Trial Outcomes & Findings for Study to Evaluate the Safety, Tolerability,Immunogenicity, and Pharmacokinetics of MEDI-528 in Healthy Adult Volunteers (NCT NCT00192296)
NCT ID: NCT00192296
Last Updated: 2014-03-06
Results Overview
Number of participants experiencing adverse events (includes both adverse events and serious adverse events)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Days 0 - 84
Results posted on
2014-03-06
Participant Flow
A total of 24 participants provided written informed consent and participated in the study between 13Aug2004 and 12Nov2004 at one site in New Orleans, Louisiana.
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
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
5
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
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
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Study to Evaluate the Safety, Tolerability,Immunogenicity, and Pharmacokinetics of MEDI-528 in Healthy Adult Volunteers
Baseline characteristics by cohort
| Measure |
MEDI-528 0.3 mg
n=6 Participants
|
MEDI-528 1 mg
n=6 Participants
|
MEDI-528 3 mg
n=6 Participants
|
MEDI-528 9 mg
n=6 Participants
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
25.8 Years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
29.8 Years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
25.5 Years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
30.5 Years
STANDARD_DEVIATION 8.2 • n=4 Participants
|
27.9 Years
STANDARD_DEVIATION 8.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Days 0 - 84Population: All subjects who received MEDI-528
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, intravenous (IV) dose
|
MEDI-528 1 mg/kg
n=6 Participants
MEDI-528 (1 mg/kg) administered as a single, IV dose
|
MEDI-528 3 mg/kg
n=6 Participants
MEDI-528 (3 mg/kg) administered as a single, IV dose
|
MEDI-528 9 mg/kg
n=6 Participants
MEDI-528 (9 mg/kg) administered as a single, IV dose
|
|---|---|---|---|---|
|
Incidence of Adverse Events
|
5 Participants
|
4 Participants
|
6 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Days 0, 7, 14, 21, and 28Population: All subjects who received MEDI-528
Number of participants with troponin levels greater than upper limit of normal (\> 0.05 ng/mL)
Outcome measures
| Measure |
MEDI-528 0.3 mg/kg
n=6 Participants
MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
|
MEDI-528 1 mg/kg
n=6 Participants
MEDI-528 (1 mg/kg) administered as a single, IV dose
|
MEDI-528 3 mg/kg
n=6 Participants
MEDI-528 (3 mg/kg) administered as a single, IV dose
|
MEDI-528 9 mg/kg
n=6 Participants
MEDI-528 (9 mg/kg) administered as a single, IV dose
|
|---|---|---|---|---|
|
Incidence of Abnormal Troponin Levels
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Days 0 - 84Population: All subjects who received MEDI-528
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, intravenous (IV) dose
|
MEDI-528 1 mg/kg
n=6 Participants
MEDI-528 (1 mg/kg) administered as a single, IV dose
|
MEDI-528 3 mg/kg
n=6 Participants
MEDI-528 (3 mg/kg) administered as a single, IV dose
|
MEDI-528 9 mg/kg
n=6 Participants
MEDI-528 (9 mg/kg) administered as a single, IV dose
|
|---|---|---|---|---|
|
Incidence of Serious Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 14, 28, 42, and 84Population: All subjects who received MEDI-528
Number of participants who had ADA detected at each time point
Outcome measures
| Measure |
MEDI-528 0.3 mg/kg
n=6 Participants
MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
|
MEDI-528 1 mg/kg
n=6 Participants
MEDI-528 (1 mg/kg) administered as a single, IV dose
|
MEDI-528 3 mg/kg
n=6 Participants
MEDI-528 (3 mg/kg) administered as a single, IV dose
|
MEDI-528 9 mg/kg
n=6 Participants
MEDI-528 (9 mg/kg) administered as a single, IV dose
|
|---|---|---|---|---|
|
Incidence of Anti-drug Antibodies (ADA) to MEDI-528
Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Anti-drug Antibodies (ADA) to MEDI-528
Day 28
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Anti-drug Antibodies (ADA) to MEDI-528
Day 42
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Anti-drug Antibodies (ADA) to MEDI-528
Day 84
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84Population: All subjects who received MEDI-528
Tmax of MEDI-528
Outcome measures
| Measure |
MEDI-528 0.3 mg/kg
n=6 Participants
MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
|
MEDI-528 1 mg/kg
n=6 Participants
MEDI-528 (1 mg/kg) administered as a single, IV dose
|
MEDI-528 3 mg/kg
n=6 Participants
MEDI-528 (3 mg/kg) administered as a single, IV dose
|
MEDI-528 9 mg/kg
n=6 Participants
MEDI-528 (9 mg/kg) administered as a single, IV dose
|
|---|---|---|---|---|
|
Time to Observed Maximum Serum Concentration (Tmax)
|
1.5 Hours
Full Range 0.0 • Interval 0.0 to 4.0
|
1.1 Hours
Interval 0.1 to 2.1
|
1.2 Hours
Interval 0.2 to 24.2
|
0.7 Hours
Interval 0.5 to 2.6
|
SECONDARY outcome
Timeframe: Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84Population: All subjects who received MEDI-528
Cmax of MEDI-528
Outcome measures
| Measure |
MEDI-528 0.3 mg/kg
n=6 Participants
MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
|
MEDI-528 1 mg/kg
n=6 Participants
MEDI-528 (1 mg/kg) administered as a single, IV dose
|
MEDI-528 3 mg/kg
n=6 Participants
MEDI-528 (3 mg/kg) administered as a single, IV dose
|
MEDI-528 9 mg/kg
n=6 Participants
MEDI-528 (9 mg/kg) administered as a single, IV dose
|
|---|---|---|---|---|
|
Observed Maximum Serum Concentration (Cmax)
|
7.2 Micrograms per milliliter
Geometric Coefficient of Variation 42
|
22.2 Micrograms per milliliter
Geometric Coefficient of Variation 30
|
59.7 Micrograms per milliliter
Geometric Coefficient of Variation 25
|
231.2 Micrograms per milliliter
Geometric Coefficient of Variation 17
|
SECONDARY outcome
Timeframe: Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84Population: All subjects who received MEDI-528
AUC(0-t) of MEDI-528
Outcome measures
| Measure |
MEDI-528 0.3 mg/kg
n=6 Participants
MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
|
MEDI-528 1 mg/kg
n=6 Participants
MEDI-528 (1 mg/kg) administered as a single, IV dose
|
MEDI-528 3 mg/kg
n=6 Participants
MEDI-528 (3 mg/kg) administered as a single, IV dose
|
MEDI-528 9 mg/kg
n=6 Participants
MEDI-528 (9 mg/kg) administered as a single, IV dose
|
|---|---|---|---|---|
|
Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]
|
2463.7 Micrograms times hours per milliliter
Geometric Coefficient of Variation 85
|
7765.6 Micrograms times hours per milliliter
Geometric Coefficient of Variation 55
|
26221.5 Micrograms times hours per milliliter
Geometric Coefficient of Variation 40
|
101476.7 Micrograms times hours per milliliter
Geometric Coefficient of Variation 16
|
SECONDARY outcome
Timeframe: Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84Population: All subjects who received MEDI-528
AUC(0-infinity) of MEDI-528
Outcome measures
| Measure |
MEDI-528 0.3 mg/kg
n=6 Participants
MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
|
MEDI-528 1 mg/kg
n=6 Participants
MEDI-528 (1 mg/kg) administered as a single, IV dose
|
MEDI-528 3 mg/kg
n=6 Participants
MEDI-528 (3 mg/kg) administered as a single, IV dose
|
MEDI-528 9 mg/kg
n=6 Participants
MEDI-528 (9 mg/kg) administered as a single, IV dose
|
|---|---|---|---|---|
|
Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]
|
3982.2 Microgram times hours per milliliter
Geometric Coefficient of Variation 67
|
10084.6 Microgram times hours per milliliter
Geometric Coefficient of Variation 50
|
30035.5 Microgram times hours per milliliter
Geometric Coefficient of Variation 40
|
112344.3 Microgram times hours per milliliter
Geometric Coefficient of Variation 22
|
SECONDARY outcome
Timeframe: Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84Population: All subjects who received MEDI-528
AUC(ext) of MEDI-528
Outcome measures
| Measure |
MEDI-528 0.3 mg/kg
n=6 Participants
MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
|
MEDI-528 1 mg/kg
n=6 Participants
MEDI-528 (1 mg/kg) administered as a single, IV dose
|
MEDI-528 3 mg/kg
n=6 Participants
MEDI-528 (3 mg/kg) administered as a single, IV dose
|
MEDI-528 9 mg/kg
n=6 Participants
MEDI-528 (9 mg/kg) administered as a single, IV dose
|
|---|---|---|---|---|
|
Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]
|
35.8 Percentage of Projected AUC
Geometric Coefficient of Variation 30
|
21.5 Percentage of Projected AUC
Geometric Coefficient of Variation 30
|
10.5 Percentage of Projected AUC
Geometric Coefficient of Variation 64
|
8.2 Percentage of Projected AUC
Geometric Coefficient of Variation 63
|
SECONDARY outcome
Timeframe: Days 0, 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84Population: All subjects who received MEDI-528
CL of MEDI-528
Outcome measures
| Measure |
MEDI-528 0.3 mg/kg
n=6 Participants
MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
|
MEDI-528 1 mg/kg
n=6 Participants
MEDI-528 (1 mg/kg) administered as a single, IV dose
|
MEDI-528 3 mg/kg
n=6 Participants
MEDI-528 (3 mg/kg) administered as a single, IV dose
|
MEDI-528 9 mg/kg
n=6 Participants
MEDI-528 (9 mg/kg) administered as a single, IV dose
|
|---|---|---|---|---|
|
Total Body Clearance (CL)
|
120.5 Milliter per day
Geometric Coefficient of Variation 51
|
160.1 Milliter per day
Geometric Coefficient of Variation 34
|
166.1 Milliter per day
Geometric Coefficient of Variation 31
|
154.6 Milliter per day
Geometric Coefficient of Variation 13
|
SECONDARY outcome
Timeframe: Days 0, 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84Population: All subjects who received MEDI-528
T1/2 of MEDI-528
Outcome measures
| Measure |
MEDI-528 0.3 mg/kg
n=6 Participants
MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
|
MEDI-528 1 mg/kg
n=6 Participants
MEDI-528 (1 mg/kg) administered as a single, IV dose
|
MEDI-528 3 mg/kg
n=6 Participants
MEDI-528 (3 mg/kg) administered as a single, IV dose
|
MEDI-528 9 mg/kg
n=6 Participants
MEDI-528 (9 mg/kg) administered as a single, IV dose
|
|---|---|---|---|---|
|
Half-life (T1/2)
|
651.1 Hours
Geometric Coefficient of Variation 24
|
559.1 Hours
Geometric Coefficient of Variation 36
|
581.3 Hours
Geometric Coefficient of Variation 21
|
594.9 Hours
Geometric Coefficient of Variation 26
|
SECONDARY outcome
Timeframe: Days 0, 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84Population: All subjects who received MEDI-528
Vz of MEDI-528
Outcome measures
| Measure |
MEDI-528 0.3 mg/kg
n=6 Participants
MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
|
MEDI-528 1 mg/kg
n=6 Participants
MEDI-528 (1 mg/kg) administered as a single, IV dose
|
MEDI-528 3 mg/kg
n=6 Participants
MEDI-528 (3 mg/kg) administered as a single, IV dose
|
MEDI-528 9 mg/kg
n=6 Participants
MEDI-528 (9 mg/kg) administered as a single, IV dose
|
|---|---|---|---|---|
|
Terminal Phase Elimination Rate (Vz)
|
4.7 Liters
Geometric Coefficient of Variation 38
|
5.4 Liters
Geometric Coefficient of Variation 30
|
5.8 Liters
Geometric Coefficient of Variation 19
|
5.5 Liters
Geometric Coefficient of Variation 18
|
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: 2 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
|
|---|---|---|---|---|
|
Infections and infestations
Vaginitis bacterial
|
0.00%
0/6 • Days 0-84
|
0.00%
0/6 • Days 0-84
|
16.7%
1/6 • Number of events 1 • Days 0-84
|
0.00%
0/6 • Days 0-84
|
|
Investigations
Blood amylase increased
|
0.00%
0/6 • Days 0-84
|
0.00%
0/6 • Days 0-84
|
16.7%
1/6 • Number of events 1 • Days 0-84
|
0.00%
0/6 • Days 0-84
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/6 • Days 0-84
|
16.7%
1/6 • Number of events 2 • Days 0-84
|
0.00%
0/6 • Days 0-84
|
33.3%
2/6 • Number of events 2 • Days 0-84
|
|
Investigations
Blood glucose increased
|
16.7%
1/6 • Number of events 1 • Days 0-84
|
0.00%
0/6 • Days 0-84
|
33.3%
2/6 • Number of events 2 • Days 0-84
|
0.00%
0/6 • Days 0-84
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/6 • Days 0-84
|
0.00%
0/6 • Days 0-84
|
16.7%
1/6 • Number of events 1 • Days 0-84
|
0.00%
0/6 • Days 0-84
|
|
Investigations
Lipase increased
|
0.00%
0/6 • Days 0-84
|
0.00%
0/6 • Days 0-84
|
16.7%
1/6 • Number of events 1 • Days 0-84
|
0.00%
0/6 • Days 0-84
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/6 • Days 0-84
|
0.00%
0/6 • Days 0-84
|
16.7%
1/6 • Number of events 1 • Days 0-84
|
0.00%
0/6 • Days 0-84
|
|
Investigations
Protein urine present
|
16.7%
1/6 • Number of events 1 • Days 0-84
|
33.3%
2/6 • Number of events 2 • Days 0-84
|
83.3%
5/6 • Number of events 5 • Days 0-84
|
16.7%
1/6 • Number of events 1 • Days 0-84
|
|
Investigations
White blood cell count decreased
|
33.3%
2/6 • Number of events 3 • Days 0-84
|
16.7%
1/6 • Number of events 1 • Days 0-84
|
0.00%
0/6 • Days 0-84
|
0.00%
0/6 • Days 0-84
|
|
Investigations
White blood cell count increased
|
0.00%
0/6 • Days 0-84
|
16.7%
1/6 • Number of events 1 • Days 0-84
|
0.00%
0/6 • Days 0-84
|
0.00%
0/6 • Days 0-84
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Days 0-84
|
16.7%
1/6 • Number of events 1 • Days 0-84
|
0.00%
0/6 • Days 0-84
|
0.00%
0/6 • Days 0-84
|
|
Vascular disorders
Hypotension
|
16.7%
1/6 • Number of events 1 • Days 0-84
|
0.00%
0/6 • Days 0-84
|
0.00%
0/6 • Days 0-84
|
0.00%
0/6 • Days 0-84
|
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