Trial Outcomes & Findings for A Study to Assess Pharmacokinetics, Safety and Tolerability of Multiple Doses of CAT-354 in Subjects With Moderate Asthma (NCT NCT00974675)
NCT ID: NCT00974675
Last Updated: 2017-05-02
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
23 participants
Primary outcome timeframe
Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21
Results posted on
2017-05-02
Participant Flow
Participant milestones
| Measure |
CAT-354 1 mg/kg
CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
CAT-354 5 mg/kg
CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
CAT-354 10 mg/kg
CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
Placebo
Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
3
|
4
|
|
Overall Study
COMPLETED
|
6
|
7
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
2
|
2
|
Reasons for withdrawal
| Measure |
CAT-354 1 mg/kg
CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
CAT-354 5 mg/kg
CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
CAT-354 10 mg/kg
CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
Placebo
Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
|
Overall Study
Participant on holiday; unable to attend
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Assess Pharmacokinetics, Safety and Tolerability of Multiple Doses of CAT-354 in Subjects With Moderate Asthma
Baseline characteristics by cohort
| Measure |
CAT-354 1 mg/kg
n=8 Participants
CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
CAT-354 5 mg/kg
n=8 Participants
CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
CAT-354 10 mg/kg
n=3 Participants
CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
Placebo
n=4 Participants
Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
39.4 years
STANDARD_DEVIATION 9.07 • n=93 Participants
|
34.6 years
STANDARD_DEVIATION 7.58 • n=4 Participants
|
43.3 years
STANDARD_DEVIATION 14.47 • n=27 Participants
|
40.0 years
STANDARD_DEVIATION 13.04 • n=483 Participants
|
38.3 years
STANDARD_DEVIATION 9.80 • n=36 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
22 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21Population: Pharmacokinetic (PK) population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax.
Outcome measures
| Measure |
CAT-354 1 mg/kg
n=8 Participants
CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
CAT-354 5 mg/kg
n=8 Participants
CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
CAT-354 10 mg/kg
n=3 Participants
CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
Placebp
Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) for CAT-354 After First Dose
|
30.3 microgram/milliliter (mcg/mL)
Standard Deviation 5.18
|
156.8 microgram/milliliter (mcg/mL)
Standard Deviation 34.55
|
306.3 microgram/milliliter (mcg/mL)
Standard Deviation 31.39
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 28; Day 35Population: PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
CAT-354 1 mg/kg
n=7 Participants
CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
CAT-354 5 mg/kg
n=7 Participants
CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
CAT-354 10 mg/kg
n=1 Participants
CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
Placebp
Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) for CAT-354 After Second Dose
|
35.0 mcg/mL
Standard Deviation 6.81
|
161.0 mcg/mL
Standard Deviation 32.81
|
298.0 mcg/mL
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 56; Day 63, 84, 105 and 147Population: PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
CAT-354 1 mg/kg
n=6 Participants
CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
CAT-354 5 mg/kg
n=7 Participants
CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
CAT-354 10 mg/kg
n=1 Participants
CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
Placebp
Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) for CAT-354 After Third Dose
|
41.1 mcg/mL
Standard Deviation 4.77
|
178.7 mcg/mL
Standard Deviation 25.41
|
393.0 mcg/mL
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21Population: PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax.
Outcome measures
| Measure |
CAT-354 1 mg/kg
n=8 Participants
CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
CAT-354 5 mg/kg
n=8 Participants
CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
CAT-354 10 mg/kg
n=3 Participants
CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
Placebp
Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
|---|---|---|---|---|
|
Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - t]) for CAT-354 After First Dose
|
299.6 (mcg*day)/mL
Standard Deviation 42.03
|
1691.3 (mcg*day)/mL
Standard Deviation 302.70
|
3106.3 (mcg*day)/mL
Standard Deviation 719.25
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21Population: PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax.
AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).
Outcome measures
| Measure |
CAT-354 1 mg/kg
n=8 Participants
CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
CAT-354 5 mg/kg
n=8 Participants
CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
CAT-354 10 mg/kg
n=3 Participants
CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
Placebp
Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
|---|---|---|---|---|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC[0 - Infinity]) for CAT-354 After First Dose
|
428.0 (mcg*day)/mL
Standard Deviation 83.33
|
2314.3 (mcg*day)/mL
Standard Deviation 392.91
|
3861.3 (mcg*day)/mL
Standard Deviation 662.42
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21Population: PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax.
Terminal elimination phase half-life is the time measured for the serum concentration to decrease by one half.
Outcome measures
| Measure |
CAT-354 1 mg/kg
n=8 Participants
CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
CAT-354 5 mg/kg
n=8 Participants
CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
CAT-354 10 mg/kg
n=3 Participants
CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
Placebp
Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
|---|---|---|---|---|
|
Apparent Terminal Elimination Phase Half-Life (t[1/2]el) for CAT-354 After First Dose
|
16.6 days
Standard Deviation 2.67
|
16.1 days
Standard Deviation 3.60
|
11.8 days
Standard Deviation 1.86
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21Population: PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax.
Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. Clearance was normalized by the body weight of the participant.
Outcome measures
| Measure |
CAT-354 1 mg/kg
n=8 Participants
CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
CAT-354 5 mg/kg
n=8 Participants
CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
CAT-354 10 mg/kg
n=3 Participants
CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
Placebp
Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
|---|---|---|---|---|
|
Clearance (CL) for CAT-354 After First Dose
|
2.41 (mL/day)/kilogram
Standard Deviation 0.45
|
2.23 (mL/day)/kilogram
Standard Deviation 0.46
|
2.64 (mL/day)/kilogram
Standard Deviation 0.42
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21Population: PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax.
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Volume of distribution was normalized to the body weight of the participant.
Outcome measures
| Measure |
CAT-354 1 mg/kg
n=8 Participants
CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
CAT-354 5 mg/kg
n=8 Participants
CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
CAT-354 10 mg/kg
n=3 Participants
CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
Placebp
Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
|---|---|---|---|---|
|
Volume of Distribution (Vd) for CAT-354 After First Dose
|
56.7 mL/kg
Standard Deviation 8.04
|
51.0 mL/kg
Standard Deviation 10.36
|
44.0 mL/kg
Standard Deviation 0.79
|
—
|
PRIMARY outcome
Timeframe: Pre-dose on Day 28Population: PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
CAT-354 1 mg/kg
n=8 Participants
CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
CAT-354 5 mg/kg
n=7 Participants
CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
CAT-354 10 mg/kg
n=1 Participants
CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
Placebp
Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
|---|---|---|---|---|
|
Observed Serum Drug Concentration for CAT-354 28 Days (C28) After First Dose
|
5.3 mcg/mL
Standard Deviation 1.33
|
27.1 mcg/mL
Standard Deviation 4.91
|
40.7 mcg/mL
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
—
|
PRIMARY outcome
Timeframe: Pre-dose on Day 56Population: PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
CAT-354 1 mg/kg
n=6 Participants
CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
CAT-354 5 mg/kg
n=7 Participants
CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
CAT-354 10 mg/kg
n=1 Participants
CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
Placebp
Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
|---|---|---|---|---|
|
Observed Serum Drug Concentration for CAT-354 28 Days (C28) After Second Dose
|
7.7 mcg/mL
Standard Deviation 1.63
|
36.0 mcg/mL
Standard Deviation 11.51
|
59.4 mcg/mL
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
—
|
PRIMARY outcome
Timeframe: Day 84Population: PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
CAT-354 1 mg/kg
n=6 Participants
CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
CAT-354 5 mg/kg
n=7 Participants
CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
CAT-354 10 mg/kg
n=1 Participants
CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
Placebp
Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
|---|---|---|---|---|
|
Observed Serum Concentration for CAT-354 28 Days (C28) After Third Dose
|
8.6 mcg/mL
Standard Deviation 1.99
|
40.6 mcg/mL
Standard Deviation 12.26
|
79.6 mcg/mL
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0 and 56; Pre-dose on Day 28; Day 4, 7, 14, 21, 63 and 84Population: PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Accumulation ratio is calculated as: R0 = AUC(56 - 84)/AUC(0 - 28) where AUC(0 - 28) and AUC(56 - 84) are the area under the serum concentration time curve over a dosage interval determined after the first dose (Day 0 to Day 28) and after the third dose (Day 56 to Day 84), respectively.
Outcome measures
| Measure |
CAT-354 1 mg/kg
n=6 Participants
CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
CAT-354 5 mg/kg
n=7 Participants
CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
CAT-354 10 mg/kg
n=1 Participants
CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
Placebp
Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
|---|---|---|---|---|
|
Accumulation Ratio (R0) for CAT-354
|
1.58 ratio
Standard Deviation 0.21
|
1.39 ratio
Standard Deviation 0.10
|
1.67 ratio
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
—
|
SECONDARY outcome
Timeframe: Day 0 to Day 147Population: Safety population included all participants who received at least 1 dose of IMP (CAT-354 or placebo) including those who did not complete the study.
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (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 events between first dose of study drug and up to Day 147 that were absent before treatment or that worsened relative to pre-treatment state.
Outcome measures
| Measure |
CAT-354 1 mg/kg
n=8 Participants
CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
CAT-354 5 mg/kg
n=8 Participants
CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
CAT-354 10 mg/kg
n=3 Participants
CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
Placebp
n=4 Participants
Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
|---|---|---|---|---|
|
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TEAEs
|
8 participants
|
8 participants
|
3 participants
|
4 participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TESAEs
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
Adverse Events
1 mg/kg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
5 mg/kg
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
10 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1 mg/kg
n=8 participants at risk
CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
5 mg/kg
n=8 participants at risk
CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
10 mg/kg
n=3 participants at risk
CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
Placebo
n=4 participants at risk
Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
|---|---|---|---|---|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/8 • Day 0 to 147
|
12.5%
1/8 • Number of events 1 • Day 0 to 147
|
0.00%
0/3 • Day 0 to 147
|
0.00%
0/4 • Day 0 to 147
|
Other adverse events
| Measure |
1 mg/kg
n=8 participants at risk
CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
5 mg/kg
n=8 participants at risk
CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
10 mg/kg
n=3 participants at risk
CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
Placebo
n=4 participants at risk
Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.
|
|---|---|---|---|---|
|
Eye disorders
Blepharospasm
|
0.00%
0/8 • Day 0 to 147
|
12.5%
1/8 • Number of events 1 • Day 0 to 147
|
0.00%
0/3 • Day 0 to 147
|
0.00%
0/4 • Day 0 to 147
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/8 • Day 0 to 147
|
12.5%
1/8 • Number of events 1 • Day 0 to 147
|
0.00%
0/3 • Day 0 to 147
|
0.00%
0/4 • Day 0 to 147
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
1/8 • Number of events 1 • Day 0 to 147
|
12.5%
1/8 • Number of events 1 • Day 0 to 147
|
0.00%
0/3 • Day 0 to 147
|
0.00%
0/4 • Day 0 to 147
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/8 • Day 0 to 147
|
0.00%
0/8 • Day 0 to 147
|
33.3%
1/3 • Number of events 1 • Day 0 to 147
|
0.00%
0/4 • Day 0 to 147
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/8 • Day 0 to 147
|
12.5%
1/8 • Number of events 1 • Day 0 to 147
|
0.00%
0/3 • Day 0 to 147
|
0.00%
0/4 • Day 0 to 147
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • Day 0 to 147
|
12.5%
1/8 • Number of events 1 • Day 0 to 147
|
0.00%
0/3 • Day 0 to 147
|
0.00%
0/4 • Day 0 to 147
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Number of events 1 • Day 0 to 147
|
0.00%
0/8 • Day 0 to 147
|
0.00%
0/3 • Day 0 to 147
|
0.00%
0/4 • Day 0 to 147
|
|
General disorders
Chest discomfort
|
0.00%
0/8 • Day 0 to 147
|
0.00%
0/8 • Day 0 to 147
|
33.3%
1/3 • Number of events 1 • Day 0 to 147
|
25.0%
1/4 • Number of events 1 • Day 0 to 147
|
|
General disorders
Feeling hot and cold
|
0.00%
0/8 • Day 0 to 147
|
12.5%
1/8 • Number of events 1 • Day 0 to 147
|
0.00%
0/3 • Day 0 to 147
|
0.00%
0/4 • Day 0 to 147
|
|
General disorders
Infusion site pain
|
0.00%
0/8 • Day 0 to 147
|
12.5%
1/8 • Number of events 1 • Day 0 to 147
|
0.00%
0/3 • Day 0 to 147
|
0.00%
0/4 • Day 0 to 147
|
|
General disorders
Pain
|
12.5%
1/8 • Number of events 1 • Day 0 to 147
|
12.5%
1/8 • Number of events 1 • Day 0 to 147
|
0.00%
0/3 • Day 0 to 147
|
0.00%
0/4 • Day 0 to 147
|
|
Infections and infestations
Lower respiratory tract infection
|
12.5%
1/8 • Number of events 1 • Day 0 to 147
|
0.00%
0/8 • Day 0 to 147
|
0.00%
0/3 • Day 0 to 147
|
25.0%
1/4 • Number of events 2 • Day 0 to 147
|
|
Infections and infestations
Nasopharyngitis
|
62.5%
5/8 • Number of events 6 • Day 0 to 147
|
87.5%
7/8 • Number of events 10 • Day 0 to 147
|
66.7%
2/3 • Number of events 2 • Day 0 to 147
|
75.0%
3/4 • Number of events 4 • Day 0 to 147
|
|
Infections and infestations
Pertussis
|
12.5%
1/8 • Number of events 1 • Day 0 to 147
|
0.00%
0/8 • Day 0 to 147
|
0.00%
0/3 • Day 0 to 147
|
0.00%
0/4 • Day 0 to 147
|
|
Infections and infestations
Pyelonephritis
|
12.5%
1/8 • Number of events 1 • Day 0 to 147
|
0.00%
0/8 • Day 0 to 147
|
0.00%
0/3 • Day 0 to 147
|
0.00%
0/4 • Day 0 to 147
|
|
Infections and infestations
Tonsillitis
|
12.5%
1/8 • Number of events 1 • Day 0 to 147
|
0.00%
0/8 • Day 0 to 147
|
0.00%
0/3 • Day 0 to 147
|
0.00%
0/4 • Day 0 to 147
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/8 • Day 0 to 147
|
12.5%
1/8 • Number of events 1 • Day 0 to 147
|
0.00%
0/3 • Day 0 to 147
|
0.00%
0/4 • Day 0 to 147
|
|
Investigations
Urine analysis abnormal
|
12.5%
1/8 • Number of events 1 • Day 0 to 147
|
0.00%
0/8 • Day 0 to 147
|
0.00%
0/3 • Day 0 to 147
|
0.00%
0/4 • Day 0 to 147
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
1/8 • Number of events 1 • Day 0 to 147
|
0.00%
0/8 • Day 0 to 147
|
0.00%
0/3 • Day 0 to 147
|
0.00%
0/4 • Day 0 to 147
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • Number of events 1 • Day 0 to 147
|
0.00%
0/8 • Day 0 to 147
|
0.00%
0/3 • Day 0 to 147
|
0.00%
0/4 • Day 0 to 147
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8 • Day 0 to 147
|
12.5%
1/8 • Number of events 1 • Day 0 to 147
|
0.00%
0/3 • Day 0 to 147
|
0.00%
0/4 • Day 0 to 147
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/8 • Day 0 to 147
|
12.5%
1/8 • Number of events 1 • Day 0 to 147
|
0.00%
0/3 • Day 0 to 147
|
0.00%
0/4 • Day 0 to 147
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/8 • Day 0 to 147
|
12.5%
1/8 • Number of events 1 • Day 0 to 147
|
0.00%
0/3 • Day 0 to 147
|
0.00%
0/4 • Day 0 to 147
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • Day 0 to 147
|
12.5%
1/8 • Number of events 1 • Day 0 to 147
|
0.00%
0/3 • Day 0 to 147
|
0.00%
0/4 • Day 0 to 147
|
|
Nervous system disorders
Headache
|
37.5%
3/8 • Number of events 3 • Day 0 to 147
|
50.0%
4/8 • Number of events 6 • Day 0 to 147
|
33.3%
1/3 • Number of events 1 • Day 0 to 147
|
50.0%
2/4 • Number of events 4 • Day 0 to 147
|
|
Nervous system disorders
Lethargy
|
0.00%
0/8 • Day 0 to 147
|
12.5%
1/8 • Number of events 1 • Day 0 to 147
|
0.00%
0/3 • Day 0 to 147
|
0.00%
0/4 • Day 0 to 147
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • Number of events 1 • Day 0 to 147
|
12.5%
1/8 • Number of events 1 • Day 0 to 147
|
0.00%
0/3 • Day 0 to 147
|
25.0%
1/4 • Number of events 1 • Day 0 to 147
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/8 • Day 0 to 147
|
12.5%
1/8 • Number of events 1 • Day 0 to 147
|
33.3%
1/3 • Number of events 2 • Day 0 to 147
|
0.00%
0/4 • Day 0 to 147
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
12.5%
1/8 • Number of events 1 • Day 0 to 147
|
0.00%
0/8 • Day 0 to 147
|
0.00%
0/3 • Day 0 to 147
|
0.00%
0/4 • Day 0 to 147
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/8 • Day 0 to 147
|
0.00%
0/8 • Day 0 to 147
|
33.3%
1/3 • Number of events 1 • Day 0 to 147
|
0.00%
0/4 • Day 0 to 147
|
|
Skin and subcutaneous tissue disorders
Eczema
|
12.5%
1/8 • Number of events 1 • Day 0 to 147
|
0.00%
0/8 • Day 0 to 147
|
0.00%
0/3 • Day 0 to 147
|
0.00%
0/4 • Day 0 to 147
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/8 • Day 0 to 147
|
12.5%
1/8 • Number of events 1 • Day 0 to 147
|
0.00%
0/3 • Day 0 to 147
|
0.00%
0/4 • Day 0 to 147
|
Additional Information
Meena Jain, MB BChir/Associate Medical Director
MedImmune, LLC
Phone: 301-398-0000
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. The PIs also agree for data to be presented first as a joint, multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER