Asthma
Conditions
Keywords
SB-240563, subcutaneous, lyophilized drug product, Mepolizumab, liquid drug product, safety syringe, auto injector
Brief summary
Mepolizumab (SB-240563) is a humanized monoclonal antibody (Immunoglobulin G1, kappa, mAb) that blocks human interleukin-5 (hIL-5) from binding to the interleukin (IL)-5 receptor complex expressed on the eosinophil cell surface and thus inhibits signaling. This study will compare the pharmacokinetics and safety of mepolizumab administered as a liquid drug product in two different devices with the reconstituted lyophilized drug product in healthy subjects. Subjects will receive a single administration of 100 milligram (mg) mepolizumab as a single injection. The randomization will be stratified by body weight (\<70 kilogram (kg), 70 \<80 kg and \>=80 kg) and the site of injection will be randomized 1:1:1 to the upper arm, abdomen or thigh. Approximately 243 healthy subjects will be randomized so that at least 9 subjects are randomized to each mepolizumab treatment within each weight strata and 3 subjects within each mepolizumab treatment, weight strata and injection site. Each subject will participate in the study for up to approximately 16 weeks (up to 85 days after drug administration), and will have a screening visit, a single dose treatment period, and a follow-up visit.
Interventions
BIOLOGICALLyophilized mepolizumab
Mepolizumab will be provided as white, uniform, lyophilized cake in vials with unit dose strength of 100 mg/vial for reconstitution in 1.2 mL sterile water for injection (SWFI). Following reconstitution it forms a clear to opalescent, colorless to pale yellow solution for SC injection.
BIOLOGICALLiquid mepolizumab
Mepolizumab will be provided as a clear to opalescent, colorless to pale yellow sterile solution for SC injection, supplied in a single-use, prefilled autoinjector or safety syringe containing 100 mg/mL mepolizumab with sodium phosphate, citric acid, sucrose ethylenediaminetetraacetic acid and polysorbate 80.
DEVICEPrefilled autoinjector
Single use, disposable autoinjector will be assembled with the prefilled syringe containing the drug product. It will enable automatic delivery of the drug product under the power of a spring mechanism following activation of the device. Start and end of injection clicks will inform the user of correct use. A plastic needle will cover shield the needle before and after injection to minimize the potential for needle stick injuries.
DEVICEPrefilled Safety Syringe
Single use, disposable safety syringe with a retracting needle guard and locking system.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years of age and over at the time of signing the informed consent. * Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, vital signs, laboratory tests, and cardiac monitoring. A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or
Exclusion criteria
, outside the reference range for the population being studied may be included only if the investigator agrees and documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures or ability to interpret study results. * Body weight \>=50 kg and body mass index (BMI) within the range 19.0-30 kg/square meter(m\^2) (inclusive) * Male or Female: A female subject is eligible to participate if she is not pregnant (as confirmed by a negative human chorionic gonadotrophin (hCG) test), not lactating, and at least one of the following conditions applies: Non-reproductive potential defined as: pre-menopausal females with documented tubal ligation; documented hysteroscopic tubal occlusion procedure with follow-up; confirmation of bilateral tubal occlusion; hysterectomy; documented bilateral oophorectomy; post- menopausal females. Subject is of reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study medication and until 16 weeks after the administration of the single dose of study medication. * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in the protocol. The subject must be able to understand and communicate in the native language of the site, e.g. German in German sites.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Mepolizumab | 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 | 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. |
| 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 | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apparent Volume of Distribution (Vd/F) of Mepolizumab | 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 | 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. |
| Terminal Phase Elimination Rate Constant (Lambda z) of Mepolizumab | 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 | 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. |
| Terminal Phase Half-life (t½) of Mepolizumab | 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 | 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. |
| Percentage of AUC(0-inf) Obtained by Extrapolation (% AUCex) of Mepolizumab | 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 | 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. |
| Number of Participants With On-treatment Non-serious Adverse Events (AEs) and Serious AEs (SAEs) | Up to 28 days post-dose | 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. |
| Number of Participants With On-treatment Systemic Reactions and Injection Site Reactions | Up to 28 days post-dose | 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. |
| Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Up to Day 85 | 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 to Cmax (Tmax) and Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) of Mepolizumab | 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 | 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. |
| Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | Baseline and up to Day 85 | 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. |
| Change From Baseline in Pulse Rate | Baseline and up to Day 85 | 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. |
| Change From Baseline in Temperature | Baseline and up to Day 85 | 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. |
| Change From Baseline in Respiratory Rate | Baseline and up to Day 85 | 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. |
| Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings | Baseline and Day 85 | 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. |
| Number of Participants With Positive Anti-mepolizumab Binding Antibodies | Up to Day 85 | 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. |
| Number of Participants With Positive Neutralizing Antibodies | Up to Day 85 | 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. |
| Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Up to Day 85 | 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. |
| Apparent Clearance (CL/F) of Mepolizumab | 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 | 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. |
Countries
Germany, United Kingdom, United States
Participant flow
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 85 |
| 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. | 79 |
| 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. | 80 |
| Total | 244 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Liquid Safety Syringe | Liquid Autoinjector | Lyophilized Vial |
|---|---|---|---|---|
| Age, Continuous | 46.7 Years STANDARD_DEVIATION 14.95 | 47.5 Years STANDARD_DEVIATION 14.94 | 46.5 Years STANDARD_DEVIATION 15 | 46.1 Years STANDARD_DEVIATION 15.06 |
| Race/Ethnicity, Customized American Indian or Alaska native | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Arabic/ North African heritage | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian and White | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 51 Participants | 18 Participants | 15 Participants | 18 Participants |
| Race/Ethnicity, Customized Black or African American and White | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Central/South Asian heritage | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized East Asian heritage | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other pacific islander | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White/Caucasian/European heritage | 186 Participants | 61 Participants | 61 Participants | 64 Participants |
| Sex: Female, Male Female | 114 Participants | 38 Participants | 36 Participants | 40 Participants |
| Sex: Female, Male Male | 130 Participants | 42 Participants | 43 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 85 | 0 / 79 | 0 / 80 |
| other Total, other adverse events | 11 / 85 | 13 / 79 | 14 / 80 |
| serious Total, serious adverse events | 0 / 85 | 0 / 79 | 0 / 80 |
Outcome results
Primary
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
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
Population: PK Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Lyophilized Vial | 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 |
| Lyophilized Vial | 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 |
| Liquid Autoinjector | 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 | 434.49 Days*µg/mL | Geometric Coefficient of Variation 22.62 |
| Liquid Autoinjector | 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 | 478.06 Days*µg/mL | Geometric Coefficient of Variation 24.76 |
| Liquid Safety Syringe | 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 | 415.15 Days*µg/mL | Geometric Coefficient of Variation 27.25 |
| Liquid Safety Syringe | 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 | 454.11 Days*µg/mL | Geometric Coefficient of Variation 28.88 |
90% CI: [1.01, 1.15]
90% CI: [0.97, 1.12]
90% CI: [1, 1.13]
90% CI: [0.95, 1.09]
Primary
Maximum Observed Plasma Concentration (Cmax) of Mepolizumab
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
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Lyophilized Vial | Maximum Observed Plasma Concentration (Cmax) of Mepolizumab | 11.57 micrograms per milliliter (µg/mL) | Geometric Coefficient of Variation 27.43 |
| Liquid Autoinjector | Maximum Observed Plasma Concentration (Cmax) of Mepolizumab | 11.98 micrograms per milliliter (µg/mL) | Geometric Coefficient of Variation 24.96 |
| Liquid Safety Syringe | Maximum Observed Plasma Concentration (Cmax) of Mepolizumab | 12.07 micrograms per milliliter (µg/mL) | Geometric Coefficient of Variation 27.29 |
90% CI: [0.98, 1.11]
90% CI: [0.99, 1.12]
Secondary
Apparent Clearance (CL/F) of Mepolizumab
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
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Lyophilized Vial | Apparent Clearance (CL/F) of Mepolizumab | 0.009242 Liters per hour (L/h) | Geometric Coefficient of Variation 27.91 |
| Liquid Autoinjector | Apparent Clearance (CL/F) of Mepolizumab | 0.008716 Liters per hour (L/h) | Geometric Coefficient of Variation 28.74 |
| Liquid Safety Syringe | Apparent Clearance (CL/F) of Mepolizumab | 0.009175 Liters per hour (L/h) | Geometric Coefficient of Variation 39.3 |
Secondary
Apparent Volume of Distribution (Vd/F) of Mepolizumab
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
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Lyophilized Vial | Apparent Volume of Distribution (Vd/F) of Mepolizumab | 7.02 Liters (L) | Geometric Coefficient of Variation 22.49 |
| Liquid Autoinjector | Apparent Volume of Distribution (Vd/F) of Mepolizumab | 6.74 Liters (L) | Geometric Coefficient of Variation 26.34 |
| Liquid Safety Syringe | Apparent Volume of Distribution (Vd/F) of Mepolizumab | 6.94 Liters (L) | Geometric Coefficient of Variation 31.84 |
Secondary
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
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
Population: All Treated Subjects (Safety) Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lyophilized Vial | 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 6.8 |
| Lyophilized Vial | 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 |
| Lyophilized Vial | 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 |
| Lyophilized Vial | 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 |
| Lyophilized Vial | 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 |
| Lyophilized Vial | 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 |
| Lyophilized Vial | 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 |
| Lyophilized Vial | 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 |
| Lyophilized Vial | 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 |
| Lyophilized Vial | 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 |
| Lyophilized Vial | 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 |
| Lyophilized Vial | 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 |
| Lyophilized Vial | 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 |
| Lyophilized Vial | 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 |
| Lyophilized Vial | 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 |
| Lyophilized Vial | 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 |
| Liquid Autoinjector | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Day 7, n=85, 78, 80 | 0.3 Millimeter of mercury (mmHg) | Standard Deviation 6.7 |
| Liquid Autoinjector | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Day 43, n=84, 79, 80 | 2.2 Millimeter of mercury (mmHg) | Standard Deviation 6.7 |
| Liquid Autoinjector | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Follow up, n=84, 79, 80 | 3.5 Millimeter of mercury (mmHg) | Standard Deviation 6.69 |
| Liquid Autoinjector | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Day 7, n=85, 78, 80 | 0.1 Millimeter of mercury (mmHg) | Standard Deviation 10.37 |
| Liquid Autoinjector | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Day 2, n=85, 79, 80 | 2.0 Millimeter of mercury (mmHg) | Standard Deviation 11.15 |
| Liquid Autoinjector | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Day 3, n=85, 79, 79 | 0.7 Millimeter of mercury (mmHg) | Standard Deviation 10.28 |
| Liquid Autoinjector | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Follow up, n=84, 79, 80 | 3.8 Millimeter of mercury (mmHg) | Standard Deviation 11.93 |
| Liquid Autoinjector | 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 9.95 |
| Liquid Autoinjector | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Day 2, n=85, 79, 80 | 3.1 Millimeter of mercury (mmHg) | Standard Deviation 6.9 |
| Liquid Autoinjector | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Day 43, n=84, 79, 80 | 2.2 Millimeter of mercury (mmHg) | Standard Deviation 10.7 |
| Liquid Autoinjector | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Day 3, n=85, 79, 79 | 1.7 Millimeter of mercury (mmHg) | Standard Deviation 6.6 |
| Liquid Autoinjector | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Day 5, n=85, 79, 80 | 2.5 Millimeter of mercury (mmHg) | Standard Deviation 10.39 |
| Liquid Autoinjector | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Day 4, n=85, 78, 80 | 1.6 Millimeter of mercury (mmHg) | Standard Deviation 7.55 |
| Liquid Autoinjector | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Day 5, n=85, 79, 80 | 2.4 Millimeter of mercury (mmHg) | Standard Deviation 7.48 |
| Liquid Autoinjector | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Day 6, n=85, 78, 80 | 0.9 Millimeter of mercury (mmHg) | Standard Deviation 7.11 |
| Liquid Autoinjector | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Day 6, n=85, 78, 80 | -0.6 Millimeter of mercury (mmHg) | Standard Deviation 9.72 |
| Liquid Safety Syringe | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Day 4, n=85, 78, 80 | 0.7 Millimeter of mercury (mmHg) | Standard Deviation 10.07 |
| Liquid Safety Syringe | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Day 7, n=85, 78, 80 | 1.2 Millimeter of mercury (mmHg) | Standard Deviation 7.5 |
| Liquid Safety Syringe | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Day 6, n=85, 78, 80 | -0.2 Millimeter of mercury (mmHg) | Standard Deviation 10.81 |
| Liquid Safety Syringe | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Day 4, n=85, 78, 80 | 0.8 Millimeter of mercury (mmHg) | Standard Deviation 6.33 |
| Liquid Safety Syringe | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Day 43, n=84, 79, 80 | 1.3 Millimeter of mercury (mmHg) | Standard Deviation 7.22 |
| Liquid Safety Syringe | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Follow up, n=84, 79, 80 | 2.9 Millimeter of mercury (mmHg) | Standard Deviation 11.67 |
| Liquid Safety Syringe | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Day 2, n=85, 79, 80 | 3.0 Millimeter of mercury (mmHg) | Standard Deviation 6.47 |
| Liquid Safety Syringe | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Follow up, n=84, 79, 80 | 2.3 Millimeter of mercury (mmHg) | Standard Deviation 6.7 |
| Liquid Safety Syringe | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Day 5, n=85, 79, 80 | 1.3 Millimeter of mercury (mmHg) | Standard Deviation 9.67 |
| Liquid Safety Syringe | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Day 6, n=85, 78, 80 | 0.2 Millimeter of mercury (mmHg) | Standard Deviation 7.96 |
| Liquid Safety Syringe | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Day 2, n=85, 79, 80 | 3.5 Millimeter of mercury (mmHg) | Standard Deviation 11.25 |
| Liquid Safety Syringe | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Day 7, n=85, 78, 80 | 1.4 Millimeter of mercury (mmHg) | Standard Deviation 11.3 |
| Liquid Safety Syringe | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Day 3, n=85, 79, 79 | 0.8 Millimeter of mercury (mmHg) | Standard Deviation 7.9 |
| Liquid Safety Syringe | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Day 3, n=85, 79, 79 | 1.3 Millimeter of mercury (mmHg) | Standard Deviation 11.12 |
| Liquid Safety Syringe | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Day 5, n=85, 79, 80 | 1.8 Millimeter of mercury (mmHg) | Standard Deviation 6.4 |
| Liquid Safety Syringe | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Day 43, n=84, 79, 80 | 0.3 Millimeter of mercury (mmHg) | Standard Deviation 11.93 |
Secondary
Change From Baseline in Pulse Rate
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
Population: All Treated Subjects (Safety) Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lyophilized Vial | Change From Baseline in Pulse Rate | Day 2, n=85, 79, 80 | 5.3 Beats per minute | Standard Deviation 9.19 |
| Lyophilized Vial | Change From Baseline in Pulse Rate | Day 3, n= 85, 79, 79 | 4.5 Beats per minute | Standard Deviation 8.01 |
| Lyophilized Vial | Change From Baseline in Pulse Rate | Day 4, n= 85, 78, 80 | 3.7 Beats per minute | Standard Deviation 8.57 |
| Lyophilized Vial | Change From Baseline in Pulse Rate | Day 5, n= 85, 79, 80 | 1.0 Beats per minute | Standard Deviation 9.02 |
| Lyophilized Vial | Change From Baseline in Pulse Rate | Day 6, n= 85, 78, 80 | 2.4 Beats per minute | Standard Deviation 8.81 |
| Lyophilized Vial | Change From Baseline in Pulse Rate | Day 7, n= 85, 78, 80 | 3.6 Beats per minute | Standard Deviation 9.05 |
| Lyophilized Vial | Change From Baseline in Pulse Rate | Day 43, n= 84, 79, 80 | 3.6 Beats per minute | Standard Deviation 10.29 |
| Lyophilized Vial | Change From Baseline in Pulse Rate | Follow up, n= 84, 79, 80 | 0.8 Beats per minute | Standard Deviation 10.56 |
| Liquid Autoinjector | Change From Baseline in Pulse Rate | Day 4, n= 85, 78, 80 | 3.9 Beats per minute | Standard Deviation 7.93 |
| Liquid Autoinjector | Change From Baseline in Pulse Rate | Day 43, n= 84, 79, 80 | 3.7 Beats per minute | Standard Deviation 7.83 |
| Liquid Autoinjector | Change From Baseline in Pulse Rate | Day 5, n= 85, 79, 80 | 1.0 Beats per minute | Standard Deviation 7.58 |
| Liquid Autoinjector | Change From Baseline in Pulse Rate | Day 6, n= 85, 78, 80 | 3.4 Beats per minute | Standard Deviation 8.46 |
| Liquid Autoinjector | Change From Baseline in Pulse Rate | Day 7, n= 85, 78, 80 | 2.5 Beats per minute | Standard Deviation 8.15 |
| Liquid Autoinjector | Change From Baseline in Pulse Rate | Day 2, n=85, 79, 80 | 5.6 Beats per minute | Standard Deviation 7.03 |
| Liquid Autoinjector | Change From Baseline in Pulse Rate | Day 3, n= 85, 79, 79 | 5.0 Beats per minute | Standard Deviation 8.85 |
| Liquid Autoinjector | Change From Baseline in Pulse Rate | Follow up, n= 84, 79, 80 | 1.0 Beats per minute | Standard Deviation 8.47 |
| Liquid Safety Syringe | Change From Baseline in Pulse Rate | Day 4, n= 85, 78, 80 | 3.2 Beats per minute | Standard Deviation 8.06 |
| Liquid Safety Syringe | Change From Baseline in Pulse Rate | Day 3, n= 85, 79, 79 | 5.0 Beats per minute | Standard Deviation 9.37 |
| Liquid Safety Syringe | Change From Baseline in Pulse Rate | Day 2, n=85, 79, 80 | 6.1 Beats per minute | Standard Deviation 9.78 |
| Liquid Safety Syringe | Change From Baseline in Pulse Rate | Day 5, n= 85, 79, 80 | 1.0 Beats per minute | Standard Deviation 8.73 |
| Liquid Safety Syringe | Change From Baseline in Pulse Rate | Day 43, n= 84, 79, 80 | 3.7 Beats per minute | Standard Deviation 10.77 |
| Liquid Safety Syringe | Change From Baseline in Pulse Rate | Day 7, n= 85, 78, 80 | 3.6 Beats per minute | Standard Deviation 10.33 |
| Liquid Safety Syringe | Change From Baseline in Pulse Rate | Day 6, n= 85, 78, 80 | 4.3 Beats per minute | Standard Deviation 9.53 |
| Liquid Safety Syringe | Change From Baseline in Pulse Rate | Follow up, n= 84, 79, 80 | 0.8 Beats per minute | Standard Deviation 8.91 |
Secondary
Change From Baseline in Respiratory Rate
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
Population: All Treated Subjects (Safety) Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lyophilized Vial | Change From Baseline in Respiratory Rate | Follow up, n= 84, 79, 80 | -0.1 breaths per minute | Standard Deviation 2.17 |
| Lyophilized Vial | Change From Baseline in Respiratory Rate | Day 2, n= 85, 79, 80 | 0.0 breaths per minute | Standard Deviation 1.9 |
| Lyophilized Vial | Change From Baseline in Respiratory Rate | Day 5, n= 85, 79, 80 | -0.2 breaths per minute | Standard Deviation 2.16 |
| Lyophilized Vial | Change From Baseline in Respiratory Rate | Day 43, n= 84, 79, 80 | 0.3 breaths per minute | Standard Deviation 2.03 |
| Lyophilized Vial | Change From Baseline in Respiratory Rate | Day 3, n= 85, 79, 79 | -0.2 breaths per minute | Standard Deviation 2.44 |
| Lyophilized Vial | Change From Baseline in Respiratory Rate | Day 6, n= 85, 78, 80 | -0.1 breaths per minute | Standard Deviation 2.03 |
| Lyophilized Vial | Change From Baseline in Respiratory Rate | Day 4, n= 85, 78, 80 | -0.5 breaths per minute | Standard Deviation 2.09 |
| Lyophilized Vial | Change From Baseline in Respiratory Rate | Day 7, n= 85, 78, 80 | -0.2 breaths per minute | Standard Deviation 2.02 |
| Liquid Autoinjector | Change From Baseline in Respiratory Rate | Day 3, n= 85, 79, 79 | 0.3 breaths per minute | Standard Deviation 2.6 |
| Liquid Autoinjector | Change From Baseline in Respiratory Rate | Day 2, n= 85, 79, 80 | 0.3 breaths per minute | Standard Deviation 2.3 |
| Liquid Autoinjector | Change From Baseline in Respiratory Rate | Day 43, n= 84, 79, 80 | 0.4 breaths per minute | Standard Deviation 2.14 |
| Liquid Autoinjector | Change From Baseline in Respiratory Rate | Follow up, n= 84, 79, 80 | 0.6 breaths per minute | Standard Deviation 2.11 |
| Liquid Autoinjector | Change From Baseline in Respiratory Rate | Day 7, n= 85, 78, 80 | 0.1 breaths per minute | Standard Deviation 2.23 |
| Liquid Autoinjector | Change From Baseline in Respiratory Rate | Day 4, n= 85, 78, 80 | 0.4 breaths per minute | Standard Deviation 2.35 |
| Liquid Autoinjector | Change From Baseline in Respiratory Rate | Day 5, n= 85, 79, 80 | 0.0 breaths per minute | Standard Deviation 2.8 |
| Liquid Autoinjector | Change From Baseline in Respiratory Rate | Day 6, n= 85, 78, 80 | 0.2 breaths per minute | Standard Deviation 2.2 |
| Liquid Safety Syringe | Change From Baseline in Respiratory Rate | Follow up, n= 84, 79, 80 | 0.5 breaths per minute | Standard Deviation 2.07 |
| Liquid Safety Syringe | Change From Baseline in Respiratory Rate | Day 2, n= 85, 79, 80 | 0.5 breaths per minute | Standard Deviation 2.15 |
| Liquid Safety Syringe | Change From Baseline in Respiratory Rate | Day 3, n= 85, 79, 79 | 0.1 breaths per minute | Standard Deviation 2.36 |
| Liquid Safety Syringe | Change From Baseline in Respiratory Rate | Day 4, n= 85, 78, 80 | 0.1 breaths per minute | Standard Deviation 2.1 |
| Liquid Safety Syringe | Change From Baseline in Respiratory Rate | Day 5, n= 85, 79, 80 | 0.2 breaths per minute | Standard Deviation 2.42 |
| Liquid Safety Syringe | Change From Baseline in Respiratory Rate | Day 6, n= 85, 78, 80 | 0.5 breaths per minute | Standard Deviation 2.45 |
| Liquid Safety Syringe | Change From Baseline in Respiratory Rate | Day 7, n= 85, 78, 80 | 0.2 breaths per minute | Standard Deviation 2.06 |
| Liquid Safety Syringe | Change From Baseline in Respiratory Rate | Day 43, n= 84, 79, 80 | 0.3 breaths per minute | Standard Deviation 2.07 |
Secondary
Change From Baseline in Temperature
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
Population: All Treated Subjects (Safety) Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lyophilized Vial | Change From Baseline in Temperature | Day 2, n=85, 79, 80 | 0.08 degree Celsius | Standard Deviation 0.362 |
| Lyophilized Vial | Change From Baseline in Temperature | Day 3, n=85, 79, 79 | 0.09 degree Celsius | Standard Deviation 0.392 |
| Lyophilized Vial | Change From Baseline in Temperature | Day 4, n=85, 78, 80 | 0.04 degree Celsius | Standard Deviation 0.289 |
| Lyophilized Vial | Change From Baseline in Temperature | Day 5, n=85, 79, 80 | -0.02 degree Celsius | Standard Deviation 0.264 |
| Lyophilized Vial | Change From Baseline in Temperature | Day 6, n= 85, 78, 80 | 0.01 degree Celsius | Standard Deviation 0.347 |
| Lyophilized Vial | Change From Baseline in Temperature | Day 7, n= 85, 78, 80 | 0.02 degree Celsius | Standard Deviation 0.281 |
| Lyophilized Vial | Change From Baseline in Temperature | Day 43, n= 84, 79, 80 | 0.04 degree Celsius | Standard Deviation 0.3 |
| Lyophilized Vial | Change From Baseline in Temperature | Follow up, n= 84, 79, 80 | 0.02 degree Celsius | Standard Deviation 0.296 |
| Liquid Autoinjector | Change From Baseline in Temperature | Day 4, n=85, 78, 80 | 0.05 degree Celsius | Standard Deviation 0.329 |
| Liquid Autoinjector | Change From Baseline in Temperature | Day 43, n= 84, 79, 80 | 0.06 degree Celsius | Standard Deviation 0.34 |
| Liquid Autoinjector | Change From Baseline in Temperature | Day 5, n=85, 79, 80 | -0.02 degree Celsius | Standard Deviation 0.335 |
| Liquid Autoinjector | Change From Baseline in Temperature | Day 6, n= 85, 78, 80 | 0.05 degree Celsius | Standard Deviation 0.35 |
| Liquid Autoinjector | Change From Baseline in Temperature | Day 7, n= 85, 78, 80 | 0.10 degree Celsius | Standard Deviation 0.348 |
| Liquid Autoinjector | Change From Baseline in Temperature | Day 2, n=85, 79, 80 | 0.08 degree Celsius | Standard Deviation 0.389 |
| Liquid Autoinjector | Change From Baseline in Temperature | Day 3, n=85, 79, 79 | 0.07 degree Celsius | Standard Deviation 0.31 |
| Liquid Autoinjector | Change From Baseline in Temperature | Follow up, n= 84, 79, 80 | 0.02 degree Celsius | Standard Deviation 0.364 |
| Liquid Safety Syringe | Change From Baseline in Temperature | Day 4, n=85, 78, 80 | -0.01 degree Celsius | Standard Deviation 0.293 |
| Liquid Safety Syringe | Change From Baseline in Temperature | Day 3, n=85, 79, 79 | -0.02 degree Celsius | Standard Deviation 0.272 |
| Liquid Safety Syringe | Change From Baseline in Temperature | Day 2, n=85, 79, 80 | 0.01 degree Celsius | Standard Deviation 0.273 |
| Liquid Safety Syringe | Change From Baseline in Temperature | Day 5, n=85, 79, 80 | -0.04 degree Celsius | Standard Deviation 0.317 |
| Liquid Safety Syringe | Change From Baseline in Temperature | Day 43, n= 84, 79, 80 | -0.01 degree Celsius | Standard Deviation 0.293 |
| Liquid Safety Syringe | Change From Baseline in Temperature | Day 7, n= 85, 78, 80 | 0.07 degree Celsius | Standard Deviation 0.28 |
| Liquid Safety Syringe | Change From Baseline in Temperature | Day 6, n= 85, 78, 80 | 0.00 degree Celsius | Standard Deviation 0.332 |
| Liquid Safety Syringe | Change From Baseline in Temperature | Follow up, n= 84, 79, 80 | 0.02 degree Celsius | Standard Deviation 0.28 |
Secondary
Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings
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
Population: All Treated Subjects (Safety) Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lyophilized Vial | Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings | Abnormal not clinically significant | 15 Participants |
| Lyophilized Vial | Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings | Abnormal clinically significant | 1 Participants |
| Liquid Autoinjector | Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings | Abnormal not clinically significant | 16 Participants |
| Liquid Autoinjector | Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings | Abnormal clinically significant | 0 Participants |
| Liquid Safety Syringe | Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings | Abnormal not clinically significant | 19 Participants |
| Liquid Safety Syringe | Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings | Abnormal clinically significant | 1 Participants |
Secondary
Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range
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
Population: All Treated Subjects (Safety) Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Protein, To high | 0 Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | AST, To low | NA Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | AST, To normal or no change | 84 Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Creatinine, To high | 1 Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | AST, To high | 0 Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Sodium, To low | 1 Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | D.bilirubin, To low | NA Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | D.bilirubin, To normal or no change | 83 Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | D.bilirubin, To high | 1 Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Sodium, To normal or no change | 83 Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Bilirubin, To low | NA Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Bilirubin, To normal or no change | 82 Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Creatinine, To low | 4 Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Bilirubin, To high | 2 Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Sodium, To high | 0 Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Calcium, To low | 0 Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Calcium, To normal or no change | 83 Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Potassium, To low | 0 Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Calcium, To high | 1 Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Urea, To low | 1 Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Creatine kinase, To low | NA Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Creatine kinase,To normal or no change | 76 Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Urea, To normal or no change | 83 Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Urea, To high | 0 Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Potassium, To normal or no change | 84 Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Glucose, To low | 1 Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Glucose, To normal or no change | 83 Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Glucose, To high | 0 Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Potassium, To high | 0 Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Albumin, To low | 0 Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Albumin, To normal or no change | 83 Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Creatinine, To normal or no change | 79 Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Albumin, To high | 1 Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Protein, To low | 1 Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | ALP, To low | 0 Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | ALP, To normal or no change | 84 Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | ALP, To high | 0 Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Protein, To normal or no change | 83 Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | ALT, To low | NA Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | ALT, To normal or no change | 84 Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Creatine kinase, To high | 8 Participants |
| Lyophilized Vial | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | ALT, To high | 0 Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Potassium, To low | 0 Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | ALP, To high | 0 Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | AST, To low | NA Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Protein, To high | 0 Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Urea, To normal or no change | 75 Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | AST, To normal or no change | 78 Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Creatinine, To low | 4 Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Albumin, To high | 0 Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | AST, To high | 1 Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Urea, To high | 2 Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | ALT, To high | 1 Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | D.bilirubin, To low | NA Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Sodium, To low | 0 Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | ALT, To normal or no change | 78 Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | D.bilirubin, To normal or no change | 79 Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Creatinine, To high | 0 Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Glucose, To low | 0 Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | D.bilirubin, To high | 0 Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Potassium, To normal or no change | 79 Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | ALP, To low | 0 Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Bilirubin, To low | NA Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Sodium, To normal or no change | 79 Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Glucose, To normal or no change | 79 Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Bilirubin, To normal or no change | 79 Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Creatine kinase, To high | 11 Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Protein, To low | 1 Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Bilirubin, To high | 0 Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Glucose, To high | 0 Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | ALT, To low | NA Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Calcium, To low | 0 Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Sodium, To high | 0 Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | ALP, To normal or no change | 79 Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Calcium, To normal or no change | 79 Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Albumin, To low | 0 Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Potassium, To high | 0 Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Calcium, To high | 0 Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Creatinine, To normal or no change | 75 Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Albumin, To normal or no change | 79 Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Creatine kinase, To low | NA Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Urea, To low | 2 Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Protein, To normal or no change | 78 Participants |
| Liquid Autoinjector | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Creatine kinase,To normal or no change | 68 Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | ALT, To low | NA Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Creatine kinase, To high | 10 Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Creatinine, To low | 1 Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Creatinine, To normal or no change | 79 Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Creatinine, To high | 0 Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Potassium, To low | 0 Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Potassium, To normal or no change | 80 Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Potassium, To high | 0 Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Protein, To low | 0 Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Protein, To normal or no change | 80 Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Protein, To high | 0 Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Sodium, To low | 0 Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Sodium, To normal or no change | 80 Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Sodium, To high | 0 Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Urea, To low | 1 Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Urea, To normal or no change | 79 Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Urea, To high | 0 Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Glucose, To low | 0 Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Glucose, To normal or no change | 80 Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Glucose, To high | 0 Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Albumin, To low | 0 Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Albumin, To normal or no change | 80 Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Albumin, To high | 0 Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | ALP, To low | 0 Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | ALP, To normal or no change | 80 Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | ALP, To high | 0 Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Creatine kinase,To normal or no change | 70 Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | ALT, To normal or no change | 80 Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | ALT, To high | 0 Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | AST, To low | NA Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | AST, To normal or no change | 80 Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | AST, To high | 0 Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | D.bilirubin, To low | NA Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | D.bilirubin, To normal or no change | 80 Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | D.bilirubin, To high | 0 Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Bilirubin, To low | NA Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Bilirubin, To normal or no change | 78 Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Bilirubin, To high | 2 Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Calcium, To low | 0 Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Calcium, To normal or no change | 79 Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Calcium, To high | 1 Participants |
| Liquid Safety Syringe | Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range | Creatine kinase, To low | NA Participants |
Secondary
Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range
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
Population: All Treated Subjects (Safety) Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lyophilized Vial | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Lymphocytes, To low | 2 Participants |
| Lyophilized Vial | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Leukocytes, To normal or no change | 73 Participants |
| Lyophilized Vial | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Neutrophils, To low | 7 Participants |
| Lyophilized Vial | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Lymphocytes, To normal or no change | 83 Participants |
| Lyophilized Vial | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Basophils, To low | NA Participants |
| Lyophilized Vial | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Monocytes, To high | 0 Participants |
| Lyophilized Vial | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Lymphocytes, To high | 0 Participants |
| Lyophilized Vial | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Eosinophils, To high | 0 Participants |
| Lyophilized Vial | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Monocytes, To normal or no change | 74 Participants |
| Lyophilized Vial | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | MCH, To low | 0 Participants |
| Lyophilized Vial | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Basophils, To high | 0 Participants |
| Lyophilized Vial | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Monocytes, To low | 11 Participants |
| Lyophilized Vial | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | MCH, To normal or no change | 84 Participants |
| Lyophilized Vial | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Erythrocytes, To normal or no change | 81 Participants |
| Lyophilized Vial | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | MCV, To high | 1 Participants |
| Lyophilized Vial | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | MCH, To high | 1 Participants |
| Lyophilized Vial | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Hematocrit, To low | 8 Participants |
| Lyophilized Vial | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | MCV, To normal or no change | 83 Participants |
| Lyophilized Vial | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | MCV, To low | 1 Participants |
| Lyophilized Vial | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Basophils, To normal or no change | 85 Participants |
| Lyophilized Vial | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Erythrocytes, To low | 4 Participants |
| Lyophilized Vial | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Hematocrit, To normal or no change | 76 Participants |
| Lyophilized Vial | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Leukocytes, To low | 11 Participants |
| Lyophilized Vial | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Platelets, To high | 0 Participants |
| Lyophilized Vial | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Hematocrit, To high | 1 Participants |
| Lyophilized Vial | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Eosinophils, To low | 58 Participants |
| Lyophilized Vial | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Platelets, To normal or no change | 85 Participants |
| Lyophilized Vial | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Hemoglobin, To low | 12 Participants |
| Lyophilized Vial | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Leukocytes, To high | 1 Participants |
| Lyophilized Vial | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Platelets, To low | 0 Participants |
| Lyophilized Vial | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Hemoglobin, To normal or no change | 73 Participants |
| Lyophilized Vial | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Erythrocytes, To high | 0 Participants |
| Lyophilized Vial | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Neutrophils, To high | 1 Participants |
| Lyophilized Vial | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Hemoglobin, To high | 0 Participants |
| Lyophilized Vial | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Eosinophils, To normal or no change | 27 Participants |
| Lyophilized Vial | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Neutrophils, To normal or no change | 77 Participants |
| Liquid Autoinjector | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Erythrocytes, To normal or no change | 78 Participants |
| Liquid Autoinjector | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Basophils, To low | NA Participants |
| Liquid Autoinjector | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Basophils, To normal or no change | 79 Participants |
| Liquid Autoinjector | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Basophils, To high | 0 Participants |
| Liquid Autoinjector | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Eosinophils, To low | 46 Participants |
| Liquid Autoinjector | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Eosinophils, To normal or no change | 33 Participants |
| Liquid Autoinjector | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Eosinophils, To high | 0 Participants |
| Liquid Autoinjector | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Hematocrit, To low | 6 Participants |
| Liquid Autoinjector | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Hematocrit, To normal or no change | 72 Participants |
| Liquid Autoinjector | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Hematocrit, To high | 1 Participants |
| Liquid Autoinjector | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Hemoglobin, To low | 8 Participants |
| Liquid Autoinjector | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Hemoglobin, To normal or no change | 70 Participants |
| Liquid Autoinjector | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Hemoglobin, To high | 1 Participants |
| Liquid Autoinjector | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Lymphocytes, To low | 0 Participants |
| Liquid Autoinjector | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Lymphocytes, To normal or no change | 79 Participants |
| Liquid Autoinjector | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Lymphocytes, To high | 0 Participants |
| Liquid Autoinjector | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | MCH, To low | 5 Participants |
| Liquid Autoinjector | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | MCH, To normal or no change | 74 Participants |
| Liquid Autoinjector | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | MCH, To high | 0 Participants |
| Liquid Autoinjector | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | MCV, To low | 0 Participants |
| Liquid Autoinjector | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | MCV, To normal or no change | 79 Participants |
| Liquid Autoinjector | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | MCV, To high | 0 Participants |
| Liquid Autoinjector | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Monocytes, To low | 8 Participants |
| Liquid Autoinjector | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Monocytes, To normal or no change | 71 Participants |
| Liquid Autoinjector | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Monocytes, To high | 0 Participants |
| Liquid Autoinjector | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Neutrophils, To low | 11 Participants |
| Liquid Autoinjector | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Neutrophils, To normal or no change | 68 Participants |
| Liquid Autoinjector | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Neutrophils, To high | 0 Participants |
| Liquid Autoinjector | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Platelets, To low | 0 Participants |
| Liquid Autoinjector | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Platelets, To normal or no change | 78 Participants |
| Liquid Autoinjector | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Platelets, To high | 1 Participants |
| Liquid Autoinjector | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Erythrocytes, To low | 0 Participants |
| Liquid Autoinjector | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Erythrocytes, To high | 1 Participants |
| Liquid Autoinjector | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Leukocytes, To low | 9 Participants |
| Liquid Autoinjector | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Leukocytes, To normal or no change | 70 Participants |
| Liquid Autoinjector | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Leukocytes, To high | 0 Participants |
| Liquid Safety Syringe | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Lymphocytes, To low | 1 Participants |
| Liquid Safety Syringe | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Leukocytes, To normal or no change | 72 Participants |
| Liquid Safety Syringe | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Neutrophils, To low | 9 Participants |
| Liquid Safety Syringe | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Hemoglobin, To high | 0 Participants |
| Liquid Safety Syringe | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Erythrocytes, To high | 0 Participants |
| Liquid Safety Syringe | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Neutrophils, To normal or no change | 71 Participants |
| Liquid Safety Syringe | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Hemoglobin, To normal or no change | 67 Participants |
| Liquid Safety Syringe | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Basophils, To high | 0 Participants |
| Liquid Safety Syringe | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Neutrophils, To high | 0 Participants |
| Liquid Safety Syringe | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Hemoglobin, To low | 13 Participants |
| Liquid Safety Syringe | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Basophils, To low | NA Participants |
| Liquid Safety Syringe | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Platelets, To low | 1 Participants |
| Liquid Safety Syringe | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Hematocrit, To high | 1 Participants |
| Liquid Safety Syringe | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Leukocytes, To low | 8 Participants |
| Liquid Safety Syringe | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Platelets, To normal or no change | 79 Participants |
| Liquid Safety Syringe | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Hematocrit, To normal or no change | 75 Participants |
| Liquid Safety Syringe | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Basophils, To normal or no change | 80 Participants |
| Liquid Safety Syringe | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Platelets, To high | 0 Participants |
| Liquid Safety Syringe | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Hematocrit, To low | 4 Participants |
| Liquid Safety Syringe | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Leukocytes, To high | 0 Participants |
| Liquid Safety Syringe | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | MCV, To low | 1 Participants |
| Liquid Safety Syringe | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | MCH, To high | 0 Participants |
| Liquid Safety Syringe | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Erythrocytes, To low | 3 Participants |
| Liquid Safety Syringe | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | MCV, To normal or no change | 79 Participants |
| Liquid Safety Syringe | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | MCH, To normal or no change | 78 Participants |
| Liquid Safety Syringe | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Eosinophils, To high | 1 Participants |
| Liquid Safety Syringe | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | MCV, To high | 0 Participants |
| Liquid Safety Syringe | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | MCH, To low | 2 Participants |
| Liquid Safety Syringe | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Eosinophils, To normal or no change | 24 Participants |
| Liquid Safety Syringe | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Monocytes, To low | 12 Participants |
| Liquid Safety Syringe | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Lymphocytes, To high | 0 Participants |
| Liquid Safety Syringe | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Erythrocytes, To normal or no change | 77 Participants |
| Liquid Safety Syringe | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Monocytes, To normal or no change | 68 Participants |
| Liquid Safety Syringe | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Lymphocytes, To normal or no change | 79 Participants |
| Liquid Safety Syringe | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Eosinophils, To low | 55 Participants |
| Liquid Safety Syringe | Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range | Monocytes, To high | 0 Participants |
Secondary
Number of Participants With On-treatment Non-serious Adverse Events (AEs) and Serious AEs (SAEs)
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
Population: All Treated Subjects (Safety) Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lyophilized Vial | Number of Participants With On-treatment Non-serious Adverse Events (AEs) and Serious AEs (SAEs) | Non-serious AEs | 11 Participants |
| Lyophilized Vial | Number of Participants With On-treatment Non-serious Adverse Events (AEs) and Serious AEs (SAEs) | SAEs | 0 Participants |
| Liquid Autoinjector | Number of Participants With On-treatment Non-serious Adverse Events (AEs) and Serious AEs (SAEs) | Non-serious AEs | 13 Participants |
| Liquid Autoinjector | Number of Participants With On-treatment Non-serious Adverse Events (AEs) and Serious AEs (SAEs) | SAEs | 0 Participants |
| Liquid Safety Syringe | Number of Participants With On-treatment Non-serious Adverse Events (AEs) and Serious AEs (SAEs) | Non-serious AEs | 14 Participants |
| Liquid Safety Syringe | Number of Participants With On-treatment Non-serious Adverse Events (AEs) and Serious AEs (SAEs) | SAEs | 0 Participants |
Secondary
Number of Participants With On-treatment Systemic Reactions and Injection Site Reactions
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
Population: All Treated Subjects (Safety) Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lyophilized Vial | Number of Participants With On-treatment Systemic Reactions and Injection Site Reactions | Systemic reactions | 0 Participants |
| Lyophilized Vial | Number of Participants With On-treatment Systemic Reactions and Injection Site Reactions | Injection site reactions | 1 Participants |
| Liquid Autoinjector | Number of Participants With On-treatment Systemic Reactions and Injection Site Reactions | Systemic reactions | 0 Participants |
| Liquid Autoinjector | Number of Participants With On-treatment Systemic Reactions and Injection Site Reactions | Injection site reactions | 1 Participants |
| Liquid Safety Syringe | Number of Participants With On-treatment Systemic Reactions and Injection Site Reactions | Systemic reactions | 0 Participants |
| Liquid Safety Syringe | Number of Participants With On-treatment Systemic Reactions and Injection Site Reactions | Injection site reactions | 2 Participants |
Secondary
Number of Participants With Positive Anti-mepolizumab Binding Antibodies
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
Population: All Treated Subjects (Safety) Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lyophilized Vial | Number of Participants With Positive Anti-mepolizumab Binding Antibodies | Transient positive | 1 Participants |
| Lyophilized Vial | Number of Participants With Positive Anti-mepolizumab Binding Antibodies | Persistent positive | 2 Participants |
| Liquid Autoinjector | Number of Participants With Positive Anti-mepolizumab Binding Antibodies | Transient positive | 1 Participants |
| Liquid Autoinjector | Number of Participants With Positive Anti-mepolizumab Binding Antibodies | Persistent positive | 4 Participants |
| Liquid Safety Syringe | Number of Participants With Positive Anti-mepolizumab Binding Antibodies | Transient positive | 0 Participants |
| Liquid Safety Syringe | Number of Participants With Positive Anti-mepolizumab Binding Antibodies | Persistent positive | 3 Participants |
Secondary
Number of Participants With Positive Neutralizing Antibodies
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
Population: All Treated Subjects (Safety) Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lyophilized Vial | Number of Participants With Positive Neutralizing Antibodies | 0 Participants |
| Liquid Autoinjector | Number of Participants With Positive Neutralizing Antibodies | 0 Participants |
| Liquid Safety Syringe | Number of Participants With Positive Neutralizing Antibodies | 0 Participants |
Secondary
Percentage of AUC(0-inf) Obtained by Extrapolation (% AUCex) of Mepolizumab
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
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Lyophilized Vial | Percentage of AUC(0-inf) Obtained by Extrapolation (% AUCex) of Mepolizumab | 7.67 Percentage | Geometric Coefficient of Variation 42.06 |
| Liquid Autoinjector | Percentage of AUC(0-inf) Obtained by Extrapolation (% AUCex) of Mepolizumab | 7.64 Percentage | Geometric Coefficient of Variation 47.3 |
| Liquid Safety Syringe | Percentage of AUC(0-inf) Obtained by Extrapolation (% AUCex) of Mepolizumab | 7.20 Percentage | Geometric Coefficient of Variation 48.24 |
Secondary
Terminal Phase Elimination Rate Constant (Lambda z) of Mepolizumab
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
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Lyophilized Vial | Terminal Phase Elimination Rate Constant (Lambda z) of Mepolizumab | 0.0013157 Per hours | Geometric Coefficient of Variation 21.51 |
| Liquid Autoinjector | Terminal Phase Elimination Rate Constant (Lambda z) of Mepolizumab | 0.0012930 Per hours | Geometric Coefficient of Variation 26.2 |
| Liquid Safety Syringe | Terminal Phase Elimination Rate Constant (Lambda z) of Mepolizumab | 0.0013228 Per hours | Geometric Coefficient of Variation 26.71 |
Secondary
Terminal Phase Half-life (t½) of Mepolizumab
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
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Lyophilized Vial | Terminal Phase Half-life (t½) of Mepolizumab | 21.95 Days | Geometric Coefficient of Variation 18.66 |
| Liquid Autoinjector | Terminal Phase Half-life (t½) of Mepolizumab | 22.34 Days | Geometric Coefficient of Variation 21.38 |
| Liquid Safety Syringe | Terminal Phase Half-life (t½) of Mepolizumab | 21.83 Days | Geometric Coefficient of Variation 21.62 |
Secondary
Time to Cmax (Tmax) and Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) of Mepolizumab
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
Population: PK Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Lyophilized Vial | Time to Cmax (Tmax) and Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) of Mepolizumab | tmax | 7.04 Days |
| Lyophilized Vial | Time to Cmax (Tmax) and Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) of Mepolizumab | tlast | 83.97 Days |
| Liquid Autoinjector | Time to Cmax (Tmax) and Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) of Mepolizumab | tmax | 7.05 Days |
| Liquid Autoinjector | Time to Cmax (Tmax) and Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) of Mepolizumab | tlast | 83.98 Days |
| Liquid Safety Syringe | Time to Cmax (Tmax) and Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) of Mepolizumab | tmax | 7.06 Days |
| Liquid Safety Syringe | Time to Cmax (Tmax) and Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) of Mepolizumab | tlast | 83.99 Days |