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This is a randomized, double-blind (sponsor-open), placebo-controlled, single-center study involving Japanese participants. The purpose of the study is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity after a single subcutaneous (SC) dose of GSK2330811 in healthy Japanese participants. GSK2330811 is a humanized immunoglobulin G1 (IgG1) monoclonal antibody that binds and inhibits the action of Oncostatin M (OSM) and is being developed for the treatment of Crohn's disease (CD) and Systemic sclerosis (SSc). Participants will be randomized to receive either GSK2330811 (450 milligram [mg]) or placebo in an approximate ratio of 7:3.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK2330811 450 mg | Experimental | Participants will receive a single 450 mg SC dose of GSK2330811, administered as three separate SC injections of 150 milligrams per milliliter [mg/mL]). |
|
| Placebo | Placebo Comparator | Participants will receive GSK2330811 matching placebo administered as three separate SC injections. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo is 0.9 percent sodium chloride solution. It will be administered as SC injection to abdomen by study personnel. Three injections will be used to match active doses. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment. Safety Population consisted of all randomized participants who received at least one dose of study treatment. | Up to Day 126 |
| Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Vital signs were measured in semi-supine position after 5 minutes of rest and included systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR). Participants were counted in the worst case category that their value changed to low, within range or high, unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became within range, were recorded in the "Within Range or No Change" category. Participants were counted twice if values changed 'To Low' and 'To High', so the percentages were not added up to 100 percent (%). Participants with missing Baseline values were assumed as within range value. PCI ranges were: SBP (lower: <85, upper: >160 millimeter of mercury [mmHg]); DBP (lower: <45, upper: >100 mmHg); HR (lower: <40, upper: >110 beats per minute). Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. | Baseline (Pre-dose, Day 1) and up to Day 126 |
| Change From Baseline in Body Temperature | Body temperature was measured in semi-supine position after 5 minutes of rest for the participants in a quiet setting without distractions. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) for GSK2330811 | Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK2330811. PK parameters were calculated using standard non-compartmental analysis. Pharmacokinetic Population consisted of all participants in the Safety population who received at least one active dose of study treatment and had at least 1 non-missing PK assessment. |
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Inclusion Criteria:
Exclusion Criteria:
Male participants of 18 to 65 years of age at the time of signing the informed consent are inclusive.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | London | NW10 7EW | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38501358 | Derived | Thorsted A, Zecchin C, Berges A, Karlsson MO, Friberg LE. Predicting the Long-Term Effects of Therapeutic Neutralization of Oncostatin M on Human Hematopoiesis. Clin Pharmacol Ther. 2024 Sep;116(3):703-715. doi: 10.1002/cpt.3246. Epub 2024 Mar 19. |
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IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
A total of 9 participants were randomized and enrolled in this study.
This was a randomized, double-blind, placebo-controlled, single-center study with single subcutaneous (SC) dose of GSK2330811 administered in healthy male Japanese participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received a single SC dose of Placebo, administered as three separate SC injections. |
| FG001 | GSK2330811 450 mg | Participants received a single 450 milligram (mg) SC dose of GSK2330811, administered as three separate SC injections of 150 milligrams per milliliter [mg/mL]). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received a single SC dose of Placebo, administered as three separate SC injections. |
| BG001 | GSK2330811 450 mg | Participants received a single 450 milligram (mg) SC dose of GSK2330811, administered as three separate SC injections of 150 milligrams per milliliter [mg/mL]). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment. Safety Population consisted of all randomized participants who received at least one dose of study treatment. | Safety Population. | Posted | Count of Participants | Participants | Up to Day 126 |
|
All-cause mortality, SAEs and non SAEs were collected up to Day 126
Safety Population consisted of all randomized participants who received at least one dose of study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received a single SC dose of Placebo, administered as three separate SC injections. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 11, 2019 | Apr 23, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 7, 2020 | Apr 23, 2021 | SAP_001.pdf |
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This is a parallel group study. Participants will be randomized to receive either GSK2330811 (450 mg) or placebo in an approximate ratio of 7:3.
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| GSK2330811 | Drug | GSK2330811 will be available as SC injection 150 mg/mL. |
|
| Baseline (Pre-dose, Day 1), Day 1: 1, 4, 8 hours; Days 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 84 and 126 |
| Number of Participants With Worst Case Abnormal Electrocardiogram (ECG) Findings | 12-lead ECGs were recorded in semi-supine position using an ECG machine. Number of participants with worst-case clinically significant and not clinically significant abnormal ECG findings have been presented. Clinically significant abnormal laboratory findings were those which were not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. | Up to Day 126 |
| Number of Participants With Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or Higher Clinical Chemistry Parameters | Blood samples were collected for the analysis of clinical chemistry parameters. Clinical chemistry parameters were summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0: Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening or disabling. Higher grade indicates more severity. Clinical chemistry parameters included: total bilirubin, calcium, creatinine and triglycerides. | Up to Day 126 |
| Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Blood samples were collected for the analysis of the following hematology parameters: hemoglobin (Hb), lymphocytes (Lympho), platelet count (PC), neutrophil count (Neutro) and White Blood Cell count (WBC). The laboratory parameters were graded according to NCI-CTCAE version 5.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates more severity. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. An increase was defined as an increase in CTCAE Grade relative to Baseline Grade. | Baseline (Pre-dose, Day 1) and up to Day 126 |
| Number of Participants With Worst Case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline | Urine samples were collected for analysis of blood, glucose, ketones and protein by a dipstick method. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine glucose, protein, blood and ketones can be read as negative (-), trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Any increase means any increase to trace, 1+, 2+ or 3+ post-Baseline relative to Baseline. Number of participants with worst case any increase in urinalysis results post-Baseline relative to Baseline has been presented. | Baseline (Pre-dose, Day 1) and up to Day 126 |
| Day 1: Pre-dose, 8 hours; Days 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 84 and 126 |
| Area Under the Plasma Concentration Time-curve From Time Zero to Infinity (AUC[0-infinity]) for GSK2330811 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2330811. PK parameters were calculated using standard non-compartmental analysis. | Day 1: Pre-dose, 8 hours; Days 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 84 and 126 |
| Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-t]) for GSK2330811 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2330811. PK parameters were calculated using standard non-compartmental analysis. | Day 1: Pre-dose, 8 hours; Days 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 84 and 126 |
| Apparent Systemic Clearance (CL/F) for GSK2330811 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2330811. PK parameters were calculated using standard non-compartmental analysis. | Day 1: Pre-dose, 8 hours; Days 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 84 and 126 |
| Time to Cmax (Tmax) for GSK2330811 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2330811. PK parameters were calculated using standard non-compartmental analysis. | Day 1: Pre-dose, 8 hours; Days 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 84 and 126 |
| Terminal Half-life (t1/2) for GSK2330811 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2330811. PK parameters were calculated using standard non-compartmental analysis. | Day 1: Pre-dose, 8 hours; Days 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 84 and 126 |
| Apparent Volume of Distribution at Steady State (Vss/F) for GSK2330811 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2330811. PK parameters were calculated using standard non-compartmental analysis. | Day 1: Pre-dose, 8 hours; Days 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 84 and 126 |
| Number of Participants With Positive Anti-GSK2330811 Antibodies | Serum samples were analyzed for the presence of anti-GSK2330811 antibodies using an antibody binding assay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Number of participants with confirmed positive anti-GSK2330811 antibodies are presented. | Up to Day 126 |
| Platelet Count Nadir for GSK2330811 | Blood samples were collected at indicated time points for analysis of platelet count nadir for GSK2330811. Nadir was defined as the lowest post-Baseline value of the platelet count. | Days 1, 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 84 and 126 |
| Time to Platelet Count Nadir for GSK2330811 | Blood samples were collected at indicated time points for analysis of platelet count nadir for GSK2330811. Nadir was defined as the lowest post-Baseline value of the platelet count. Time to nadir was defined as Study Day of Nadir minus 1. | Days 1, 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 84 and 126 |
| Hemoglobin Nadir for GSK2330811 | Blood samples were collected at the indicated time points for analysis of hemoglobin nadir for GSK2330811. Nadir was defined as the lowest post-Baseline value of the hemoglobin. | Days 1, 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 84 and 126 |
| Time to Hemoglobin Nadir for GSK2330811 | Blood samples were collected at indicated time points for analysis of hemoglobin nadir for GSK2330811. Nadir was defined as the lowest post-Baseline value of the hemoglobin. Time to nadir was defined as Study Day of Nadir minus 1. | Days 1, 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 84 and 126 |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | GSK2330811 450 mg | Participants received a single 450 milligram (mg) SC dose of GSK2330811, administered as three separate SC injections of 150 milligrams per milliliter [mg/mL]). |
|
|
| Primary | Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Vital signs were measured in semi-supine position after 5 minutes of rest and included systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR). Participants were counted in the worst case category that their value changed to low, within range or high, unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became within range, were recorded in the "Within Range or No Change" category. Participants were counted twice if values changed 'To Low' and 'To High', so the percentages were not added up to 100 percent (%). Participants with missing Baseline values were assumed as within range value. PCI ranges were: SBP (lower: <85, upper: >160 millimeter of mercury [mmHg]); DBP (lower: <45, upper: >100 mmHg); HR (lower: <40, upper: >110 beats per minute). Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. | Safety Population. | Posted | Count of Participants | Participants | Baseline (Pre-dose, Day 1) and up to Day 126 |
|
|
|
| Primary | Change From Baseline in Body Temperature | Body temperature was measured in semi-supine position after 5 minutes of rest for the participants in a quiet setting without distractions. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Degrees Celsius | Baseline (Pre-dose, Day 1), Day 1: 1, 4, 8 hours; Days 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 84 and 126 |
|
|
|
| Primary | Number of Participants With Worst Case Abnormal Electrocardiogram (ECG) Findings | 12-lead ECGs were recorded in semi-supine position using an ECG machine. Number of participants with worst-case clinically significant and not clinically significant abnormal ECG findings have been presented. Clinically significant abnormal laboratory findings were those which were not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. | Safety Population. | Posted | Count of Participants | Participants | Up to Day 126 |
|
|
|
| Primary | Number of Participants With Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or Higher Clinical Chemistry Parameters | Blood samples were collected for the analysis of clinical chemistry parameters. Clinical chemistry parameters were summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0: Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening or disabling. Higher grade indicates more severity. Clinical chemistry parameters included: total bilirubin, calcium, creatinine and triglycerides. | Safety Population. | Posted | Count of Participants | Participants | Up to Day 126 |
|
|
|
| Primary | Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Blood samples were collected for the analysis of the following hematology parameters: hemoglobin (Hb), lymphocytes (Lympho), platelet count (PC), neutrophil count (Neutro) and White Blood Cell count (WBC). The laboratory parameters were graded according to NCI-CTCAE version 5.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates more severity. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. An increase was defined as an increase in CTCAE Grade relative to Baseline Grade. | Safety Population. | Posted | Count of Participants | Participants | Baseline (Pre-dose, Day 1) and up to Day 126 |
|
|
|
| Primary | Number of Participants With Worst Case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline | Urine samples were collected for analysis of blood, glucose, ketones and protein by a dipstick method. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine glucose, protein, blood and ketones can be read as negative (-), trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Any increase means any increase to trace, 1+, 2+ or 3+ post-Baseline relative to Baseline. Number of participants with worst case any increase in urinalysis results post-Baseline relative to Baseline has been presented. | Safety Population. | Posted | Count of Participants | Participants | Baseline (Pre-dose, Day 1) and up to Day 126 |
|
|
|
| Secondary | Maximum Plasma Concentration (Cmax) for GSK2330811 | Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK2330811. PK parameters were calculated using standard non-compartmental analysis. Pharmacokinetic Population consisted of all participants in the Safety population who received at least one active dose of study treatment and had at least 1 non-missing PK assessment. | PK Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | Day 1: Pre-dose, 8 hours; Days 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 84 and 126 |
|
|
|
| Secondary | Area Under the Plasma Concentration Time-curve From Time Zero to Infinity (AUC[0-infinity]) for GSK2330811 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2330811. PK parameters were calculated using standard non-compartmental analysis. | PK Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanogram per milliliter | Day 1: Pre-dose, 8 hours; Days 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 84 and 126 |
|
|
|
| Secondary | Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-t]) for GSK2330811 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2330811. PK parameters were calculated using standard non-compartmental analysis. | PK Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanogram per milliliter | Day 1: Pre-dose, 8 hours; Days 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 84 and 126 |
|
|
|
| Secondary | Apparent Systemic Clearance (CL/F) for GSK2330811 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2330811. PK parameters were calculated using standard non-compartmental analysis. | PK Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter per hour | Day 1: Pre-dose, 8 hours; Days 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 84 and 126 |
|
|
|
| Secondary | Time to Cmax (Tmax) for GSK2330811 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2330811. PK parameters were calculated using standard non-compartmental analysis. | PK Population. | Posted | Median | Full Range | Hours | Day 1: Pre-dose, 8 hours; Days 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 84 and 126 |
|
|
|
| Secondary | Terminal Half-life (t1/2) for GSK2330811 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2330811. PK parameters were calculated using standard non-compartmental analysis. | PK Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | Day 1: Pre-dose, 8 hours; Days 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 84 and 126 |
|
|
|
| Secondary | Apparent Volume of Distribution at Steady State (Vss/F) for GSK2330811 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2330811. PK parameters were calculated using standard non-compartmental analysis. | PK Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter | Day 1: Pre-dose, 8 hours; Days 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 84 and 126 |
|
|
|
| Secondary | Number of Participants With Positive Anti-GSK2330811 Antibodies | Serum samples were analyzed for the presence of anti-GSK2330811 antibodies using an antibody binding assay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Number of participants with confirmed positive anti-GSK2330811 antibodies are presented. | Safety Population. | Posted | Count of Participants | Participants | Up to Day 126 |
|
|
|
| Secondary | Platelet Count Nadir for GSK2330811 | Blood samples were collected at indicated time points for analysis of platelet count nadir for GSK2330811. Nadir was defined as the lowest post-Baseline value of the platelet count. | Safety Population. | Posted | Mean | Standard Deviation | Giga cells per liter | Days 1, 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 84 and 126 |
|
|
|
| Secondary | Time to Platelet Count Nadir for GSK2330811 | Blood samples were collected at indicated time points for analysis of platelet count nadir for GSK2330811. Nadir was defined as the lowest post-Baseline value of the platelet count. Time to nadir was defined as Study Day of Nadir minus 1. | Safety Population. | Posted | Median | Full Range | Days | Days 1, 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 84 and 126 |
|
|
|
| Secondary | Hemoglobin Nadir for GSK2330811 | Blood samples were collected at the indicated time points for analysis of hemoglobin nadir for GSK2330811. Nadir was defined as the lowest post-Baseline value of the hemoglobin. | Safety Population. | Posted | Mean | Standard Deviation | Grams per liter | Days 1, 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 84 and 126 |
|
|
|
| Secondary | Time to Hemoglobin Nadir for GSK2330811 | Blood samples were collected at indicated time points for analysis of hemoglobin nadir for GSK2330811. Nadir was defined as the lowest post-Baseline value of the hemoglobin. Time to nadir was defined as Study Day of Nadir minus 1. | Safety Population. | Posted | Median | Full Range | Days | Days 1, 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 84 and 126 |
|
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 2 |
| 2 |
| EG001 | GSK2330811 450 mg | Participants received a single 450 milligram (mg) SC dose of GSK2330811, administered as three separate SC injections of 150 milligrams per milliliter [mg/mL]). | 0 | 7 | 0 | 7 | 6 | 7 |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Face injury | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Suspected COVID-19 | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| SBP, To high |
|
| DBP, To low |
|
| DBP, To Within Range or No Change |
|
| DBP, To high |
|
| HR, To low |
|
| HR, To Within Range or No Change |
|
| HR, To high |
|
| Day 1: 4 hour, n=2,7 |
|
|
| Day 1: 8 hour, n=2,7 |
|
|
| Day 2: n=2,7 |
|
|
| Day 3: n=2,7 |
|
|
| Day 5: n=2,7 |
|
|
| Day 7: n=2,7 |
|
|
| Day 10: n=2,7 |
|
|
| Day 14: n=2,7 |
|
|
| Day 21: n=2,7 |
|
|
| Day 28: n=2,7 |
|
|
| Day 42: n=2,7 |
|
|
| Day 56: n=2,6 |
|
|
| Day 84: n=1,6 |
|
|
| Day 126: n=0,6 |
|
|
| Total Bilirubin, Grade 3 |
|
| Total Bilirubin, Grade 4 |
|
| Calcium, Grade 1 |
|
| Calcium, Grade 2 |
|
| Calcium, Grade 3 |
|
| Calcium, Grade 4 |
|
| Creatinine, Grade 1 |
|
| Creatinine, Grade 2 |
|
| Creatinine, Grade 3 |
|
| Creatinine, Grade 4 |
|
| Triglycerides, Grade 1 |
|
| Triglycerides, Grade 2 |
|
| Triglycerides, Grade 3 |
|
| Triglycerides, Grade 4 |
|
| Hb, Anemia, increase to Grade 3 |
|
| Hb, Anemia, increase to Grade 4 |
|
| Hb, Hb increased, increase to Grade 1 |
|
| Hb, Hb increased, increase to Grade 2 |
|
| Hb, Hb increased, increase to Grade 3 |
|
| Hb, Hb increased, increase to Grade 4 |
|
| Lympho,Lympho count decreased, increase to Grade 1 |
|
| Lympho,Lympho count decreased, increase to Grade 2 |
|
| Lympho,Lympho count decreased, increase to Grade 3 |
|
| Lympho,Lympho count decreased, increase to Grade 4 |
|
| Lympho,Lympho count increased, increase to Grade 1 |
|
| Lympho,Lympho count increased, increase to Grade 2 |
|
| Lympho,Lympho count increased, increase to Grade 3 |
|
| Lympho,Lympho count increased, increase to Grade 4 |
|
| PC, PC decreased,increase to Grade 1 |
|
| PC, PC decreased,increase to Grade 2 |
|
| PC, PC decreased,increase to Grade 3 |
|
| PC, PC decreased,increase to Grade 4 |
|
| Neutro,Neutro count decreased,increase to Grade 1 |
|
| Neutro,Neutro count decreased,increase to Grade 2 |
|
| Neutro,Neutro count decreased,increase to Grade 3 |
|
| Neutro,Neutro count decreased,increase to Grade 4 |
|
| WBC,Leukocytosis, increase to Grade 1 |
|
| WBC,Leukocytosis, increase to Grade 2 |
|
| WBC,Leukocytosis, increase to Grade 3 |
|
| WBC,Leukocytosis, increase to Grade 4 |
|
| WBC,WBC decreased, increase to Grade 1 |
|
| WBC,WBC decreased, increase to Grade 2 |
|
| WBC,WBC decreased, increase to Grade 3 |
|
| WBC,WBC decreased, increase to Grade 4 |
|
| Ketones |
|
| Protein |
|