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A Study to Compare the Pharmacokinetics of Mepolizumab as a Liquid Drug in a Safety Syringe or an Autoinjector Versus Lyophilised Drug

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ClinicalTrials.gov Identifier: NCT03014674
Recruitment Status : Completed
First Posted : January 9, 2017
Results First Posted : August 14, 2018
Last Update Posted : December 3, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Asthma
Interventions Biological: Lyophilized mepolizumab
Biological: Liquid mepolizumab
Device: Prefilled autoinjector
Device: Prefilled Safety Syringe
Enrollment 246
Recruitment Details 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).
Pre-assignment Details A total of 246 participants were randomized and 244 participants received study treatment. Two participants were randomized in error
Arm/Group Title Lyophilized Vial Liquid Autoinjector Liquid Safety Syringe
Hide Arm/Group Description 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. 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. 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.
Period Title: Overall Study
Started 85 79 80
Completed 84 79 80
Not Completed 1 0 0
Reason Not Completed
Withdrawal by Subject             1             0             0
Arm/Group Title Lyophilized Vial Liquid Autoinjector Liquid Safety Syringe Total
Hide Arm/Group Description 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 85 79 80 244
Hide Baseline Analysis Population Description
All Treated Subjects (Safety) comprised of all participants who received mepolizumab.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 85 participants 79 participants 80 participants 244 participants
46.1  (15.06) 46.5  (15.00) 47.5  (14.94) 46.7  (14.95)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants 79 participants 80 participants 244 participants
Female
40
  47.1%
36
  45.6%
38
  47.5%
114
  46.7%
Male
45
  52.9%
43
  54.4%
42
  52.5%
130
  53.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants 79 participants 80 participants 244 participants
Black or African American
18
  21.2%
15
  19.0%
18
  22.5%
51
  20.9%
American Indian or Alaska native
1
   1.2%
0
   0.0%
0
   0.0%
1
   0.4%
Central/South Asian heritage
1
   1.2%
0
   0.0%
0
   0.0%
1
   0.4%
East Asian heritage
0
   0.0%
1
   1.3%
0
   0.0%
1
   0.4%
Native Hawaiian or other pacific islander
0
   0.0%
1
   1.3%
0
   0.0%
1
   0.4%
Arabic/ North African heritage
0
   0.0%
0
   0.0%
1
   1.3%
1
   0.4%
White/Caucasian/European heritage
64
  75.3%
61
  77.2%
61
  76.3%
186
  76.2%
Asian and White
0
   0.0%
1
   1.3%
0
   0.0%
1
   0.4%
Black or African American and White
1
   1.2%
0
   0.0%
0
   0.0%
1
   0.4%
1.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Mepolizumab
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population
Arm/Group Title Lyophilized Vial Liquid Autoinjector Liquid Safety Syringe
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 85 79 80
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: micrograms per milliliter (µg/mL)
11.57
(27.43%)
11.98
(24.96%)
12.07
(27.29%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lyophilized Vial, Liquid Autoinjector
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% confidence interval (CI) for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for Cmax.
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.04
Confidence Interval (2-Sided) 90%
0.98 to 1.11
Estimation Comments Ratio (autoinjector/lyophilized drug) for Cmax has been presented
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lyophilized Vial, Liquid Safety Syringe
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% CI for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for Cmax.
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.06
Confidence Interval (2-Sided) 90%
0.99 to 1.12
Estimation Comments Ratio (safety syringe/lyophilized drug) for Cmax has been presented
2.Primary Outcome
Title 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
Hide Description 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).
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population
Arm/Group Title Lyophilized Vial Liquid Autoinjector Liquid Safety Syringe
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 85 79 80
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Days*µg/mL
AUC(0-t), n=85, 79, 80 Number Analyzed 85 participants 79 participants 80 participants
403.84
(25.84%)
434.49
(22.62%)
415.15
(27.25%)
AUC(0-inf), n=84, 79, 80 Number Analyzed 84 participants 79 participants 80 participants
450.83
(25.65%)
478.06
(24.76%)
454.11
(28.88%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lyophilized Vial, Liquid Autoinjector
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% CI for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for AUC (0-t)
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.08
Confidence Interval (2-Sided) 90%
1.01 to 1.15
Estimation Comments Ratio (autoinjector/lyophilized drug) for AUC(0-t) has been presented
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lyophilized Vial, Liquid Safety Syringe
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% CI for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for AUC (0-t).
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.04
Confidence Interval (2-Sided) 90%
0.97 to 1.12
Estimation Comments Ratio (safety syringe/lyophilized drug) for AUC(0-t) has been presented
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lyophilized Vial, Liquid Autoinjector
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% CI for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for AUC (0-inf).
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.07
Confidence Interval (2-Sided) 90%
1.00 to 1.13
Estimation Comments Ratio (autoinjector/lyophilized drug) for AUC(0-inf) has been presented
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Lyophilized Vial, Liquid Safety Syringe
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% CI for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for AUC (0-inf).
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.02
Confidence Interval (2-Sided) 90%
0.95 to 1.09
Estimation Comments Ratio (safety syringe/lyophilized drug) for AUC(0-inf) has been presented
3.Secondary Outcome
Title Time to Cmax (Tmax) and Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) of Mepolizumab
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population
Arm/Group Title Lyophilized Vial Liquid Autoinjector Liquid Safety Syringe
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 85 79 80
Median (Full Range)
Unit of Measure: Days
tmax
7.04
(0.9 to 14.1)
7.05
(2.9 to 21.0)
7.06
(1.9 to 14.0)
tlast
83.97
(14.0 to 87.0)
83.98
(81.1 to 87.1)
83.99
(55.9 to 87.9)
4.Secondary Outcome
Title Apparent Clearance (CL/F) of Mepolizumab
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population
Arm/Group Title Lyophilized Vial Liquid Autoinjector Liquid Safety Syringe
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 84 79 80
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liters per hour (L/h)
0.009242
(27.91%)
0.008716
(28.74%)
0.009175
(39.30%)
5.Secondary Outcome
Title Apparent Volume of Distribution (Vd/F) of Mepolizumab
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population
Arm/Group Title Lyophilized Vial Liquid Autoinjector Liquid Safety Syringe
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 84 79 80
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liters (L)
7.02
(22.49%)
6.74
(26.34%)
6.94
(31.84%)
6.Secondary Outcome
Title Terminal Phase Elimination Rate Constant (Lambda z) of Mepolizumab
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population
Arm/Group Title Lyophilized Vial Liquid Autoinjector Liquid Safety Syringe
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 84 79 80
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Per hours
0.0013157
(21.51%)
0.0012930
(26.20%)
0.0013228
(26.71%)
7.Secondary Outcome
Title Terminal Phase Half-life (t½) of Mepolizumab
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population
Arm/Group Title Lyophilized Vial Liquid Autoinjector Liquid Safety Syringe
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 84 79 80
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Days
21.95
(18.66%)
22.34
(21.38%)
21.83
(21.62%)
8.Secondary Outcome
Title Percentage of AUC(0-inf) Obtained by Extrapolation (% AUCex) of Mepolizumab
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population
Arm/Group Title Lyophilized Vial Liquid Autoinjector Liquid Safety Syringe
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 84 79 80
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Percentage
7.67
(42.06%)
7.64
(47.30%)
7.20
(48.24%)
9.Secondary Outcome
Title Number of Participants With On-treatment Non-serious Adverse Events (AEs) and Serious AEs (SAEs)
Hide Description 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.
Time Frame Up to 28 days post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Subjects (Safety) Population
Arm/Group Title Lyophilized Vial Liquid Autoinjector Liquid Safety Syringe
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 85 79 80
Measure Type: Number
Unit of Measure: Participants
Non-serious AEs 11 13 14
SAEs 0 0 0
10.Secondary Outcome
Title Number of Participants With On-treatment Systemic Reactions and Injection Site Reactions
Hide Description 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.
Time Frame Up to 28 days post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Subjects (Safety) Population
Arm/Group Title Lyophilized Vial Liquid Autoinjector Liquid Safety Syringe
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 85 79 80
Measure Type: Number
Unit of Measure: Participants
Systemic reactions 0 0 0
Injection site reactions 1 1 2
11.Secondary Outcome
Title Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range
Hide Description 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.
Time Frame Up to Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Subjects (Safety) Population
Arm/Group Title Lyophilized Vial Liquid Autoinjector Liquid Safety Syringe
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 85 79 80
Measure Type: Number
Unit of Measure: Participants
Basophils, To low NA [1]  NA [1]  NA [1] 
Basophils, To normal or no change 85 79 80
Basophils, To high 0 0 0
Eosinophils, To low 58 46 55
Eosinophils, To normal or no change 27 33 24
Eosinophils, To high 0 0 1
Hematocrit, To low 8 6 4
Hematocrit, To normal or no change 76 72 75
Hematocrit, To high 1 1 1
Hemoglobin, To low 12 8 13
Hemoglobin, To normal or no change 73 70 67
Hemoglobin, To high 0 1 0
Lymphocytes, To low 2 0 1
Lymphocytes, To normal or no change 83 79 79
Lymphocytes, To high 0 0 0
MCH, To low 0 5 2
MCH, To normal or no change 84 74 78
MCH, To high 1 0 0
MCV, To low 1 0 1
MCV, To normal or no change 83 79 79
MCV, To high 1 0 0
Monocytes, To low 11 8 12
Monocytes, To normal or no change 74 71 68
Monocytes, To high 0 0 0
Neutrophils, To low 7 11 9
Neutrophils, To normal or no change 77 68 71
Neutrophils, To high 1 0 0
Platelets, To low 0 0 1
Platelets, To normal or no change 85 78 79
Platelets, To high 0 1 0
Erythrocytes, To low 4 0 3
Erythrocytes, To normal or no change 81 78 77
Erythrocytes, To high 0 1 0
Leukocytes, To low 11 9 8
Leukocytes, To normal or no change 73 70 72
Leukocytes, To high 1 0 0
[1]
For basophils the “to low” category is not applicable (NA) as the lower limit of normal is zero for this parameter.
12.Secondary Outcome
Title Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
Hide Description 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.
Time Frame Up to Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Subjects (Safety) Population
Arm/Group Title Lyophilized Vial Liquid Autoinjector Liquid Safety Syringe
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 84 79 80
Measure Type: Number
Unit of Measure: Participants
Glucose, To low 1 0 0
Glucose, To normal or no change 83 79 80
Glucose, To high 0 0 0
Albumin, To low 0 0 0
Albumin, To normal or no change 83 79 80
Albumin, To high 1 0 0
ALP, To low 0 0 0
ALP, To normal or no change 84 79 80
ALP, To high 0 0 0
ALT, To low NA [1]  NA [1]  NA [1] 
ALT, To normal or no change 84 78 80
ALT, To high 0 1 0
AST, To low NA [1]  NA [1]  NA [1] 
AST, To normal or no change 84 78 80
AST, To high 0 1 0
D.bilirubin, To low NA [1]  NA [1]  NA [1] 
D.bilirubin, To normal or no change 83 79 80
D.bilirubin, To high 1 0 0
Bilirubin, To low NA [1]  NA [1]  NA [1] 
Bilirubin, To normal or no change 82 79 78
Bilirubin, To high 2 0 2
Calcium, To low 0 0 0
Calcium, To normal or no change 83 79 79
Calcium, To high 1 0 1
Creatine kinase, To low NA [1]  NA [1]  NA [1] 
Creatine kinase,To normal or no change 76 68 70
Creatine kinase, To high 8 11 10
Creatinine, To low 4 4 1
Creatinine, To normal or no change 79 75 79
Creatinine, To high 1 0 0
Potassium, To low 0 0 0
Potassium, To normal or no change 84 79 80
Potassium, To high 0 0 0
Protein, To low 1 1 0
Protein, To normal or no change 83 78 80
Protein, To high 0 0 0
Sodium, To low 1 0 0
Sodium, To normal or no change 83 79 80
Sodium, To high 0 0 0
Urea, To low 1 2 1
Urea, To normal or no change 83 75 79
Urea, To high 0 2 0
[1]
NA indicates data was not available as the lower limit of normal is zero for this parameter
13.Secondary Outcome
Title Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Hide Description 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.
Time Frame Baseline and up to Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Subjects (Safety) Population
Arm/Group Title Lyophilized Vial Liquid Autoinjector Liquid Safety Syringe
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 85 79 80
Mean (Standard Deviation)
Unit of Measure: Millimeter of mercury (mmHg)
DBP, Day 2, n=85, 79, 80 Number Analyzed 85 participants 79 participants 80 participants
1.9  (7.36) 3.1  (6.90) 3.0  (6.47)
DBP, Day 3, n=85, 79, 79 Number Analyzed 85 participants 79 participants 79 participants
0.2  (7.06) 1.7  (6.60) 0.8  (7.90)
DBP, Day 4, n=85, 78, 80 Number Analyzed 85 participants 78 participants 80 participants
0.7  (6.44) 1.6  (7.55) 0.8  (6.33)
DBP, Day 5, n=85, 79, 80 Number Analyzed 85 participants 79 participants 80 participants
1.2  (7.04) 2.4  (7.48) 1.8  (6.40)
DBP, Day 6, n=85, 78, 80 Number Analyzed 85 participants 78 participants 80 participants
0.8  (6.80) 0.9  (7.11) 0.2  (7.96)
DBP, Day 7, n=85, 78, 80 Number Analyzed 85 participants 78 participants 80 participants
0.4  (7.44) 0.3  (6.70) 1.2  (7.50)
DBP, Day 43, n=84, 79, 80 Number Analyzed 84 participants 79 participants 80 participants
0.9  (8.04) 2.2  (6.70) 1.3  (7.22)
DBP, Follow up, n=84, 79, 80 Number Analyzed 84 participants 79 participants 80 participants
3.3  (8.26) 3.5  (6.69) 2.3  (6.70)
SBP, Day 2, n=85, 79, 80 Number Analyzed 85 participants 79 participants 80 participants
3.1  (10.61) 2.0  (11.15) 3.5  (11.25)
SBP, Day 3, n=85, 79, 79 Number Analyzed 85 participants 79 participants 79 participants
2.4  (10.45) 0.7  (10.28) 1.3  (11.12)
SBP, Day 4, n=85, 78, 80 Number Analyzed 85 participants 78 participants 80 participants
1.7  (9.51) 1.7  (9.95) 0.7  (10.07)
SBP, Day 5, n=85, 79, 80 Number Analyzed 85 participants 79 participants 80 participants
2.1  (11.03) 2.5  (10.39) 1.3  (9.67)
SBP, Day 6, n=85, 78, 80 Number Analyzed 85 participants 78 participants 80 participants
1.1  (9.38) -0.6  (9.72) -0.2  (10.81)
SBP, Day 7, n=85, 78, 80 Number Analyzed 85 participants 78 participants 80 participants
1.1  (10.95) 0.1  (10.37) 1.4  (11.30)
SBP, Day 43, n=84, 79, 80 Number Analyzed 84 participants 79 participants 80 participants
2.5  (11.21) 2.2  (10.70) 0.3  (11.93)
SBP, Follow up, n=84, 79, 80 Number Analyzed 84 participants 79 participants 80 participants
5.7  (10.21) 3.8  (11.93) 2.9  (11.67)
14.Secondary Outcome
Title Change From Baseline in Pulse Rate
Hide Description 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.
Time Frame Baseline and up to Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Subjects (Safety) Population
Arm/Group Title Lyophilized Vial Liquid Autoinjector Liquid Safety Syringe
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 85 79 80
Mean (Standard Deviation)
Unit of Measure: Beats per minute
Day 2, n=85, 79, 80 Number Analyzed 85 participants 79 participants 80 participants
5.3  (9.19) 5.6  (7.03) 6.1  (9.78)
Day 3, n= 85, 79, 79 Number Analyzed 85 participants 79 participants 79 participants
4.5  (8.01) 5.0  (8.85) 5.0  (9.37)
Day 4, n= 85, 78, 80 Number Analyzed 85 participants 78 participants 80 participants
3.7  (8.57) 3.9  (7.93) 3.2  (8.06)
Day 5, n= 85, 79, 80 Number Analyzed 85 participants 79 participants 80 participants
1.0  (9.02) 1.0  (7.58) 1.0  (8.73)
Day 6, n= 85, 78, 80 Number Analyzed 85 participants 78 participants 80 participants
2.4  (8.81) 3.4  (8.46) 4.3  (9.53)
Day 7, n= 85, 78, 80 Number Analyzed 85 participants 78 participants 80 participants
3.6  (9.05) 2.5  (8.15) 3.6  (10.33)
Day 43, n= 84, 79, 80 Number Analyzed 84 participants 79 participants 80 participants
3.6  (10.29) 3.7  (7.83) 3.7  (10.77)
Follow up, n= 84, 79, 80 Number Analyzed 84 participants 79 participants 80 participants
0.8  (10.56) 1.0  (8.47) 0.8  (8.91)
15.Secondary Outcome
Title Change From Baseline in Temperature
Hide Description 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.
Time Frame Baseline and up to Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Subjects (Safety) Population
Arm/Group Title Lyophilized Vial Liquid Autoinjector Liquid Safety Syringe
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 85 79 80
Mean (Standard Deviation)
Unit of Measure: degree Celsius
Day 2, n=85, 79, 80 Number Analyzed 85 participants 79 participants 80 participants
0.08  (0.362) 0.08  (0.389) 0.01  (0.273)
Day 3, n=85, 79, 79 Number Analyzed 85 participants 79 participants 79 participants
0.09  (0.392) 0.07  (0.310) -0.02  (0.272)
Day 4, n=85, 78, 80 Number Analyzed 85 participants 78 participants 80 participants
0.04  (0.289) 0.05  (0.329) -0.01  (0.293)
Day 5, n=85, 79, 80 Number Analyzed 85 participants 79 participants 80 participants
-0.02  (0.264) -0.02  (0.335) -0.04  (0.317)
Day 6, n= 85, 78, 80 Number Analyzed 85 participants 78 participants 80 participants
0.01  (0.347) 0.05  (0.350) 0.00  (0.332)
Day 7, n= 85, 78, 80 Number Analyzed 85 participants 78 participants 80 participants
0.02  (0.281) 0.10  (0.348) 0.07  (0.280)
Day 43, n= 84, 79, 80 Number Analyzed 84 participants 79 participants 80 participants
0.04  (0.300) 0.06  (0.340) -0.01  (0.293)
Follow up, n= 84, 79, 80 Number Analyzed 84 participants 79 participants 80 participants
0.02  (0.296) 0.02  (0.364) 0.02  (0.280)
16.Secondary Outcome
Title Change From Baseline in Respiratory Rate
Hide Description 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.
Time Frame Baseline and up to Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Subjects (Safety) Population
Arm/Group Title Lyophilized Vial Liquid Autoinjector Liquid Safety Syringe
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 85 79 80
Mean (Standard Deviation)
Unit of Measure: breaths per minute
Day 2, n= 85, 79, 80 Number Analyzed 85 participants 79 participants 80 participants
0.0  (1.90) 0.3  (2.30) 0.5  (2.15)
Day 3, n= 85, 79, 79 Number Analyzed 85 participants 79 participants 79 participants
-0.2  (2.44) 0.3  (2.60) 0.1  (2.36)
Day 4, n= 85, 78, 80 Number Analyzed 85 participants 78 participants 80 participants
-0.5  (2.09) 0.4  (2.35) 0.1  (2.10)
Day 5, n= 85, 79, 80 Number Analyzed 85 participants 79 participants 80 participants
-0.2  (2.16) 0.0  (2.80) 0.2  (2.42)
Day 6, n= 85, 78, 80 Number Analyzed 85 participants 78 participants 80 participants
-0.1  (2.03) 0.2  (2.20) 0.5  (2.45)
Day 7, n= 85, 78, 80 Number Analyzed 85 participants 78 participants 80 participants
-0.2  (2.02) 0.1  (2.23) 0.2  (2.06)
Day 43, n= 84, 79, 80 Number Analyzed 84 participants 79 participants 80 participants
0.3  (2.03) 0.4  (2.14) 0.3  (2.07)
Follow up, n= 84, 79, 80 Number Analyzed 84 participants 79 participants 80 participants
-0.1  (2.17) 0.6  (2.11) 0.5  (2.07)
17.Secondary Outcome
Title Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings
Hide Description 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.
Time Frame Baseline and Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Subjects (Safety) Population
Arm/Group Title Lyophilized Vial Liquid Autoinjector Liquid Safety Syringe
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 84 79 80
Measure Type: Number
Unit of Measure: Participants
Abnormal not clinically significant 15 16 19
Abnormal clinically significant 1 0 1
18.Secondary Outcome
Title Number of Participants With Positive Anti-mepolizumab Binding Antibodies
Hide Description 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.
Time Frame Up to Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Subjects (Safety) Population
Arm/Group Title Lyophilized Vial Liquid Autoinjector Liquid Safety Syringe
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 84 79 80
Measure Type: Number
Unit of Measure: Participants
Transient positive 1 1 0
Persistent positive 2 4 3
19.Secondary Outcome
Title Number of Participants With Positive Neutralizing Antibodies
Hide Description 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.
Time Frame Up to Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Subjects (Safety) Population
Arm/Group Title Lyophilized Vial Liquid Autoinjector Liquid Safety Syringe
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 3 5 3
Measure Type: Number
Unit of Measure: Participants
0 0 0
Time Frame 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.
Adverse Event Reporting Description All Treated Subjects (Safety) comprised of all participants who received mepolizumab.
 
Arm/Group Title Lyophilized Vial Liquid Autoinjector Liquid Safety Syringe
Hide Arm/Group Description 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. 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. 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.
All-Cause Mortality
Lyophilized Vial Liquid Autoinjector Liquid Safety Syringe
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/85 (0.00%)      0/79 (0.00%)      0/80 (0.00%)    
Hide Serious Adverse Events
Lyophilized Vial Liquid Autoinjector Liquid Safety Syringe
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/85 (0.00%)      0/79 (0.00%)      0/80 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Lyophilized Vial Liquid Autoinjector Liquid Safety Syringe
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/85 (12.94%)      13/79 (16.46%)      14/80 (17.50%)    
General disorders       
Fatigue  1  5/85 (5.88%)  5 2/79 (2.53%)  2 1/80 (1.25%)  1
Infections and infestations       
Viral upper respiratory tract infection  1  2/85 (2.35%)  2 3/79 (3.80%)  3 6/80 (7.50%)  6
Nervous system disorders       
Headache  1  6/85 (7.06%)  6 9/79 (11.39%)  9 8/80 (10.00%)  9
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
EMail: GSKClinicalSupportHD@gsk.com
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03014674    
Other Study ID Numbers: 204958
2016-002405-19 ( EudraCT Number )
First Submitted: December 15, 2016
First Posted: January 9, 2017
Results First Submitted: July 17, 2018
Results First Posted: August 14, 2018
Last Update Posted: December 3, 2019