Trial Outcomes & Findings for A Study to Compare the Pharmacokinetics of Mepolizumab as a Liquid Drug in a Safety Syringe or an Autoinjector Versus Lyophilised Drug (NCT NCT03014674)
NCT ID: NCT03014674
Last Updated: 2019-12-03
Results Overview
Blood samples were collected at indicated time points. Cmax following a single dose administration of liquid mepolizumab using a safety syringe and an autoinjector were compared with reconstituted lyophilized drug product from the vial. Pharmacokinetic (PK) Population comprised of all participants receiving study drug for whom a pharmacokinetic sample was obtained and analyzed.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
246 participants
Primary outcome timeframe
Day 1 (pre-dose, 2 hours, and 8 hours post-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57 and 85 post-dose
Results posted on
2019-12-03
Participant Flow
This was a randomized, multi-center, open-label, parallel-group, single-dose study in healthy participants. The participants were administered one of 3 different mepolizumab treatments (a liquid drug product in a safety syringe; a liquid drug product in an autoinjector; a reconstituted lyophilized drug product from a vial).
A total of 246 participants were randomized and 244 participants received study treatment. Two participants were randomized in error
Participant milestones
| Measure |
Lyophilized Vial
Participants were administered 100 milligram per milliliter (mg/mL) subcutaneous (SC) dose of mepolizumab as lyophilized powder reconstituted with sterile water for injection from vial. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Autoinjector
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled autoinjector. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Safety Syringe
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled safety syringe. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
|---|---|---|---|
|
Overall Study
STARTED
|
85
|
79
|
80
|
|
Overall Study
COMPLETED
|
84
|
79
|
80
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Lyophilized Vial
Participants were administered 100 milligram per milliliter (mg/mL) subcutaneous (SC) dose of mepolizumab as lyophilized powder reconstituted with sterile water for injection from vial. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Autoinjector
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled autoinjector. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Safety Syringe
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled safety syringe. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
A Study to Compare the Pharmacokinetics of Mepolizumab as a Liquid Drug in a Safety Syringe or an Autoinjector Versus Lyophilised Drug
Baseline characteristics by cohort
| Measure |
Lyophilized Vial
n=85 Participants
Participants were administered 100 milligram per milliliter (mg/mL) subcutaneous (SC) dose of mepolizumab as lyophilized powder reconstituted with sterile water for injection from vial. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Autoinjector
n=79 Participants
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled autoinjector. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Safety Syringe
n=80 Participants
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled safety syringe. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Total
n=244 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46.1 Years
STANDARD_DEVIATION 15.06 • n=5 Participants
|
46.5 Years
STANDARD_DEVIATION 15.00 • n=7 Participants
|
47.5 Years
STANDARD_DEVIATION 14.94 • n=5 Participants
|
46.7 Years
STANDARD_DEVIATION 14.95 • n=4 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
114 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
130 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Central/South Asian heritage
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
East Asian heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other pacific islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Arabic/ North African heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian/European heritage
|
64 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
186 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian and White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American and White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose, 2 hours, and 8 hours post-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57 and 85 post-dosePopulation: PK Population
Blood samples were collected at indicated time points. Cmax following a single dose administration of liquid mepolizumab using a safety syringe and an autoinjector were compared with reconstituted lyophilized drug product from the vial. Pharmacokinetic (PK) Population comprised of all participants receiving study drug for whom a pharmacokinetic sample was obtained and analyzed.
Outcome measures
| Measure |
Lyophilized Vial
n=85 Participants
Participants were administered 100 milligram per milliliter (mg/mL) subcutaneous (SC) dose of mepolizumab as lyophilized powder reconstituted with sterile water for injection from vial. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Autoinjector
n=79 Participants
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled autoinjector. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Safety Syringe
n=80 Participants
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled safety syringe. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Mepolizumab
|
11.57 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 27.43
|
11.98 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 24.96
|
12.07 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 27.29
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose, 2 hours, and 8 hours post-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57 and 85 post-dosePopulation: PK Population
Blood samples were collected at indicated time points. AUC(0-t) and AUC(0-inf) following a single dose administration of liquid mepolizumab using a safety syringe and an autoinjector were compared with lyophilized drug product. Fixed effects analysis of covariance model was used for analysis. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
Outcome measures
| Measure |
Lyophilized Vial
n=85 Participants
Participants were administered 100 milligram per milliliter (mg/mL) subcutaneous (SC) dose of mepolizumab as lyophilized powder reconstituted with sterile water for injection from vial. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Autoinjector
n=79 Participants
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled autoinjector. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Safety Syringe
n=80 Participants
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled safety syringe. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
|---|---|---|---|
|
Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-t]), AUC From Time Zero Extrapolated to Infinite Time (AUC[0-inf]) of Mepolizumab
AUC(0-t), n=85, 79, 80
|
403.84 Days*µg/mL
Geometric Coefficient of Variation 25.84
|
434.49 Days*µg/mL
Geometric Coefficient of Variation 22.62
|
415.15 Days*µg/mL
Geometric Coefficient of Variation 27.25
|
|
Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-t]), AUC From Time Zero Extrapolated to Infinite Time (AUC[0-inf]) of Mepolizumab
AUC(0-inf), n=84, 79, 80
|
450.83 Days*µg/mL
Geometric Coefficient of Variation 25.65
|
478.06 Days*µg/mL
Geometric Coefficient of Variation 24.76
|
454.11 Days*µg/mL
Geometric Coefficient of Variation 28.88
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 2 hours, and 8 hours post-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57 and 85 post-dosePopulation: PK Population
Blood samples were collected at indicated time points. Tmax and tlast following a single dose administration of liquid mepolizumab using a safety syringe and an autoinjector were compared with lyophilized drug product.
Outcome measures
| Measure |
Lyophilized Vial
n=85 Participants
Participants were administered 100 milligram per milliliter (mg/mL) subcutaneous (SC) dose of mepolizumab as lyophilized powder reconstituted with sterile water for injection from vial. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Autoinjector
n=79 Participants
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled autoinjector. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Safety Syringe
n=80 Participants
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled safety syringe. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
|---|---|---|---|
|
Time to Cmax (Tmax) and Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) of Mepolizumab
tmax
|
7.04 Days
Interval 0.9 to 14.1
|
7.05 Days
Interval 2.9 to 21.0
|
7.06 Days
Interval 1.9 to 14.0
|
|
Time to Cmax (Tmax) and Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) of Mepolizumab
tlast
|
83.97 Days
Interval 14.0 to 87.0
|
83.98 Days
Interval 81.1 to 87.1
|
83.99 Days
Interval 55.9 to 87.9
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 2 hours, and 8 hours post-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57 and 85 post-dosePopulation: PK Population
Blood samples were collected at indicated time points . CL/F following a single dose administration of liquid mepolizumab using a safety syringe and an autoinjector were compared with lyophilized drug product. Only those participants with data available were analyzed.
Outcome measures
| Measure |
Lyophilized Vial
n=84 Participants
Participants were administered 100 milligram per milliliter (mg/mL) subcutaneous (SC) dose of mepolizumab as lyophilized powder reconstituted with sterile water for injection from vial. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Autoinjector
n=79 Participants
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled autoinjector. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Safety Syringe
n=80 Participants
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled safety syringe. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
|---|---|---|---|
|
Apparent Clearance (CL/F) of Mepolizumab
|
0.009242 Liters per hour (L/h)
Geometric Coefficient of Variation 27.91
|
0.008716 Liters per hour (L/h)
Geometric Coefficient of Variation 28.74
|
0.009175 Liters per hour (L/h)
Geometric Coefficient of Variation 39.30
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 2 hours, and 8 hours post-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57 and 85 post-dosePopulation: PK Population
Blood samples were collected at indicated time points. Vd/F following a single dose administration of liquid mepolizumab using a safety syringe and an autoinjector were compared with lyophilized drug product. Only those participants with data available were analyzed.
Outcome measures
| Measure |
Lyophilized Vial
n=84 Participants
Participants were administered 100 milligram per milliliter (mg/mL) subcutaneous (SC) dose of mepolizumab as lyophilized powder reconstituted with sterile water for injection from vial. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Autoinjector
n=79 Participants
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled autoinjector. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Safety Syringe
n=80 Participants
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled safety syringe. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
|---|---|---|---|
|
Apparent Volume of Distribution (Vd/F) of Mepolizumab
|
7.02 Liters (L)
Geometric Coefficient of Variation 22.49
|
6.74 Liters (L)
Geometric Coefficient of Variation 26.34
|
6.94 Liters (L)
Geometric Coefficient of Variation 31.84
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 2 hours, and 8 hours post-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57 and 85 post-dosePopulation: PK Population
Blood samples were collected at indicated time points. Lambda z following a single dose administration of liquid mepolizumab using a safety syringe and an autoinjector were compared with lyophilized drug product. Only those participants with data available were analyzed.
Outcome measures
| Measure |
Lyophilized Vial
n=84 Participants
Participants were administered 100 milligram per milliliter (mg/mL) subcutaneous (SC) dose of mepolizumab as lyophilized powder reconstituted with sterile water for injection from vial. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Autoinjector
n=79 Participants
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled autoinjector. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Safety Syringe
n=80 Participants
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled safety syringe. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
|---|---|---|---|
|
Terminal Phase Elimination Rate Constant (Lambda z) of Mepolizumab
|
0.0013157 Per hours
Geometric Coefficient of Variation 21.51
|
0.0012930 Per hours
Geometric Coefficient of Variation 26.20
|
0.0013228 Per hours
Geometric Coefficient of Variation 26.71
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 2 hours, and 8 hours post-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57 and 85 post-dosePopulation: PK Population
Blood samples were collected at indicated time points for calculating t½. t½ following a single dose administration of liquid mepolizumab using a safety syringe and an autoinjector were compared with lyophilized drug product. Only those participants with data available were analyzed.
Outcome measures
| Measure |
Lyophilized Vial
n=84 Participants
Participants were administered 100 milligram per milliliter (mg/mL) subcutaneous (SC) dose of mepolizumab as lyophilized powder reconstituted with sterile water for injection from vial. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Autoinjector
n=79 Participants
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled autoinjector. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Safety Syringe
n=80 Participants
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled safety syringe. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
|---|---|---|---|
|
Terminal Phase Half-life (t½) of Mepolizumab
|
21.95 Days
Geometric Coefficient of Variation 18.66
|
22.34 Days
Geometric Coefficient of Variation 21.38
|
21.83 Days
Geometric Coefficient of Variation 21.62
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 2 hours, and 8 hours post-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57 and 85 post-dosePopulation: PK Population
Blood samples were collected at indicated time points. Percentage AUCex following a single dose administration of liquid mepolizumab using a safety syringe and an autoinjector were compared with lyophilized drug product. Only those participants with data available were analyzed.
Outcome measures
| Measure |
Lyophilized Vial
n=84 Participants
Participants were administered 100 milligram per milliliter (mg/mL) subcutaneous (SC) dose of mepolizumab as lyophilized powder reconstituted with sterile water for injection from vial. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Autoinjector
n=79 Participants
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled autoinjector. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Safety Syringe
n=80 Participants
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled safety syringe. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
|---|---|---|---|
|
Percentage of AUC(0-inf) Obtained by Extrapolation (% AUCex) of Mepolizumab
|
7.67 Percentage
Geometric Coefficient of Variation 42.06
|
7.64 Percentage
Geometric Coefficient of Variation 47.30
|
7.20 Percentage
Geometric Coefficient of Variation 48.24
|
SECONDARY outcome
Timeframe: Up to 28 days post-dosePopulation: All Treated Subjects (Safety) Population
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or events associated with liver injury and impaired liver function were categorized as SAE. All Treated Subjects (Safety) comprised of all participants who received mepolizumab. Participants with non-serious AEs (3 percentage threshold) and SAEs has been reported.
Outcome measures
| Measure |
Lyophilized Vial
n=85 Participants
Participants were administered 100 milligram per milliliter (mg/mL) subcutaneous (SC) dose of mepolizumab as lyophilized powder reconstituted with sterile water for injection from vial. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Autoinjector
n=79 Participants
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled autoinjector. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Safety Syringe
n=80 Participants
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled safety syringe. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
|---|---|---|---|
|
Number of Participants With On-treatment Non-serious Adverse Events (AEs) and Serious AEs (SAEs)
Non-serious AEs
|
11 Participants
|
13 Participants
|
14 Participants
|
|
Number of Participants With On-treatment Non-serious Adverse Events (AEs) and Serious AEs (SAEs)
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 28 days post-dosePopulation: All Treated Subjects (Safety) Population
Adverse events of special interest like local injection site reactions and systemic reactions like allergic Type I hypersensitivity were reported along with AEs and SAEs. Participants with local injection site reaction and Allergic Type I hypersensitivity systemic reactions are reported here.
Outcome measures
| Measure |
Lyophilized Vial
n=85 Participants
Participants were administered 100 milligram per milliliter (mg/mL) subcutaneous (SC) dose of mepolizumab as lyophilized powder reconstituted with sterile water for injection from vial. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Autoinjector
n=79 Participants
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled autoinjector. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Safety Syringe
n=80 Participants
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled safety syringe. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
|---|---|---|---|
|
Number of Participants With On-treatment Systemic Reactions and Injection Site Reactions
Systemic reactions
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With On-treatment Systemic Reactions and Injection Site Reactions
Injection site reactions
|
1 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to Day 85Population: All Treated Subjects (Safety) Population
Hematology parameters included assessment of platelet count, erythrocytes, leukocytes, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), neutrophils, lymphocytes, monocytes, eosinophils, basophils, hemoglobin and hematocrit. Participants were counted in the worst case category that their value changes to Low, Normal or High. Participants whose value category was unchanged or whose value became normal, were recorded in the "To Normal or No Change" category. The worst case post-Baseline values has been reported. For basophils the "to low" category is not applicable (NA) as the lower limit of normal is zero for this parameter.
Outcome measures
| Measure |
Lyophilized Vial
n=85 Participants
Participants were administered 100 milligram per milliliter (mg/mL) subcutaneous (SC) dose of mepolizumab as lyophilized powder reconstituted with sterile water for injection from vial. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Autoinjector
n=79 Participants
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled autoinjector. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Safety Syringe
n=80 Participants
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled safety syringe. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
|---|---|---|---|
|
Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range
Basophils, To low
|
NA Participants
For basophils the "to low" category is not applicable (NA) as the lower limit of normal is zero for this parameter.
|
NA Participants
For basophils the "to low" category is not applicable (NA) as the lower limit of normal is zero for this parameter.
|
NA Participants
For basophils the "to low" category is not applicable (NA) as the lower limit of normal is zero for this parameter.
|
|
Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range
Basophils, To normal or no change
|
85 Participants
|
79 Participants
|
80 Participants
|
|
Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range
Basophils, To high
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range
Eosinophils, To low
|
58 Participants
|
46 Participants
|
55 Participants
|
|
Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range
Eosinophils, To normal or no change
|
27 Participants
|
33 Participants
|
24 Participants
|
|
Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range
Eosinophils, To high
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range
Hematocrit, To low
|
8 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range
Hematocrit, To normal or no change
|
76 Participants
|
72 Participants
|
75 Participants
|
|
Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range
Hematocrit, To high
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range
Hemoglobin, To low
|
12 Participants
|
8 Participants
|
13 Participants
|
|
Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range
Hemoglobin, To normal or no change
|
73 Participants
|
70 Participants
|
67 Participants
|
|
Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range
Hemoglobin, To high
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range
Lymphocytes, To low
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range
Lymphocytes, To normal or no change
|
83 Participants
|
79 Participants
|
79 Participants
|
|
Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range
Lymphocytes, To high
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range
MCH, To low
|
0 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range
MCH, To normal or no change
|
84 Participants
|
74 Participants
|
78 Participants
|
|
Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range
MCH, To high
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range
MCV, To low
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range
MCV, To normal or no change
|
83 Participants
|
79 Participants
|
79 Participants
|
|
Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range
MCV, To high
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range
Monocytes, To low
|
11 Participants
|
8 Participants
|
12 Participants
|
|
Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range
Monocytes, To normal or no change
|
74 Participants
|
71 Participants
|
68 Participants
|
|
Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range
Monocytes, To high
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range
Neutrophils, To low
|
7 Participants
|
11 Participants
|
9 Participants
|
|
Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range
Neutrophils, To normal or no change
|
77 Participants
|
68 Participants
|
71 Participants
|
|
Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range
Neutrophils, To high
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range
Platelets, To low
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range
Platelets, To normal or no change
|
85 Participants
|
78 Participants
|
79 Participants
|
|
Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range
Platelets, To high
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range
Erythrocytes, To low
|
4 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range
Erythrocytes, To normal or no change
|
81 Participants
|
78 Participants
|
77 Participants
|
|
Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range
Erythrocytes, To high
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range
Leukocytes, To low
|
11 Participants
|
9 Participants
|
8 Participants
|
|
Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range
Leukocytes, To normal or no change
|
73 Participants
|
70 Participants
|
72 Participants
|
|
Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range
Leukocytes, To high
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 85Population: All Treated Subjects (Safety) Population
Blood samples were collected to evaluate clinical chemistry parameters, which included assessment of creatinine, creatine kinase, glucose, protein, potassium, urea, sodium, calcium, alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), direct bilirubin (D.bili) and bilirubin, and albumin. Participants were counted in the worst case category that their value changes to Low, Normal or High. Participants whose value category was unchanged or whose value became normal, were recorded in the "To Normal or No Change" category. The worst case post-Baseline values has been reported. Only those participants with data available at the specified data points were analyzed. For the category "to low " NA indicates data was not available as the lower limit of normal is zero for this parameter.
Outcome measures
| Measure |
Lyophilized Vial
n=84 Participants
Participants were administered 100 milligram per milliliter (mg/mL) subcutaneous (SC) dose of mepolizumab as lyophilized powder reconstituted with sterile water for injection from vial. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Autoinjector
n=79 Participants
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled autoinjector. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Safety Syringe
n=80 Participants
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled safety syringe. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
|---|---|---|---|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
Glucose, To low
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
Glucose, To normal or no change
|
83 Participants
|
79 Participants
|
80 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
Glucose, To high
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
Albumin, To low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
Albumin, To normal or no change
|
83 Participants
|
79 Participants
|
80 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
Albumin, To high
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
ALP, To low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
ALP, To normal or no change
|
84 Participants
|
79 Participants
|
80 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
ALP, To high
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
ALT, To low
|
NA Participants
NA indicates data was not available as the lower limit of normal is zero for this parameter
|
NA Participants
NA indicates data was not available as the lower limit of normal is zero for this parameter
|
NA Participants
NA indicates data was not available as the lower limit of normal is zero for this parameter
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
ALT, To normal or no change
|
84 Participants
|
78 Participants
|
80 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
AST, To low
|
NA Participants
NA indicates data was not available as the lower limit of normal is zero for this parameter
|
NA Participants
NA indicates data was not available as the lower limit of normal is zero for this parameter
|
NA Participants
NA indicates data was not available as the lower limit of normal is zero for this parameter
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
D.bilirubin, To low
|
NA Participants
NA indicates data was not available as the lower limit of normal is zero for this parameter
|
NA Participants
NA indicates data was not available as the lower limit of normal is zero for this parameter
|
NA Participants
NA indicates data was not available as the lower limit of normal is zero for this parameter
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
D.bilirubin, To normal or no change
|
83 Participants
|
79 Participants
|
80 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
Bilirubin, To normal or no change
|
82 Participants
|
79 Participants
|
78 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
Bilirubin, To high
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
Calcium, To low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
Calcium, To normal or no change
|
83 Participants
|
79 Participants
|
79 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
Calcium, To high
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
Creatine kinase, To low
|
NA Participants
NA indicates data was not available as the lower limit of normal is zero for this parameter
|
NA Participants
NA indicates data was not available as the lower limit of normal is zero for this parameter
|
NA Participants
NA indicates data was not available as the lower limit of normal is zero for this parameter
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
Creatine kinase,To normal or no change
|
76 Participants
|
68 Participants
|
70 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
Creatine kinase, To high
|
8 Participants
|
11 Participants
|
10 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
Creatinine, To low
|
4 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
Creatinine, To normal or no change
|
79 Participants
|
75 Participants
|
79 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
Creatinine, To high
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
Potassium, To low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
Potassium, To normal or no change
|
84 Participants
|
79 Participants
|
80 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
Potassium, To high
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
Protein, To low
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
Protein, To normal or no change
|
83 Participants
|
78 Participants
|
80 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
Protein, To high
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
Sodium, To low
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
Sodium, To normal or no change
|
83 Participants
|
79 Participants
|
80 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
Sodium, To high
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
Urea, To low
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
Urea, To normal or no change
|
83 Participants
|
75 Participants
|
79 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
Urea, To high
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
ALT, To high
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
AST, To normal or no change
|
84 Participants
|
78 Participants
|
80 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
AST, To high
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
D.bilirubin, To high
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
Bilirubin, To low
|
NA Participants
NA indicates data was not available as the lower limit of normal is zero for this parameter
|
NA Participants
NA indicates data was not available as the lower limit of normal is zero for this parameter
|
NA Participants
NA indicates data was not available as the lower limit of normal is zero for this parameter
|
SECONDARY outcome
Timeframe: Baseline and up to Day 85Population: All Treated Subjects (Safety) Population
SBP and DBP were measured in supine position after 5 minutes rest. Baseline values for each assessment was the latest available assessment prior to receiving the single dose of mepolizumab. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Outcome measures
| Measure |
Lyophilized Vial
n=85 Participants
Participants were administered 100 milligram per milliliter (mg/mL) subcutaneous (SC) dose of mepolizumab as lyophilized powder reconstituted with sterile water for injection from vial. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Autoinjector
n=79 Participants
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled autoinjector. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Safety Syringe
n=80 Participants
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled safety syringe. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
|---|---|---|---|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Day 2, n=85, 79, 80
|
1.9 Millimeter of mercury (mmHg)
Standard Deviation 7.36
|
3.1 Millimeter of mercury (mmHg)
Standard Deviation 6.90
|
3.0 Millimeter of mercury (mmHg)
Standard Deviation 6.47
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Day 3, n=85, 79, 79
|
0.2 Millimeter of mercury (mmHg)
Standard Deviation 7.06
|
1.7 Millimeter of mercury (mmHg)
Standard Deviation 6.60
|
0.8 Millimeter of mercury (mmHg)
Standard Deviation 7.90
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Day 4, n=85, 78, 80
|
0.7 Millimeter of mercury (mmHg)
Standard Deviation 6.44
|
1.6 Millimeter of mercury (mmHg)
Standard Deviation 7.55
|
0.8 Millimeter of mercury (mmHg)
Standard Deviation 6.33
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Day 5, n=85, 79, 80
|
1.2 Millimeter of mercury (mmHg)
Standard Deviation 7.04
|
2.4 Millimeter of mercury (mmHg)
Standard Deviation 7.48
|
1.8 Millimeter of mercury (mmHg)
Standard Deviation 6.40
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Day 6, n=85, 78, 80
|
0.8 Millimeter of mercury (mmHg)
Standard Deviation 6.80
|
0.9 Millimeter of mercury (mmHg)
Standard Deviation 7.11
|
0.2 Millimeter of mercury (mmHg)
Standard Deviation 7.96
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Day 7, n=85, 78, 80
|
0.4 Millimeter of mercury (mmHg)
Standard Deviation 7.44
|
0.3 Millimeter of mercury (mmHg)
Standard Deviation 6.70
|
1.2 Millimeter of mercury (mmHg)
Standard Deviation 7.50
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Day 43, n=84, 79, 80
|
0.9 Millimeter of mercury (mmHg)
Standard Deviation 8.04
|
2.2 Millimeter of mercury (mmHg)
Standard Deviation 6.70
|
1.3 Millimeter of mercury (mmHg)
Standard Deviation 7.22
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Follow up, n=84, 79, 80
|
3.3 Millimeter of mercury (mmHg)
Standard Deviation 8.26
|
3.5 Millimeter of mercury (mmHg)
Standard Deviation 6.69
|
2.3 Millimeter of mercury (mmHg)
Standard Deviation 6.70
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Day 2, n=85, 79, 80
|
3.1 Millimeter of mercury (mmHg)
Standard Deviation 10.61
|
2.0 Millimeter of mercury (mmHg)
Standard Deviation 11.15
|
3.5 Millimeter of mercury (mmHg)
Standard Deviation 11.25
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Day 3, n=85, 79, 79
|
2.4 Millimeter of mercury (mmHg)
Standard Deviation 10.45
|
0.7 Millimeter of mercury (mmHg)
Standard Deviation 10.28
|
1.3 Millimeter of mercury (mmHg)
Standard Deviation 11.12
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Day 4, n=85, 78, 80
|
1.7 Millimeter of mercury (mmHg)
Standard Deviation 9.51
|
1.7 Millimeter of mercury (mmHg)
Standard Deviation 9.95
|
0.7 Millimeter of mercury (mmHg)
Standard Deviation 10.07
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Day 5, n=85, 79, 80
|
2.1 Millimeter of mercury (mmHg)
Standard Deviation 11.03
|
2.5 Millimeter of mercury (mmHg)
Standard Deviation 10.39
|
1.3 Millimeter of mercury (mmHg)
Standard Deviation 9.67
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Day 6, n=85, 78, 80
|
1.1 Millimeter of mercury (mmHg)
Standard Deviation 9.38
|
-0.6 Millimeter of mercury (mmHg)
Standard Deviation 9.72
|
-0.2 Millimeter of mercury (mmHg)
Standard Deviation 10.81
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Day 7, n=85, 78, 80
|
1.1 Millimeter of mercury (mmHg)
Standard Deviation 10.95
|
0.1 Millimeter of mercury (mmHg)
Standard Deviation 10.37
|
1.4 Millimeter of mercury (mmHg)
Standard Deviation 11.30
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Day 43, n=84, 79, 80
|
2.5 Millimeter of mercury (mmHg)
Standard Deviation 11.21
|
2.2 Millimeter of mercury (mmHg)
Standard Deviation 10.70
|
0.3 Millimeter of mercury (mmHg)
Standard Deviation 11.93
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Follow up, n=84, 79, 80
|
5.7 Millimeter of mercury (mmHg)
Standard Deviation 10.21
|
3.8 Millimeter of mercury (mmHg)
Standard Deviation 11.93
|
2.9 Millimeter of mercury (mmHg)
Standard Deviation 11.67
|
SECONDARY outcome
Timeframe: Baseline and up to Day 85Population: All Treated Subjects (Safety) Population
Pulse rate was measured in supine position after 5 minutes rest. Baseline values for each assessment was the latest available assessment prior to receiving the single dose of mepolizumab. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Outcome measures
| Measure |
Lyophilized Vial
n=85 Participants
Participants were administered 100 milligram per milliliter (mg/mL) subcutaneous (SC) dose of mepolizumab as lyophilized powder reconstituted with sterile water for injection from vial. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Autoinjector
n=79 Participants
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled autoinjector. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Safety Syringe
n=80 Participants
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled safety syringe. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
|---|---|---|---|
|
Change From Baseline in Pulse Rate
Day 2, n=85, 79, 80
|
5.3 Beats per minute
Standard Deviation 9.19
|
5.6 Beats per minute
Standard Deviation 7.03
|
6.1 Beats per minute
Standard Deviation 9.78
|
|
Change From Baseline in Pulse Rate
Day 3, n= 85, 79, 79
|
4.5 Beats per minute
Standard Deviation 8.01
|
5.0 Beats per minute
Standard Deviation 8.85
|
5.0 Beats per minute
Standard Deviation 9.37
|
|
Change From Baseline in Pulse Rate
Day 4, n= 85, 78, 80
|
3.7 Beats per minute
Standard Deviation 8.57
|
3.9 Beats per minute
Standard Deviation 7.93
|
3.2 Beats per minute
Standard Deviation 8.06
|
|
Change From Baseline in Pulse Rate
Day 5, n= 85, 79, 80
|
1.0 Beats per minute
Standard Deviation 9.02
|
1.0 Beats per minute
Standard Deviation 7.58
|
1.0 Beats per minute
Standard Deviation 8.73
|
|
Change From Baseline in Pulse Rate
Day 6, n= 85, 78, 80
|
2.4 Beats per minute
Standard Deviation 8.81
|
3.4 Beats per minute
Standard Deviation 8.46
|
4.3 Beats per minute
Standard Deviation 9.53
|
|
Change From Baseline in Pulse Rate
Day 7, n= 85, 78, 80
|
3.6 Beats per minute
Standard Deviation 9.05
|
2.5 Beats per minute
Standard Deviation 8.15
|
3.6 Beats per minute
Standard Deviation 10.33
|
|
Change From Baseline in Pulse Rate
Day 43, n= 84, 79, 80
|
3.6 Beats per minute
Standard Deviation 10.29
|
3.7 Beats per minute
Standard Deviation 7.83
|
3.7 Beats per minute
Standard Deviation 10.77
|
|
Change From Baseline in Pulse Rate
Follow up, n= 84, 79, 80
|
0.8 Beats per minute
Standard Deviation 10.56
|
1.0 Beats per minute
Standard Deviation 8.47
|
0.8 Beats per minute
Standard Deviation 8.91
|
SECONDARY outcome
Timeframe: Baseline and up to Day 85Population: All Treated Subjects (Safety) Population
Temperature was measured in supine position after 5 minutes rest. Baseline values for each assessment was the latest available assessment prior to receiving the single dose of mepolizumab. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Outcome measures
| Measure |
Lyophilized Vial
n=85 Participants
Participants were administered 100 milligram per milliliter (mg/mL) subcutaneous (SC) dose of mepolizumab as lyophilized powder reconstituted with sterile water for injection from vial. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Autoinjector
n=79 Participants
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled autoinjector. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Safety Syringe
n=80 Participants
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled safety syringe. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
|---|---|---|---|
|
Change From Baseline in Temperature
Day 5, n=85, 79, 80
|
-0.02 degree Celsius
Standard Deviation 0.264
|
-0.02 degree Celsius
Standard Deviation 0.335
|
-0.04 degree Celsius
Standard Deviation 0.317
|
|
Change From Baseline in Temperature
Day 6, n= 85, 78, 80
|
0.01 degree Celsius
Standard Deviation 0.347
|
0.05 degree Celsius
Standard Deviation 0.350
|
0.00 degree Celsius
Standard Deviation 0.332
|
|
Change From Baseline in Temperature
Day 7, n= 85, 78, 80
|
0.02 degree Celsius
Standard Deviation 0.281
|
0.10 degree Celsius
Standard Deviation 0.348
|
0.07 degree Celsius
Standard Deviation 0.280
|
|
Change From Baseline in Temperature
Day 43, n= 84, 79, 80
|
0.04 degree Celsius
Standard Deviation 0.300
|
0.06 degree Celsius
Standard Deviation 0.340
|
-0.01 degree Celsius
Standard Deviation 0.293
|
|
Change From Baseline in Temperature
Follow up, n= 84, 79, 80
|
0.02 degree Celsius
Standard Deviation 0.296
|
0.02 degree Celsius
Standard Deviation 0.364
|
0.02 degree Celsius
Standard Deviation 0.280
|
|
Change From Baseline in Temperature
Day 2, n=85, 79, 80
|
0.08 degree Celsius
Standard Deviation 0.362
|
0.08 degree Celsius
Standard Deviation 0.389
|
0.01 degree Celsius
Standard Deviation 0.273
|
|
Change From Baseline in Temperature
Day 3, n=85, 79, 79
|
0.09 degree Celsius
Standard Deviation 0.392
|
0.07 degree Celsius
Standard Deviation 0.310
|
-0.02 degree Celsius
Standard Deviation 0.272
|
|
Change From Baseline in Temperature
Day 4, n=85, 78, 80
|
0.04 degree Celsius
Standard Deviation 0.289
|
0.05 degree Celsius
Standard Deviation 0.329
|
-0.01 degree Celsius
Standard Deviation 0.293
|
SECONDARY outcome
Timeframe: Baseline and up to Day 85Population: All Treated Subjects (Safety) Population
Respiratory rate was measured in supine position after 5 minutes rest. Baseline values for each assessment was the latest available assessment prior to receiving the single dose of mepolizumab. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Outcome measures
| Measure |
Lyophilized Vial
n=85 Participants
Participants were administered 100 milligram per milliliter (mg/mL) subcutaneous (SC) dose of mepolizumab as lyophilized powder reconstituted with sterile water for injection from vial. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Autoinjector
n=79 Participants
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled autoinjector. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Safety Syringe
n=80 Participants
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled safety syringe. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
|---|---|---|---|
|
Change From Baseline in Respiratory Rate
Day 2, n= 85, 79, 80
|
0.0 breaths per minute
Standard Deviation 1.90
|
0.3 breaths per minute
Standard Deviation 2.30
|
0.5 breaths per minute
Standard Deviation 2.15
|
|
Change From Baseline in Respiratory Rate
Day 3, n= 85, 79, 79
|
-0.2 breaths per minute
Standard Deviation 2.44
|
0.3 breaths per minute
Standard Deviation 2.60
|
0.1 breaths per minute
Standard Deviation 2.36
|
|
Change From Baseline in Respiratory Rate
Day 4, n= 85, 78, 80
|
-0.5 breaths per minute
Standard Deviation 2.09
|
0.4 breaths per minute
Standard Deviation 2.35
|
0.1 breaths per minute
Standard Deviation 2.10
|
|
Change From Baseline in Respiratory Rate
Day 5, n= 85, 79, 80
|
-0.2 breaths per minute
Standard Deviation 2.16
|
0.0 breaths per minute
Standard Deviation 2.80
|
0.2 breaths per minute
Standard Deviation 2.42
|
|
Change From Baseline in Respiratory Rate
Day 6, n= 85, 78, 80
|
-0.1 breaths per minute
Standard Deviation 2.03
|
0.2 breaths per minute
Standard Deviation 2.20
|
0.5 breaths per minute
Standard Deviation 2.45
|
|
Change From Baseline in Respiratory Rate
Day 7, n= 85, 78, 80
|
-0.2 breaths per minute
Standard Deviation 2.02
|
0.1 breaths per minute
Standard Deviation 2.23
|
0.2 breaths per minute
Standard Deviation 2.06
|
|
Change From Baseline in Respiratory Rate
Day 43, n= 84, 79, 80
|
0.3 breaths per minute
Standard Deviation 2.03
|
0.4 breaths per minute
Standard Deviation 2.14
|
0.3 breaths per minute
Standard Deviation 2.07
|
|
Change From Baseline in Respiratory Rate
Follow up, n= 84, 79, 80
|
-0.1 breaths per minute
Standard Deviation 2.17
|
0.6 breaths per minute
Standard Deviation 2.11
|
0.5 breaths per minute
Standard Deviation 2.07
|
SECONDARY outcome
Timeframe: Baseline and Day 85Population: All Treated Subjects (Safety) Population
Single measurements of 12-lead ECGs were obtained after 5 minutes of rest in a supine position for the participant. ECG was performed on Day 1 and Day 85 using an automated ECG machine. Baseline values for each assessment was the latest available assessment prior to receiving the single dose of mepolizumab. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Participants with abnormal ECG findings that are clinically not significant and clinically significant data has been presented here. The data of worst case post-Baseline is presented here. Only those participants available at the specified time points were analyzed.
Outcome measures
| Measure |
Lyophilized Vial
n=84 Participants
Participants were administered 100 milligram per milliliter (mg/mL) subcutaneous (SC) dose of mepolizumab as lyophilized powder reconstituted with sterile water for injection from vial. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Autoinjector
n=79 Participants
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled autoinjector. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Safety Syringe
n=80 Participants
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled safety syringe. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
|---|---|---|---|
|
Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings
Abnormal not clinically significant
|
15 Participants
|
16 Participants
|
19 Participants
|
|
Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings
Abnormal clinically significant
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Day 85Population: All Treated Subjects (Safety) Population
Blood samples were collected for the determination of anti-mepolizumab antibodies. A binding anti-drug antibody (ADA) assay was performed. There were three tiered analysis: screening, confirmation and titration. The results of binding ADA were categorized as negative, transient positive (defined as a single confirmatory positive immunogenic response that does not occur at the final study assessment) or persistent positive (defined as a confirmatory positive immunogenic response for at least 2 consecutive assessments excluding the Screening visit, or a single result at the final study assessment). A participant was considered positive if they had at least one positive post-Baseline ADA result. Number of participants with positive anti-mepolizumab antibodies at any time post-Baseline are presented here. Only those participants available at the specified time points were analyzed.
Outcome measures
| Measure |
Lyophilized Vial
n=84 Participants
Participants were administered 100 milligram per milliliter (mg/mL) subcutaneous (SC) dose of mepolizumab as lyophilized powder reconstituted with sterile water for injection from vial. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Autoinjector
n=79 Participants
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled autoinjector. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Safety Syringe
n=80 Participants
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled safety syringe. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
|---|---|---|---|
|
Number of Participants With Positive Anti-mepolizumab Binding Antibodies
Transient positive
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Positive Anti-mepolizumab Binding Antibodies
Persistent positive
|
2 Participants
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to Day 85Population: All Treated Subjects (Safety) Population
Blood samples were collected for the determination of positive neutralizing antibodies. A neutralizing antibody assay was performed. Neutralizing antibody test was only carried out for participants who have had a positive confirmatory binding antibody test result at visit. A participant was considered positive if they had at least one positive post-Baseline neutralizing antibody result. Number of participants with positive neutralizing antibodies at any time post-Baseline are presented here. Only those participants available at the specified time points were analyzed.
Outcome measures
| Measure |
Lyophilized Vial
n=3 Participants
Participants were administered 100 milligram per milliliter (mg/mL) subcutaneous (SC) dose of mepolizumab as lyophilized powder reconstituted with sterile water for injection from vial. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Autoinjector
n=5 Participants
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled autoinjector. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Safety Syringe
n=3 Participants
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled safety syringe. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
|---|---|---|---|
|
Number of Participants With Positive Neutralizing Antibodies
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Lyophilized Vial
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Liquid Autoinjector
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Liquid Safety Syringe
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lyophilized Vial
n=85 participants at risk
Participants were administered 100 milligram per milliliter (mg/mL) subcutaneous (SC) dose of mepolizumab as lyophilized powder reconstituted with sterile water for injection from vial. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Autoinjector
n=79 participants at risk
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled autoinjector. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
Liquid Safety Syringe
n=80 participants at risk
Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled safety syringe. Participants were administered a single SC dose in upper arm, abdomen or thigh.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
7.1%
6/85 • Number of events 6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and up to 28 days post-dose.
All Treated Subjects (Safety) comprised of all participants who received mepolizumab.
|
11.4%
9/79 • Number of events 9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and up to 28 days post-dose.
All Treated Subjects (Safety) comprised of all participants who received mepolizumab.
|
10.0%
8/80 • Number of events 9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and up to 28 days post-dose.
All Treated Subjects (Safety) comprised of all participants who received mepolizumab.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.4%
2/85 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and up to 28 days post-dose.
All Treated Subjects (Safety) comprised of all participants who received mepolizumab.
|
3.8%
3/79 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and up to 28 days post-dose.
All Treated Subjects (Safety) comprised of all participants who received mepolizumab.
|
7.5%
6/80 • Number of events 6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and up to 28 days post-dose.
All Treated Subjects (Safety) comprised of all participants who received mepolizumab.
|
|
General disorders
Fatigue
|
5.9%
5/85 • Number of events 5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and up to 28 days post-dose.
All Treated Subjects (Safety) comprised of all participants who received mepolizumab.
|
2.5%
2/79 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and up to 28 days post-dose.
All Treated Subjects (Safety) comprised of all participants who received mepolizumab.
|
1.2%
1/80 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and up to 28 days post-dose.
All Treated Subjects (Safety) comprised of all participants who received mepolizumab.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER