Trial Outcomes & Findings for A Study to Assess Bioavailability and Pharmacokinetics of CAT- 354 (NCT NCT00638989)
NCT ID: NCT00638989
Last Updated: 2017-05-04
Results Overview
Bioavailability (F) is a measurement of the rate and extent to which a drug reaches the systemic circulation. Absolute bioavailability of the subcutaneous doses was assessed by the geometric least-square means ratios of subcutaneous to intravenous dose-normalized area under the serum concentration-time curve from time zero to infinity (AUC \[0 - infinity\]/Dose). AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).
COMPLETED
PHASE1
30 participants
Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56
2017-05-04
Participant Flow
Participant milestones
| Measure |
CAT-354 150 mg (Intravenous)
A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
|
CAT-354 150 mg (Subcutaneous)
A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
|
CAT-354 300 mg (Subcutaneous)
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
CAT-354 150 mg (Intravenous)
A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
|
CAT-354 150 mg (Subcutaneous)
A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
|
CAT-354 300 mg (Subcutaneous)
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Assess Bioavailability and Pharmacokinetics of CAT- 354
Baseline characteristics by cohort
| Measure |
CAT-354 150 mg (Intravenous)
n=10 Participants
A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
|
CAT-354 150 mg (Subcutaneous)
n=10 Participants
A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
|
CAT-354 300 mg (Subcutaneous)
n=10 Participants
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
30.4 years
STANDARD_DEVIATION 8.3 • n=39 Participants
|
39.3 years
STANDARD_DEVIATION 8.6 • n=41 Participants
|
27.8 years
STANDARD_DEVIATION 10.4 • n=35 Participants
|
32.5 years
STANDARD_DEVIATION 10.1 • n=31 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
30 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56Population: Pharmacokinetic (PK) population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate maximum observed serum concentration (Cmax).
Bioavailability (F) is a measurement of the rate and extent to which a drug reaches the systemic circulation. Absolute bioavailability of the subcutaneous doses was assessed by the geometric least-square means ratios of subcutaneous to intravenous dose-normalized area under the serum concentration-time curve from time zero to infinity (AUC \[0 - infinity\]/Dose). AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).
Outcome measures
| Measure |
CAT-354 150 mg (Subcutaneous)
n=10 Participants
A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
|
CAT-354 300 mg (Subcutaneous)
n=10 Participants
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
|
CAT-354 300 mg (Subcutaneous)
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
|
|---|---|---|---|
|
Absolute Bioavailability of CAT-354 After Subcutaneous Dose
|
62.1 percent bioavailability
Interval 48.5 to 79.6
|
60.1 percent bioavailability
Interval 46.9 to 77.1
|
—
|
SECONDARY outcome
Timeframe: Day 0 to 56Population: Safety population included all participants randomized to treatment, and 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 administration of study drug and up to Day 56 that were absent before treatment or that worsened relative to pre-treatment state.
Outcome measures
| Measure |
CAT-354 150 mg (Subcutaneous)
n=10 Participants
A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
|
CAT-354 300 mg (Subcutaneous)
n=10 Participants
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
|
CAT-354 300 mg (Subcutaneous)
n=10 Participants
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
|
|---|---|---|---|
|
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TEAEs
|
5 participants
|
5 participants
|
4 participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TESAEs
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 0 and Day 56Population: Safety population included all participants randomized to treatment, and received at least 1 dose of study medication.
Outcome measures
| Measure |
CAT-354 150 mg (Subcutaneous)
n=10 Participants
A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
|
CAT-354 300 mg (Subcutaneous)
n=10 Participants
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
|
CAT-354 300 mg (Subcutaneous)
n=10 Participants
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
|
|---|---|---|---|
|
Number of Participants Exhibiting Anti-Drug Antibodies for CAT-354 at Any Visit
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56Population: PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.
AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).
