Trial Outcomes & Findings for Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of GSK2330811 in Healthy Japanese Participants (NCT NCT04138043)
NCT ID: NCT04138043
Last Updated: 2021-05-24
Results Overview
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.
COMPLETED
PHASE1
9 participants
Up to Day 126
2021-05-24
Participant Flow
This was a randomized, double-blind, placebo-controlled, single-center study with single subcutaneous (SC) dose of GSK2330811 administered in healthy male Japanese participants.
A total of 9 participants were randomized and enrolled in this study.
Participant milestones
| Measure |
Placebo
Participants received a single SC dose of Placebo, administered as three separate SC injections.
|
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 \[mg/mL\]).
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
7
|
|
Overall Study
COMPLETED
|
2
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Participants received a single SC dose of Placebo, administered as three separate SC injections.
|
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 \[mg/mL\]).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of GSK2330811 in Healthy Japanese Participants
Baseline characteristics by cohort
| Measure |
Placebo
n=2 Participants
Participants received a single SC dose of Placebo, administered as three separate SC injections.
|
GSK2330811 450 mg
n=7 Participants
Participants received a single 450 milligram (mg) SC dose of GSK2330811, administered as three separate SC injections of 150 milligrams per milliliter \[mg/mL\]).
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.0 Years
STANDARD_DEVIATION 2.83 • n=5 Participants
|
29.1 Years
STANDARD_DEVIATION 6.52 • n=7 Participants
|
27.3 Years
STANDARD_DEVIATION 6.76 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese Heritage
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Day 126Population: Safety Population.
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.
Outcome measures
| Measure |
Placebo
n=2 Participants
Participants received a single SC dose of Placebo, administered as three separate SC injections.
|
GSK2330811 450 mg
n=7 Participants
Participants received a single 450 milligram (mg) SC dose of GSK2330811, administered as three separate SC injections of 150 milligrams per milliliter \[mg/mL\]).
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
2 Participants
|
6 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Pre-dose, Day 1) and up to Day 126Population: Safety Population.
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.
Outcome measures
| Measure |
Placebo
n=2 Participants
Participants received a single SC dose of Placebo, administered as three separate SC injections.
|
GSK2330811 450 mg
n=7 Participants
Participants received a single 450 milligram (mg) SC dose of GSK2330811, administered as three separate SC injections of 150 milligrams per milliliter \[mg/mL\]).
|
|---|---|---|
|
Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
SBP, To low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
SBP, To high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
DBP, To low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
DBP, To Within Range or No Change
|
2 Participants
|
7 Participants
|
|
Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
DBP, To high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
HR, To high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
SBP, To Within Range or No Change
|
2 Participants
|
7 Participants
|
|
Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
HR, To low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
HR, To Within Range or No Change
|
2 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Baseline (Pre-dose, Day 1), Day 1: 1, 4, 8 hours; Days 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 84 and 126Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
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.
Outcome measures
| Measure |
Placebo
n=2 Participants
Participants received a single SC dose of Placebo, administered as three separate SC injections.
|
GSK2330811 450 mg
n=7 Participants
Participants received a single 450 milligram (mg) SC dose of GSK2330811, administered as three separate SC injections of 150 milligrams per milliliter \[mg/mL\]).
|
|---|---|---|
|
Change From Baseline in Body Temperature
Day 5: n=2,7
|
0.20 Degrees Celsius
Standard Deviation 0.424
|
-0.06 Degrees Celsius
Standard Deviation 0.800
|
|
Change From Baseline in Body Temperature
Day 1: 1 hour, n=2,7
|
0.15 Degrees Celsius
Standard Deviation 0.212
|
0.06 Degrees Celsius
Standard Deviation 0.237
|
|
Change From Baseline in Body Temperature
Day 1: 4 hour, n=2,7
|
0.40 Degrees Celsius
Standard Deviation 0.283
|
0.07 Degrees Celsius
Standard Deviation 0.287
|
|
Change From Baseline in Body Temperature
Day 1: 8 hour, n=2,7
|
0.45 Degrees Celsius
Standard Deviation 0.071
|
0.40 Degrees Celsius
Standard Deviation 0.346
|
|
Change From Baseline in Body Temperature
Day 2: n=2,7
|
-0.15 Degrees Celsius
Standard Deviation 0.919
|
-0.03 Degrees Celsius
Standard Deviation 0.486
|
|
Change From Baseline in Body Temperature
Day 3: n=2,7
|
-0.30 Degrees Celsius
Standard Deviation 0.283
|
-0.34 Degrees Celsius
Standard Deviation 0.336
|
|
Change From Baseline in Body Temperature
Day 7: n=2,7
|
-0.30 Degrees Celsius
Standard Deviation 0.566
|
0.09 Degrees Celsius
Standard Deviation 0.521
|
|
Change From Baseline in Body Temperature
Day 10: n=2,7
|
-0.10 Degrees Celsius
Standard Deviation 0.283
|
-0.10 Degrees Celsius
Standard Deviation 0.862
|
|
Change From Baseline in Body Temperature
Day 14: n=2,7
|
0.25 Degrees Celsius
Standard Deviation 0.495
|
0.21 Degrees Celsius
Standard Deviation 0.537
|
|
Change From Baseline in Body Temperature
Day 21: n=2,7
|
0.05 Degrees Celsius
Standard Deviation 0.212
|
0.09 Degrees Celsius
Standard Deviation 0.609
|
|
Change From Baseline in Body Temperature
Day 28: n=2,7
|
0.20 Degrees Celsius
Standard Deviation 0.424
|
-0.06 Degrees Celsius
Standard Deviation 0.670
|
|
Change From Baseline in Body Temperature
Day 42: n=2,7
|
-0.60 Degrees Celsius
Standard Deviation 0.283
|
-0.10 Degrees Celsius
Standard Deviation 0.695
|
|
Change From Baseline in Body Temperature
Day 56: n=2,6
|
0.00 Degrees Celsius
Standard Deviation 0.141
|
-0.03 Degrees Celsius
Standard Deviation 0.715
|
|
Change From Baseline in Body Temperature
Day 84: n=1,6
|
0.90 Degrees Celsius
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
0.30 Degrees Celsius
Standard Deviation 0.494
|
|
Change From Baseline in Body Temperature
Day 126: n=0,6
|
—
|
0.28 Degrees Celsius
Standard Deviation 0.595
|
PRIMARY outcome
Timeframe: Up to Day 126Population: Safety Population.
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.
Outcome measures
| Measure |
Placebo
n=2 Participants
Participants received a single SC dose of Placebo, administered as three separate SC injections.
|
GSK2330811 450 mg
n=7 Participants
Participants received a single 450 milligram (mg) SC dose of GSK2330811, administered as three separate SC injections of 150 milligrams per milliliter \[mg/mL\]).
|
|---|---|---|
|
Number of Participants With Worst Case Abnormal Electrocardiogram (ECG) Findings
Abnormal - not clinically significant
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Case Abnormal Electrocardiogram (ECG) Findings
Abnormal - clinically significant
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 126Population: Safety Population.
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.
Outcome measures
| Measure |
Placebo
n=2 Participants
Participants received a single SC dose of Placebo, administered as three separate SC injections.
|
GSK2330811 450 mg
n=7 Participants
Participants received a single 450 milligram (mg) SC dose of GSK2330811, administered as three separate SC injections of 150 milligrams per milliliter \[mg/mL\]).
|
|---|---|---|
|
Number of Participants With Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or Higher Clinical Chemistry Parameters
Calcium, Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or Higher Clinical Chemistry Parameters
Calcium, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or Higher Clinical Chemistry Parameters
Creatinine, Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or Higher Clinical Chemistry Parameters
Total Bilirubin, Grade 1
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or Higher Clinical Chemistry Parameters
Total Bilirubin, Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or Higher Clinical Chemistry Parameters
Total Bilirubin, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or Higher Clinical Chemistry Parameters
Total Bilirubin, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or Higher Clinical Chemistry Parameters
Calcium, Grade 1
|
2 Participants
|
5 Participants
|
|
Number of Participants With Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or Higher Clinical Chemistry Parameters
Calcium, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or Higher Clinical Chemistry Parameters
Creatinine, Grade 1
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or Higher Clinical Chemistry Parameters
Creatinine, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or Higher Clinical Chemistry Parameters
Creatinine, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or Higher Clinical Chemistry Parameters
Triglycerides, Grade 1
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or Higher Clinical Chemistry Parameters
Triglycerides, Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or Higher Clinical Chemistry Parameters
Triglycerides, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or Higher Clinical Chemistry Parameters
Triglycerides, Grade 4
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Pre-dose, Day 1) and up to Day 126Population: Safety Population.
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.
Outcome measures
| Measure |
Placebo
n=2 Participants
Participants received a single SC dose of Placebo, administered as three separate SC injections.
|
GSK2330811 450 mg
n=7 Participants
Participants received a single 450 milligram (mg) SC dose of GSK2330811, administered as three separate SC injections of 150 milligrams per milliliter \[mg/mL\]).
|
|---|---|---|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Hb, Anemia, increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Hb, Hb increased, increase to Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Lympho,Lympho count decreased, increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
PC, PC decreased,increase to Grade 3
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
PC, PC decreased,increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Neutro,Neutro count decreased,increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Neutro,Neutro count decreased,increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
WBC,WBC decreased, increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Hb, Anemia, increase to Grade 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Hb, Anemia, increase to Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Hb, Anemia, increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Hb, Hb increased, increase to Grade 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Hb, Hb increased, increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Hb, Hb increased, increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Lympho,Lympho count decreased, increase to Grade 1
|
0 Participants
|
3 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Lympho,Lympho count decreased, increase to Grade 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Lympho,Lympho count decreased, increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Lympho,Lympho count increased, increase to Grade 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Lympho,Lympho count increased, increase to Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Lympho,Lympho count increased, increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Lympho,Lympho count increased, increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
PC, PC decreased,increase to Grade 1
|
0 Participants
|
3 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
PC, PC decreased,increase to Grade 2
|
0 Participants
|
2 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Neutro,Neutro count decreased,increase to Grade 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Neutro,Neutro count decreased,increase to Grade 2
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
WBC,Leukocytosis, increase to Grade 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
WBC,Leukocytosis, increase to Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
WBC,Leukocytosis, increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
WBC,Leukocytosis, increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
WBC,WBC decreased, increase to Grade 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
WBC,WBC decreased, increase to Grade 2
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
WBC,WBC decreased, increase to Grade 3
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Pre-dose, Day 1) and up to Day 126Population: Safety Population.
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.
Outcome measures
| Measure |
Placebo
n=2 Participants
Participants received a single SC dose of Placebo, administered as three separate SC injections.
|
GSK2330811 450 mg
n=7 Participants
Participants received a single 450 milligram (mg) SC dose of GSK2330811, administered as three separate SC injections of 150 milligrams per milliliter \[mg/mL\]).
|
|---|---|---|
|
Number of Participants With Worst Case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline
Blood
|
1 Participants
|
1 Participants
|
|
Number of Participants With Worst Case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline
Glucose
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline
Ketones
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline
Protein
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 8 hours; Days 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 84 and 126Population: PK Population.
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.
Outcome measures
| Measure |
Placebo
n=7 Participants
Participants received a single SC dose of Placebo, administered as three separate SC injections.
|
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 \[mg/mL\]).
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) for GSK2330811
|
63259.308 Nanogram per milliliter
Geometric Coefficient of Variation 14.9290
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 8 hours; Days 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 84 and 126Population: PK Population.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2330811. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Placebo
n=7 Participants
Participants received a single SC dose of Placebo, administered as three separate SC injections.
|
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 \[mg/mL\]).
|
|---|---|---|
|
Area Under the Plasma Concentration Time-curve From Time Zero to Infinity (AUC[0-infinity]) for GSK2330811
|
45371065.201 Hours*nanogram per milliliter
Geometric Coefficient of Variation 22.1925
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 8 hours; Days 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 84 and 126Population: PK Population.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2330811. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Placebo
n=7 Participants
Participants received a single SC dose of Placebo, administered as three separate SC injections.
|
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 \[mg/mL\]).
|
|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-t]) for GSK2330811
|
43157791.065 Hours*nanogram per milliliter
Geometric Coefficient of Variation 22.8839
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 8 hours; Days 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 84 and 126Population: PK Population.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2330811. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Placebo
n=7 Participants
Participants received a single SC dose of Placebo, administered as three separate SC injections.
|
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 \[mg/mL\]).
|
|---|---|---|
|
Apparent Systemic Clearance (CL/F) for GSK2330811
|
0.010 Liter per hour
Geometric Coefficient of Variation 22.1925
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 8 hours; Days 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 84 and 126Population: PK Population.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2330811. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Placebo
n=7 Participants
Participants received a single SC dose of Placebo, administered as three separate SC injections.
|
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 \[mg/mL\]).
|
|---|---|---|
|
Time to Cmax (Tmax) for GSK2330811
|
143.380 Hours
Interval 94.82 to 216.25
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 8 hours; Days 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 84 and 126Population: PK Population.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2330811. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Placebo
n=7 Participants
Participants received a single SC dose of Placebo, administered as three separate SC injections.
|
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 \[mg/mL\]).
|
|---|---|---|
|
Terminal Half-life (t1/2) for GSK2330811
|
469.117 Hours
Geometric Coefficient of Variation 14.8081
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 8 hours; Days 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 84 and 126Population: PK Population.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2330811. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Placebo
n=7 Participants
Participants received a single SC dose of Placebo, administered as three separate SC injections.
|
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 \[mg/mL\]).
|
|---|---|---|
|
Apparent Volume of Distribution at Steady State (Vss/F) for GSK2330811
|
6.713 Liter
Geometric Coefficient of Variation 12.2891
|
—
|
SECONDARY outcome
Timeframe: Up to Day 126Population: Safety Population.
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.
Outcome measures
| Measure |
Placebo
n=2 Participants
Participants received a single SC dose of Placebo, administered as three separate SC injections.
|
GSK2330811 450 mg
n=7 Participants
Participants received a single 450 milligram (mg) SC dose of GSK2330811, administered as three separate SC injections of 150 milligrams per milliliter \[mg/mL\]).
|
|---|---|---|
|
Number of Participants With Positive Anti-GSK2330811 Antibodies
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 1, 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 84 and 126Population: Safety Population.
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.
Outcome measures
| Measure |
Placebo
n=2 Participants
Participants received a single SC dose of Placebo, administered as three separate SC injections.
|
GSK2330811 450 mg
n=7 Participants
Participants received a single 450 milligram (mg) SC dose of GSK2330811, administered as three separate SC injections of 150 milligrams per milliliter \[mg/mL\]).
|
|---|---|---|
|
Platelet Count Nadir for GSK2330811
|
211.5 Giga cells per liter
Standard Deviation 27.58
|
79.1 Giga cells per liter
Standard Deviation 29.48
|
SECONDARY outcome
Timeframe: Days 1, 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 84 and 126Population: Safety Population.
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.
Outcome measures
| Measure |
Placebo
n=2 Participants
Participants received a single SC dose of Placebo, administered as three separate SC injections.
|
GSK2330811 450 mg
n=7 Participants
Participants received a single 450 milligram (mg) SC dose of GSK2330811, administered as three separate SC injections of 150 milligrams per milliliter \[mg/mL\]).
|
|---|---|---|
|
Time to Platelet Count Nadir for GSK2330811
|
44.0 Days
Interval 4.0 to 84.0
|
20.0 Days
Interval 20.0 to 26.0
|
SECONDARY outcome
Timeframe: Days 1, 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 84 and 126Population: Safety Population.
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.
Outcome measures
| Measure |
Placebo
n=2 Participants
Participants received a single SC dose of Placebo, administered as three separate SC injections.
|
GSK2330811 450 mg
n=7 Participants
Participants received a single 450 milligram (mg) SC dose of GSK2330811, administered as three separate SC injections of 150 milligrams per milliliter \[mg/mL\]).
|
|---|---|---|
|
Hemoglobin Nadir for GSK2330811
|
136.0 Grams per liter
Standard Deviation 8.49
|
134.9 Grams per liter
Standard Deviation 6.69
|
SECONDARY outcome
Timeframe: Days 1, 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 84 and 126Population: Safety Population.
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.
Outcome measures
| Measure |
Placebo
n=2 Participants
Participants received a single SC dose of Placebo, administered as three separate SC injections.
|
GSK2330811 450 mg
n=7 Participants
Participants received a single 450 milligram (mg) SC dose of GSK2330811, administered as three separate SC injections of 150 milligrams per milliliter \[mg/mL\]).
|
|---|---|---|
|
Time to Hemoglobin Nadir for GSK2330811
|
30.5 Days
Interval 20.0 to 41.0
|
55.0 Days
Interval 14.0 to 125.0
|
Adverse Events
Placebo
GSK2330811 450 mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=2 participants at risk
Participants received a single SC dose of Placebo, administered as three separate SC injections.
|
GSK2330811 450 mg
n=7 participants at risk
Participants received a single 450 milligram (mg) SC dose of GSK2330811, administered as three separate SC injections of 150 milligrams per milliliter \[mg/mL\]).
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/2 • 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.
|
71.4%
5/7 • Number of events 5 • 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.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
50.0%
1/2 • Number of events 1 • 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.
|
0.00%
0/7 • 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.
|
|
Injury, poisoning and procedural complications
Face injury
|
50.0%
1/2 • Number of events 1 • 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.
|
0.00%
0/7 • 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.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/2 • 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.
|
14.3%
1/7 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • 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.
|
14.3%
1/7 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/2 • 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.
|
14.3%
1/7 • Number of events 1 • 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.
|
|
General disorders
Injection site bruising
|
0.00%
0/2 • 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.
|
14.3%
1/7 • Number of events 1 • 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.
|
|
General disorders
Injection site pain
|
50.0%
1/2 • Number of events 1 • 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.
|
0.00%
0/7 • 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.
|
|
Infections and infestations
Nasopharyngitis
|
50.0%
1/2 • Number of events 1 • 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.
|
0.00%
0/7 • 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.
|
|
Infections and infestations
Oral herpes
|
50.0%
1/2 • Number of events 1 • 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.
|
0.00%
0/7 • 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.
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/2 • 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.
|
14.3%
1/7 • Number of events 1 • 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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/2 • 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.
|
14.3%
1/7 • Number of events 1 • 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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2 • 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.
|
14.3%
1/7 • Number of events 1 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER