Safety, Tolerability, Pharmacokinetics and Target Engagement of GSK3858279 in Healthy Caucasian, Chinese and Japanese Participants

A Randomised, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, Target Engagement and Immunogenicity of a Single Subcutaneous Dose of GSK3858279 Administered to Healthy Caucasian, Chinese and Japanese Participants

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05174013

Enrollment

Registered

2021-12-30

Start date

2022-02-14

Completion date

2023-04-17

Last updated

2025-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Pharmacokinetics, Safety, Tolerability, GSK3858279, Placebo, Caucasian, Chinese, Japanese

Brief summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), target engagement (TE) and immunogenicity of GSK3858279 when administered to healthy Caucasian, Chinese and Japanese participants.

Interventions

DRUGGSK3858279

GSK3858279 will be administered

DRUGPlacebo

Placebo will be administered

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

This will be a double blind study

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Participants between 20 and 65 years of age inclusive, at the time of signing the informed consent. * Volunteers who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. * Participant capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. * Participants who have evidence of completed vaccination for Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) with an approved vaccine. * Body weight within the range 45 - 100 killogram (kg) and body mass index (BMI) within the range 18-29.9 kg per meter square (/m2) (inclusive). * Japanese participants are eligible based on meeting all of the following: * Participants born in Japan * Descendants of four ethnic Japanese grandparents and two ethnic Japanese parents. * Have lived outside Japan for less than (\<) 10 years at the time of screening * Chinese participants are eligible based on meeting all of the following * Participants born in mainland China, Hong Kong or Taiwan * Descendants of four Chinese grandparents and two Chinese parents * Have lived outside China, Hong Kong or Taiwan for \<10 years at the time of screening * Caucasian participants are eligible based on meeting the following * Declaration of familial Caucasian/European ancestry (having 2 parents of Caucasian/European ancestry and 4 grandparents of Caucasian/European ancestry) * Male or female participant * Male participants are eligible to participate if they agree to the following for at least 28 weeks after the dose of study intervention: Refrain from donating sperm plus either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR must agree to use contraception/barrier as detailed below: agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant. * A female participant is eligible to participate if she is of non-reproductive potential. * Capable of giving signed informed consent.

Exclusion criteria

* History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, haematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data. * Personal or family history of cardiomyopathy. * Abnormal blood pressure at screening as determined by the investigator. * History of symptomatic herpes zoster. * Evidence of active or latent tuberculosis (TB) as documented by medical history, examination, and TB testing with a positive (not indeterminate) QuantiFERON test. * Significant allergies to humanized monoclonal antibodies as per principal investigator's and GSK medical monitor's judgements. * History or evidence of clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A (IgA) dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis). * History of lymphoma, leukaemia, or any malignancy within the last 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years. ALT greater than (\>)1.5 times upper limit of normal (ULN) . * Bilirubin \>1.5 times ULN (isolated bilirubin \>1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35 percent \[%\]). * Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). * Corrected QT (QTc) \>450 milliseconds (msec). * History of Stevens Johnson Syndrome. * Known immunodeficiency. * Participants with a chronic infection (for example \[e.g.\], osteomyelitis), who have been receiving treatment within three months prior to dosing or individuals with an active infection. * Previous or current history of bleeding diathesis, excessive bleeding or coagulation disorders. * History of significant medical illness in the opinion of the investigator would interfere with the study procedures and / or assessments. * Intended use of over-the-counter or prescription medication including herbal medications within 7 days prior to dosing until final follow-up visit. * Live vaccine(s) or plans to receive such vaccines within 1 month of screening until final follow-up visit. * Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing. * Treatment with antiplatelet or anticoagulant agents within 7 days of dosing. * Major surgery (as per investigator's judgement) within 3 months prior to dosing. * Participation in the study would result in loss of blood or blood products in excess of 500 milliliters (mL) within 3 months. * Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day. * Current enrolment or past participation in any other clinical study involving an investigational drug intervention within the last 3 months or 5 half-lives (whichever is longer) of signing the ICF. * Presence of Hepatitis B surface antigen (HBsAg) at screening. * Presence of the Hepatitis B core antibody (HBcAb) at screening. * Positive Hepatitis C antibody test result at screening. * Positive Hepatitis C Ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study intervention. * Abnormal clinically significant echocardiogram at screening, as assessed by the investigator. * Cardiac troponin or N-terminal pro B-type natriuretic peptide (NT-proBNP) levels out of normal range at screening. * Positive pre-study drug/alcohol screen. * Positive human immunodeficiency virus (HIV) antibody test. * Positive coronavirus disease 2019 (COVID-19): SARS-CoV2 polymerase chain reaction (PCR) or lateral flow test of a combined throat and nasopharyngeal swab or nasal swab only. * Regular alcohol consumption within 6 months prior to the study defined as: an average weekly intake of \>14 units for males and \>14 units for females. One unit is equivalent to 8 grams of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits. * Regular use of known drugs of abuse. * Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.

Design outcomes

Primary

Measure	Time frame	Description
Time of Occurrence of Cmax (Tmax) of GSK3858279	Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43, 57, 85, 113, 141, 155 and 169 Days	Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.
Change From Baseline in Vital Signs: Body Temperature	Baseline and Day 169	The vital sign followed in this analysis was body temperature, expressed as degree Celsius. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Change From Baseline in Vital Signs: Respiratory Rate	Baseline and Day 169	The vital signs followed in this analysis was respiratory rate, expressed as Breaths per minute. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) Interval	Baseline and Day 169	Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Baseline was defined as the average of the triplicate pre-dose assessments on Day 1 of Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Area Under the Plasma Concentration-Time Curve From Time Zero to 56 Days AUC (0-56)] of GSK3858279	Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43 and 57	Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate pharmacokinetic (PK) parameters. PK parameter population consist of all participants in the PK Population, for whom valid and evaluable PK parameters were derived. This population was used in the assessment and characterization of PK parameters.
AUC From Time Zero to the Last Measurable Concentration (0-t) Post-Dose of GSK3858279	Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43, 57, 85, 113, 141, 155 and 169 Days	Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate pharmacokinetic (PK) parameters. PK parameter population consist of all participants in the PK Population, for whom valid and evaluable PK parameters were derived. This population was used in the assessment and characterization of PK parameters.
Time of Occurrence of Last Quantifiable Concentration (Tlast) of GSK3858279	Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43, 57, 85, 113, 141, 155 and 169 Days	Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.
Maximum Observed Concentration (Cmax) of GSK3858279	Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43, 57, 85, 113, 141, 155 and 169 Days	Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.
Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAE's) And Withdrawals Due to AE's	Up to 169 days	An AE is defined as 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. SAEs are defined as any untoward medical occurrence that, at any dose: results in death, cause life threatening events which requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability or incapacity and birth defect or congenital anomaly. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169.
Change From Baseline in Hematology Parameter of Platelet Count	Baseline and Day 169	Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Change From Baseline in Hematology Parameter of Hemoglobin	Baseline and Day 169	Blood samples were collected for the assessment of change from baseline in hematology parameters Hemoglobin. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Change From Baseline in Hematology Parameter of Hematocrit	Baseline and Day 169	Blood samples were collected for the assessment of change from baseline in hematology parameters Hematocrit. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils	Baseline and Day 169	Blood samples were collected for the assessment of hematology parameters including (WBC) count with differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP)	Baseline and Day 169	Blood samples were collected for the assessment of clinical chemistry parameters including AST, ALT, AP. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Change From Baseline in Clinical Chemistry Parameter of Total Protein	Baseline and Day 169	Blood samples were collected for the assessment of clinical chemistry parameters including total Protein. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin	Baseline and Day 169	Blood samples were collected for the assessment of clinical chemistry parameters including Total bilirubin. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Change From Baseline in Clinical Chemistry Parameter of Direct Bilirubin, Creatinine	Baseline and Day 169	Blood samples were collected for the assessment of clinical chemistry parameters including Direct bilirubin, Creatinine. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Change From Baseline in Clinical Chemistry Parameter of Urea, Glucose, Potassium, Sodium	Baseline and Day 169	Blood samples were collected for the assessment of clinical chemistry parameters including Urea, Glucose, Potassium, Sodium. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Baseline and Day 169	Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine, indicated as ratio of urine density to water density. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Baseline and Day 169	Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 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 acidic pH (5.0 - 6.0). The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Baseline and Day 169	The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as increase to trace, increase to 1+ (low concentrations present), increase to 2+ (moderate concentrations present) and increase to 3+ (high concentrations present) indicating proportional concentrations in the urine sample. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data for worst-case post-Baseline relative to Baseline is presented.
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	Baseline and Day 169	The vital sign followed in this analysis was both systolic and diastolic blood pressure, expressed as millimetre of mercury. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Change From Baseline in Vital Signs: Pulse Rate	Baseline and Day 169	The vital signs followed in this analysis was pulse rate, expressed as beats per minute. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.

Secondary

Measure	Time frame	Description
Cmax of Total CCL17 in Serum Following GSK3858279	Baseline (Day 1) and at Days 7, 14, 28 and 56 Post dose	Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.
Tmax of Total CCL17 in Serum Following GSK3858279	Baseline (Day 1) and at Days 7, 14, 28 and 56 Post dose	Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters. The study intervention dose was administered on Study Day 1(baseline), where 7 days post-dose totals to Study Day 1+7days = Study Day 8. Following results of Day 8, Day 15, Day 29 and Day 57 corelates to timepoints Day 7, Day 14, Day 28 and Day 56 post dose values and same are presented here.
Maximum Fold Change in Total CCL17 in Serum Following GSK3858279 Administration	Baseline (Day 1) and Days 56 Post dose	Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.
Fold Increase in Total CCL17 in Serum Following GSK3858279 Administration	Baseline (Day 1) and at Days 7, 14, 28 and 56 Post dose	Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters. The study intervention dose was administered on Study Day 1(baseline), where 7 days post-dose totals to Study Day 1+7days = Study Day 8. Following results of Day 8, Day 15, Day 29 and Day 57 corelates to timepoints Day 7, Day 14, Day 28 and Day 56 post dose values and same are presented here.
Number of Participants With Pre-existing Anti-drug Antibodies (ADA's)	Day 169	Serum samples were collected for the determination of anti- GSK3858279 antibodies (ADA). 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. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample. Additionally, confirmed positive ADA samples were also tested in a validated neutralizing antibody assay to determine the potential neutralizing activity of the ADA.
Number of Participants With Treatment-Emergent ADA's Over Time	Day 169	Serum samples were collected for the determination of anti- GSK3858279 antibodies (ADA).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. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample. Additionally, confirmed positive ADA samples were also tested in a validated neutralizing antibody assay to determine the potential neutralizing activity of the ADA.
Percentage Change From Baseline in Free CCL17	Baseline (Day 1) and at Days 7, 14, 28 and 56 Post dose	Blood samples were collected from participants at time points after the administration of study treatment to investigate PK parameters. The study intervention dose was administered on Study Day 1(baseline), where 7 days post-dose totals to Study Day 1+7days = Study Day 8. Following results of Day 8, Day 15, Day 29 and Day 57 corelates to timepoints Day 7, Day 14, Day 28 and Day 56 post dose values and same are presented here.

Countries

Australia

Participant flow

Recruitment details

Out of 91 participants screened, 32 participants were enrolled in the study (57 participants were screen failures). The most common reasons for screen failure were not meeting inclusion/exclusion criteria for 45 participants and physician decision for 10 participants.

Pre-assignment details

Of 32 participants who were enrolled and randomized, 1 participant from GSK3858279 Caucasian arm did not receive any study intervention due to high blood pressure (BP). A total of 29 participants completed the study (Placebo: 10 participants \[91%\] and GSK3858279: 19 participants \[95%\]).

Participants by arm

Arm	Count
GSK3858279 Caucasian Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.	6
GSK3858279 Chinese Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.	7
GSK3858279 Japanese Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.	7
Caucasian Placebo Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.	4
Chinese Placebo Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.	3
Japanese Placebo Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.	4
Total	31

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005
Overall Study	Lost to Follow-up	0	0	0	1	0	0
Overall Study	Withdrawal by Subject	0	0	1	0	0	0

Baseline characteristics

Characteristic	GSK3858279 Caucasian	GSK3858279 Chinese	GSK3858279 Japanese	Caucasian Placebo	Chinese Placebo	Japanese Placebo	Total
Age, Customized 20 - 65 (years of age)	6 Participants	7 Participants	7 Participants	4 Participants	3 Participants	4 Participants	31 Participants
Race/Ethnicity, Customized ASIAN	0 Participants	7 Participants	7 Participants	0 Participants	3 Participants	4 Participants	21 Participants
Race/Ethnicity, Customized WHITE	6 Participants	0 Participants	0 Participants	4 Participants	0 Participants	0 Participants	10 Participants
Sex: Female, Male Female	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Sex: Female, Male Male	6 Participants	7 Participants	7 Participants	3 Participants	3 Participants	4 Participants	30 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk
deaths Total, all-cause mortality	0 / 6	0 / 7	0 / 7	0 / 4	0 / 3	0 / 4
other Total, other adverse events	5 / 6	6 / 7	2 / 7	4 / 4	1 / 3	2 / 4
serious Total, serious adverse events	0 / 6	0 / 7	0 / 7	0 / 4	0 / 3	0 / 4

Outcome results

Primary

Area Under the Plasma Concentration-Time Curve From Time Zero to 56 Days AUC (0-56)] of GSK3858279

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate pharmacokinetic (PK) parameters. PK parameter population consist of all participants in the PK Population, for whom valid and evaluable PK parameters were derived. This population was used in the assessment and characterization of PK parameters.

Time frame: Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43 and 57

Population: All participants in the safety population who received an active dose of study treatment and had at least one reportable Pharmacokinetic (PK) assessment.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
GSK3858279 Caucasian	Area Under the Plasma Concentration-Time Curve From Time Zero to 56 Days AUC (0-56)] of GSK3858279	87592.7 day* nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 15.8
GSK3858279 Chinese	Area Under the Plasma Concentration-Time Curve From Time Zero to 56 Days AUC (0-56)] of GSK3858279	86412.2 day* nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 28.2
GSK3858279 Japanese	Area Under the Plasma Concentration-Time Curve From Time Zero to 56 Days AUC (0-56)] of GSK3858279	77742.0 day* nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 22.5

Primary

AUC From Time Zero to the Last Measurable Concentration (0-t) Post-Dose of GSK3858279

Time frame: Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43, 57, 85, 113, 141, 155 and 169 Days

Population: All participants in the safety population who received an active dose of study treatment and had at least one reportable PK assessment.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
GSK3858279 Caucasian	AUC From Time Zero to the Last Measurable Concentration (0-t) Post-Dose of GSK3858279	88679.6 daynanograms per milliliter (dayng/mL)	Geometric Coefficient of Variation 17.6
GSK3858279 Chinese	AUC From Time Zero to the Last Measurable Concentration (0-t) Post-Dose of GSK3858279	87201.8 daynanograms per milliliter (dayng/mL)	Geometric Coefficient of Variation 29.1
GSK3858279 Japanese	AUC From Time Zero to the Last Measurable Concentration (0-t) Post-Dose of GSK3858279	77009.4 daynanograms per milliliter (dayng/mL)	Geometric Coefficient of Variation 21

Primary

Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP)

Blood samples were collected for the assessment of clinical chemistry parameters including AST, ALT, AP. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.

Time frame: Baseline and Day 169

Population: The analysis was performed on the Safety Set that included all randomized participants who received at least one injection of study intervention. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for specified time points.

Primary

Change From Baseline in Clinical Chemistry Parameter of Direct Bilirubin, Creatinine

Blood samples were collected for the assessment of clinical chemistry parameters including Direct bilirubin, Creatinine. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.

Time frame: Baseline and Day 169

Arm	Measure	Group	Value (MEAN)	Dispersion
GSK3858279 Caucasian	Change From Baseline in Clinical Chemistry Parameter of Direct Bilirubin, Creatinine	Direct Bilirubin,	-1.8 micromole per liter (umol/L)	Standard Deviation 1.47
GSK3858279 Caucasian	Change From Baseline in Clinical Chemistry Parameter of Direct Bilirubin, Creatinine	Creatinine	1.8 micromole per liter (umol/L)	Standard Deviation 8.86
GSK3858279 Chinese	Change From Baseline in Clinical Chemistry Parameter of Direct Bilirubin, Creatinine	Direct Bilirubin,	0.0 micromole per liter (umol/L)	Standard Deviation 2.16
GSK3858279 Chinese	Change From Baseline in Clinical Chemistry Parameter of Direct Bilirubin, Creatinine	Creatinine	-1.8 micromole per liter (umol/L)	Standard Deviation 8.85
GSK3858279 Japanese	Change From Baseline in Clinical Chemistry Parameter of Direct Bilirubin, Creatinine	Direct Bilirubin,	-0.3 micromole per liter (umol/L)	Standard Deviation 0.82
GSK3858279 Japanese	Change From Baseline in Clinical Chemistry Parameter of Direct Bilirubin, Creatinine	Creatinine	3.0 micromole per liter (umol/L)	Standard Deviation 4.94
Caucasian Placebo	Change From Baseline in Clinical Chemistry Parameter of Direct Bilirubin, Creatinine	Direct Bilirubin,	-1.7 micromole per liter (umol/L)	Standard Deviation 0.58
Caucasian Placebo	Change From Baseline in Clinical Chemistry Parameter of Direct Bilirubin, Creatinine	Creatinine	5.7 micromole per liter (umol/L)	Standard Deviation 10.69
Chinese Placebo	Change From Baseline in Clinical Chemistry Parameter of Direct Bilirubin, Creatinine	Direct Bilirubin,	0.0 micromole per liter (umol/L)	Standard Deviation 1.41
Chinese Placebo	Change From Baseline in Clinical Chemistry Parameter of Direct Bilirubin, Creatinine	Creatinine	14.5 micromole per liter (umol/L)	Standard Deviation 7.78
Japanese Placebo	Change From Baseline in Clinical Chemistry Parameter of Direct Bilirubin, Creatinine	Direct Bilirubin,	1.3 micromole per liter (umol/L)	Standard Deviation 3.51
Japanese Placebo	Change From Baseline in Clinical Chemistry Parameter of Direct Bilirubin, Creatinine	Creatinine	0.0 micromole per liter (umol/L)	Standard Deviation 3.61

Primary

Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin

Blood samples were collected for the assessment of clinical chemistry parameters including Total bilirubin. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.

Time frame: Baseline and Day 169

Population: The analysis was performed on the Safety Set that included all randomized participants who received at least one injection of study intervention.

Arm	Measure	Value (MEAN)	Dispersion
GSK3858279 Caucasian	Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin	-5.3 micromole per liter (umol/L)	Standard Deviation 3.88
GSK3858279 Chinese	Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin	-0.3 micromole per liter (umol/L)	Standard Deviation 4.79
GSK3858279 Japanese	Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin	-1.5 micromole per liter (umol/L)	Standard Deviation 3.73
Caucasian Placebo	Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin	-4.7 micromole per liter (umol/L)	Standard Deviation 1.53
Chinese Placebo	Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin	0.5 micromole per liter (umol/L)	Standard Deviation 2.12
Japanese Placebo	Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin	1.3 micromole per liter (umol/L)	Standard Deviation 6.03

Primary

Change From Baseline in Clinical Chemistry Parameter of Total Protein

Blood samples were collected for the assessment of clinical chemistry parameters including total Protein. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.

Time frame: Baseline and Day 169

Population: The analysis was performed on the Safety Set that included all randomized participants who received at least one injection of study intervention.

Arm	Measure	Value (MEAN)	Dispersion
GSK3858279 Caucasian	Change From Baseline in Clinical Chemistry Parameter of Total Protein	2.2 Gram Per Liter (g/L)	Standard Deviation 1.94
GSK3858279 Chinese	Change From Baseline in Clinical Chemistry Parameter of Total Protein	2.5 Gram Per Liter (g/L)	Standard Deviation 2.89
GSK3858279 Japanese	Change From Baseline in Clinical Chemistry Parameter of Total Protein	0.8 Gram Per Liter (g/L)	Standard Deviation 4.45
Caucasian Placebo	Change From Baseline in Clinical Chemistry Parameter of Total Protein	0.3 Gram Per Liter (g/L)	Standard Deviation 2.52
Chinese Placebo	Change From Baseline in Clinical Chemistry Parameter of Total Protein	-0.5 Gram Per Liter (g/L)	Standard Deviation 4.95
Japanese Placebo	Change From Baseline in Clinical Chemistry Parameter of Total Protein	3.3 Gram Per Liter (g/L)	Standard Deviation 1.53

Primary

Change From Baseline in Clinical Chemistry Parameter of Urea, Glucose, Potassium, Sodium

Blood samples were collected for the assessment of clinical chemistry parameters including Urea, Glucose, Potassium, Sodium. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.

Time frame: Baseline and Day 169

Arm	Measure	Group	Value (MEAN)	Dispersion
GSK3858279 Caucasian	Change From Baseline in Clinical Chemistry Parameter of Urea, Glucose, Potassium, Sodium	Glucose	0.25 millimoles per liter (mmol/L)	Standard Deviation 0.575
GSK3858279 Caucasian	Change From Baseline in Clinical Chemistry Parameter of Urea, Glucose, Potassium, Sodium	Potassium	0.00 millimoles per liter (mmol/L)	Standard Deviation 0.4
GSK3858279 Caucasian	Change From Baseline in Clinical Chemistry Parameter of Urea, Glucose, Potassium, Sodium	Sodium	1.8 millimoles per liter (mmol/L)	Standard Deviation 0.98
GSK3858279 Caucasian	Change From Baseline in Clinical Chemistry Parameter of Urea, Glucose, Potassium, Sodium	Urea	1.43 millimoles per liter (mmol/L)	Standard Deviation 0.907
GSK3858279 Chinese	Change From Baseline in Clinical Chemistry Parameter of Urea, Glucose, Potassium, Sodium	Sodium	-1.8 millimoles per liter (mmol/L)	Standard Deviation 3.4
GSK3858279 Chinese	Change From Baseline in Clinical Chemistry Parameter of Urea, Glucose, Potassium, Sodium	Glucose	0.03 millimoles per liter (mmol/L)	Standard Deviation 0.171
GSK3858279 Chinese	Change From Baseline in Clinical Chemistry Parameter of Urea, Glucose, Potassium, Sodium	Potassium	-0.08 millimoles per liter (mmol/L)	Standard Deviation 0.189
GSK3858279 Chinese	Change From Baseline in Clinical Chemistry Parameter of Urea, Glucose, Potassium, Sodium	Urea	0.38 millimoles per liter (mmol/L)	Standard Deviation 1.715
GSK3858279 Japanese	Change From Baseline in Clinical Chemistry Parameter of Urea, Glucose, Potassium, Sodium	Urea	0.87 millimoles per liter (mmol/L)	Standard Deviation 1.718
GSK3858279 Japanese	Change From Baseline in Clinical Chemistry Parameter of Urea, Glucose, Potassium, Sodium	Potassium	-0.15 millimoles per liter (mmol/L)	Standard Deviation 0.302
GSK3858279 Japanese	Change From Baseline in Clinical Chemistry Parameter of Urea, Glucose, Potassium, Sodium	Glucose	0.18 millimoles per liter (mmol/L)	Standard Deviation 0.549
GSK3858279 Japanese	Change From Baseline in Clinical Chemistry Parameter of Urea, Glucose, Potassium, Sodium	Sodium	0.5 millimoles per liter (mmol/L)	Standard Deviation 3.02
Caucasian Placebo	Change From Baseline in Clinical Chemistry Parameter of Urea, Glucose, Potassium, Sodium	Urea	1.03 millimoles per liter (mmol/L)	Standard Deviation 0.862
Caucasian Placebo	Change From Baseline in Clinical Chemistry Parameter of Urea, Glucose, Potassium, Sodium	Sodium	0.7 millimoles per liter (mmol/L)	Standard Deviation 1.53
Caucasian Placebo	Change From Baseline in Clinical Chemistry Parameter of Urea, Glucose, Potassium, Sodium	Glucose	0.23 millimoles per liter (mmol/L)	Standard Deviation 0.651
Caucasian Placebo	Change From Baseline in Clinical Chemistry Parameter of Urea, Glucose, Potassium, Sodium	Potassium	0.33 millimoles per liter (mmol/L)	Standard Deviation 0.115
Chinese Placebo	Change From Baseline in Clinical Chemistry Parameter of Urea, Glucose, Potassium, Sodium	Potassium	-0.45 millimoles per liter (mmol/L)	Standard Deviation 0.212
Chinese Placebo	Change From Baseline in Clinical Chemistry Parameter of Urea, Glucose, Potassium, Sodium	Glucose	1.10 millimoles per liter (mmol/L)	Standard Deviation 1.98
Chinese Placebo	Change From Baseline in Clinical Chemistry Parameter of Urea, Glucose, Potassium, Sodium	Urea	1.45 millimoles per liter (mmol/L)	Standard Deviation 0.495
Chinese Placebo	Change From Baseline in Clinical Chemistry Parameter of Urea, Glucose, Potassium, Sodium	Sodium	0.0 millimoles per liter (mmol/L)	Standard Deviation 1.41
Japanese Placebo	Change From Baseline in Clinical Chemistry Parameter of Urea, Glucose, Potassium, Sodium	Sodium	1.0 millimoles per liter (mmol/L)	Standard Deviation 0
Japanese Placebo	Change From Baseline in Clinical Chemistry Parameter of Urea, Glucose, Potassium, Sodium	Potassium	0.03 millimoles per liter (mmol/L)	Standard Deviation 0.058
Japanese Placebo	Change From Baseline in Clinical Chemistry Parameter of Urea, Glucose, Potassium, Sodium	Glucose	0.27 millimoles per liter (mmol/L)	Standard Deviation 0.208
Japanese Placebo	Change From Baseline in Clinical Chemistry Parameter of Urea, Glucose, Potassium, Sodium	Urea	1.13 millimoles per liter (mmol/L)	Standard Deviation 0.723

Primary

Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) Interval

Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Baseline was defined as the average of the triplicate pre-dose assessments on Day 1 of Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Time frame: Baseline and Day 169

Arm	Measure	Group	Value (MEAN)	Dispersion
GSK3858279 Caucasian	Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) Interval	QT Interval	-16.278 milliseconds (msec)	Standard Deviation 26.0431
GSK3858279 Caucasian	Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) Interval	QRS Duration	-2.833 milliseconds (msec)	Standard Deviation 7.9631
GSK3858279 Caucasian	Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) Interval	QTcB Interval	4.333 milliseconds (msec)	Standard Deviation 12.5131
GSK3858279 Caucasian	Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) Interval	QTcF Interval	-2.333 milliseconds (msec)	Standard Deviation 13.5859
GSK3858279 Caucasian	Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) Interval	PR Interval	-5.000 milliseconds (msec)	Standard Deviation 6.4601
GSK3858279 Chinese	Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) Interval	QTcB Interval	5.917 milliseconds (msec)	Standard Deviation 8.7575
GSK3858279 Chinese	Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) Interval	PR Interval	-4.000 milliseconds (msec)	Standard Deviation 7.4486
GSK3858279 Chinese	Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) Interval	QRS Duration	-2.083 milliseconds (msec)	Standard Deviation 4.7561
GSK3858279 Chinese	Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) Interval	QT Interval	-7.083 milliseconds (msec)	Standard Deviation 15.8052
GSK3858279 Chinese	Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) Interval	QTcF Interval	1.583 milliseconds (msec)	Standard Deviation 4.9319
GSK3858279 Japanese	Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) Interval	QTcF Interval	-2.611 milliseconds (msec)	Standard Deviation 15.3122
GSK3858279 Japanese	Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) Interval	PR Interval	-7.889 milliseconds (msec)	Standard Deviation 21.1152
GSK3858279 Japanese	Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) Interval	QT Interval	-18.056 milliseconds (msec)	Standard Deviation 33.7859
GSK3858279 Japanese	Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) Interval	QRS Duration	-0.444 milliseconds (msec)	Standard Deviation 8.841
GSK3858279 Japanese	Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) Interval	QTcB Interval	7.333 milliseconds (msec)	Standard Deviation 8.8292
Caucasian Placebo	Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) Interval	QRS Duration	1.667 milliseconds (msec)	Standard Deviation 6.2272
Caucasian Placebo	Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) Interval	PR Interval	-15.778 milliseconds (msec)	Standard Deviation 7.5817
Caucasian Placebo	Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) Interval	QTcB Interval	13.667 milliseconds (msec)	Standard Deviation 9.5975
Caucasian Placebo	Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) Interval	QT Interval	-15.222 milliseconds (msec)	Standard Deviation 16.4057
Caucasian Placebo	Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) Interval	QTcF Interval	3.778 milliseconds (msec)	Standard Deviation 11.4956
Chinese Placebo	Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) Interval	PR Interval	-8.167 milliseconds (msec)	Standard Deviation 4.4783
Chinese Placebo	Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) Interval	QRS Duration	3.167 milliseconds (msec)	Standard Deviation 3.5355
Chinese Placebo	Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) Interval	QT Interval	-21.333 milliseconds (msec)	Standard Deviation 26.8701
Chinese Placebo	Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) Interval	QTcB Interval	21.500 milliseconds (msec)	Standard Deviation 17.2063
Chinese Placebo	Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) Interval	QTcF Interval	6.667 milliseconds (msec)	Standard Deviation 20.2704
Japanese Placebo	Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) Interval	QT Interval	-7.111 milliseconds (msec)	Standard Deviation 14.6148
Japanese Placebo	Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) Interval	QRS Duration	-3.667 milliseconds (msec)	Standard Deviation 4.5092
Japanese Placebo	Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) Interval	PR Interval	6.111 milliseconds (msec)	Standard Deviation 12.6242
Japanese Placebo	Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) Interval	QTcF Interval	-4.111 milliseconds (msec)	Standard Deviation 9.7144
Japanese Placebo	Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) Interval	QTcB Interval	-2.444 milliseconds (msec)	Standard Deviation 7.1518

Primary

Change From Baseline in Hematology Parameter of Hematocrit

Blood samples were collected for the assessment of change from baseline in hematology parameters Hematocrit. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.

Time frame: Baseline and Day 169

Population: The analysis was performed on the Safety Set that included all randomized participants who received at least one injection of study intervention.

Arm	Measure	Value (MEAN)	Dispersion
GSK3858279 Caucasian	Change From Baseline in Hematology Parameter of Hematocrit	-0.027 Liter/liter (L/L)	Standard Deviation 0.0367
GSK3858279 Chinese	Change From Baseline in Hematology Parameter of Hematocrit	-0.010 Liter/liter (L/L)	Standard Deviation 0.0408
GSK3858279 Japanese	Change From Baseline in Hematology Parameter of Hematocrit	-0.005 Liter/liter (L/L)	Standard Deviation 0.0259
Caucasian Placebo	Change From Baseline in Hematology Parameter of Hematocrit	-0.027 Liter/liter (L/L)	Standard Deviation 0.0321
Chinese Placebo	Change From Baseline in Hematology Parameter of Hematocrit	-0.035 Liter/liter (L/L)	Standard Deviation 0.0495
Japanese Placebo	Change From Baseline in Hematology Parameter of Hematocrit	-0.013 Liter/liter (L/L)	Standard Deviation 0.0208

Primary

Change From Baseline in Hematology Parameter of Hemoglobin

Blood samples were collected for the assessment of change from baseline in hematology parameters Hemoglobin. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.

Time frame: Baseline and Day 169

Population: The analysis was performed on the Safety Set that included all randomized participants who received at least one injection of study intervention.

Arm	Measure	Value (MEAN)	Dispersion
GSK3858279 Caucasian	Change From Baseline in Hematology Parameter of Hemoglobin	-7.5 Gram Per Liter (g/L)	Standard Deviation 13.79
GSK3858279 Chinese	Change From Baseline in Hematology Parameter of Hemoglobin	-6.0 Gram Per Liter (g/L)	Standard Deviation 10.42
GSK3858279 Japanese	Change From Baseline in Hematology Parameter of Hemoglobin	-2.0 Gram Per Liter (g/L)	Standard Deviation 10.79
Caucasian Placebo	Change From Baseline in Hematology Parameter of Hemoglobin	-5.3 Gram Per Liter (g/L)	Standard Deviation 7.37
Chinese Placebo	Change From Baseline in Hematology Parameter of Hemoglobin	-10.5 Gram Per Liter (g/L)	Standard Deviation 16.26
Japanese Placebo	Change From Baseline in Hematology Parameter of Hemoglobin	-3.0 Gram Per Liter (g/L)	Standard Deviation 3.61

Primary

Change From Baseline in Hematology Parameter of Platelet Count

Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.

Time frame: Baseline and Day 169

Population: The analysis was performed on the Safety Set that included all randomized participants who received at least one injection of study intervention.

Arm	Measure	Value (MEAN)	Dispersion
GSK3858279 Caucasian	Change From Baseline in Hematology Parameter of Platelet Count	2.8 Giga cells per liter (10^9/L)	Standard Deviation 25.9
GSK3858279 Chinese	Change From Baseline in Hematology Parameter of Platelet Count	18.0 Giga cells per liter (10^9/L)	Standard Deviation 18.81
GSK3858279 Japanese	Change From Baseline in Hematology Parameter of Platelet Count	-4.2 Giga cells per liter (10^9/L)	Standard Deviation 12.27
Caucasian Placebo	Change From Baseline in Hematology Parameter of Platelet Count	7.0 Giga cells per liter (10^9/L)	Standard Deviation 15.59
Chinese Placebo	Change From Baseline in Hematology Parameter of Platelet Count	16.0 Giga cells per liter (10^9/L)	Standard Deviation 39.6
Japanese Placebo	Change From Baseline in Hematology Parameter of Platelet Count	-12.3 Giga cells per liter (10^9/L)	Standard Deviation 6.51

Primary

Change From Baseline in Vital Signs: Body Temperature

The vital sign followed in this analysis was body temperature, expressed as degree Celsius. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.

Time frame: Baseline and Day 169

Population: The analysis was performed on the Safety Set that included all randomized participants who received at least one injection of study intervention.

Arm	Measure	Value (MEAN)	Dispersion
GSK3858279 Caucasian	Change From Baseline in Vital Signs: Body Temperature	0.07 Degree Celsius	Standard Deviation 0.468
GSK3858279 Chinese	Change From Baseline in Vital Signs: Body Temperature	-0.03 Degree Celsius	Standard Deviation 0.33
GSK3858279 Japanese	Change From Baseline in Vital Signs: Body Temperature	0.48 Degree Celsius	Standard Deviation 0.436
Caucasian Placebo	Change From Baseline in Vital Signs: Body Temperature	-0.10 Degree Celsius	Standard Deviation 0.5
Chinese Placebo	Change From Baseline in Vital Signs: Body Temperature	0.00 Degree Celsius	Standard Deviation 0.141
Japanese Placebo	Change From Baseline in Vital Signs: Body Temperature	-0.03 Degree Celsius	Standard Deviation 0.115

Primary

Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)

The vital sign followed in this analysis was both systolic and diastolic blood pressure, expressed as millimetre of mercury. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.

Time frame: Baseline and Day 169

Arm	Measure	Group	Value (MEAN)	Dispersion
GSK3858279 Caucasian	Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	Diastolic Blood Pressure	5.2 Millimetre of Mercury (mmHg)	Standard Deviation 10.26
GSK3858279 Caucasian	Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	Systolic Blood Pressure	5.3 Millimetre of Mercury (mmHg)	Standard Deviation 13
GSK3858279 Chinese	Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	Diastolic Blood Pressure	4.0 Millimetre of Mercury (mmHg)	Standard Deviation 2
GSK3858279 Chinese	Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	Systolic Blood Pressure	0.8 Millimetre of Mercury (mmHg)	Standard Deviation 7.37
GSK3858279 Japanese	Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	Diastolic Blood Pressure	3.5 Millimetre of Mercury (mmHg)	Standard Deviation 8.24
GSK3858279 Japanese	Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	Systolic Blood Pressure	0.8 Millimetre of Mercury (mmHg)	Standard Deviation 6.18
Caucasian Placebo	Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	Systolic Blood Pressure	-1.0 Millimetre of Mercury (mmHg)	Standard Deviation 7.21
Caucasian Placebo	Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	Diastolic Blood Pressure	1.3 Millimetre of Mercury (mmHg)	Standard Deviation 4.73
Chinese Placebo	Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	Systolic Blood Pressure	5.0 Millimetre of Mercury (mmHg)	Standard Deviation 5.66
Chinese Placebo	Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	Diastolic Blood Pressure	8.5 Millimetre of Mercury (mmHg)	Standard Deviation 12.02
Japanese Placebo	Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	Diastolic Blood Pressure	-1.0 Millimetre of Mercury (mmHg)	Standard Deviation 3.61
Japanese Placebo	Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	Systolic Blood Pressure	0.0 Millimetre of Mercury (mmHg)	Standard Deviation 5

Primary

Change From Baseline in Vital Signs: Pulse Rate

The vital signs followed in this analysis was pulse rate, expressed as beats per minute. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.

Time frame: Baseline and Day 169

Population: The analysis was performed on the Safety Set that included all randomized participants who received at least one injection of study intervention.

Arm	Measure	Value (MEAN)	Dispersion
GSK3858279 Caucasian	Change From Baseline in Vital Signs: Pulse Rate	6.5 Beats per minute (bpm)	Standard Deviation 11.74
GSK3858279 Chinese	Change From Baseline in Vital Signs: Pulse Rate	16.0 Beats per minute (bpm)	Standard Deviation 18.17
GSK3858279 Japanese	Change From Baseline in Vital Signs: Pulse Rate	6.8 Beats per minute (bpm)	Standard Deviation 11.58
Caucasian Placebo	Change From Baseline in Vital Signs: Pulse Rate	6.7 Beats per minute (bpm)	Standard Deviation 6.03
Chinese Placebo	Change From Baseline in Vital Signs: Pulse Rate	10.0 Beats per minute (bpm)	Standard Deviation 1.41
Japanese Placebo	Change From Baseline in Vital Signs: Pulse Rate	4.3 Beats per minute (bpm)	Standard Deviation 9.02

Primary

Change From Baseline in Vital Signs: Respiratory Rate

The vital signs followed in this analysis was respiratory rate, expressed as Breaths per minute. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.

Time frame: Baseline and Day 169

Population: The analysis was performed on the Safety Set that included all randomized participants who received at least one injection of study intervention.

Arm	Measure	Value (MEAN)	Dispersion
GSK3858279 Caucasian	Change From Baseline in Vital Signs: Respiratory Rate	-0.5 Breaths per minute	Standard Deviation 1.76
GSK3858279 Chinese	Change From Baseline in Vital Signs: Respiratory Rate	-0.8 Breaths per minute	Standard Deviation 0.96
GSK3858279 Japanese	Change From Baseline in Vital Signs: Respiratory Rate	-1.0 Breaths per minute	Standard Deviation 1.67
Caucasian Placebo	Change From Baseline in Vital Signs: Respiratory Rate	-2.0 Breaths per minute	Standard Deviation 2
Chinese Placebo	Change From Baseline in Vital Signs: Respiratory Rate	-0.5 Breaths per minute	Standard Deviation 2.12
Japanese Placebo	Change From Baseline in Vital Signs: Respiratory Rate	-0.7 Breaths per minute	Standard Deviation 2.31

Primary

Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils

Blood samples were collected for the assessment of hematology parameters including (WBC) count with differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.

Time frame: Baseline and Day 169

Arm	Measure	Group	Value (MEAN)	Dispersion
GSK3858279 Caucasian	Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils	Lymphocytes	0.02 Giga cells per liter (10^9/L)	Standard Deviation 0.172
GSK3858279 Caucasian	Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils	Monocytes	0.00 Giga cells per liter (10^9/L)	Standard Deviation 0.063
GSK3858279 Caucasian	Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils	Eosinophils	0.00 Giga cells per liter (10^9/L)	Standard Deviation 0.084
GSK3858279 Caucasian	Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils	Basophils	0.01 Giga cells per liter (10^9/L)	Standard Deviation 0.02
GSK3858279 Caucasian	Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils	Neutrophils	-0.12 Giga cells per liter (10^9/L)	Standard Deviation 0.791
GSK3858279 Chinese	Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils	Basophils	0.00 Giga cells per liter (10^9/L)	Standard Deviation 0
GSK3858279 Chinese	Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils	Lymphocytes	0.10 Giga cells per liter (10^9/L)	Standard Deviation 0.141
GSK3858279 Chinese	Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils	Monocytes	0.05 Giga cells per liter (10^9/L)	Standard Deviation 0.071
GSK3858279 Chinese	Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils	Eosinophils	-0.03 Giga cells per liter (10^9/L)	Standard Deviation 0.035
GSK3858279 Chinese	Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils	Neutrophils	-0.25 Giga cells per liter (10^9/L)	Standard Deviation 0.212
GSK3858279 Japanese	Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils	Lymphocytes	0.04 Giga cells per liter (10^9/L)	Standard Deviation 0.261
GSK3858279 Japanese	Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils	Basophils	0.00 Giga cells per liter (10^9/L)	Standard Deviation 0
GSK3858279 Japanese	Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils	Eosinophils	0.02 Giga cells per liter (10^9/L)	Standard Deviation 0.135
GSK3858279 Japanese	Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils	Monocytes	0.10 Giga cells per liter (10^9/L)	Standard Deviation 0.122
GSK3858279 Japanese	Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils	Neutrophils	0.54 Giga cells per liter (10^9/L)	Standard Deviation 1.001
Caucasian Placebo	Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils	Eosinophils	-0.07 Giga cells per liter (10^9/L)	Standard Deviation 0.115
Caucasian Placebo	Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils	Lymphocytes	0.03 Giga cells per liter (10^9/L)	Standard Deviation 0.306
Caucasian Placebo	Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils	Monocytes	-0.10 Giga cells per liter (10^9/L)	Standard Deviation 0.265
Caucasian Placebo	Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils	Basophils	0.00 Giga cells per liter (10^9/L)	Standard Deviation 0
Caucasian Placebo	Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils	Neutrophils	-0.97 Giga cells per liter (10^9/L)	Standard Deviation 1.079
Chinese Placebo	Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils	Eosinophils	0.03 Giga cells per liter (10^9/L)	Standard Deviation 0.035
Chinese Placebo	Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils	Monocytes	0.05 Giga cells per liter (10^9/L)	Standard Deviation 0.071
Chinese Placebo	Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils	Lymphocytes	0.15 Giga cells per liter (10^9/L)	Standard Deviation 0.212
Chinese Placebo	Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils	Neutrophils	1.15 Giga cells per liter (10^9/L)	Standard Deviation 1.061
Chinese Placebo	Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils	Basophils	-0.03 Giga cells per liter (10^9/L)	Standard Deviation 0.035
Japanese Placebo	Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils	Basophils	0.00 Giga cells per liter (10^9/L)	Standard Deviation 0
Japanese Placebo	Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils	Monocytes	0.10 Giga cells per liter (10^9/L)	Standard Deviation 0.1
Japanese Placebo	Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils	Eosinophils	0.68 Giga cells per liter (10^9/L)	Standard Deviation 1.098
Japanese Placebo	Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils	Neutrophils	0.07 Giga cells per liter (10^9/L)	Standard Deviation 0.462
Japanese Placebo	Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils	Lymphocytes	-0.20 Giga cells per liter (10^9/L)	Standard Deviation 0.361

Primary

Maximum Observed Concentration (Cmax) of GSK3858279

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.

Time frame: Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43, 57, 85, 113, 141, 155 and 169 Days

Population: All participants in the safety population who received an active dose of study treatment and had at least one reportable PK assessment.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
GSK3858279 Caucasian	Maximum Observed Concentration (Cmax) of GSK3858279	9135.3 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 42
GSK3858279 Chinese	Maximum Observed Concentration (Cmax) of GSK3858279	6851.4 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 41.4
GSK3858279 Japanese	Maximum Observed Concentration (Cmax) of GSK3858279	8295.4 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 39.8

Primary

Number of Participants With Abnormal Urinalysis Results by Dipstick Method

The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as increase to trace, increase to 1+ (low concentrations present), increase to 2+ (moderate concentrations present) and increase to 3+ (high concentrations present) indicating proportional concentrations in the urine sample. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data for worst-case post-Baseline relative to Baseline is presented.

Time frame: Baseline and Day 169

Population: The analysis was performed on the Safety Set that included all randomized participants who received at least one injection of study intervention.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Occult Blood, Any Increase	1 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Bilirubin, Increase to 1+	1 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Bilirubin, Any Increase	1 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Ketones, Increase to TRACE	3 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Protein, Increase to TRACE	2 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Leukocyte Esterase, Increase to 1+	0 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Occult Blood, Increase to 2+	0 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Urobilinogen, Increase to 1+	0 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Ketones, Any Increase	3 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Urobilinogen, Increase to 3+	0 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Protein, Increase to 1+	0 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Bilirubin, Increase to TRACE	0 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Leukocyte Esterase, Increase to TRACE	0 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Glucose, Increase to 4+	0 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Leukocyte Esterase, Any Increase	0 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Glucose, Increase to 3+	0 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Protein, Increase to 2+	0 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Occult Blood, Increase to 3+	0 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Nitrite, Any Increase	0 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Urobilinogen, Increase to 2+	0 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Glucose, Increase to 2+	0 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Nitrite, Increase to POSITIVE	0 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Protein, Increase to 3+	0 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Urobilinogen, Increase to 4+	0 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Leukocyte Esterase, Increase to 4+	0 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Glucose, Increase to 1+	0 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Ketones, Increase to 4+	0 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Glucose, Increase to TRACE	0 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Protein, Increase to 4+	0 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Leukocyte Esterase, Increase to 2+	0 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Occult Blood, Increase to 4+	0 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Occult Blood, Increase to 1+	1 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Glucose, Any Increase	0 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Ketones, Increase to 1+	0 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Urobilinogen, Any Increase	0 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Ketones, Increase to 3+	0 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Occult Blood, Increase to TRACE	0 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Bilirubin, Increase to 4+	0 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Leukocyte Esterase, Increase to 3+	0 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Bilirubin, Increase to 3+	0 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Urobilinogen, Increase to TRACE	0 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Ketones, Increase to 2+	0 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Protein, Any Increase	2 Participants
GSK3858279 Caucasian	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Bilirubin, Increase to 2+	0 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Bilirubin, Increase to 2+	0 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Bilirubin, Increase to 1+	1 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Urobilinogen, Increase to 1+	0 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Bilirubin, Increase to TRACE	0 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Urobilinogen, Increase to 2+	0 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Bilirubin, Any Increase	1 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Urobilinogen, Increase to 4+	0 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Urobilinogen, Increase to 3+	0 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Leukocyte Esterase, Increase to 2+	0 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Occult Blood, Increase to 1+	0 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Leukocyte Esterase, Any Increase	0 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Leukocyte Esterase, Increase to 4+	0 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Leukocyte Esterase, Increase to 1+	0 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Occult Blood, Increase to 2+	0 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Protein, Any Increase	2 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Leukocyte Esterase, Increase to TRACE	0 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Occult Blood, Increase to 3+	0 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Ketones, Increase to 4+	0 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Ketones, Increase to 3+	0 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Occult Blood, Increase to 4+	0 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Nitrite, Any Increase	0 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Ketones, Increase to 2+	0 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Ketones, Increase to 1+	0 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Ketones, Increase to TRACE	5 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Protein, Increase to TRACE	1 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Occult Blood, Any Increase	1 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Ketones, Any Increase	5 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Glucose, Increase to 4+	0 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Protein, Increase to 1+	1 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Nitrite, Increase to POSITIVE	0 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Glucose, Increase to 3+	0 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Protein, Increase to 2+	0 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Glucose, Increase to 2+	0 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Glucose, Increase to 1+	0 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Protein, Increase to 3+	0 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Glucose, Increase to TRACE	0 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Protein, Increase to 4+	0 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Leukocyte Esterase, Increase to 3+	0 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Glucose, Any Increase	0 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Bilirubin, Increase to 4+	0 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Urobilinogen, Any Increase	0 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Bilirubin, Increase to 3+	0 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Urobilinogen, Increase to TRACE	0 Participants
GSK3858279 Chinese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Occult Blood, Increase to TRACE	1 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Occult Blood, Increase to 3+	0 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Occult Blood, Any Increase	1 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Occult Blood, Increase to TRACE	0 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Occult Blood, Increase to 1+	1 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Occult Blood, Increase to 2+	0 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Bilirubin, Any Increase	1 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Occult Blood, Increase to 4+	0 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Protein, Any Increase	2 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Protein, Increase to TRACE	2 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Protein, Increase to 1+	0 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Protein, Increase to 2+	0 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Protein, Increase to 3+	0 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Protein, Increase to 4+	0 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Urobilinogen, Any Increase	1 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Urobilinogen, Increase to TRACE	0 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Urobilinogen, Increase to 1+	0 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Urobilinogen, Increase to 2+	0 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Urobilinogen, Increase to 3+	1 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Urobilinogen, Increase to 4+	0 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Bilirubin, Increase to TRACE	0 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Bilirubin, Increase to 1+	1 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Bilirubin, Increase to 2+	0 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Bilirubin, Increase to 3+	0 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Bilirubin, Increase to 4+	0 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Glucose, Any Increase	0 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Glucose, Increase to TRACE	0 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Glucose, Increase to 1+	0 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Glucose, Increase to 2+	0 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Glucose, Increase to 3+	0 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Glucose, Increase to 4+	0 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Ketones, Any Increase	4 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Ketones, Increase to TRACE	3 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Ketones, Increase to 1+	0 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Ketones, Increase to 2+	1 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Ketones, Increase to 3+	0 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Ketones, Increase to 4+	0 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Leukocyte Esterase, Any Increase	0 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Leukocyte Esterase, Increase to TRACE	0 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Leukocyte Esterase, Increase to 1+	0 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Leukocyte Esterase, Increase to 2+	0 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Leukocyte Esterase, Increase to 3+	0 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Leukocyte Esterase, Increase to 4+	0 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Nitrite, Any Increase	0 Participants
GSK3858279 Japanese	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Nitrite, Increase to POSITIVE	0 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Bilirubin, Any Increase	0 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Nitrite, Increase to POSITIVE	0 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Protein, Increase to 1+	0 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Ketones, Increase to 4+	0 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Bilirubin, Increase to 2+	0 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Glucose, Increase to 4+	0 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Protein, Increase to 4+	0 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Occult Blood, Increase to 3+	0 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Urobilinogen, Increase to 2+	0 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Protein, Increase to TRACE	1 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Glucose, Increase to TRACE	0 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Ketones, Any Increase	2 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Glucose, Any Increase	0 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Ketones, Increase to 3+	0 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Occult Blood, Any Increase	1 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Leukocyte Esterase, Increase to 2+	0 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Leukocyte Esterase, Increase to 4+	0 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Ketones, Increase to TRACE	2 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Urobilinogen, Increase to 4+	0 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Occult Blood, Increase to 4+	0 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Protein, Any Increase	1 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Urobilinogen, Increase to 3+	0 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Ketones, Increase to 1+	0 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Bilirubin, Increase to 3+	0 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Ketones, Increase to 2+	0 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Urobilinogen, Increase to TRACE	0 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Urobilinogen, Increase to 1+	0 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Occult Blood, Increase to 1+	0 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Protein, Increase to 3+	0 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Leukocyte Esterase, Increase to 1+	1 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Leukocyte Esterase, Increase to 3+	0 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Glucose, Increase to 1+	0 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Urobilinogen, Any Increase	0 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Leukocyte Esterase, Increase to TRACE	0 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Bilirubin, Increase to TRACE	0 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Protein, Increase to 2+	0 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Occult Blood, Increase to TRACE	0 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Glucose, Increase to 2+	0 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Bilirubin, Increase to 4+	0 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Nitrite, Any Increase	0 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Occult Blood, Increase to 2+	1 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Bilirubin, Increase to 1+	0 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Leukocyte Esterase, Any Increase	1 Participants
Caucasian Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Glucose, Increase to 3+	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Urobilinogen, Increase to TRACE	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Leukocyte Esterase, Increase to 2+	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Bilirubin, Increase to 2+	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Urobilinogen, Any Increase	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Bilirubin, Increase to 3+	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Bilirubin, Increase to 4+	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Protein, Increase to 4+	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Glucose, Any Increase	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Protein, Increase to 3+	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Nitrite, Increase to POSITIVE	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Glucose, Increase to TRACE	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Glucose, Increase to 1+	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Protein, Increase to 2+	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Leukocyte Esterase, Increase to 3+	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Glucose, Increase to 2+	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Protein, Increase to 1+	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Glucose, Increase to 3+	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Occult Blood, Any Increase	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Glucose, Increase to 4+	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Protein, Increase to TRACE	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Ketones, Any Increase	3 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Protein, Any Increase	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Ketones, Increase to TRACE	3 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Leukocyte Esterase, Increase to 4+	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Ketones, Increase to 1+	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Occult Blood, Increase to 4+	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Ketones, Increase to 2+	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Ketones, Increase to 3+	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Occult Blood, Increase to 3+	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Ketones, Increase to 4+	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Leukocyte Esterase, Any Increase	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Occult Blood, Increase to 2+	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Leukocyte Esterase, Increase to TRACE	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Occult Blood, Increase to 1+	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Nitrite, Any Increase	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Leukocyte Esterase, Increase to 1+	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Urobilinogen, Increase to 3+	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Occult Blood, Increase to TRACE	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Urobilinogen, Increase to 4+	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Urobilinogen, Increase to 2+	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Bilirubin, Any Increase	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Urobilinogen, Increase to 1+	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Bilirubin, Increase to TRACE	0 Participants
Chinese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Bilirubin, Increase to 1+	0 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Glucose, Increase to 3+	0 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Leukocyte Esterase, Increase to 3+	0 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Bilirubin, Any Increase	0 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Leukocyte Esterase, Any Increase	1 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Urobilinogen, Increase to 1+	0 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Protein, Increase to 1+	0 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Glucose, Increase to 2+	0 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Glucose, Increase to 1+	0 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Bilirubin, Increase to 2+	0 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Leukocyte Esterase, Increase to TRACE	0 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Occult Blood, Increase to 1+	0 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Nitrite, Any Increase	0 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Protein, Increase to 4+	0 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Protein, Increase to 2+	0 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Glucose, Increase to TRACE	0 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Bilirubin, Increase to 1+	0 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Leukocyte Esterase, Increase to 1+	1 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Occult Blood, Increase to TRACE	0 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Bilirubin, Increase to TRACE	0 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Urobilinogen, Increase to 3+	0 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Protein, Increase to 3+	0 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Urobilinogen, Increase to 2+	0 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Bilirubin, Increase to 3+	0 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Glucose, Any Increase	0 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Urobilinogen, Increase to TRACE	0 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Occult Blood, Increase to 4+	0 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Urobilinogen, Increase to 4+	0 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Leukocyte Esterase, Increase to 4+	0 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Ketones, Increase to 1+	0 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Leukocyte Esterase, Increase to 2+	0 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Ketones, Increase to 2+	0 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Ketones, Increase to TRACE	1 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Occult Blood, Increase to 3+	0 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Protein, Any Increase	2 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Ketones, Any Increase	1 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Occult Blood, Any Increase	0 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Ketones, Increase to 3+	0 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Bilirubin, Increase to 4+	0 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Glucose, Increase to 4+	0 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Nitrite, Increase to POSITIVE	0 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Protein, Increase to TRACE	2 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Urobilinogen, Any Increase	0 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Ketones, Increase to 4+	0 Participants
Japanese Placebo	Number of Participants With Abnormal Urinalysis Results by Dipstick Method	Occult Blood, Increase to 2+	0 Participants

Primary

Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAE's) And Withdrawals Due to AE's

An AE is defined as 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. SAEs are defined as any untoward medical occurrence that, at any dose: results in death, cause life threatening events which requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability or incapacity and birth defect or congenital anomaly. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169.

Time frame: Up to 169 days

Population: The analysis was performed on the Safety Set that included all randomized participants who received at least one injection of study intervention.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
GSK3858279 Caucasian	Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAE's) And Withdrawals Due to AE's	SAE	0 Participants
GSK3858279 Caucasian	Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAE's) And Withdrawals Due to AE's	AE	5 Participants
GSK3858279 Caucasian	Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAE's) And Withdrawals Due to AE's	Withdrawals Due to AE	0 Participants
GSK3858279 Chinese	Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAE's) And Withdrawals Due to AE's	SAE	0 Participants
GSK3858279 Chinese	Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAE's) And Withdrawals Due to AE's	AE	6 Participants
GSK3858279 Chinese	Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAE's) And Withdrawals Due to AE's	Withdrawals Due to AE	0 Participants
GSK3858279 Japanese	Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAE's) And Withdrawals Due to AE's	SAE	0 Participants
GSK3858279 Japanese	Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAE's) And Withdrawals Due to AE's	AE	2 Participants
GSK3858279 Japanese	Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAE's) And Withdrawals Due to AE's	Withdrawals Due to AE	0 Participants
Caucasian Placebo	Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAE's) And Withdrawals Due to AE's	SAE	0 Participants
Caucasian Placebo	Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAE's) And Withdrawals Due to AE's	AE	4 Participants
Caucasian Placebo	Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAE's) And Withdrawals Due to AE's	Withdrawals Due to AE	0 Participants
Chinese Placebo	Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAE's) And Withdrawals Due to AE's	SAE	0 Participants
Chinese Placebo	Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAE's) And Withdrawals Due to AE's	AE	1 Participants
Chinese Placebo	Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAE's) And Withdrawals Due to AE's	Withdrawals Due to AE	0 Participants
Japanese Placebo	Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAE's) And Withdrawals Due to AE's	AE	2 Participants
Japanese Placebo	Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAE's) And Withdrawals Due to AE's	Withdrawals Due to AE	0 Participants
Japanese Placebo	Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAE's) And Withdrawals Due to AE's	SAE	0 Participants

Primary

Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)

Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 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 acidic pH (5.0 - 6.0). The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.

Time frame: Baseline and Day 169

Population: The analysis was performed on the Safety Set that included all randomized participants who received at least one injection of study intervention.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
GSK3858279 Caucasian	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Any Increase	5 Participants
GSK3858279 Caucasian	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Increase to 6.5	1 Participants
GSK3858279 Caucasian	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Increase to 7.5	1 Participants
GSK3858279 Caucasian	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Increase to 8.5	1 Participants
GSK3858279 Caucasian	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Increase to 8.0	1 Participants
GSK3858279 Caucasian	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Increase to 7.0	1 Participants
GSK3858279 Chinese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Any Increase	6 Participants
GSK3858279 Chinese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Increase to 7.5	2 Participants
GSK3858279 Chinese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Increase to 6.5	2 Participants
GSK3858279 Chinese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Increase to 8.0	2 Participants
GSK3858279 Chinese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Increase to 7.0	0 Participants
GSK3858279 Chinese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Increase to 8.5	0 Participants
GSK3858279 Japanese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Increase to 8.0	2 Participants
GSK3858279 Japanese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Any Increase	4 Participants
GSK3858279 Japanese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Increase to 7.0	0 Participants
GSK3858279 Japanese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Increase to 6.5	0 Participants
GSK3858279 Japanese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Increase to 8.5	0 Participants
GSK3858279 Japanese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Increase to 7.5	2 Participants
Caucasian Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Any Increase	2 Participants
Caucasian Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Increase to 8.5	0 Participants
Caucasian Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Increase to 6.5	0 Participants
Caucasian Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Increase to 7.0	0 Participants
Caucasian Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Increase to 7.5	0 Participants
Caucasian Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Increase to 8.0	2 Participants
Chinese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Increase to 7.0	0 Participants
Chinese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Increase to 6.5	0 Participants
Chinese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Any Increase	2 Participants
Chinese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Increase to 8.5	0 Participants
Chinese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Increase to 8.0	0 Participants
Chinese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Increase to 7.5	2 Participants
Japanese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Increase to 8.5	0 Participants
Japanese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Any Increase	3 Participants
Japanese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Increase to 7.0	1 Participants
Japanese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Increase to 7.5	2 Participants
Japanese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Increase to 8.0	0 Participants
Japanese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Increase to 6.5	0 Participants

Primary

Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)

Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine, indicated as ratio of urine density to water density. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.

Time frame: Baseline and Day 169

Population: The analysis was performed on the Safety Set that included all randomized participants who received at least one injection of study intervention.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
GSK3858279 Caucasian	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.031	0 Participants
GSK3858279 Caucasian	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.024	0 Participants
GSK3858279 Caucasian	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.033	0 Participants
GSK3858279 Caucasian	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.026	0 Participants
GSK3858279 Caucasian	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.034	1 Participants
GSK3858279 Caucasian	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.02	1 Participants
GSK3858279 Caucasian	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.028	0 Participants
GSK3858279 Caucasian	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.021	1 Participants
GSK3858279 Caucasian	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.027	0 Participants
GSK3858279 Caucasian	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Any Increase	6 Participants
GSK3858279 Caucasian	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.025	1 Participants
GSK3858279 Caucasian	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.029	1 Participants
GSK3858279 Caucasian	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.03	0 Participants
GSK3858279 Caucasian	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.036	1 Participants
GSK3858279 Caucasian	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.032	0 Participants
GSK3858279 Caucasian	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.019	0 Participants
GSK3858279 Chinese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.036	1 Participants
GSK3858279 Chinese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.027	0 Participants
GSK3858279 Chinese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Any Increase	7 Participants
GSK3858279 Chinese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.03	3 Participants
GSK3858279 Chinese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.028	1 Participants
GSK3858279 Chinese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.019	0 Participants
GSK3858279 Chinese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.034	0 Participants
GSK3858279 Chinese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.02	0 Participants
GSK3858279 Chinese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.033	1 Participants
GSK3858279 Chinese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.021	0 Participants
GSK3858279 Chinese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.029	0 Participants
GSK3858279 Chinese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.024	0 Participants
GSK3858279 Chinese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.032	0 Participants
GSK3858279 Chinese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.025	1 Participants
GSK3858279 Chinese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.031	0 Participants
GSK3858279 Chinese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.026	0 Participants
GSK3858279 Japanese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.019	1 Participants
GSK3858279 Japanese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.026	0 Participants
GSK3858279 Japanese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.024	2 Participants
GSK3858279 Japanese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.036	0 Participants
GSK3858279 Japanese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.029	0 Participants
GSK3858279 Japanese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.034	1 Participants
GSK3858279 Japanese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Any Increase	7 Participants
GSK3858279 Japanese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.027	0 Participants
GSK3858279 Japanese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.033	1 Participants
GSK3858279 Japanese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.025	0 Participants
GSK3858279 Japanese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.02	0 Participants
GSK3858279 Japanese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.028	0 Participants
GSK3858279 Japanese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.021	0 Participants
GSK3858279 Japanese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.031	1 Participants
GSK3858279 Japanese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.03	0 Participants
GSK3858279 Japanese	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.032	1 Participants
Caucasian Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.02	0 Participants
Caucasian Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.026	1 Participants
Caucasian Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.029	0 Participants
Caucasian Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.034	0 Participants
Caucasian Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.036	0 Participants
Caucasian Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Any Increase	4 Participants
Caucasian Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.019	0 Participants
Caucasian Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.021	1 Participants
Caucasian Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.024	0 Participants
Caucasian Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.025	1 Participants
Caucasian Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.027	0 Participants
Caucasian Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.028	1 Participants
Caucasian Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.03	0 Participants
Caucasian Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.031	0 Participants
Caucasian Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.032	0 Participants
Caucasian Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.033	0 Participants
Chinese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.025	0 Participants
Chinese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.021	0 Participants
Chinese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.02	0 Participants
Chinese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.029	0 Participants
Chinese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.031	0 Participants
Chinese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.033	0 Participants
Chinese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.026	0 Participants
Chinese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.019	0 Participants
Chinese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.024	0 Participants
Chinese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.034	0 Participants
Chinese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.03	1 Participants
Chinese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Any Increase	3 Participants
Chinese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.036	0 Participants
Chinese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.028	0 Participants
Chinese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.032	1 Participants
Chinese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.027	1 Participants
Japanese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.029	1 Participants
Japanese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.026	0 Participants
Japanese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.03	0 Participants
Japanese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.025	0 Participants
Japanese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.031	0 Participants
Japanese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.024	0 Participants
Japanese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.021	0 Participants
Japanese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.032	2 Participants
Japanese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.02	0 Participants
Japanese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.036	0 Participants
Japanese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.033	1 Participants
Japanese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.019	0 Participants
Japanese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Any Increase	4 Participants
Japanese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.034	0 Participants
Japanese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.028	0 Participants
Japanese Placebo	Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)	Increase to 1.027	0 Participants

Primary

Time of Occurrence of Cmax (Tmax) of GSK3858279

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.

Time frame: Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43, 57, 85, 113, 141, 155 and 169 Days

Population: All participants in the safety population who received an active dose of study treatment and had at least one reportable PK assessment.

Arm	Measure	Value (MEDIAN)
GSK3858279 Caucasian	Time of Occurrence of Cmax (Tmax) of GSK3858279	2.004 day
GSK3858279 Chinese	Time of Occurrence of Cmax (Tmax) of GSK3858279	3.919 day
GSK3858279 Japanese	Time of Occurrence of Cmax (Tmax) of GSK3858279	3.217 day

Primary

Time of Occurrence of Last Quantifiable Concentration (Tlast) of GSK3858279

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.

Time frame: Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43, 57, 85, 113, 141, 155 and 169 Days

Population: All participants in the safety population who received an active dose of study treatment and had at least one reportable PK assessment.

Arm	Measure	Value (MEDIAN)
GSK3858279 Caucasian	Time of Occurrence of Last Quantifiable Concentration (Tlast) of GSK3858279	56.115 day
GSK3858279 Chinese	Time of Occurrence of Last Quantifiable Concentration (Tlast) of GSK3858279	56.062 day
GSK3858279 Japanese	Time of Occurrence of Last Quantifiable Concentration (Tlast) of GSK3858279	55.964 day

Secondary

Cmax of Total CCL17 in Serum Following GSK3858279

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.

Time frame: Baseline (Day 1) and at Days 7, 14, 28 and 56 Post dose

Population: All participants in the safety population who had at least one reportable TE assessment.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
GSK3858279 Caucasian	Cmax of Total CCL17 in Serum Following GSK3858279	68969.794 Picogram per milliliter (pg/mL)	Geometric Coefficient of Variation 30.025
GSK3858279 Chinese	Cmax of Total CCL17 in Serum Following GSK3858279	62648.760 Picogram per milliliter (pg/mL)	Geometric Coefficient of Variation 29.529
GSK3858279 Japanese	Cmax of Total CCL17 in Serum Following GSK3858279	55177.740 Picogram per milliliter (pg/mL)	Geometric Coefficient of Variation 20.37
Caucasian Placebo	Cmax of Total CCL17 in Serum Following GSK3858279	1661.847 Picogram per milliliter (pg/mL)	Geometric Coefficient of Variation 31.284
Chinese Placebo	Cmax of Total CCL17 in Serum Following GSK3858279	733.904 Picogram per milliliter (pg/mL)	Geometric Coefficient of Variation 4.084
Japanese Placebo	Cmax of Total CCL17 in Serum Following GSK3858279	621.421 Picogram per milliliter (pg/mL)	Geometric Coefficient of Variation 61.396

Secondary

Fold Increase in Total CCL17 in Serum Following GSK3858279 Administration

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters. The study intervention dose was administered on Study Day 1(baseline), where 7 days post-dose totals to Study Day 1+7days = Study Day 8. Following results of Day 8, Day 15, Day 29 and Day 57 corelates to timepoints Day 7, Day 14, Day 28 and Day 56 post dose values and same are presented here.

Time frame: Baseline (Day 1) and at Days 7, 14, 28 and 56 Post dose

Population: All participants in the safety population who had at least one reportable TE assessment.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
GSK3858279 Caucasian	Fold Increase in Total CCL17 in Serum Following GSK3858279 Administration	Day 8	76.489 Fold Change
GSK3858279 Caucasian	Fold Increase in Total CCL17 in Serum Following GSK3858279 Administration	Day 15	61.874 Fold Change
GSK3858279 Caucasian	Fold Increase in Total CCL17 in Serum Following GSK3858279 Administration	Day 29	26.405 Fold Change
GSK3858279 Caucasian	Fold Increase in Total CCL17 in Serum Following GSK3858279 Administration	Day 57	7.049 Fold Change
GSK3858279 Chinese	Fold Increase in Total CCL17 in Serum Following GSK3858279 Administration	Day 29	61.250 Fold Change
GSK3858279 Chinese	Fold Increase in Total CCL17 in Serum Following GSK3858279 Administration	Day 15	110.634 Fold Change
GSK3858279 Chinese	Fold Increase in Total CCL17 in Serum Following GSK3858279 Administration	Day 8	93.537 Fold Change
GSK3858279 Chinese	Fold Increase in Total CCL17 in Serum Following GSK3858279 Administration	Day 57	16.002 Fold Change
GSK3858279 Japanese	Fold Increase in Total CCL17 in Serum Following GSK3858279 Administration	Day 57	5.056 Fold Change
GSK3858279 Japanese	Fold Increase in Total CCL17 in Serum Following GSK3858279 Administration	Day 29	21.448 Fold Change
GSK3858279 Japanese	Fold Increase in Total CCL17 in Serum Following GSK3858279 Administration	Day 15	56.857 Fold Change
GSK3858279 Japanese	Fold Increase in Total CCL17 in Serum Following GSK3858279 Administration	Day 8	70.025 Fold Change
Caucasian Placebo	Fold Increase in Total CCL17 in Serum Following GSK3858279 Administration	Day 8	0.866 Fold Change
Caucasian Placebo	Fold Increase in Total CCL17 in Serum Following GSK3858279 Administration	Day 57	0.942 Fold Change
Caucasian Placebo	Fold Increase in Total CCL17 in Serum Following GSK3858279 Administration	Day 15	0.977 Fold Change
Caucasian Placebo	Fold Increase in Total CCL17 in Serum Following GSK3858279 Administration	Day 29	0.971 Fold Change
Chinese Placebo	Fold Increase in Total CCL17 in Serum Following GSK3858279 Administration	Day 29	0.960 Fold Change
Chinese Placebo	Fold Increase in Total CCL17 in Serum Following GSK3858279 Administration	Day 57	0.867 Fold Change
Chinese Placebo	Fold Increase in Total CCL17 in Serum Following GSK3858279 Administration	Day 15	1.000 Fold Change
Chinese Placebo	Fold Increase in Total CCL17 in Serum Following GSK3858279 Administration	Day 8	0.975 Fold Change
Japanese Placebo	Fold Increase in Total CCL17 in Serum Following GSK3858279 Administration	Day 15	1.072 Fold Change
Japanese Placebo	Fold Increase in Total CCL17 in Serum Following GSK3858279 Administration	Day 29	1.145 Fold Change
Japanese Placebo	Fold Increase in Total CCL17 in Serum Following GSK3858279 Administration	Day 57	1.082 Fold Change
Japanese Placebo	Fold Increase in Total CCL17 in Serum Following GSK3858279 Administration	Day 8	1.025 Fold Change

Secondary

Maximum Fold Change in Total CCL17 in Serum Following GSK3858279 Administration

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.

Time frame: Baseline (Day 1) and Days 56 Post dose

Population: All participants in the safety population who had at least one reportable TE assessment.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
GSK3858279 Caucasian	Maximum Fold Change in Total CCL17 in Serum Following GSK3858279 Administration	77.479 Fold Change	Geometric Coefficient of Variation 4.674
GSK3858279 Chinese	Maximum Fold Change in Total CCL17 in Serum Following GSK3858279 Administration	113.436 Fold Change	Geometric Coefficient of Variation 34.212
GSK3858279 Japanese	Maximum Fold Change in Total CCL17 in Serum Following GSK3858279 Administration	73.474 Fold Change	Geometric Coefficient of Variation 58.664
Caucasian Placebo	Maximum Fold Change in Total CCL17 in Serum Following GSK3858279 Administration	1.155 Fold Change	Geometric Coefficient of Variation 14.377
Chinese Placebo	Maximum Fold Change in Total CCL17 in Serum Following GSK3858279 Administration	1.270 Fold Change	Geometric Coefficient of Variation 3.027
Japanese Placebo	Maximum Fold Change in Total CCL17 in Serum Following GSK3858279 Administration	1.383 Fold Change	Geometric Coefficient of Variation 29.136

Secondary

Number of Participants With Pre-existing Anti-drug Antibodies (ADA's)

Serum samples were collected for the determination of anti- GSK3858279 antibodies (ADA). 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. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample. Additionally, confirmed positive ADA samples were also tested in a validated neutralizing antibody assay to determine the potential neutralizing activity of the ADA.

Time frame: Day 169

Population: All participants in the safety population who had at least one reportable TE assessment.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GSK3858279 Caucasian	Number of Participants With Pre-existing Anti-drug Antibodies (ADA's)	0 Participants
GSK3858279 Chinese	Number of Participants With Pre-existing Anti-drug Antibodies (ADA's)	0 Participants
GSK3858279 Japanese	Number of Participants With Pre-existing Anti-drug Antibodies (ADA's)	0 Participants
Caucasian Placebo	Number of Participants With Pre-existing Anti-drug Antibodies (ADA's)	0 Participants
Chinese Placebo	Number of Participants With Pre-existing Anti-drug Antibodies (ADA's)	0 Participants
Japanese Placebo	Number of Participants With Pre-existing Anti-drug Antibodies (ADA's)	0 Participants

Secondary

Number of Participants With Treatment-Emergent ADA's Over Time

Serum samples were collected for the determination of anti- GSK3858279 antibodies (ADA).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. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample. Additionally, confirmed positive ADA samples were also tested in a validated neutralizing antibody assay to determine the potential neutralizing activity of the ADA.

Time frame: Day 169

Population: All participants in the safety population who had at least one reportable TE assessment.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GSK3858279 Caucasian	Number of Participants With Treatment-Emergent ADA's Over Time	0 Participants
GSK3858279 Chinese	Number of Participants With Treatment-Emergent ADA's Over Time	0 Participants
GSK3858279 Japanese	Number of Participants With Treatment-Emergent ADA's Over Time	0 Participants
Caucasian Placebo	Number of Participants With Treatment-Emergent ADA's Over Time	0 Participants
Chinese Placebo	Number of Participants With Treatment-Emergent ADA's Over Time	0 Participants
Japanese Placebo	Number of Participants With Treatment-Emergent ADA's Over Time	0 Participants

Secondary

Percentage Change From Baseline in Free CCL17

Blood samples were collected from participants at time points after the administration of study treatment to investigate PK parameters. The study intervention dose was administered on Study Day 1(baseline), where 7 days post-dose totals to Study Day 1+7days = Study Day 8. Following results of Day 8, Day 15, Day 29 and Day 57 corelates to timepoints Day 7, Day 14, Day 28 and Day 56 post dose values and same are presented here.

Time frame: Baseline (Day 1) and at Days 7, 14, 28 and 56 Post dose

Population: All participants in the safety population who had at least one reportable Target Engagement (TE) assessment.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
GSK3858279 Caucasian	Percentage Change From Baseline in Free CCL17	Day 8, Percent change	89.715 Percent change (%)
GSK3858279 Caucasian	Percentage Change From Baseline in Free CCL17	Day 15, Percent change	60.524 Percent change (%)
GSK3858279 Caucasian	Percentage Change From Baseline in Free CCL17	Day 29, Percent change	0.529 Percent change (%)
GSK3858279 Caucasian	Percentage Change From Baseline in Free CCL17	Day 57, Percent change	1.380 Percent change (%)
GSK3858279 Chinese	Percentage Change From Baseline in Free CCL17	Day 57, Percent change	0.100 Percent change (%)
GSK3858279 Chinese	Percentage Change From Baseline in Free CCL17	Day 8, Percent change	85.825 Percent change (%)
GSK3858279 Chinese	Percentage Change From Baseline in Free CCL17	Day 15, Percent change	50.249 Percent change (%)
GSK3858279 Chinese	Percentage Change From Baseline in Free CCL17	Day 29, Percent change	0.165 Percent change (%)
GSK3858279 Japanese	Percentage Change From Baseline in Free CCL17	Day 29, Percent change	0.606 Percent change (%)
GSK3858279 Japanese	Percentage Change From Baseline in Free CCL17	Day 8, Percent change	88.461 Percent change (%)
GSK3858279 Japanese	Percentage Change From Baseline in Free CCL17	Day 15, Percent change	59.183 Percent change (%)
GSK3858279 Japanese	Percentage Change From Baseline in Free CCL17	Day 57, Percent change	0.527 Percent change (%)
Caucasian Placebo	Percentage Change From Baseline in Free CCL17	Day 8, Percent change	22.353 Percent change (%)
Caucasian Placebo	Percentage Change From Baseline in Free CCL17	Day 15, Percent change	7.528 Percent change (%)
Caucasian Placebo	Percentage Change From Baseline in Free CCL17	Day 57, Percent change	14.136 Percent change (%)
Caucasian Placebo	Percentage Change From Baseline in Free CCL17	Day 29, Percent change	3.665 Percent change (%)
Chinese Placebo	Percentage Change From Baseline in Free CCL17	Day 15, Percent change	0.528 Percent change (%)
Chinese Placebo	Percentage Change From Baseline in Free CCL17	Day 29, Percent change	0.316 Percent change (%)
Chinese Placebo	Percentage Change From Baseline in Free CCL17	Day 57, Percent change	1.416 Percent change (%)
Chinese Placebo	Percentage Change From Baseline in Free CCL17	Day 8, Percent change	0.452 Percent change (%)
Japanese Placebo	Percentage Change From Baseline in Free CCL17	Day 57, Percent change	2.875 Percent change (%)
Japanese Placebo	Percentage Change From Baseline in Free CCL17	Day 8, Percent change	0.863 Percent change (%)
Japanese Placebo	Percentage Change From Baseline in Free CCL17	Day 15, Percent change	0.787 Percent change (%)
Japanese Placebo	Percentage Change From Baseline in Free CCL17	Day 29, Percent change	0.558 Percent change (%)

Secondary

Tmax of Total CCL17 in Serum Following GSK3858279

Time frame: Baseline (Day 1) and at Days 7, 14, 28 and 56 Post dose

Population: All participants in the safety population who had at least one reportable TE assessment.

Arm	Measure	Value (MEAN)	Dispersion
GSK3858279 Caucasian	Tmax of Total CCL17 in Serum Following GSK3858279	9.333 day	Standard Deviation 5.7155
GSK3858279 Chinese	Tmax of Total CCL17 in Serum Following GSK3858279	14.000 day	Standard Deviation 4.0415
GSK3858279 Japanese	Tmax of Total CCL17 in Serum Following GSK3858279	8.571 day	Standard Deviation 3.8668
Caucasian Placebo	Tmax of Total CCL17 in Serum Following GSK3858279	57.000 day	Standard Deviation 75.7276
Chinese Placebo	Tmax of Total CCL17 in Serum Following GSK3858279	1.083 day	Standard Deviation 0.7217
Japanese Placebo	Tmax of Total CCL17 in Serum Following GSK3858279	26.313 day	Standard Deviation 38.8659

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Arm	Measure	Group	Value (MEAN)	Dispersion
GSK3858279 Caucasian	Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP)	Alanine Aminotransferase (ALT)	3.2 Units per liter (U/L)	Standard Deviation 9.7
GSK3858279 Caucasian	Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP)	Aspartate Aminotransferase (AST)	2.3 Units per liter (U/L)	Standard Deviation 5.72
GSK3858279 Caucasian	Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP)	Alkaline Phosphatase (AP)	0.8 Units per liter (U/L)	Standard Deviation 12.16
GSK3858279 Chinese	Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP)	Alanine Aminotransferase (ALT)	9.3 Units per liter (U/L)	Standard Deviation 17.25
GSK3858279 Chinese	Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP)	Aspartate Aminotransferase (AST)	12.0 Units per liter (U/L)	Standard Deviation 19.37
GSK3858279 Chinese	Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP)	Alkaline Phosphatase (AP)	1.3 Units per liter (U/L)	Standard Deviation 6.34
GSK3858279 Japanese	Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP)	Aspartate Aminotransferase (AST)	0.8 Units per liter (U/L)	Standard Deviation 6.74
GSK3858279 Japanese	Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP)	Alkaline Phosphatase (AP)	-6.5 Units per liter (U/L)	Standard Deviation 14.18
GSK3858279 Japanese	Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP)	Alanine Aminotransferase (ALT)	4.0 Units per liter (U/L)	Standard Deviation 4.15
Caucasian Placebo	Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP)	Alkaline Phosphatase (AP)	0.0 Units per liter (U/L)	Standard Deviation 7.94
Caucasian Placebo	Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP)	Alanine Aminotransferase (ALT)	17.3 Units per liter (U/L)	Standard Deviation 5.13
Caucasian Placebo	Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP)	Aspartate Aminotransferase (AST)	11.0 Units per liter (U/L)	Standard Deviation 3.61
Chinese Placebo	Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP)	Aspartate Aminotransferase (AST)	1.0 Units per liter (U/L)	Standard Deviation 4.24
Chinese Placebo	Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP)	Alkaline Phosphatase (AP)	-3.0 Units per liter (U/L)	Standard Deviation 8.49
Chinese Placebo	Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP)	Alanine Aminotransferase (ALT)	-3.0 Units per liter (U/L)	Standard Deviation 5.66
Japanese Placebo	Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP)	Alanine Aminotransferase (ALT)	-2.0 Units per liter (U/L)	Standard Deviation 11.79
Japanese Placebo	Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP)	Alkaline Phosphatase (AP)	-4.3 Units per liter (U/L)	Standard Deviation 11.06
Japanese Placebo	Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP)	Aspartate Aminotransferase (AST)	-1.3 Units per liter (U/L)	Standard Deviation 3.06

Safety, Tolerability, Pharmacokinetics and Target Engagement of GSK3858279 in Healthy Caucasian, Chinese and Japanese Participants

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Masking description

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Area Under the Plasma Concentration-Time Curve From Time Zero to 56 Days AUC (0-56)] of GSK3858279

AUC From Time Zero to the Last Measurable Concentration (0-t) Post-Dose of GSK3858279

Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP)

Change From Baseline in Clinical Chemistry Parameter of Direct Bilirubin, Creatinine

Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin

Change From Baseline in Clinical Chemistry Parameter of Total Protein

Change From Baseline in Clinical Chemistry Parameter of Urea, Glucose, Potassium, Sodium

Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) Interval

Change From Baseline in Hematology Parameter of Hematocrit

Change From Baseline in Hematology Parameter of Hemoglobin

Change From Baseline in Hematology Parameter of Platelet Count

Change From Baseline in Vital Signs: Body Temperature

Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)

Change From Baseline in Vital Signs: Pulse Rate

Change From Baseline in Vital Signs: Respiratory Rate

Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils

Maximum Observed Concentration (Cmax) of GSK3858279

Number of Participants With Abnormal Urinalysis Results by Dipstick Method

Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAE's) And Withdrawals Due to AE's

Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)

Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)

Time of Occurrence of Cmax (Tmax) of GSK3858279

Time of Occurrence of Last Quantifiable Concentration (Tlast) of GSK3858279

Cmax of Total CCL17 in Serum Following GSK3858279

Fold Increase in Total CCL17 in Serum Following GSK3858279 Administration

Maximum Fold Change in Total CCL17 in Serum Following GSK3858279 Administration

Number of Participants With Pre-existing Anti-drug Antibodies (ADA's)

Number of Participants With Treatment-Emergent ADA's Over Time

Percentage Change From Baseline in Free CCL17

Tmax of Total CCL17 in Serum Following GSK3858279