Trial Outcomes & Findings for A Study to Evaluate the Safety of MEDI2338 in Subjects With Chronic Obstructive Pulmonary Disease (NCT NCT01322594)
NCT ID: NCT01322594
Last Updated: 2013-10-23
Results Overview
Number of participants experiencing adverse events (includes both adverse events and serious adverse events)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
31 participants
Primary outcome timeframe
Days 1 - 92
Results posted on
2013-10-23
Participant Flow
A total of 31 participants provided written informed consent and participated in the study at 3 sites in South Africa (2 sites) and the United Kingdom (1 site) between 24Feb2011 and 25Nov2011.
Eligibile participants in the 10 and 30 mg dose groups received MEDI2338 in an open-label manner. Eligible participants in the 100, 300, and 1000 dose groups were randomized in a 3:1 ratio to receive MEDI2338 or placebo.
Participant milestones
| Measure |
Placebo
Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 10 MG
MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 30 MG
MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 100 MG
MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 300 MG
MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 1000 MG
MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
3
|
6
|
7
|
6
|
|
Overall Study
COMPLETED
|
6
|
3
|
3
|
6
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Safety of MEDI2338 in Subjects With Chronic Obstructive Pulmonary Disease
Baseline characteristics by cohort
| Measure |
Placebo
n=6 Participants
Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 10 MG
n=3 Participants
MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 30 MG
n=3 Participants
MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 100 MG
n=6 Participants
MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 300 MG
n=7 Participants
MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 1000 MG
n=6 Participants
MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age Continuous
|
61.3 Years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
57.0 Years
STANDARD_DEVIATION 4.0 • n=7 Participants
|
59.7 Years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
60.3 Years
STANDARD_DEVIATION 7.1 • n=4 Participants
|
55.1 Years
STANDARD_DEVIATION 5.3 • n=21 Participants
|
60.8 Years
STANDARD_DEVIATION 6.0 • n=10 Participants
|
59.1 Years
STANDARD_DEVIATION 6.8 • n=115 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Days 1 - 92Population: All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis
Number of participants experiencing adverse events (includes both adverse events and serious adverse events)
Outcome measures
| Measure |
MEDI2338 10 MG
n=3 Participants
MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 30 MG
n=3 Participants
MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 100 MG
n=6 Participants
MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 300 MG
n=7 Participants
MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 1000 MG
n=6 Participants
MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
Placebo
n=6 Participants
Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
|---|---|---|---|---|---|---|
|
Incidence of Adverse Events
|
3 Participants
|
3 Participants
|
6 Participants
|
7 Participants
|
5 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Days 1 - 92Population: All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis
Number of participants experiencing serious adverse events
Outcome measures
| Measure |
MEDI2338 10 MG
n=3 Participants
MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 30 MG
n=3 Participants
MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 100 MG
n=6 Participants
MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 300 MG
n=7 Participants
MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 1000 MG
n=6 Participants
MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
Placebo
n=6 Participants
Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
|---|---|---|---|---|---|---|
|
Incidence of Serious Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Days 1 - 92Population: All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis
Number of participants experiencing clinically significant hematology laboratory results. A clinically significant hematology laboratory result is defined as an abnormal hematology laboratory result that results in a treatment-emergent adverse event.
Outcome measures
| Measure |
MEDI2338 10 MG
n=3 Participants
MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 30 MG
n=3 Participants
MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 100 MG
n=6 Participants
MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 300 MG
n=7 Participants
MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 1000 MG
n=6 Participants
MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
Placebo
n=6 Participants
Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
|---|---|---|---|---|---|---|
|
Incidence of Clinically Significant Hematology Laboratory Results
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Days 1 - 92Population: All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis
Number of participants experiencing clinically significant electrocardiogram results. A clinically significant electrocardiogram result is defined as an abnormal electrocardiogram result that results in a treatment-emergent adverse event.
Outcome measures
| Measure |
MEDI2338 10 MG
n=3 Participants
MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 30 MG
n=3 Participants
MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 100 MG
n=6 Participants
MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 300 MG
n=7 Participants
MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 1000 MG
n=6 Participants
MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
Placebo
n=6 Participants
Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
|---|---|---|---|---|---|---|
|
Incidence of Clinically Significant Electrocardiogram Results
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Days 1 - 92Population: All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis
Number of participants experiencing clinically significant vital signs results. A clinically significant vital signs result is defined as an abnormal vital signs result that results in a treatment-emergent adverse event.
Outcome measures
| Measure |
MEDI2338 10 MG
n=3 Participants
MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 30 MG
n=3 Participants
MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 100 MG
n=6 Participants
MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 300 MG
n=7 Participants
MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 1000 MG
n=6 Participants
MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
Placebo
n=6 Participants
Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
|---|---|---|---|---|---|---|
|
Incidence of Clinically Significant Vital Signs Results
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Days 1 - 92Population: All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis
Number of participants experiencing clinically significant serum chemistry laboratory results. A clinically significant serum chemistry laboratory result is defined as an abnormal serum chemistry laboratory result that results in a treatment-emergent adverse event.
Outcome measures
| Measure |
MEDI2338 10 MG
n=3 Participants
MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 30 MG
n=3 Participants
MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 100 MG
n=6 Participants
MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 300 MG
n=7 Participants
MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 1000 MG
n=6 Participants
MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
Placebo
n=6 Participants
Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
|---|---|---|---|---|---|---|
|
Incidence of Clinically Significant Serum Chemistry Laboratory Results
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)Population: Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the pharmacokinetic analysis
Area under the serum concentration-time curve from time zerio to infinity of MEDI2338
Outcome measures
| Measure |
MEDI2338 10 MG
n=3 Participants
MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 30 MG
n=3 Participants
MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 100 MG
n=6 Participants
MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 300 MG
n=7 Participants
MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 1000 MG
n=6 Participants
MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
Placebo
Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Infinity
|
27550.5 ng x day/mL
Standard Deviation 8163.6
|
104751.1 ng x day/mL
Standard Deviation 40826.2
|
281781.5 ng x day/mL
Standard Deviation 61554.1
|
915668.6 ng x day/mL
Standard Deviation 342545.7
|
3081728.5 ng x day/mL
Standard Deviation 846989.4
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)Population: Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the pharmacokinetic analysis
Area under the serum concentration-time profile from time zero to the last measurable time point of MEDI2338
Outcome measures
| Measure |
MEDI2338 10 MG
n=3 Participants
MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 30 MG
n=3 Participants
MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 100 MG
n=6 Participants
MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 300 MG
n=7 Participants
MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 1000 MG
n=6 Participants
MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
Placebo
Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration-Time Profile From Time Zero to the Last Measurable Time Point
|
24427.8 ng x day/mL
Standard Deviation 8086.4
|
87549.7 ng x day/mL
Standard Deviation 31391.2
|
250155.6 ng x day/mL
Standard Deviation 40613.8
|
846433.3 ng x day/mL
Standard Deviation 303849.8
|
2909818.8 ng x day/mL
Standard Deviation 812729.7
|
—
|
SECONDARY outcome
Timeframe: Days 1, 57, and 92Population: Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the analysis of ADA
Number of participants with ADA to MEDI2338
Outcome measures
| Measure |
MEDI2338 10 MG
n=3 Participants
MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 30 MG
n=3 Participants
MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 100 MG
n=6 Participants
MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 300 MG
n=7 Participants
MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 1000 MG
n=6 Participants
MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
Placebo
Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
|---|---|---|---|---|---|---|
|
Incidence of Anti-drug Antibodies (ADA) to MEDI2338
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)Population: Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the pharmacokinetic analysis
Cmax of MEDI2338
Outcome measures
| Measure |
MEDI2338 10 MG
n=3 Participants
MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 30 MG
n=3 Participants
MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 100 MG
n=6 Participants
MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 300 MG
n=7 Participants
MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 1000 MG
n=6 Participants
MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
Placebo
Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
|---|---|---|---|---|---|---|
|
Observed Maximum Concentration (Cmax)
|
2458.0 ng/mL
Standard Deviation 589.1
|
9722.2 ng/mL
Standard Deviation 4376.8
|
27122.6 ng/mL
Standard Deviation 2845.9
|
106042.5 ng/mL
Standard Deviation 23883.9
|
337004.5 ng/mL
Standard Deviation 51793.8
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)Population: Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the pharmacokinetic analysis
t1/2 of MEDI2338
Outcome measures
| Measure |
MEDI2338 10 MG
n=3 Participants
MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 30 MG
n=3 Participants
MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 100 MG
n=6 Participants
MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 300 MG
n=7 Participants
MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 1000 MG
n=6 Participants
MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
Placebo
Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
|---|---|---|---|---|---|---|
|
Apparent Terminal Elimination Phase Half-life (t1/2)
|
34.85 Days
Standard Deviation 5.30
|
40.85 Days
Standard Deviation 3.51
|
28.46 Days
Standard Deviation 3.37
|
26.76 Days
Standard Deviation 5.54
|
24.87 Days
Standard Deviation 3.27
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)Population: Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the pharmacokinetic analysis
CL of MEDI2338
Outcome measures
| Measure |
MEDI2338 10 MG
n=3 Participants
MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 30 MG
n=3 Participants
MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 100 MG
n=6 Participants
MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 300 MG
n=7 Participants
MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
MEDI2338 1000 MG
n=6 Participants
MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
Placebo
Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
|
|---|---|---|---|---|---|---|
|
Clearance (CL)
|
0.387 L/Days
Standard Deviation 0.125
|
0.312 L/Days
Standard Deviation 0.099
|
0.365 L/Days
Standard Deviation 0.071
|
0.360 L/Days
Standard Deviation 0.110
|
0.346 L/Days
Standard Deviation 0.097
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
MEDI2338 10 MG
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
MEDI2338 30 MG
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
MEDI2338 100 MG
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
MEDI2338 300 MG
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
MEDI2338 1000 MG
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=6 participants at risk
|
MEDI2338 10 MG
n=3 participants at risk
|
MEDI2338 30 MG
n=3 participants at risk
|
MEDI2338 100 MG
n=6 participants at risk
|
MEDI2338 300 MG
n=7 participants at risk
|
MEDI2338 1000 MG
n=6 participants at risk
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Bradycardia
|
0.00%
0/6 • Days 1-92
|
0.00%
0/3 • Days 1-92
|
0.00%
0/3 • Days 1-92
|
33.3%
2/6 • Number of events 2 • Days 1-92
|
0.00%
0/7 • Days 1-92
|
16.7%
1/6 • Number of events 1 • Days 1-92
|
|
Cardiac disorders
Ventricular extrasystoles
|
16.7%
1/6 • Number of events 1 • Days 1-92
|
0.00%
0/3 • Days 1-92
|
0.00%
0/3 • Days 1-92
|
0.00%
0/6 • Days 1-92
|
14.3%
1/7 • Number of events 1 • Days 1-92
|
0.00%
0/6 • Days 1-92
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • Days 1-92
|
33.3%
1/3 • Number of events 1 • Days 1-92
|
0.00%
0/3 • Days 1-92
|
16.7%
1/6 • Number of events 1 • Days 1-92
|
0.00%
0/7 • Days 1-92
|
0.00%
0/6 • Days 1-92
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Days 1-92
|
0.00%
0/3 • Days 1-92
|
33.3%
1/3 • Number of events 1 • Days 1-92
|
0.00%
0/6 • Days 1-92
|
0.00%
0/7 • Days 1-92
|
16.7%
1/6 • Number of events 1 • Days 1-92
|
|
Infections and infestations
Sinusitis
|
33.3%
2/6 • Number of events 2 • Days 1-92
|
0.00%
0/3 • Days 1-92
|
0.00%
0/3 • Days 1-92
|
0.00%
0/6 • Days 1-92
|
0.00%
0/7 • Days 1-92
|
0.00%
0/6 • Days 1-92
|
|
Injury, poisoning and procedural complications
Contusion
|
16.7%
1/6 • Number of events 1 • Days 1-92
|
0.00%
0/3 • Days 1-92
|
33.3%
1/3 • Number of events 1 • Days 1-92
|
0.00%
0/6 • Days 1-92
|
0.00%
0/7 • Days 1-92
|
0.00%
0/6 • Days 1-92
|
|
Injury, poisoning and procedural complications
Laceration
|
33.3%
2/6 • Number of events 2 • Days 1-92
|
0.00%
0/3 • Days 1-92
|
0.00%
0/3 • Days 1-92
|
0.00%
0/6 • Days 1-92
|
14.3%
1/7 • Number of events 1 • Days 1-92
|
0.00%
0/6 • Days 1-92
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • Days 1-92
|
0.00%
0/3 • Days 1-92
|
33.3%
1/3 • Number of events 1 • Days 1-92
|
0.00%
0/6 • Days 1-92
|
14.3%
1/7 • Number of events 1 • Days 1-92
|
0.00%
0/6 • Days 1-92
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Days 1-92
|
0.00%
0/3 • Days 1-92
|
33.3%
1/3 • Number of events 1 • Days 1-92
|
33.3%
2/6 • Number of events 2 • Days 1-92
|
14.3%
1/7 • Number of events 1 • Days 1-92
|
16.7%
1/6 • Number of events 1 • Days 1-92
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1 • Days 1-92
|
33.3%
1/3 • Number of events 2 • Days 1-92
|
0.00%
0/3 • Days 1-92
|
33.3%
2/6 • Number of events 2 • Days 1-92
|
14.3%
1/7 • Number of events 1 • Days 1-92
|
33.3%
2/6 • Number of events 4 • Days 1-92
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/6 • Days 1-92
|
0.00%
0/3 • Days 1-92
|
66.7%
2/3 • Number of events 2 • Days 1-92
|
16.7%
1/6 • Number of events 1 • Days 1-92
|
14.3%
1/7 • Number of events 1 • Days 1-92
|
16.7%
1/6 • Number of events 1 • Days 1-92
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Days 1-92
|
66.7%
2/3 • Number of events 2 • Days 1-92
|
33.3%
1/3 • Number of events 1 • Days 1-92
|
0.00%
0/6 • Days 1-92
|
14.3%
1/7 • Number of events 1 • Days 1-92
|
0.00%
0/6 • Days 1-92
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Days 1-92
|
33.3%
1/3 • Number of events 1 • Days 1-92
|
0.00%
0/3 • Days 1-92
|
0.00%
0/6 • Days 1-92
|
14.3%
1/7 • Number of events 1 • Days 1-92
|
0.00%
0/6 • Days 1-92
|
Additional Information
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. The PIs also agree for data to be presented first as a joint, multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER