Trial Outcomes & Findings for A Study to Assess the Efficacy, Safety, and Tolerability of CAT-354 in Subjects With Asthma (NCT NCT00640016)
NCT ID: NCT00640016
Last Updated: 2017-01-31
Results Overview
Change in doubling concentrations of methacholine was calculated as Log2 PC20 (Visit x) - Log2 PC20 (Baseline), where x was the post-baseline assessment (Day 28) and PC20 was provocative concentration of methacholine causing 20 percent fall in forced expiratory volume in 1 second (FEV1). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Change in doubling concentration was summarized for sub-therapeutic dose (placebo and CAT-354 1 milligram/kilogram \[mg/kg\]) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.
TERMINATED
PHASE2
14 participants
Baseline and Day 28
2017-01-31
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
CAT-354 1 mg/kg
CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
CAT-354 5 mg/kg
CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
CAT-354 10 mg/kg
CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
4
|
4
|
|
Overall Study
Treated
|
3
|
2
|
4
|
4
|
|
Overall Study
COMPLETED
|
1
|
1
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
3
|
3
|
Reasons for withdrawal
| Measure |
Placebo
Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
CAT-354 1 mg/kg
CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
CAT-354 5 mg/kg
CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
CAT-354 10 mg/kg
CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Overall Study
Study termination
|
2
|
1
|
3
|
2
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Assess the Efficacy, Safety, and Tolerability of CAT-354 in Subjects With Asthma
Baseline characteristics by cohort
| Measure |
Placebo
n=3 Participants
Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
CAT-354 1 mg/kg
n=3 Participants
CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
CAT-354 5 mg/kg
n=4 Participants
CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
CAT-354 10 mg/kg
n=4 Participants
CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
34.00 years
STANDARD_DEVIATION 11.136 • n=93 Participants
|
34.00 years
STANDARD_DEVIATION 14.933 • n=4 Participants
|
37.75 years
STANDARD_DEVIATION 9.878 • n=27 Participants
|
40.75 years
STANDARD_DEVIATION 15.086 • n=483 Participants
|
37.00 years
STANDARD_DEVIATION 11.708 • n=36 Participants
|
|
Gender
Female
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
11 Participants
n=36 Participants
|
|
Gender
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 28Population: Safety population included all participants who received at least 1 dose of study medication. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.
Change in doubling concentrations of methacholine was calculated as Log2 PC20 (Visit x) - Log2 PC20 (Baseline), where x was the post-baseline assessment (Day 28) and PC20 was provocative concentration of methacholine causing 20 percent fall in forced expiratory volume in 1 second (FEV1). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Change in doubling concentration was summarized for sub-therapeutic dose (placebo and CAT-354 1 milligram/kilogram \[mg/kg\]) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.
Outcome measures
| Measure |
Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)
n=8 Participants
CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)
n=5 Participants
Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
CAT-354 10 mg/kg
CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
CAT-354 10 mg/kg
CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
|---|---|---|---|---|
|
Change From Baseline in Doubling Concentration of Methacholine at Day 28
Baseline (n=8, 5)
|
-0.604 log2 milligram/deciliter (mg/dL)
Standard Deviation 2.4080
|
-1.545 log2 milligram/deciliter (mg/dL)
Standard Deviation 0.8952
|
—
|
—
|
|
Change From Baseline in Doubling Concentration of Methacholine at Day 28
Change at Day 28 (n=5, 4)
|
-0.207 log2 milligram/deciliter (mg/dL)
Standard Deviation 1.0450
|
0.125 log2 milligram/deciliter (mg/dL)
Standard Deviation 2.3433
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 56, 84 or early termination (any time before Day 84)Population: Safety population included all participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure, and 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.
Change in doubling concentrations of methacholine was calculated as Log2 PC20 (Visit x) - Log2 PC20 (Baseline), where x was the post-baseline assessment (Day 28) and PC20 was provocative concentration of methacholine causing 20 percent fall in forced expiratory volume in 1 second (FEV1). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Change in doubling concentration was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.
Outcome measures
| Measure |
Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)
n=3 Participants
CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)
n=2 Participants
Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
CAT-354 10 mg/kg
CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
CAT-354 10 mg/kg
CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
|---|---|---|---|---|
|
Change From Baseline in Doubling Concentration of Methacholine at Day 56, 84 or Early Termination
Change at Day 56 (n=2, 2)
|
0.062 log2 mg/dL
Standard Deviation 1.1309
|
-1.423 log2 mg/dL
Standard Deviation 0.4059
|
—
|
—
|
|
Change From Baseline in Doubling Concentration of Methacholine at Day 56, 84 or Early Termination
Change at Early termination (n=3, 2)
|
-0.514 log2 mg/dL
Standard Deviation 0.8636
|
0.417 log2 mg/dL
Standard Deviation 0.9840
|
—
|
—
|
|
Change From Baseline in Doubling Concentration of Methacholine at Day 56, 84 or Early Termination
Change at Day 84 (n=2, 2)
|
-0.038 log2 mg/dL
Standard Deviation 0.1410
|
-1.846 log2 mg/dL
Standard Deviation 0.0431
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 30 minutes and 6 hours post-end of infusion on Day 0, 28 and 56; Day 4, 14, 35, 63, 84 or early termination (any time before Day 84)Population: Safety population included all participants who received at least 1 dose of study medication. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.
The FEV1 was maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV1 was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.
Outcome measures
| Measure |
Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)
n=8 Participants
CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)
n=5 Participants
Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
CAT-354 10 mg/kg
CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
CAT-354 10 mg/kg
CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
|---|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1)
Day 56: Predose (n=2, 2)
|
2.555 liters
Standard Deviation 0.6718
|
2.700 liters
Standard Deviation 0.3677
|
—
|
—
|
|
Forced Expiratory Volume in 1 Second (FEV1)
Day 56: 30 minutes postdose (n=2, 2)
|
2.705 liters
Standard Deviation 0.7990
|
2.830 liters
Standard Deviation 0.1697
|
—
|
—
|
|
Forced Expiratory Volume in 1 Second (FEV1)
Day 56: 6 hours postdose (n=2, 2)
|
2.510 liters
Standard Deviation 0.7071
|
2.690 liters
Standard Deviation 0.2404
|
—
|
—
|
|
Forced Expiratory Volume in 1 Second (FEV1)
Day 63 (n= 2, 2)
|
2.505 liters
Standard Deviation 0.6859
|
2.580 liters
Standard Deviation 0.0283
|
—
|
—
|
|
Forced Expiratory Volume in 1 Second (FEV1)
Day 84: (n=2, 2)
|
2.680 liters
Standard Deviation 0.7778
|
2.540 liters
Standard Deviation 0.4101
|
—
|
—
|
|
Forced Expiratory Volume in 1 Second (FEV1)
Early Termination (n=4, 3)
|
3.018 liters
Standard Deviation 0.5803
|
2.867 liters
Standard Deviation 0.4400
|
—
|
—
|
|
Forced Expiratory Volume in 1 Second (FEV1)
Day 0: Predose (n=8, 5)
|
2.718 liters
Standard Deviation 0.5458
|
2.640 liters
Standard Deviation 0.3994
|
—
|
—
|
|
Forced Expiratory Volume in 1 Second (FEV1)
Day 0: 30 minutes postdose (n=8, 5)
|
2.684 liters
Standard Deviation 0.5695
|
2.624 liters
Standard Deviation 0.4126
|
—
|
—
|
|
Forced Expiratory Volume in 1 Second (FEV1)
Day 0: 6 hours postdose (n=8, 5)
|
2.606 liters
Standard Deviation 0.5731
|
2.550 liters
Standard Deviation 0.4304
|
—
|
—
|
|
Forced Expiratory Volume in 1 Second (FEV1)
Day 4 (n=8, 5)
|
2.814 liters
Standard Deviation 0.6048
|
2.606 liters
Standard Deviation 0.2919
|
—
|
—
|
|
Forced Expiratory Volume in 1 Second (FEV1)
Day 14 (n=6, 5)
|
2.323 liters
Standard Deviation 0.5703
|
2.520 liters
Standard Deviation 0.0812
|
—
|
—
|
|
Forced Expiratory Volume in 1 Second (FEV1)
Day 28: Predose (n=5, 4)
|
2.598 liters
Standard Deviation 0.4676
|
2.850 liters
Standard Deviation 0.2082
|
—
|
—
|
|
Forced Expiratory Volume in 1 Second (FEV1)
Day 28: 30 minutes postdose (n=4, 4)
|
2.535 liters
Standard Deviation 0.5639
|
2.918 liters
Standard Deviation 0.2822
|
—
|
—
|
|
Forced Expiratory Volume in 1 Second (FEV1)
Day 28: 6 hours postdose (n=4, 4)
|
2.400 liters
Standard Deviation 0.5254
|
2.665 liters
Standard Deviation 0.2748
|
—
|
—
|
|
Forced Expiratory Volume in 1 Second (FEV1)
Day 35 (n= 4, 4)
|
2.260 liters
Standard Deviation 0.5464
|
2.778 liters
Standard Deviation 0.4228
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 30 minutes and 6 hours post-end of infusion on Day 0, 28 and 56; Day 4, 14, 35, 63, 84 or early termination (any time before Day 84)Population: Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.