Outcome measures
| Measure |
CAT-354 150 mg (Subcutaneous)
n=10 Participants
A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
|
CAT-354 300 mg (Subcutaneous)
n=10 Participants
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
|
CAT-354 300 mg (Subcutaneous)
n=10 Participants
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
|
|---|---|---|---|
|
Area Under the Concentration-time Curve From Zero to Infinity (AUC [0 - Infinity])
|
903 (microgram*day)/milliliter (mcg*day/mL)
Standard Deviation 291
|
548 (microgram*day)/milliliter (mcg*day/mL)
Standard Deviation 143
|
1080 (microgram*day)/milliliter (mcg*day/mL)
Standard Deviation 315
|
SECONDARY outcome
Timeframe: Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56Population: PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.
Outcome measures
| Measure |
CAT-354 150 mg (Subcutaneous)
n=10 Participants
A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
|
CAT-354 300 mg (Subcutaneous)
n=10 Participants
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
|
CAT-354 300 mg (Subcutaneous)
n=10 Participants
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
|
|---|---|---|---|
|
Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - 56])
|
765 mcg*day/mL
Standard Deviation 220
|
467 mcg*day/mL
Standard Deviation 122
|
881 mcg*day/mL
Standard Deviation 287
|
SECONDARY outcome
Timeframe: Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56Population: PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.
AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity). (AUC \[0 - infinity\]) was normalized by CAT-354 dose.
Outcome measures
| Measure |
CAT-354 150 mg (Subcutaneous)
n=10 Participants
A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
|
CAT-354 300 mg (Subcutaneous)
n=10 Participants
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
|
CAT-354 300 mg (Subcutaneous)
n=10 Participants
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
|
|---|---|---|---|
|
Dose Normalized Area Under the Concentration-time Curve From Zero to Infinity ([AUC {0 - Infinity}]/Dose)
|
6.02 ([mcg*day]/mL)/mg
Standard Deviation 1.94
|
3.66 ([mcg*day]/mL)/mg
Standard Deviation 0.953
|
3.59 ([mcg*day]/mL)/mg
Standard Deviation 1.05
|
SECONDARY outcome
Timeframe: Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56Population: PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.
Outcome measures
| Measure |
CAT-354 150 mg (Subcutaneous)
n=10 Participants
A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
|
CAT-354 300 mg (Subcutaneous)
n=10 Participants
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
|
CAT-354 300 mg (Subcutaneous)
n=10 Participants
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
|
|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax)
|
58.3 microgram/milliliter (mcg/mL)
Standard Deviation 14.4
|
17.1 microgram/milliliter (mcg/mL)
Standard Deviation 5.91
|
36.6 microgram/milliliter (mcg/mL)
Standard Deviation 13.1
|
SECONDARY outcome
Timeframe: Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56Population: PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.
Outcome measures
| Measure |
CAT-354 150 mg (Subcutaneous)
n=10 Participants
A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
|
CAT-354 300 mg (Subcutaneous)
n=10 Participants
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
|
CAT-354 300 mg (Subcutaneous)
n=10 Participants
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
|
|---|---|---|---|
|
Dose Normalized Maximum Observed Concentration (Cmax/Dose)
|
0.389 (mcg/mL)/mg
Standard Deviation 0.096
|
0.114 (mcg/mL)/mg
Standard Deviation 0.039
|
0.122 (mcg/mL)/mg
Standard Deviation 0.044
|
SECONDARY outcome
Timeframe: Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56Population: PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.
Outcome measures
| Measure |
CAT-354 150 mg (Subcutaneous)
n=10 Participants
A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
|
CAT-354 300 mg (Subcutaneous)
n=10 Participants
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
|
CAT-354 300 mg (Subcutaneous)
n=10 Participants
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
|
|---|---|---|---|
|
Time to Reach Maximum Observed Serum Concentration (Tmax)
|
0.063 days
Interval 0.042 to 1.02
|
5 days
Interval 3.0 to 9.0
|
5 days
Interval 3.0 to 9.0
|
SECONDARY outcome
Timeframe: Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56Population: PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.
Terminal phase elimination half-life is the time measured for the serum concentration to decrease by one half.
Outcome measures
| Measure |
CAT-354 150 mg (Subcutaneous)
n=10 Participants
A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
|
CAT-354 300 mg (Subcutaneous)
n=10 Participants
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
|
CAT-354 300 mg (Subcutaneous)
n=10 Participants
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
|
|---|---|---|---|
|
Terminal Phase Elimination Half Life (t1/2)
|
21.4 days
Standard Deviation 2.46
|
19.2 days
Standard Deviation 3.1
|
19.4 days
Standard Deviation 3.59
|
SECONDARY outcome
Timeframe: Predose, 30 minutes, at 1, 3, 8 and 24 hours post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56Population: PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after subcutaneous dose (apparent systemic clearance) is influenced by the fraction of the dose absorbed (bioavailability).
Outcome measures
| Measure |
CAT-354 150 mg (Subcutaneous)
n=10 Participants
A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
|
CAT-354 300 mg (Subcutaneous)
n=10 Participants
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
|
CAT-354 300 mg (Subcutaneous)
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
|
|---|---|---|---|
|
Apparent Systemic Clearance (CL/F) After Subcutaneous Dose
|
292 mL/day
Standard Deviation 82.3
|
307 mL/day
Standard Deviation 109
|
—
|
SECONDARY outcome
Timeframe: Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56Population: PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Outcome measures
| Measure |
CAT-354 150 mg (Subcutaneous)
n=10 Participants
A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
|
CAT-354 300 mg (Subcutaneous)
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
|
CAT-354 300 mg (Subcutaneous)
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
|
|---|---|---|---|
|
Apparent Systemic Clearance (CL/F) After Intravenous Dose
|
188 mL/day
Standard Deviation 84.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, end of infusion, 30 minutes, at 1, 3, 8 and 24 hours post-end of infusion on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56Population: PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate 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 at steady state (Vss) after intravenous dosing was estimated by the formula Vss=MRT(Infinity)\*CL, where MRT(Infinity)= AUCM(Infinity)/AUC(0 - infinity) where MRT(Infinity) = mean residence time at infinity, CL= clearance, AUCM\[Infinity\] = area under the moment curve, and AUC (0 - infinity) = area under the serum concentration versus time curve from time zero (predose) to extrapolated infinite time (0 - infinity).
Outcome measures
| Measure |
CAT-354 150 mg (Subcutaneous)
n=10 Participants
A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
|
CAT-354 300 mg (Subcutaneous)
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
|
CAT-354 300 mg (Subcutaneous)
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
|
|---|---|---|---|
|
Volume of Distribution at Steady State (Vss) After Intravenous Infusion
|
4960 mL
Standard Deviation 1440
|
—
|
—
|
Adverse Events
CAT-354 150 mg (Intravenous)
CAT-354 150 mg (Subcutaneous)
CAT-354 300 mg (Subcutaneous)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CAT-354 150 mg (Intravenous)
n=10 participants at risk
A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
|
CAT-354 150 mg (Subcutaneous)
n=10 participants at risk
A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
|
CAT-354 300 mg (Subcutaneous)
n=10 participants at risk
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
|
|---|---|---|---|
|
Eye disorders
Eye pruritus
|
10.0%
1/10 • Number of events 1 • Day 0 to 56
|
0.00%
0/10 • Day 0 to 56
|
0.00%
0/10 • Day 0 to 56
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • Day 0 to 56
|
10.0%
1/10 • Number of events 1 • Day 0 to 56
|
0.00%
0/10 • Day 0 to 56
|
|
General disorders
Feeling cold
|
0.00%
0/10 • Day 0 to 56
|
10.0%
1/10 • Number of events 1 • Day 0 to 56
|
0.00%
0/10 • Day 0 to 56
|
|
General disorders
Feeling hot
|
10.0%
1/10 • Number of events 1 • Day 0 to 56
|
0.00%
0/10 • Day 0 to 56
|
0.00%
0/10 • Day 0 to 56
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
10.0%
1/10 • Number of events 1 • Day 0 to 56
|
0.00%
0/10 • Day 0 to 56
|
0.00%
0/10 • Day 0 to 56
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/10 • Day 0 to 56
|
0.00%
0/10 • Day 0 to 56
|
10.0%
1/10 • Number of events 1 • Day 0 to 56
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/10 • Day 0 to 56
|
0.00%
0/10 • Day 0 to 56
|
10.0%
1/10 • Number of events 2 • Day 0 to 56
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • Number of events 1 • Day 0 to 56
|
0.00%
0/10 • Day 0 to 56
|
0.00%
0/10 • Day 0 to 56
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
10.0%
1/10 • Number of events 1 • Day 0 to 56
|
0.00%
0/10 • Day 0 to 56
|
0.00%
0/10 • Day 0 to 56
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
1/10 • Number of events 1 • Day 0 to 56
|
0.00%
0/10 • Day 0 to 56
|
0.00%
0/10 • Day 0 to 56
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/10 • Day 0 to 56
|
0.00%
0/10 • Day 0 to 56
|
10.0%
1/10 • Number of events 1 • Day 0 to 56
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • Number of events 1 • Day 0 to 56
|
10.0%
1/10 • Number of events 1 • Day 0 to 56
|
0.00%
0/10 • Day 0 to 56
|
|
Nervous system disorders
Headache
|
40.0%
4/10 • Number of events 4 • Day 0 to 56
|
40.0%
4/10 • Number of events 7 • Day 0 to 56
|
10.0%
1/10 • Number of events 3 • Day 0 to 56
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/10 • Day 0 to 56
|
10.0%
1/10 • Number of events 1 • Day 0 to 56
|
0.00%
0/10 • Day 0 to 56
|
|
Nervous system disorders
Somnolence
|
10.0%
1/10 • Number of events 1 • Day 0 to 56
|
0.00%
0/10 • Day 0 to 56
|
0.00%
0/10 • Day 0 to 56
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/10 • Day 0 to 56
|
0.00%
0/10 • Day 0 to 56
|
10.0%
1/10 • Number of events 1 • Day 0 to 56
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/10 • Day 0 to 56
|
0.00%
0/10 • Day 0 to 56
|
10.0%
1/10 • Number of events 1 • Day 0 to 56
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • Number of events 1 • Day 0 to 56
|
0.00%
0/10 • Day 0 to 56
|
0.00%
0/10 • Day 0 to 56
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/10 • Day 0 to 56
|
0.00%
0/10 • Day 0 to 56
|
10.0%
1/10 • Number of events 1 • Day 0 to 56
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.0%
1/10 • Number of events 1 • Day 0 to 56
|
0.00%
0/10 • Day 0 to 56
|
0.00%
0/10 • Day 0 to 56
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hype
|
0.00%
0/10 • Day 0 to 56
|
20.0%
2/10 • Number of events 2 • Day 0 to 56
|
0.00%
0/10 • Day 0 to 56
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pa
|
10.0%
1/10 • Number of events 1 • Day 0 to 56
|
0.00%
0/10 • Day 0 to 56
|
0.00%
0/10 • Day 0 to 56
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
10.0%
1/10 • Number of events 1 • Day 0 to 56
|
0.00%
0/10 • Day 0 to 56
|
0.00%
0/10 • Day 0 to 56
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
10.0%
1/10 • Number of events 1 • Day 0 to 56
|
10.0%
1/10 • Number of events 1 • Day 0 to 56
|
0.00%
0/10 • Day 0 to 56
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
10.0%
1/10 • Number of events 1 • Day 0 to 56
|
0.00%
0/10 • Day 0 to 56
|
0.00%
0/10 • Day 0 to 56
|
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.
- Publication restrictions are in place
Restriction type: OTHER