Trial Outcomes & Findings for Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single-Dose Subcutaneous Administration of MEDI-528 (NCT NCT00116168)
NCT ID: NCT00116168
Last Updated: 2013-12-11
Results Overview
Number of participants experiencing adverse events (includes both adverse events and serious adverse events)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
29 participants
Primary outcome timeframe
Days 0 - 84
Results posted on
2013-12-11
Participant Flow
A total of 29 participants provided written informed consent and participated in the study at 2 sites in the United States of America between 10Jun2005 and 18Apr2006.
Eligible participants received MEDI-528 in an open-label manner.
Participant milestones
| Measure |
MEDI-528 0.3 mg
|
MEDI-528 1 mg
|
MEDI-528 3 mg
|
MEDI-528 9 mg
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
11
|
6
|
6
|
|
Overall Study
COMPLETED
|
0
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
0
|
0
|
Reasons for withdrawal
| Measure |
MEDI-528 0.3 mg
|
MEDI-528 1 mg
|
MEDI-528 3 mg
|
MEDI-528 9 mg
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
5
|
0
|
0
|
Baseline Characteristics
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single-Dose Subcutaneous Administration of MEDI-528
Baseline characteristics by cohort
| Measure |
MEDI-528 0.3 mg
n=6 Participants
|
MEDI-528 1 mg
n=11 Participants
|
MEDI-528 3 mg
n=6 Participants
|
MEDI-528 9 mg
n=6 Participants
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
27.2 Years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
25.2 Years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
34.7 Years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
33.2 Years
STANDARD_DEVIATION 13.9 • n=4 Participants
|
29.2 Years
STANDARD_DEVIATION 10.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Days 0 - 84Population: All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina)
Number of participants experiencing adverse events (includes both adverse events and serious adverse events)
Outcome measures
| Measure |
MEDI-528 0.3 mg/kg
n=6 Participants
MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
|
MEDI-528 1 mg/kg
n=6 Participants
MEDI-528 (1 mg/kg) administered as a single, SC dose
|
MEDI-528 3 mg/kg
n=6 Participants
MEDI-528 (3 mg/kg) administered as a single, SC dose
|
MEDI-528 9 mg/kg
n=6 Participants
MEDI-528 (9 mg/kg) administered as a single, SC dose
|
|---|---|---|---|---|
|
Incidence of Adverse Events
|
5 Participants
|
4 Participants
|
6 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Days 0, 1, 7, 14, and 28Population: All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina)
Number of participants with troponin levels greater than upper limit of normal
Outcome measures
| Measure |
MEDI-528 0.3 mg/kg
n=6 Participants
MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
|
MEDI-528 1 mg/kg
n=6 Participants
MEDI-528 (1 mg/kg) administered as a single, SC dose
|
MEDI-528 3 mg/kg
n=6 Participants
MEDI-528 (3 mg/kg) administered as a single, SC dose
|
MEDI-528 9 mg/kg
n=6 Participants
MEDI-528 (9 mg/kg) administered as a single, SC dose
|
|---|---|---|---|---|
|
Incidence of Abnormal Troponin Levels
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Days 0, 7, 14, 21, 28, 42, and 84Population: All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina)
Number of participants with clinically significant changes from baseline in neurologic exam
Outcome measures
| Measure |
MEDI-528 0.3 mg/kg
n=6 Participants
MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
|
MEDI-528 1 mg/kg
n=6 Participants
MEDI-528 (1 mg/kg) administered as a single, SC dose
|
MEDI-528 3 mg/kg
n=6 Participants
MEDI-528 (3 mg/kg) administered as a single, SC dose
|
MEDI-528 9 mg/kg
n=6 Participants
MEDI-528 (9 mg/kg) administered as a single, SC dose
|
|---|---|---|---|---|
|
Incidence of Clinically Significant Changes From Baseline in Neurologic Exam
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Days 0 and 28Population: All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina)
Number of participants with changes from baseline in the Day 28 MRI of the brain
Outcome measures
| Measure |
MEDI-528 0.3 mg/kg
n=6 Participants
MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
|
MEDI-528 1 mg/kg
n=6 Participants
MEDI-528 (1 mg/kg) administered as a single, SC dose
|
MEDI-528 3 mg/kg
n=6 Participants
MEDI-528 (3 mg/kg) administered as a single, SC dose
|
MEDI-528 9 mg/kg
n=6 Participants
MEDI-528 (9 mg/kg) administered as a single, SC dose
|
|---|---|---|---|---|
|
Incidence of Changes From Baseline in the Day 28 Magnetic Resonance Imaging (MRI) of the Brain
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Days 0 - 84Population: All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina)
Number of participants experiencing serious adverse events
Outcome measures
| Measure |
MEDI-528 0.3 mg/kg
n=6 Participants
MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
|
MEDI-528 1 mg/kg
n=6 Participants
MEDI-528 (1 mg/kg) administered as a single, SC dose
|
MEDI-528 3 mg/kg
n=6 Participants
MEDI-528 (3 mg/kg) administered as a single, SC dose
|
MEDI-528 9 mg/kg
n=6 Participants
MEDI-528 (9 mg/kg) administered as a single, SC dose
|
|---|---|---|---|---|
|
Incidence of Serious Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 0, 14, 28, 42, and 84Population: All subjects who received MEDI-528 (no safety or ADA information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Partial ADA information was available in the 0.3 mg/kg group (Day 0 and 14, n=5; Day 28, n=2; Day 42 and 84, n = 0)
Number of participants with ADA to MEDI-528
Outcome measures
| Measure |
MEDI-528 0.3 mg/kg
n=5 Participants
MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
|
MEDI-528 1 mg/kg
n=6 Participants
MEDI-528 (1 mg/kg) administered as a single, SC dose
|
MEDI-528 3 mg/kg
n=6 Participants
MEDI-528 (3 mg/kg) administered as a single, SC dose
|
MEDI-528 9 mg/kg
n=6 Participants
MEDI-528 (9 mg/kg) administered as a single, SC dose
|
|---|---|---|---|---|
|
Incidence of Anti-drug Antibodies (ADA) to MEDI-528
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84Population: All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.
Tmax of MEDI-528
Outcome measures
| Measure |
MEDI-528 0.3 mg/kg
n=4 Participants
MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
|
MEDI-528 1 mg/kg
n=6 Participants
MEDI-528 (1 mg/kg) administered as a single, SC dose
|
MEDI-528 3 mg/kg
n=6 Participants
MEDI-528 (3 mg/kg) administered as a single, SC dose
|
MEDI-528 9 mg/kg
n=6 Participants
MEDI-528 (9 mg/kg) administered as a single, SC dose
|
|---|---|---|---|---|
|
Time to Observed Maximum Serum Concentration (Tmax)
|
5.51 Days
Standard Deviation 1.90
|
4.17 Days
Standard Deviation 1.60
|
4.50 Days
Standard Deviation 1.52
|
5.00 Days
Standard Deviation 1.90
|
SECONDARY outcome
Timeframe: Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84Population: All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.
Cmax of MEDI-528
Outcome measures
| Measure |
MEDI-528 0.3 mg/kg
n=4 Participants
MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
|
MEDI-528 1 mg/kg
n=6 Participants
MEDI-528 (1 mg/kg) administered as a single, SC dose
|
MEDI-528 3 mg/kg
n=6 Participants
MEDI-528 (3 mg/kg) administered as a single, SC dose
|
MEDI-528 9 mg/kg
n=6 Participants
MEDI-528 (9 mg/kg) administered as a single, SC dose
|
|---|---|---|---|---|
|
Observed Maximum Serum Concentration (Cmax)
|
2.83 Micrograms per milliliter
Standard Deviation 0.73
|
14.48 Micrograms per milliliter
Standard Deviation 6.68
|
23.00 Micrograms per milliliter
Standard Deviation 5.62
|
82.50 Micrograms per milliliter
Standard Deviation 19.64
|
SECONDARY outcome
Timeframe: Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84Population: All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.
AUC(0-t) of MEDI-528
Outcome measures
| Measure |
MEDI-528 0.3 mg/kg
n=4 Participants
MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
|
MEDI-528 1 mg/kg
n=6 Participants
MEDI-528 (1 mg/kg) administered as a single, SC dose
|
MEDI-528 3 mg/kg
n=6 Participants
MEDI-528 (3 mg/kg) administered as a single, SC dose
|
MEDI-528 9 mg/kg
n=6 Participants
MEDI-528 (9 mg/kg) administered as a single, SC dose
|
|---|---|---|---|---|
|
Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]
|
18.47 Micrograms times day per milliliter
Standard Deviation 10.26
|
329.7 Micrograms times day per milliliter
Standard Deviation 113.72
|
923.27 Micrograms times day per milliliter
Standard Deviation 226.71
|
3053.34 Micrograms times day per milliliter
Standard Deviation 908.30
|
SECONDARY outcome
Timeframe: Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84Population: All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.
AUC(0-infinity) of MEDI-528
Outcome measures
| Measure |
MEDI-528 0.3 mg/kg
n=2 Participants
MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
|
MEDI-528 1 mg/kg
n=6 Participants
MEDI-528 (1 mg/kg) administered as a single, SC dose
|
MEDI-528 3 mg/kg
n=6 Participants
MEDI-528 (3 mg/kg) administered as a single, SC dose
|
MEDI-528 9 mg/kg
n=6 Participants
MEDI-528 (9 mg/kg) administered as a single, SC dose
|
|---|---|---|---|---|
|
Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)] of MEDI-528
|
40.78 Microgram times day per milliliter
Standard Deviation 0.34
|
667.68 Microgram times day per milliliter
Standard Deviation 201.99
|
1287.31 Microgram times day per milliliter
Standard Deviation 413.92
|
3770.06 Microgram times day per milliliter
Standard Deviation 1396.66
|
SECONDARY outcome
Timeframe: Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84Population: All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.
AUC(ext) of MEDI-528
Outcome measures
| Measure |
MEDI-528 0.3 mg/kg
n=2 Participants
MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
|
MEDI-528 1 mg/kg
n=6 Participants
MEDI-528 (1 mg/kg) administered as a single, SC dose
|
MEDI-528 3 mg/kg
n=6 Participants
MEDI-528 (3 mg/kg) administered as a single, SC dose
|
MEDI-528 9 mg/kg
n=6 Participants
MEDI-528 (9 mg/kg) administered as a single, SC dose
|
|---|---|---|---|---|
|
Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]
|
33.32 Percent
Standard Deviation 6.26
|
50.90 Percent
Standard Deviation 13.82
|
26.05 Percent
Standard Deviation 9.16
|
16.61 Percent
Standard Deviation 8.97
|
SECONDARY outcome
Timeframe: Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84Population: All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.
CL of MEDI-528
Outcome measures
| Measure |
MEDI-528 0.3 mg/kg
n=2 Participants
MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
|
MEDI-528 1 mg/kg
n=6 Participants
MEDI-528 (1 mg/kg) administered as a single, SC dose
|
MEDI-528 3 mg/kg
n=6 Participants
MEDI-528 (3 mg/kg) administered as a single, SC dose
|
MEDI-528 9 mg/kg
n=6 Participants
MEDI-528 (9 mg/kg) administered as a single, SC dose
|
|---|---|---|---|---|
|
Total Body Clearance (CL)
|
0.49 Liter per day
Standard Deviation 0.00
|
0.12 Liter per day
Standard Deviation 0.05
|
0.19 Liter per day
Standard Deviation 0.10
|
0.20 Liter per day
Standard Deviation 0.09
|
SECONDARY outcome
Timeframe: Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84Population: All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.
T1/2 of MEDI-528
Outcome measures
| Measure |
MEDI-528 0.3 mg/kg
n=2 Participants
MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
|
MEDI-528 1 mg/kg
n=6 Participants
MEDI-528 (1 mg/kg) administered as a single, SC dose
|
MEDI-528 3 mg/kg
n=6 Participants
MEDI-528 (3 mg/kg) administered as a single, SC dose
|
MEDI-528 9 mg/kg
n=6 Participants
MEDI-528 (9 mg/kg) administered as a single, SC dose
|
|---|---|---|---|---|
|
Half-life (T1/2)
|
6.47 Days
Standard Deviation 0.85
|
86.85 Days
Standard Deviation 19.86
|
44.43 Days
Standard Deviation 11.48
|
33.44 Days
Standard Deviation 11.32
|
SECONDARY outcome
Timeframe: Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84Population: All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.
Vz/F of MEDI-528
Outcome measures
| Measure |
MEDI-528 0.3 mg/kg
n=2 Participants
MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
|
MEDI-528 1 mg/kg
n=6 Participants
MEDI-528 (1 mg/kg) administered as a single, SC dose
|
MEDI-528 3 mg/kg
n=6 Participants
MEDI-528 (3 mg/kg) administered as a single, SC dose
|
MEDI-528 9 mg/kg
n=6 Participants
MEDI-528 (9 mg/kg) administered as a single, SC dose
|
|---|---|---|---|---|
|
Apparent Extravascular Terminal Phase Volume of Distribution (Vz/F)
|
4.58 Liters
Standard Deviation 0.64
|
14.57 Liters
Standard Deviation 8.61
|
10.91 Liters
Standard Deviation 1.21
|
8.65 Liters
Standard Deviation 1.40
|
Adverse Events
MEDI-528 0.3 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
MEDI-528 1 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
MEDI-528 3 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
MEDI-528 9 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MEDI-528 0.3 mg
n=6 participants at risk
|
MEDI-528 1 mg
n=6 participants at risk
|
MEDI-528 3 mg
n=6 participants at risk
|
MEDI-528 9 mg
n=6 participants at risk
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
16.7%
1/6 • Number of events 1 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
33.3%
2/6 • Number of events 3 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
16.7%
1/6 • Number of events 1 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
16.7%
1/6 • Number of events 2 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
|
General disorders
Injection site bruising
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
33.3%
2/6 • Number of events 2 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
|
General disorders
Injection site pain
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
16.7%
1/6 • Number of events 1 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
33.3%
2/6 • Number of events 2 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
|
General disorders
Pain
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
16.7%
1/6 • Number of events 1 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
16.7%
1/6 • Number of events 1 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
|
Infections and infestations
Ear infection
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
16.7%
1/6 • Number of events 1 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
1/6 • Number of events 1 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
16.7%
1/6 • Number of events 1 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
16.7%
1/6 • Number of events 1 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
|
Investigations
Blood bicarbonate decreased
|
33.3%
2/6 • Number of events 2 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
16.7%
1/6 • Number of events 1 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
|
Investigations
Blood chloride increased
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
16.7%
1/6 • Number of events 1 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
16.7%
1/6 • Number of events 1 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
33.3%
2/6 • Number of events 2 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
|
Investigations
Blood glucose increased
|
16.7%
1/6 • Number of events 1 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
33.3%
2/6 • Number of events 2 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
16.7%
1/6 • Number of events 1 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
|
Investigations
Blood urea increased
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
16.7%
1/6 • Number of events 1 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
|
Investigations
Lymph node palpable
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
16.7%
1/6 • Number of events 2 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
16.7%
1/6 • Number of events 2 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
33.3%
2/6 • Number of events 4 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
|
Investigations
Protein urine present
|
50.0%
3/6 • Number of events 3 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
16.7%
1/6 • Number of events 1 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
|
Investigations
Red blood cells urine positive
|
16.7%
1/6 • Number of events 1 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
33.3%
2/6 • Number of events 2 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
|
Investigations
White blood cell count decreased
|
16.7%
1/6 • Number of events 1 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
|
Investigations
White blood cell count increased
|
16.7%
1/6 • Number of events 1 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
16.7%
1/6 • Number of events 1 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
16.7%
1/6 • Number of events 1 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
16.7%
1/6 • Number of events 1 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
33.3%
2/6 • Number of events 2 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
16.7%
1/6 • Number of events 1 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
33.3%
2/6 • Number of events 2 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
16.7%
1/6 • Number of events 1 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
16.7%
1/6 • Number of events 1 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
16.7%
1/6 • Number of events 1 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
16.7%
1/6 • Number of events 1 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
16.7%
1/6 • Number of events 1 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
|
Reproductive system and breast disorders
Haematospermia
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
16.7%
1/6 • Number of events 1 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
50.0%
3/6 • Number of events 3 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
33.3%
2/6 • Number of events 2 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
16.7%
1/6 • Number of events 1 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
16.7%
1/6 • Number of events 1 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
33.3%
2/6 • Number of events 2 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
66.7%
4/6 • Number of events 9 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
16.7%
1/6 • Number of events 1 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
16.7%
1/6 • Number of events 1 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
33.3%
2/6 • Number of events 2 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
16.7%
1/6 • Number of events 1 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
0.00%
0/6 • Days 0-84
No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
|
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.
- Publication restrictions are in place
Restriction type: OTHER