The FVC was volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.
Outcome measures
| Measure |
Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)
n=8 Participants
CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)
n=5 Participants
Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
CAT-354 10 mg/kg
CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
CAT-354 10 mg/kg
CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
|---|---|---|---|---|
|
Forced Vital Capacity (FVC)
Day 56: 6 hours postdose (n=2, 2)
|
3.715 liters
Standard Deviation 0.6435
|
3.545 liters
Standard Deviation 0.3748
|
—
|
—
|
|
Forced Vital Capacity (FVC)
Day 84: (n=2, 2)
|
3.710 liters
Standard Deviation 0.6505
|
3.415 liters
Standard Deviation 0.3323
|
—
|
—
|
|
Forced Vital Capacity (FVC)
Early Termination (n=4, 3)
|
3.908 liters
Standard Deviation 0.8070
|
4.193 liters
Standard Deviation 0.8364
|
—
|
—
|
|
Forced Vital Capacity (FVC)
Day 0: Predose (n= 8, 5)
|
3.828 liters
Standard Deviation 0.8215
|
3.666 liters
Standard Deviation 0.6068
|
—
|
—
|
|
Forced Vital Capacity (FVC)
Day 0: 30 minutes postdose (n= 8, 5)
|
3.823 liters
Standard Deviation 0.6500
|
3.722 liters
Standard Deviation 0.6752
|
—
|
—
|
|
Forced Vital Capacity (FVC)
Day 0: 6 hours postdose (n= 8, 5)
|
3.808 liters
Standard Deviation 0.7718
|
3.722 liters
Standard Deviation 0.7297
|
—
|
—
|
|
Forced Vital Capacity (FVC)
Day 4 (n= 8, 5)
|
3.988 liters
Standard Deviation 0.6058
|
3.824 liters
Standard Deviation 0.7415
|
—
|
—
|
|
Forced Vital Capacity (FVC)
Day 14 (n=6, 5)
|
3.462 liters
Standard Deviation 0.5926
|
3.710 liters
Standard Deviation 0.5220
|
—
|
—
|
|
Forced Vital Capacity (FVC)
Day 28: Predose (n=5, 4)
|
3.908 liters
Standard Deviation 0.7670
|
3.883 liters
Standard Deviation 0.6412
|
—
|
—
|
|
Forced Vital Capacity (FVC)
Day 28: 30 minutes postdose (n=4, 4)
|
3.878 liters
Standard Deviation 0.7876
|
3.980 liters
Standard Deviation 0.7951
|
—
|
—
|
|
Forced Vital Capacity (FVC)
Day 28: 6 hours postdose (n=4, 4)
|
3.810 liters
Standard Deviation 0.7409
|
3.790 liters
Standard Deviation 0.4830
|
—
|
—
|
|
Forced Vital Capacity (FVC)
Day 35 (n=4, 4)
|
3.613 liters
Standard Deviation 0.6874
|
3.920 liters
Standard Deviation 0.7777
|
—
|
—
|
|
Forced Vital Capacity (FVC)
Day 56: Predose (n=2, 2)
|
3.700 liters
Standard Deviation 0.5233
|
3.410 liters
Standard Deviation 0.3818
|
—
|
—
|
|
Forced Vital Capacity (FVC)
Day 56: 30 minutes postdose (n=2, 2)
|
3.775 liters
Standard Deviation 0.5303
|
3.540 liters
Standard Deviation 0.4667
|
—
|
—
|
|
Forced Vital Capacity (FVC)
Day 63 (n=2, 2)
|
3.705 liters
Standard Deviation 0.5162
|
3.575 liters
Standard Deviation 0.5020
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 30 minutes and 6 hours post-end of infusion on Day 0, 28 and 56; Day 4, 14, 35, Day 63, 84 or early termination (any time before Day 84)Population: Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.
Percentage of FEV1 was calculated as (FEV1/FVC)\*100. It signified the percentage of the total amount of air exhaled from the lungs during the first second of forced exhalation. FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Result was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.
Outcome measures
| Measure |
Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)
n=8 Participants
CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)
n=5 Participants
Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
CAT-354 10 mg/kg
CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
CAT-354 10 mg/kg
CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
|---|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) as Percentage of Forced Vital Capacity (FVC)
Day 0: 30 minutes postdose (n=8, 5)
|
70.250 percentage of FVC
Standard Deviation 9.1613
|
71.600 percentage of FVC
Standard Deviation 13.1833
|
—
|
—
|
|
Forced Expiratory Volume in 1 Second (FEV1) as Percentage of Forced Vital Capacity (FVC)
Day 0: Predose (n=8, 5)
|
71.875 percentage of FVC
Standard Deviation 10.3156
|
72.600 percentage of FVC
Standard Deviation 11.4149
|
—
|
—
|
|
Forced Expiratory Volume in 1 Second (FEV1) as Percentage of Forced Vital Capacity (FVC)
Day 0: 6 hours postdose (n=8, 5)
|
69.125 percentage of FVC
Standard Deviation 12.5178
|
69.600 percentage of FVC
Standard Deviation 12.1984
|
—
|
—
|
|
Forced Expiratory Volume in 1 Second (FEV1) as Percentage of Forced Vital Capacity (FVC)
Day 14 (n=6, 5)
|
66.667 percentage of FVC
Standard Deviation 7.5011
|
68.800 percentage of FVC
Standard Deviation 8.1670
|
—
|
—
|
|
Forced Expiratory Volume in 1 Second (FEV1) as Percentage of Forced Vital Capacity (FVC)
Day 28: 30 minutes postdose (n=4, 4)
|
66.500 percentage of FVC
Standard Deviation 13.9881
|
74.500 percentage of FVC
Standard Deviation 9.6782
|
—
|
—
|
|
Forced Expiratory Volume in 1 Second (FEV1) as Percentage of Forced Vital Capacity (FVC)
Day 56: 30 minutes postdose (n=2, 2)
|
71.000 percentage of FVC
Standard Deviation 11.3137
|
81.000 percentage of FVC
Standard Deviation 15.5563
|
—
|
—
|
|
Forced Expiratory Volume in 1 Second (FEV1) as Percentage of Forced Vital Capacity (FVC)
Day 56: 6 hours postdose (n=2, 2)
|
67.000 percentage of FVC
Standard Deviation 7.0711
|
76.500 percentage of FVC
Standard Deviation 14.8492
|
—
|
—
|
|
Forced Expiratory Volume in 1 Second (FEV1) as Percentage of Forced Vital Capacity (FVC)
Day 63 (n=2, 2)
|
66.500 percentage of FVC
Standard Deviation 9.1924
|
72.500 percentage of FVC
Standard Deviation 9.1924
|
—
|
—
|
|
Forced Expiratory Volume in 1 Second (FEV1) as Percentage of Forced Vital Capacity (FVC)
Day 84 (n=2, 2)
|
71.500 percentage of FVC
Standard Deviation 9.1924
|
75.500 percentage of FVC
Standard Deviation 19.0919
|
—
|
—
|
|
Forced Expiratory Volume in 1 Second (FEV1) as Percentage of Forced Vital Capacity (FVC)
Early Termination (n=4, 3)
|
77.750 percentage of FVC
Standard Deviation 9.8107
|
69.000 percentage of FVC
Standard Deviation 5.5678
|
—
|
—
|
|
Forced Expiratory Volume in 1 Second (FEV1) as Percentage of Forced Vital Capacity (FVC)
Day 4 (n=8, 5)
|
71.000 percentage of FVC
Standard Deviation 13.1909
|
69.400 percentage of FVC
Standard Deviation 8.7063
|
—
|
—
|
|
Forced Expiratory Volume in 1 Second (FEV1) as Percentage of Forced Vital Capacity (FVC)
Day 28: Predose (n=5, 4)
|
67.400 percentage of FVC
Standard Deviation 13.1263
|
74.500 percentage of FVC
Standard Deviation 11.2694
|
—
|
—
|
|
Forced Expiratory Volume in 1 Second (FEV1) as Percentage of Forced Vital Capacity (FVC)
Day 28: 6 hours postdose (n=4, 4)
|
63.750 percentage of FVC
Standard Deviation 12.3390
|
71.250 percentage of FVC
Standard Deviation 13.8173
|
—
|
—
|
|
Forced Expiratory Volume in 1 Second (FEV1) as Percentage of Forced Vital Capacity (FVC)
Day 35 (n=4, 4)
|
62.500 percentage of FVC
Standard Deviation 7.5498
|
71.750 percentage of FVC
Standard Deviation 7.8049
|
—
|
—
|
|
Forced Expiratory Volume in 1 Second (FEV1) as Percentage of Forced Vital Capacity (FVC)
Day 56: Predose (n=2, 2)
|
68.000 percentage of FVC
Standard Deviation 8.4853
|
80.000 percentage of FVC
Standard Deviation 19.7990
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 28, 56, 84 or early termination (any time before Day 84)Population: Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.
The ACQ is questionnaire that comprises of 7-questions evaluating participant's asthma control. Six self-administered questions assess asthma control over the past week covering nocturnal waking, morning symptoms, activity limitations, shortness of breath, wheezing, and short-acting bronchodilator use; using 7-point ordinal rating scale from 0 (good control) to 6 (poor control). Seventh question is completed by a health professional on forced expiratory volume in 1 second (FEV1) percentage (%) predicted; scale: 0 (greater than \[\>\] 95% predicted) to 6 (less than \[\<\] 50% predicted. Final score is the average score of the 7 questions, with a score range of 0 (well controlled) to 6 (extremely poor controlled). Result was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.
Outcome measures
| Measure |
Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)
n=8 Participants
CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)
n=5 Participants
Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
CAT-354 10 mg/kg
CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
CAT-354 10 mg/kg
CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
|---|---|---|---|---|
|
Asthma Control Questionnaire (ACQ) Total Score
Day 28 (n=5, 4)
|
2.00 units on a scale
Standard Deviation 0.416
|
1.46 units on a scale
Standard Deviation 0.914
|
—
|
—
|
|
Asthma Control Questionnaire (ACQ) Total Score
Baseline (n=8, 5)
|
2.44 units on a scale
Standard Deviation 0.737
|
1.77 units on a scale
Standard Deviation 0.861
|
—
|
—
|
|
Asthma Control Questionnaire (ACQ) Total Score
Day 56 (n=2, 2)
|
1.43 units on a scale
Standard Deviation 0.808
|
1.50 units on a scale
Standard Deviation 1.111
|
—
|
—
|
|
Asthma Control Questionnaire (ACQ) Total Score
Day 84 (n=2, 2)
|
1.57 units on a scale
Standard Deviation 1.010
|
2.36 units on a scale
Standard Deviation 0.101
|
—
|
—
|
|
Asthma Control Questionnaire (ACQ) Total Score
Early Termination (n=5, 3)
|
1.72 units on a scale
Standard Deviation 1.304
|
0.57 units on a scale
Standard Deviation 0.378
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 to 84Population: Data was not collected and hence, not analyzed for this outcome measure because the study was prematurely terminated on the basis of several factors namely, observed low rate of participant randomisation into the study; delay caused by temporary halt of study and potential for expiry date of investigation medicinal product before end of study.
The FEV1 was maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 0, 4, 14, 28, 35, 56, 63 to Day and 84Population: Data was not collected and hence, not analyzed for this outcome measure because the study was prematurely terminated on the basis of several factors namely, observed low rate of participant randomisation into the study; delay caused by temporary halt of study and potential for expiry date of investigation medicinal product before end of study.
Participants recorded asthma symptoms, use of reliever inhalers (beta-agonist use for symptom relief and as prophylaxis), and morning and evening peak expiratory flow (PEF) measurements in a diary.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 0 to Day 84Population: Data was not collected and hence, not analyzed for this outcome measure because the study was prematurely terminated on the basis of several factors namely, observed low rate of participant randomisation into the study; delay caused by temporary halt of study and potential for expiry date of investigation medicinal product before end of study.
Exacerbation was defined as: Mild (determined from diary data) - 2 consecutive days satisfying the same or 1 of the following criteria: any night with awakening(s) due to asthma or morning PEF 20 % or more below baseline where baseline = average of the 10 days before randomization or as-needed medication use of 2 inhalations or more in 24 hours above baseline where baseline = average of the 10 days before randomization. Severe (determined by taking an exacerbation update and history): deterioration of asthma resulting in emergency treatment or hospitalization or need for oral steroids for 3 days or more (as judged by the Investigator).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 0 to Day 84Population: Data was not collected and hence, not analyzed for this outcome measure because the study was prematurely terminated on the basis of several factors namely, observed low rate of participant randomisation into the study; delay caused by temporary halt of study and potential for expiry date of investigation medicinal product before end of study.
Peak flow is a participant's maximum speed of expiration.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 0, 28, 84 or early termination (any time before Day 84)Population: Data was not collected and hence, not analyzed for this outcome measure because the study was prematurely terminated on the basis of several factors namely, observed low rate of participant randomisation into the study; delay caused by temporary halt of study and potential for expiry date of investigation medicinal product before end of study.
The AQLQ: a 32-item questionnaire evaluating quality of life of participants with asthma including 4 domains (symptoms, activity limitations, emotional function, and environmental stimuli). Participants are asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean response to all questions. The 4 domain scores are the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose, 10 minutes and 6 hours post-end of infusion on Day 0, 28 and 56Population: Pharmacokinetic (PK) population included all participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Outcome measures
| Measure |
Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)
n=1 Participants
CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)
n=1 Participants
Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 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 60 minutes on Day 0, 28 and 56.
|
CAT-354 10 mg/kg
CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) for CAT-354
After first dose (Day 0)
|
27.7 microgram/milliliter (mcg/mL)
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
219 microgram/milliliter (mcg/mL)
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
163 microgram/milliliter (mcg/mL)
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
—
|
|
Maximum Observed Serum Concentration (Cmax) for CAT-354
After second dose (Day 28)
|
34.5 microgram/milliliter (mcg/mL)
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
255 microgram/milliliter (mcg/mL)
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
235 microgram/milliliter (mcg/mL)
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
—
|
|
Maximum Observed Serum Concentration (Cmax) for CAT-354
After third dose (Day 56)
|
33.4 microgram/milliliter (mcg/mL)
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
338 microgram/milliliter (mcg/mL)
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
251 microgram/milliliter (mcg/mL)
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
—
|
SECONDARY outcome
Timeframe: Predose, 10 minutes and 6 hours post-end of infusion on Day 0, 28 and 56Population: PK population included all participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Outcome measures
| Measure |
Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)
n=1 Participants
CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)
n=1 Participants
Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 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 60 minutes on Day 0, 28 and 56.
|
CAT-354 10 mg/kg
CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
|---|---|---|---|---|
|
Minimum Observed Serum Concentration (Cmin) for CAT-354
After third dose (Day 56)
|
9.70 mcg/mL
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
85.5 mcg/mL
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
68.4 mcg/mL
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
—
|
|
Minimum Observed Serum Concentration (Cmin) for CAT-354
After first dose (Day 0)
|
4.84 mcg/mL
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
51.8 mcg/mL
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
52.8 mcg/mL
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
—
|
|
Minimum Observed Serum Concentration (Cmin) for CAT-354
After second dose (Day 28)
|
7.91 mcg/mL
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
54.1 mcg/mL
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
64.4 mcg/mL
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
—
|
SECONDARY outcome
Timeframe: Predose, 10 minutes and 6 hours post-end of infusion on Day 0, 28 and 56Population: PK population included all participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Outcome measures
| Measure |
Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)
n=1 Participants
CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)
n=1 Participants
Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 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 60 minutes on Day 0, 28 and 56.
|
CAT-354 10 mg/kg
CAT-354 10 mg/kg of body weight intravenous infusion over 60 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 (Day 0)
|
335 microgram*day/milliliter (mcg*day/mL)
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
2820 microgram*day/milliliter (mcg*day/mL)
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
2090 microgram*day/milliliter (mcg*day/mL)
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
—
|
|
Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC [0 - t]) for CAT-354
After second dose (Day 28)
|
408 microgram*day/milliliter (mcg*day/mL)
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
4720 microgram*day/milliliter (mcg*day/mL)
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
3080 microgram*day/milliliter (mcg*day/mL)
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
—
|
|
Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC [0 - t]) for CAT-354
After third dose (Day 56)
|
499 microgram*day/milliliter (mcg*day/mL)
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
3690 microgram*day/milliliter (mcg*day/mL)
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
3420 microgram*day/milliliter (mcg*day/mL)
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
—
|
SECONDARY outcome
Timeframe: Predose, 10 minutes and 6 hours post-end of infusion on Day 0, 28 and 56Population: PK population included all participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Accumulation ratio (RA) is calculated for Cmax, Cmin and AUC as RA for Cmax = Cmax (56 - 84)/Cmax (0 - 28); Similarily, RA for Cmin = Cmin (56 - 84)/Cmin (0 - 28) and RA for AUC= AUC (56 - 84)/AUC (0 - 28) where Cmax (0 - 28) and Cmax (56 - 84) are the maximum observed serum concentration after first dose (Day 0 to Day 28) and after third dose (Day 56 to Day 84), respectively; Cmin (0 - 28) and Cmin (56 - 84) are the minimum observed serum concentration after first and third dose, respectively; AUC (0 - 28) and AUC (56 - 84) are the area under the serum concentration time curve over a dosage interval determined after first and third dose, respectively.
Outcome measures
| Measure |
Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)
n=1 Participants
CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)
n=1 Participants
Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 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 60 minutes on Day 0, 28 and 56.
|
CAT-354 10 mg/kg
CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
|---|---|---|---|---|
|
Accumulation Ratio for CAT-354 (RA)
RA for Cmin
|
1.20 ratio
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
1.54 ratio
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
1.73 ratio
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
—
|
|
Accumulation Ratio for CAT-354 (RA)
RA for Cmax
|
2.00 ratio
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
1.65 ratio
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
1.30 ratio
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
—
|
|
Accumulation Ratio for CAT-354 (RA)
RA for AUC
|
1.49 ratio
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
1.31 ratio
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
1.64 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 84Population: Safety population included all participants who received at least 1 dose of study medication.
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 84 that were absent before treatment or that worsened relative to pre-treatment state.
Outcome measures
| Measure |
Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)
n=3 Participants
CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)
n=2 Participants
Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
CAT-354 10 mg/kg
n=4 Participants
CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
CAT-354 10 mg/kg
n=4 Participants
CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
|---|---|---|---|---|
|
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TEAEs
|
2 participants
|
2 participants
|
4 participants
|
3 participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TESAEs
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
Adverse Events
Placebo
CAT-354 1 mg/kg
CAT-354 5 mg/kg
CAT-354 10 mg/kg
Serious adverse events
| Measure |
Placebo
n=3 participants at risk
Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56
|
CAT-354 1 mg/kg
n=2 participants at risk
CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
CAT-354 5 mg/kg
n=4 participants at risk
CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
CAT-354 10 mg/kg
n=4 participants at risk
CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
|---|---|---|---|---|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3 • Day 0 to 84
|
0.00%
0/2 • Day 0 to 84
|
0.00%
0/4 • Day 0 to 84
|
25.0%
1/4 • Number of events 1 • Day 0 to 84
|
Other adverse events
| Measure |
Placebo
n=3 participants at risk
Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56
|
CAT-354 1 mg/kg
n=2 participants at risk
CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
CAT-354 5 mg/kg
n=4 participants at risk
CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
CAT-354 10 mg/kg
n=4 participants at risk
CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Day 0 to 84
|
0.00%
0/2 • Day 0 to 84
|
25.0%
1/4 • Number of events 1 • Day 0 to 84
|
0.00%
0/4 • Day 0 to 84
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Day 0 to 84
|
0.00%
0/2 • Day 0 to 84
|
25.0%
1/4 • Number of events 1 • Day 0 to 84
|
0.00%
0/4 • Day 0 to 84
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Day 0 to 84
|
0.00%
0/2 • Day 0 to 84
|
25.0%
1/4 • Number of events 1 • Day 0 to 84
|
0.00%
0/4 • Day 0 to 84
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Day 0 to 84
|
0.00%
0/2 • Day 0 to 84
|
25.0%
1/4 • Number of events 1 • Day 0 to 84
|
0.00%
0/4 • Day 0 to 84
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Day 0 to 84
|
0.00%
0/2 • Day 0 to 84
|
25.0%
1/4 • Number of events 2 • Day 0 to 84
|
25.0%
1/4 • Number of events 1 • Day 0 to 84
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • Day 0 to 84
|
0.00%
0/2 • Day 0 to 84
|
0.00%
0/4 • Day 0 to 84
|
25.0%
1/4 • Number of events 1 • Day 0 to 84
|
|
General disorders
Inflammation
|
0.00%
0/3 • Day 0 to 84
|
0.00%
0/2 • Day 0 to 84
|
0.00%
0/4 • Day 0 to 84
|
25.0%
1/4 • Number of events 1 • Day 0 to 84
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/3 • Day 0 to 84
|
0.00%
0/2 • Day 0 to 84
|
0.00%
0/4 • Day 0 to 84
|
50.0%
2/4 • Number of events 3 • Day 0 to 84
|
|
Infections and infestations
Nasopharyngitis
|
66.7%
2/3 • Number of events 2 • Day 0 to 84
|
100.0%
2/2 • Number of events 2 • Day 0 to 84
|
25.0%
1/4 • Number of events 1 • Day 0 to 84
|
25.0%
1/4 • Number of events 1 • Day 0 to 84
|
|
Infections and infestations
Urinary tract infection
|
33.3%
1/3 • Number of events 1 • Day 0 to 84
|
0.00%
0/2 • Day 0 to 84
|
0.00%
0/4 • Day 0 to 84
|
0.00%
0/4 • Day 0 to 84
|
|
Investigations
Forced expiratory volume decreased
|
0.00%
0/3 • Day 0 to 84
|
0.00%
0/2 • Day 0 to 84
|
25.0%
1/4 • Number of events 1 • Day 0 to 84
|
0.00%
0/4 • Day 0 to 84
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • Day 0 to 84
|
0.00%
0/2 • Day 0 to 84
|
25.0%
1/4 • Number of events 1 • Day 0 to 84
|
0.00%
0/4 • Day 0 to 84
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Day 0 to 84
|
50.0%
1/2 • Number of events 1 • Day 0 to 84
|
0.00%
0/4 • Day 0 to 84
|
0.00%
0/4 • Day 0 to 84
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Day 0 to 84
|
0.00%
0/2 • Day 0 to 84
|
25.0%
1/4 • Number of events 1 • Day 0 to 84
|
0.00%
0/4 • Day 0 to 84
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • Day 0 to 84
|
0.00%
0/2 • Day 0 to 84
|
25.0%
1/4 • Number of events 1 • Day 0 to 84
|
0.00%
0/4 • Day 0 to 84
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
33.3%
1/3 • Number of events 2 • Day 0 to 84
|
0.00%
0/2 • Day 0 to 84
|
25.0%
1/4 • Number of events 1 • Day 0 to 84
|
0.00%
0/4 • Day 0 to 84
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • Day 0 to 84
|
50.0%
1/2 • Number of events 1 • Day 0 to 84
|
0.00%
0/4 • Day 0 to 84
|
0.00%
0/4 • Day 0 to 84
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Day 0 to 84
|
0.00%
0/2 • Day 0 to 84
|
25.0%
1/4 • Number of events 1 • Day 0 to 84
|
0.00%
0/4 • Day 0 to 84
|
Additional Information
Meena Jain, MB BChir/Associate Medical Director
MedImmune, LLC
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 Principal Investigator (PIs) also agree for data to be presented first as a joint, multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER