4.85 mg/dL
Standard Deviation 4.01
|
3.90 mg/dL
Standard Deviation NA
Standard deviation cannot be determined as only 1 participant was available.
|
3.38 mg/dL
Standard Deviation 1.48
|
1.67 mg/dL
Standard Deviation 0.46
|
|
Change From Baseline in Serum Concentration of Pre Beta 1-High Density Lipoprotein at Day 29
Change at Day 29
|
-0.20 mg/dL
Standard Deviation 1.27
|
-0.02 mg/dL
Standard Deviation 0.84
|
0.13 mg/dL
Standard Deviation 0.32
|
0.40 mg/dL
Standard Deviation 0.62
|
-1.12 mg/dL
Standard Deviation 3.21
|
-1.10 mg/dL
Standard Deviation NA
Standard deviation cannot be determined as only 1 participant was available.
|
1.33 mg/dL
Standard Deviation 1.44
|
0.10 mg/dL
Standard Deviation 0.60
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 57Population: Pharmacokinetic (PK) population: All participants in the as-treated population who had atleast one detectable LCAT serum concentration measurement.
The change from baseline in serum concentration of lecithin-cholesterol acyltransferase was estimated.
Outcome measures
| Measure |
Placebo Intravenous (IV)
n=6 Participants
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 24 Milligram (mg) IV
n=6 Participants
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
|
MEDI6012 80 mg IV
n=6 Participants
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 240 mg IV
n=6 Participants
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
|
MEDI6012 800 mg IV
n=5 Participants
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
|
Placebo Subcutaneous (SC)
n=6 Participants
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 80 mg SC
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 600 mg SC
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Serum Concentration of Lecithin-Cholesterol Acyltransferase (LCAT) at Day 57
Baseline (Day 1)
|
1250.0 mcg/mL
Standard Deviation 0.0
|
1250.0 mcg/mL
Standard Deviation 0.0
|
1250.0 mcg/mL
Standard Deviation 0.0
|
1250.0 mcg/mL
Standard Deviation 0.0
|
1250.0 mcg/mL
Standard Deviation 0.0
|
1250.0 mcg/mL
Standard Deviation 0.0
|
—
|
—
|
|
Change From Baseline in Serum Concentration of Lecithin-Cholesterol Acyltransferase (LCAT) at Day 57
Change at Day 57
|
0.0 mcg/mL
Standard Deviation NA
Standard deviation cannot be determined as only 1 participant was available.
|
—
|
—
|
0.0 mcg/mL
Standard Deviation 0.0
|
0.0 mcg/mL
Standard Deviation NA
Standard deviation cannot be determined as only 1 participant was available.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)Population: PK population. PK data of MEDI6012 80 mg SC dose group was not interpretable as concentration levels were predominantly beneath the limit of quantitation (\<2.5 mcg/mL).
The first occurrence of the maximum observed plasma concentration of MEDI6012 determined directly from the raw concentration time data.
Outcome measures
| Measure |
Placebo Intravenous (IV)
n=6 Participants
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 24 Milligram (mg) IV
n=6 Participants
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
|
MEDI6012 80 mg IV
n=6 Participants
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 240 mg IV
n=6 Participants
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
|
MEDI6012 800 mg IV
n=6 Participants
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
|
Placebo Subcutaneous (SC)
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 80 mg SC
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 600 mg SC
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) of MEDI6012
|
5.02 micrograms/milliliter (mcg/mL)
Standard Deviation 2.25
|
20.2 micrograms/milliliter (mcg/mL)
Standard Deviation 4.15
|
73.5 micrograms/milliliter (mcg/mL)
Standard Deviation 9.40
|
229 micrograms/milliliter (mcg/mL)
Standard Deviation 55.4
|
22.8 micrograms/milliliter (mcg/mL)
Standard Deviation 9.75
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)Population: PK population. PK data of MEDI6012 80 mg SC dose group was not interpretable as concentration levels were predominantly beneath the limit of quantitation (\<2.5 mcg/mL).
The time at which Cmax of MEDI6012 was observed determined directly from raw concentration time data.
Outcome measures
| Measure |
Placebo Intravenous (IV)
n=6 Participants
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 24 Milligram (mg) IV
n=6 Participants
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
|
MEDI6012 80 mg IV
n=6 Participants
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 240 mg IV
n=6 Participants
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
|
MEDI6012 800 mg IV
n=6 Participants
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
|
Placebo Subcutaneous (SC)
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 80 mg SC
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 600 mg SC
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Reach Concentration Maximum (Tmax) of MEDI6012
|
1.00 hrs
Full Range 2.25 • Interval 1.0 to 1.0
|
1.00 hrs
Full Range 4.15 • Interval 1.0 to 1.5
|
1.00 hrs
Full Range 9.40 • Interval 1.0 to 2.0
|
1.00 hrs
Full Range 55.4 • Interval 1.0 to 1.5
|
48.0 hrs
Full Range 9.75 • Interval 48.0 to 72.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)Population: PK population. PK data of MEDI6012 80 mg SC dose group was not interpretable as concentration levels were predominantly beneath the limit of quantitation (\<2.5 mcg/mL).
The area under the concentration-time curve from 0 to 168 hrs of MEDI6012.
Outcome measures
| Measure |
Placebo Intravenous (IV)
n=6 Participants
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 24 Milligram (mg) IV
n=6 Participants
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
|
MEDI6012 80 mg IV
n=6 Participants
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 240 mg IV
n=6 Participants
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
|
MEDI6012 800 mg IV
n=6 Participants
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
|
Placebo Subcutaneous (SC)
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 80 mg SC
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 600 mg SC
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration Time Curve From 0 to 168 Hrs (AUC [0-168]) of MEDI6012
|
137 mcg*hr/mL
Standard Deviation 55.0
|
805 mcg*hr/mL
Standard Deviation 265
|
2760 mcg*hr/mL
Standard Deviation 249
|
8470 mcg*hr/mL
Standard Deviation 2000
|
2460 mcg*hr/mL
Standard Deviation 824
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)Population: PK population. PK data of MEDI6012 80 mg SC dose group was not interpretable as concentration levels were predominantly beneath the limit of quantitation (\<2.5 mcg/mL).
Area under the plasma concentration time-curve from zero to the last measured concentration (AUC \[0-last\]) of MEDI6012.
Outcome measures
| Measure |
Placebo Intravenous (IV)
n=6 Participants
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 24 Milligram (mg) IV
n=6 Participants
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
|
MEDI6012 80 mg IV
n=6 Participants
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 240 mg IV
n=6 Participants
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
|
MEDI6012 800 mg IV
n=6 Participants
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
|
Placebo Subcutaneous (SC)
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 80 mg SC
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 600 mg SC
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration Time Curve From Time Zero to Last Quantifiable Concentration (AUC [0-last]) of MEDI6012
|
46.8 mcg*hr/mL
Standard Deviation 42.7 • Interval 1.0 to 1.0
|
683 mcg*hr/mL
Standard Deviation 267 • Interval 1.0 to 1.5
|
2760 mcg*hr/mL
Standard Deviation 249 • Interval 1.0 to 2.0
|
9020 mcg*hr/mL
Standard Deviation 2760 • Interval 1.0 to 1.5
|
2460 mcg*hr/mL
Standard Deviation 824 • Interval 48.0 to 72.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)Population: PK population. PK data of MEDI6012 80 mg SC dose group was not interpretable as concentration levels were predominantly beneath the limit of quantitation (\<2.5 mcg/mL).
The area under the concentration-time curve to infinite time of MEDI6012.
Outcome measures
| Measure |
Placebo Intravenous (IV)
n=6 Participants
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 24 Milligram (mg) IV
n=6 Participants
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
|
MEDI6012 80 mg IV
n=6 Participants
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 240 mg IV
n=6 Participants
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
|
MEDI6012 800 mg IV
n=6 Participants
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
|
Placebo Subcutaneous (SC)
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 80 mg SC
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 600 mg SC
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration Time Curve to Infinite Time (AUC [0-inf]) of MEDI6012
|
137 mcg*hr/mL
Standard Deviation 56.1
|
887 mcg*hr/mL
Standard Deviation 308
|
3030 mcg*hr/mL
Standard Deviation 298
|
9510 mcg*hr/mL
Standard Deviation 2720
|
3560 mcg*hr/mL
Standard Deviation 732
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)Population: PK population. PK data of MEDI6012 80 mg SC dose group was not interpretable as concentration levels were predominantly beneath the limit of quantitation (\<2.5 mcg/mL).
The t1/2 is the time measured for the plasma concentration to decrease by one half.
Outcome measures
| Measure |
Placebo Intravenous (IV)
n=6 Participants
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 24 Milligram (mg) IV
n=6 Participants
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
|
MEDI6012 80 mg IV
n=6 Participants
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 240 mg IV
n=6 Participants
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
|
MEDI6012 800 mg IV
n=6 Participants
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
|
Placebo Subcutaneous (SC)
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 80 mg SC
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 600 mg SC
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Elimination Half Life (t1/2) of MEDI6012
|
17.6 hrs
Standard Deviation 5.47
|
46.9 hrs
Standard Deviation 17.6
|
45.7 hrs
Standard Deviation 3.67
|
55.4 hrs
Standard Deviation 14.2
|
89.5 hrs
Standard Deviation 46.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose), 15, 29 and 57Population: Immunogenicity population: All participants in the as-treated population with at least one serum sample available for immunogenicity testing.
Participants were tested for immunogenicity to MEDI6012. The neutralization assay measures the capacity of participant's plasma (antibodies) to inhibit the binding of MEDI6012 to its target.
Outcome measures
| Measure |
Placebo Intravenous (IV)
n=8 Participants
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 24 Milligram (mg) IV
n=6 Participants
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
|
MEDI6012 80 mg IV
n=6 Participants
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 240 mg IV
n=6 Participants
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
|
MEDI6012 800 mg IV
n=6 Participants
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
|
Placebo Subcutaneous (SC)
n=4 Participants
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 80 mg SC
n=6 Participants
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 600 mg SC
n=6 Participants
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive Anti-Drug Antibodies for MEDI6012
Day 1 (predose)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive Anti-Drug Antibodies for MEDI6012
Day 15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Positive Anti-Drug Antibodies for MEDI6012
Day 29
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Positive Anti-Drug Antibodies for MEDI6012
Day 57
|
—
|
0 Participants
|
—
|
—
|
2 Participants
|
—
|
1 Participants
|
—
|
Adverse Events
Placebo Intravenous (IV)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
MEDI6012 24 Milligram (mg) IV
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
MEDI6012 80 mg IV
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
MEDI6012 240 mg IV
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
MEDI6012 800 mg IV
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo Subcutaneous (SC)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
MEDI6012 80 mg SC
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
MEDI6012 600 mg SC
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Intravenous (IV)
n=8 participants at risk
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 24 Milligram (mg) IV
n=6 participants at risk
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
|
MEDI6012 80 mg IV
n=6 participants at risk
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 240 mg IV
n=6 participants at risk
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
|
MEDI6012 800 mg IV
n=6 participants at risk
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
|
Placebo Subcutaneous (SC)
n=4 participants at risk
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
|
MEDI6012 80 mg SC
n=6 participants at risk
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
|
MEDI6012 600 mg SC
n=6 participants at risk
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/8 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/4 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/8 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/4 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/8 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/4 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
Eye disorders
Diplopia
|
0.00%
0/8 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/4 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/8 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/4 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/4 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/4 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/4 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
50.0%
2/4 • Number of events 3 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/4 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
General disorders
Fatigue
|
0.00%
0/8 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/4 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
General disorders
Infusion site bruising
|
0.00%
0/8 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/4 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
General disorders
Infusion site reaction
|
0.00%
0/8 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/4 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
General disorders
Injection site bruising
|
0.00%
0/8 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/4 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
General disorders
Injection site erythema
|
0.00%
0/8 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/4 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
33.3%
2/6 • Number of events 2 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/8 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/4 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
General disorders
Injection site pain
|
0.00%
0/8 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/4 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
General disorders
Injection site reaction
|
0.00%
0/8 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/4 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
33.3%
2/6 • Number of events 2 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
General disorders
Medical device site irritation
|
0.00%
0/8 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/4 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/8 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/4 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
Investigations
High density lipoprotein decreased
|
0.00%
0/8 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/4 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
Investigations
Respiratory rate increased
|
0.00%
0/8 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/4 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/8 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/4 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/4 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/4 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/8 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/4 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
16.7%
1/6 • Number of events 3 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/4 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
33.3%
2/6 • Number of events 2 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
Nervous system disorders
Lethargy
|
0.00%
0/8 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/4 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
Nervous system disorders
Migraine
|
0.00%
0/8 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/8 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/4 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
Nervous system disorders
Slow speech
|
0.00%
0/8 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/4 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
Nervous system disorders
Somnolence
|
0.00%
0/8 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/4 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/8 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/4 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
Renal and urinary disorders
Microalbuminuria
|
0.00%
0/8 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/4 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/8 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/4 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/8 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/4 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/8 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/4 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/8 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/4 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/4 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/4 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
Vascular disorders
Hypertension
|
0.00%
0/8 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/4 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
|
Vascular disorders
Hypotension
|
0.00%
0/8 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/4 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
0.00%
0/6 • Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
|
Additional Information
Richard George, MD, Director, Clinical Development
MedImmune, LLC
Phone: +1-301-398-5681
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER