| Primary | Number of Participants With Non-serious Adverse Events (AE) and Serious Adverse Events (SAE) | 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 participants enrolled into the study who have received a dose of study medication (GSK1795091 or placebo) were included in the All Subjects Population. Participants with non-serious AEs (5 percentage threshold) and SAEs has been reported. | | Posted | | Count of Participants | | Participants | | Up to Day 32 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5. | | OG001 | Part 1: GSK1795091 7 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5. | | OG002 | Part 1: GSK1795091 21 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5. | | OG003 | Part 1: GSK1795091 60 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5. | | OG004 | Part 1: GSK1795091 Repeated 60 ng | In Part one sequential group evaluation, participants were randomized to receive single IV repeat dose of GSK1795091 60 ng as the study was restarted. Participants were observed inpatient until discharge on Day 5. | | OG005 | Part 1: GSK1795091 100 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 100 ng. Participants were observed inpatient until discharge on Day 5. |
| | | Title | Denominators | Categories |
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| Any SAE | | |
| |
| Primary | Change From Baseline in Body Temperature Part 1 | Body temperature was measured in semi-supine position after 5 minutes rest. Baseline values are the last non-missing pre-dose assessments. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. | | Posted | | Mean | Standard Deviation | Celsius | | Baseline, Day 1 (1, 2, 4, 6, 8, 12, 16 hours), Day 2, Day 3, Day 4, Day 5, and Day 7. | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5. | | OG001 | Part 1: GSK1795091 7 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5. | | OG002 | Part 1: GSK1795091 21 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5. | | OG003 |
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| Primary | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | Systolic and diastolic BP was measured in semi-supine position after 5 minutes rest. Baseline values are the last non-missing pre-dose assessments. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. | | Posted | | Mean | Standard Deviation | Millimeter of mercury (mmHg) | | Baseline, Day 1 (1, 2, 4, 6, 8, 12, 16 hours), Day 2, Day 3, Day 4, Day 5, and Day 7. | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5. | | OG001 | Part 1: GSK1795091 7 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5. | | OG002 | Part 1: GSK1795091 21 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5. |
|
| Primary | Change From Baseline in Pulse Rate Part 1 | Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline values are the last non-missing pre-dose assessments. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. | | Posted | | Mean | Standard Deviation | Beats per minute | | Baseline, Day 1 (1, 2, 4, 6, 8, 12, 16 hours), Day 2, Day 3, Day 4, Day 5, and Day 7. | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5. | | OG001 | Part 1: GSK1795091 7 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5. | | OG002 | Part 1: GSK1795091 21 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5. | | OG003 |
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| Primary | Change From Baseline in Respiratory Rate Part 1 | Respiratory rate was measured in semi-supine position after 5 minutes rest. Baseline values are the last non-missing pre-dose assessments. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. | | Posted | | Mean | Standard Deviation | Breaths per minute | | Baseline, Day 1 (1, 2, 4, 6, 8, 12, 16 hours), Day 2, Day 3, Day 4, Day 5, and Day 7. | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5. | | OG001 | Part 1: GSK1795091 7 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 nanogram (ng). Participants were observed inpatient until discharge on Day 5. | | OG002 | Part 1: GSK1795091 21 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5. | | OG003 |
|
| Primary | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Hematology parameters included hemoglobin (HGB), hematocrit (HCT), Red Blood Cell (RBC) count, White Blood Cell (WBC) count with differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils), platelet count, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC). Reference range for basophil was 0.01 - 0.07*10^9/Liters (L), eosinophils 0.03 - 0.5*10^9/L, HCT 0.38 - 0.48 proportion of RBC in blood, HGB 126 - 165*gram (g)/L, lymphocytes 1.08 - 3*10^9/L, MCH 26.3 - 32.8*picogram (pg), MCHC 324 - 359*g/L, MCV 77 - 94.9*femtoliter (fL), monocytes 0.3 - 0.92*10^9/L, neutrophils 1.46 - 5.85*10^9/L, platelets 155 - 342*10^9/L, erythrocytes 4.12 - 5.74*10^12/L, leukocytes 3.19 - 8.71*10^9/L. Values below these ranges were considered as low and above these ranges were considered as high (H). Data for participants from any visit post-screening with values > reference range high and < reference range low are report. | | Posted | | Count of Participants | | Participants | | Up to Day 7 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5. | | OG001 | Part 1: GSK1795091 7 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5. |
|
| Primary | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Clinical chemistry parameters with reference range were albumin 35-52*g/L, Alkaline phosphatase (ALP) 30-120*International units/L (IU/L), Alanine aminotransferase (ALT) 0-50 * IU/L, Aspartate aminotransferase (AST) 0-50*IU/L, direct bilirubin 0-3.4* micromoles/L (µmol/L), bilirubin 5-21*µmol/L, calcium 2.2-2.65* millimoles/L (mmol/L), cholesterol 0-5.19* mmol/L, creatinine 59-104* µmol/L, C-reactive protein (CRP) 0-5*milligram (mg)/L,Gamma Glutamyl Transferase (GGT) 4.1-5.9*mmol/L, high density lipoproteins (HDL) cholesterol 0.99-2.32*mmol/L, potassium 3.5-5.1*mmol/L, low density lipoproteins (LDL) cholesterol 0-3.3*mmol/L, protein 66-83*g/L, sodium 136-146 * mmol/L, triglycerides 0-2.25 * mmol/L, glucose 4.1-5.9*mmol/L, and urea 2.8-7.2*mmol/L. Values below these ranges were considered as low and above these ranges were considered as high. Data for participants from any visit post-screening with values > reference range high and < reference range low are reported. | | Posted | | Count of Participants | | Participants | | Up to Day 7 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5. | | OG001 | Part 1: GSK1795091 7 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5. |
|
| Primary | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Urinalysis included microscopic examination parameters like Casts, REC, SEC, Urine erythrocytes and Urine leukocytes. Data at indicated time points were reported. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles). NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point. | | Posted | | Mean | Standard Deviation | Cells per high power field | | Pre-dose Day -1 and Day 1, Day 2, Day 4 and Day 7 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5. | | OG001 | Part 1: GSK1795091 7 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5. | | OG002 | Part 1: GSK1795091 21 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5. |
|
| Primary | Ketones and Urine Glucose at Indicated Time Points | Urinalysis included parameters like ketones and urine glucose. Data at indicated time points were reported. | | Posted | | Mean | Standard Deviation | Millimoles per liter | | Pre-dose Day -1 and Day 1, Day 2, Day 4 and Day 7 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5. | | OG001 | Part 1: GSK1795091 7 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5. | | OG002 | Part 1: GSK1795091 21 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5. | | OG003 | Part 1: GSK1795091 60 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5. |
|
| Primary | Occult Blood at Indicated Time Points | Urinalysis included parameter like Occult blood. Data at indicated time points were reported. | | Posted | | Mean | Standard Deviation | 10^9 cells per liter | | Pre-dose Day -1 and Day 1, Day 2, Day 4 and Day 7 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5. | | OG001 | Part 1: GSK1795091 7 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5. | | OG002 | Part 1: GSK1795091 21 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5. | | OG003 | Part 1: GSK1795091 60 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5. |
|
| Primary | Urine Protein at Indicated Time Points | Urinalysis included parameter like Urine protein. Data at indicated time points were reported. | | Posted | | Mean | Standard Deviation | Gram per liter | | Pre-dose Day -1 and Day 1, Day 2, Day 4 and Day 7 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5. | | OG001 | Part 1: GSK1795091 7 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5. | | OG002 | Part 1: GSK1795091 21 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5. | | OG003 | Part 1: GSK1795091 60 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5. |
|
| Primary | Specific Gravity at Indicated Time Points | Urinalysis included parameter like specific gravity. Urinary specific gravity is a measure of the concentration of solutes in the urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine. | | Posted | | Mean | Standard Deviation | Ratio | | Pre-dose Day -1 and Day 1, Day 2, Day 4 and Day 7 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5. | | OG001 | Part 1: GSK1795091 7 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5. | | OG002 | Part 1: GSK1795091 21 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5. | | OG003 |
|
| Primary | Urine Potential of Hydrogen (pH) at Indicated Time Points | Urinalysis parameters included urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). | | Posted | | Mean | Standard Deviation | pH | | Pre-dose Day -1 and Day 1, Day 2, Day 4 and Day 7 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5. | | OG001 | Part 1: GSK1795091 7 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5. | | OG002 | Part 1: GSK1795091 21 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5. | | OG003 |
|
| Primary | Number of Participants With Abnormal Electrocardiograms (ECG) Findings Worst Case Post-Baseline | Single measurements of 12-lead ECGs were obtained after 10 minutes of rest in a semi-supine position for the participant. Participants with abnormal ECG findings that are clinically not significant (NCS) and clinically significant (CS) data has been presented here. The data of worst case post-Baseline is presented here. | | Posted | | Count of Participants | | Participants | | Up to Day 32 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5. | | OG001 | Part 1: GSK1795091 7 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5. | | OG002 | Part 1: GSK1795091 21 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5. | |
|
| Secondary | Maximum Observed Drug Concentration (Cmax) of GSK1795091 for Part 1 | Blood samples were collected at indicated time points. The Pharmacokinetic (PK) parameters were calculated for each participant using a non-compartmental method. All participants for whom, at least, one valid and evaluable pharmacokinetic parameter (AUC or Cmax) was derived were included in PK Parameter Population. Only those participants with data available at the specified data points were analyzed. | PK Parameter Population. NA indicates data was not available for 7 ng Arm as all concentration outcomes at 7 ng were not quantifiable because all results were below the limit of quantification. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Picogram/milliliter (pg/mL) | | Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK1795091 7 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5. | | OG001 | Part 1: GSK1795091 21 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5. | | OG002 |
|
| Secondary | Time of Occurrence of Cmax (Tmax) and Terminal Half Life (t1/2) of GSK1795091 for Part 1 | Blood samples were collected at indicated time points. The PK parameters were calculated for each participant using a non-compartmental method. Only those participants with data available at the specified data points were analyzed. | PK Parameter Population. NA indicates data was not available for 7 ng Arm as all concentration outcomes at 7 ng were not quantifiable because all results were below the limit of quantification. | Posted | | Mean | Standard Deviation | Hours | | Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK1795091 7 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5. | | OG001 | Part 1: GSK1795091 21 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5. | | OG002 | Part 1: GSK1795091 60 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5. |
|
| Secondary | Partial Area Under the Concentration-time Curve to Time t (AUC[0-t]), Area Under the Concentration-time Curve (AUC) From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK1795091 for Part 1 | Blood samples were collected at indicated time points. The PK parameters were calculated for each participant using a non-compartmental method. AUC (0-t) was used interchangeably with AUC to last time of quantifiable concentration (AUC[0-last]) .Only those participants with data available at the specified data points were analyzed. | PK Parameter Population. NA indicates data was not available as all concentration outcomes at 7ng were not quantifiable because all results were below the limit of quantification. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*pg/mL | | Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK1795091 7 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5. | | OG001 | Part 1: GSK1795091 21 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5. | | OG002 |
|
| Secondary | Clearance (CL) of GSK1795091 for Part 1 | Blood samples were collected at indicated time points. The PK parameters were calculated for each participant using a non-compartmental method. Only those participants with data available at the specified data points were analyzed. | PK Parameter Population. NA indicates data was not available as all concentration outcomes at 7ng were not quantifiable because all results were below the limit of quantification. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liters per hour (L/h) | | Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK1795091 7 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5. | | OG001 | Part 1: GSK1795091 21 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5. | | OG002 | Part 1: GSK1795091 60 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5. |
|
| Secondary | Volume of Distribution of GSK1795091 for Part 1 | Blood samples were collected at indicated time points. The PK parameters were calculated for each participant using a non-compartmental method. Only those participants with data available at the specified data points were analyzed. | PK Parameter Population. NA indicates data was not available as all concentration outcomes at 7ng were not quantifiable because all results were below the limit of quantification. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liters (L) | | Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK1795091 7 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5. | | OG001 | Part 1: GSK1795091 21 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5. | | OG002 | Part 1: GSK1795091 60 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5. |
|
| Secondary | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | Blood samples were collected at indicated time points for the assessment of IL-6. Baseline (Day 1) was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Percentage fold change equals to 100*change from Baseline divided by Baseline. All participants in the "All Subjects Population" for whom valid and evaluable pharmacodynamic parameters were derived are included in Pharmacodynamic (PD) Population. Data from multiplex immunoassay has been reported. | | Posted | | Mean | Standard Deviation | Percent fold change | | Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5. | | OG001 | Part 1: GSK1795091 7 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5. | | OG002 | Part 1: GSK1795091 21 ng | |
|
| Secondary | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | Blood samples were collected at indicated time points for the assessment of TNF-alpha. Baseline (Day 1) was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Percentage fold change equals to 100*change from Baseline divided by Baseline. Data from multiplex immunoassay has been reported. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles). | | Posted | | Mean | Standard Deviation | Percent fold change | | Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5. | | OG001 | Part 1: GSK1795091 7 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5. | | OG002 | Part 1: GSK1795091 21 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5. |
|
| Secondary | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | Blood samples were collected at indicated time points for the assessment of IFN-gamma. Baseline (Day 1) was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Percentage fold change equals to 100*change from Baseline divided by Baseline. Data from multiplex immunoassay has been reported. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles). | | Posted | | Mean | Standard Deviation | Percent fold change | | Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5. | | OG001 | Part 1: GSK1795091 7 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5. | | OG002 | Part 1: GSK1795091 21 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5. |
|
| Secondary | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | Blood samples were collected at indicated time points for the assessment of IP-10. Baseline (Day 1) was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Percentage fold change equals to 100*change from Baseline divided by Baseline. | | Posted | | Mean | Standard Deviation | Percent fold change | | Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5. | | OG001 | Part 1: GSK1795091 7 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5. | | OG002 | Part 1: GSK1795091 21 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5. |
|
| Secondary | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | Blood samples were collected at indicated time points for the assessment of MCP-1. Baseline (Day 1) was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Percentage fold change equals to 100*change from Baseline divided by Baseline. | | Posted | | Mean | Standard Deviation | Percent fold change | | Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5. | | OG001 | Part 1: GSK1795091 7 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5. | | OG002 | Part 1: GSK1795091 21 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5. |
|
| Secondary | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | Blood samples were collected at indicated time points for the assessment of GCSF. Baseline was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Percentage fold change equals to 100*change from Baseline divided by Baseline. | | Posted | | Mean | Standard Deviation | Percent fold change | | Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5. | | OG001 | Part 1: GSK1795091 7 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5. | | OG002 | Part 1: GSK1795091 21 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5. |
|
| Secondary | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | Blood samples were collected at indicated time points for the assessment of IL-1Ra. Baseline was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Percentage fold change equals to 100*change from Baseline divided by Baseline. | | Posted | | Mean | Standard Deviation | Percent fold change | | Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5. | | OG001 | Part 1: GSK1795091 7 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5. | | OG002 | Part 1: GSK1795091 21 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5. |
|
| Secondary | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | Blood samples were collected at indicated time points for the assessment of IL-10. Baseline was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Percentage fold change equals to 100*change from Baseline divided by Baseline. | | Posted | | Mean | Standard Deviation | Percent fold change | | Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5. | | OG001 | Part 1: GSK1795091 7 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5. | | OG002 | Part 1: GSK1795091 21 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5. |
|
| Secondary | Change From Baseline in WBC Differential for Part 1 | WBC differential included Lymphocytes Count, Monocytes Count, Granulocytes Count including neutrophils and eosinophil. Baseline (Day 1) was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles). | | Posted | | Mean | Standard Deviation | 10^9 cells per liter | | Baseline, 4, 24 and 144 hours | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5. | | OG001 | Part 1: GSK1795091 7 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5. | | OG002 | Part 1: GSK1795091 21 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5. |
|
| Secondary | Change From Baseline in CRP for Part 1 | Blood samples were collected at indicated time points for the assessment of CRP. Baseline was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. | | Posted | | Mean | Standard Deviation | mg/L | | Baseline, Days 2, 4 and 7 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5. | | OG001 | Part 1: GSK1795091 7 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5. | | OG002 | Part 1: GSK1795091 21 ng | In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5. | | OG003 | Part 1: GSK1795091 60 ng |
|
| Secondary | Maximum Observed Drug Concentration (Cmax) of GSK1795091 for Part 2 | Cmax assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of Adverse events (AEs) of unknown etiology. | PK Parameter Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study. | Posted | | | | | | Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | All Participants in Part 2 | In part 2, two doses GSK1795091 determined by results from Part 1 were planned in parallel group evaluation. Part 2 was discontinued by the Sponsor prior to its scheduled start and no participants were enrolled. |
| |
| Secondary | Time of Occurrence of Cmax (Tmax) and Terminal Half Life (t1/2) of GSK1795091 for Part 2 | Tmax and t1/2 assessments were planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. | PK Parameter Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study. | Posted | | | | | | Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | All Participants in Part 2 | In part 2, two doses GSK1795091 determined by results from Part 1 were planned in parallel group evaluation. Part 2 was discontinued by the Sponsor prior to its scheduled start and no participants were enrolled. |
| |
| Secondary | Partial Area Under the Concentration-time Curve to Time = t (AUC[0-t]), Area Under the Concentration-time Curve (AUC) From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK1795091 for Part 2 | AUC (0-t) and AUC (0-inf) assessments were planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. | PK Parameter Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study. | Posted | | | | | | Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | All Participants in Part 2 | In part 2, two doses GSK1795091 determined by results from Part 1 were planned in parallel group evaluation. Part 2 was discontinued by the Sponsor prior to its scheduled start and no participants were enrolled. |
| |
| Secondary | Area Under the Concentration-time Curve (AUC) Time Curve for a Dosing Interval (AUC[0-tau]), AUC (0-last) of GSK1795091 for Part 2 | AUC (0-tau) and AUC (0-last) assessments were planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. | PK Parameter Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study. | Posted | | | | | | Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | All Participants in Part 2 | In part 2, two doses GSK1795091 determined by results from Part 1 were planned in parallel group evaluation. Part 2 was discontinued by the Sponsor prior to its scheduled start and no participants were enrolled. |
| |
| Secondary | Clearance (CL) of GSK1795091 for Part 2 | CL assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. | PK Parameter Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study. | Posted | | | | | | Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | All Participants in Part 2 | In part 2, two doses GSK1795091 determined by results from Part 1 were planned in parallel group evaluation. Part 2 was discontinued by the Sponsor prior to its scheduled start and no participants were enrolled. |
| |
| Secondary | Volume of Distribution of GSK1795091 for Part 2 | Volume of distribution assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. | PK Parameter Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study. | Posted | | | | | | Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | All Participants in Part 2 | In part 2, two doses GSK1795091 determined by results from Part 1 were planned in parallel group evaluation. Part 2 was discontinued by the Sponsor prior to its scheduled start and no participants were enrolled. |
| |
| Secondary | Accumulation Ratio of GSK1795091 for Part 2 | Accumulation ratio assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. | PK Parameter Population. Data were not collected for part 2 as none of the participant was enrolled into Part 2 of the study. | Posted | | | | | | Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | All Participants in Part 2 | In part 2, two doses GSK1795091 determined by results from Part 1 were planned in parallel group evaluation. Part 2 was discontinued by the Sponsor prior to its scheduled start and no participants were enrolled. |
| |
| Secondary | Time Invariance of GSK1795091 for Part 2 | Time invariance assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. | PK Parameter Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study. | Posted | | | | | | Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | All Participants in Part 2 | In part 2, two doses GSK1795091 determined by results from Part 1 were planned in parallel group evaluation. Part 2 was discontinued by the Sponsor prior to its scheduled start and no participants were enrolled. |
| |
| Secondary | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 2 | IL-6 assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. | PD Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study. | Posted | | | | | | Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours | | | | ID | Title | Description |
|---|
| OG000 | All Participants in Part 2 | In part 2, two doses GSK1795091 determined by results from Part 1 were planned in parallel group evaluation. Part 2 was discontinued by the Sponsor prior to its scheduled start and no participants were enrolled. |
| |
| Secondary | Percentage Fold Change of Concentration of TNF-alpha From Baseline for Part 2 | TNF-alpha assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. | PD Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study. | Posted | | | | | | Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours | | | | ID | Title | Description |
|---|
| OG000 | All Participants in Part 2 | In part 2, two doses GSK1795091 determined by results from Part 1 were planned in parallel group evaluation. Part 2 was discontinued by the Sponsor prior to its scheduled start and no participants were enrolled. |
| |
| Secondary | Percentage Fold Change of Concentration of IFN-gamma From Baseline for Part 2 | IFN-gamma assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. | PD Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study. | Posted | | | | | | Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours | | | | ID | Title | Description |
|---|
| OG000 | All Participants in Part 2 | In part 2, two doses GSK1795091 determined by results from Part 1 were planned in parallel group evaluation. Part 2 was discontinued by the Sponsor prior to its scheduled start and no participants were enrolled. |
| |
| Secondary | Percentage Fold Change of Concentration of IP-10 From Baseline for Part 2 | IP-10 assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. | PD Population. The data was not collected for Part 2 because no Par. were enrolled into this part of the study. | Posted | | | | | | Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours | | | | ID | Title | Description |
|---|
| OG000 | All Participants in Part 2 | In part 2, two doses GSK1795091 determined by results from Part 1 were planned in parallel group evaluation. Part 2 was discontinued by the Sponsor prior to its scheduled start and no participants were enrolled. |
| |
| Secondary | Percentage Fold Change of Concentration of MCP-1 From Baseline for Part 2 | MCP-1 assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. | PD Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study. | Posted | | | | | | Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours | | | | ID | Title | Description |
|---|
| OG000 | All Participants in Part 2 | In part 2, two doses GSK1795091 determined by results from Part 1 were planned in parallel group evaluation. Part 2 was discontinued by the Sponsor prior to its scheduled start and no participants were enrolled. |
| |
| Secondary | Percentage Fold Change of Concentration of GCSF From Baseline for Part 2 | GCSF assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. | PD Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study. | Posted | | | | | | Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours | | | | ID | Title | Description |
|---|
| OG000 | All Participants in Part 2 | In part 2, two doses GSK1795091 determined by results from Part 1 were planned in parallel group evaluation. Part 2 was discontinued by the Sponsor prior to its scheduled start and no participants were enrolled. |
| |
| Secondary | Percentage Fold Change of Concentration of IL-1Ra From Baseline for Part 2 | IL-1Ra assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. | PD Population. The data was not collected for Part 2 because no Par. were enrolled into this part of the study. | Posted | | | | | | Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours | | | | ID | Title | Description |
|---|
| OG000 | All Participants in Part 2 | In part 2, two doses GSK1795091 determined by results from Part 1 were planned in parallel group evaluation. Part 2 was discontinued by the Sponsor prior to its scheduled start and no participants were enrolled. |
| |
| Secondary | Percentage Fold Change of Concentration of IL-10 From Baseline for Part 2 | IL-10 assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. | PD Population. The data was not collected for Part 2 because no Par. were enrolled into this part of the study. | Posted | | | | | | Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours | | | | ID | Title | Description |
|---|
| OG000 | All Participants in Part 2 | In part 2, two doses GSK1795091 determined by results from Part 1 were planned in parallel group evaluation. Part 2 was discontinued by the Sponsor prior to its scheduled start and no participants were enrolled. |
| |
| Secondary | Change From Baseline in WBC Differential for Part 2 | WBC differential assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. | All Subjects Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study. | Posted | | | | | | Baseline, 2, 24 and 144 hours | | | | ID | Title | Description |
|---|
| OG000 | All Participants in Part 2 | In part 2, two doses GSK1795091 determined by results from Part 1 were planned in parallel group evaluation. Part 2 was discontinued by the Sponsor prior to its scheduled start and no participants were enrolled. |
| |
| Secondary | Number of Participants With Urinalysis Parameters Outside Reference Range for Part 2 | Urinalysis as part of safety assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. | All Subjects Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study. | Posted | | | | | | Up to Day 7 | | | | ID | Title | Description |
|---|
| OG000 | All Participants in Part 2 | In part 2, two doses GSK1795091 determined by results from Part 1 were planned in parallel group evaluation. Part 2 was discontinued by the Sponsor prior to its scheduled start and no participants were enrolled. |
| |
| Secondary | Number of Participants With Hematology Parameters Outside Reference Range in Part 2 | Hematology as part of safety assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. | All Subjects Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study. | Posted | | | | | | Up to Day 7 | | | | ID | Title | Description |
|---|
| OG000 | All Participants in Part 2 | In part 2, two doses GSK1795091 determined by results from Part 1 were planned in parallel group evaluation. Part 2 was discontinued by the Sponsor prior to its scheduled start and no participants were enrolled. |
| |
| Secondary | Number of Participants With Clinical Chemistry Parameters Outside Reference Range in Part 2 | Clinical chemistry as part of safety assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. | All Subjects Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study. | Posted | | | | | | Up to Day 7 | | | | ID | Title | Description |
|---|
| OG000 | All Participants in Part 2 | In part 2, two doses GSK1795091 determined by results from Part 1 were planned in parallel group evaluation. Part 2 was discontinued by the Sponsor prior to its scheduled start and no participants were enrolled. |
| |
| Secondary | Change From Baseline in CRP for Part 2 | CRP assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. | All Subjects Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study. | Posted | | | | | | Baseline and Pre-dose, 1, 2, 4, 8, 12, 16, 24, and 48 hours post dose | | | | ID | Title | Description |
|---|
| OG000 | All Participants in Part 2 | In part 2, two doses GSK1795091 determined by results from Part 1 were planned in parallel group evaluation. Part 2 was discontinued by the Sponsor prior to its scheduled start and no participants were enrolled. |
| |
| Secondary | Change From Baseline in Body Temperature for Part 2 | Body temperature was planned to be measured in Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. | All Subjects Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study. | Posted | | | | | | Baseline and up to Day 7 | | | | ID | Title | Description |
|---|
| OG000 | All Participants in Part 2 | In part 2, two doses GSK1795091 determined by results from Part 1 were planned in parallel group evaluation. Part 2 was discontinued by the Sponsor prior to its scheduled start and no participants were enrolled. |
| |
| Secondary | Change From Baseline in SBP and DBP for Part 2 | SBP and DBP was planned to be measured in Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. | All Subjects Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study. | Posted | | | | | | Baseline and up to Day 7 | | | | ID | Title | Description |
|---|
| OG000 | All Participants in Part 2 | In part 2, two doses GSK1795091 determined by results from Part 1 were planned in parallel group evaluation. Part 2 was discontinued by the Sponsor prior to its scheduled start and no participants were enrolled. |
| |
| Secondary | Change From Baseline in Respiratory Rate for Part 2 | Respiratory rate was planned to be measured in Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. | All Subjects Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study. | Posted | | | | | | Baseline and up to Day 7 | | | | ID | Title | Description |
|---|
| OG000 | All Participants in Part 2 | In part 2, two doses GSK1795091 determined by results from Part 1 were planned in parallel group evaluation. Part 2 was discontinued by the Sponsor prior to its scheduled start and no participants were enrolled. |
| |
| Secondary | Change From Baseline in Pulse Rate for Part 2 | Pulse rate was planned to be measured in Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. Baseline (Day 1) was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. | All Subjects Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study. | Posted | | | | | | Baseline and up to Day 7 | | | | ID | Title | Description |
|---|
| OG000 | All Participants in Part 2 | In part 2, two doses GSK1795091 determined by results from Part 1 were planned in parallel group evaluation. Part 2 was discontinued by the Sponsor prior to its scheduled start and no participants were enrolled. |
| |