Trial Outcomes & Findings for Safety, Tolerability, Pharmacokinetics and Target Engagement of GSK3858279 in Healthy Caucasian, Chinese and Japanese Participants (NCT NCT05174013)

NCT ID: NCT05174013

Last Updated: 2025-05-15

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 33 participants
• Primary outcome timeframe: Up to 169 days
• Results posted on: 2025-05-15

Participant Flow

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.

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%]).

Participant milestones

Measure	GSK3858279 Caucasian Participants received 240 milligrams (mg) of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.	GSK3858279 Chinese Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.	GSK3858279 Japanese Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.	Caucasian Placebo Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.	Chinese Placebo Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.	Japanese Placebo Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Overall Study STARTED	6	7	7	4	3	4
Overall Study COMPLETED	6	7	6	3	3	4
Overall Study NOT COMPLETED	0	0	1	1	0	0

Reasons for withdrawal

Measure	GSK3858279 Caucasian Participants received 240 milligrams (mg) of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.	GSK3858279 Chinese Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.	GSK3858279 Japanese Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.	Caucasian Placebo Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.	Chinese Placebo Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.	Japanese Placebo Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
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

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

Baseline characteristics by cohort

Measure	GSK3858279 Caucasian n=6 Participants Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.	GSK3858279 Chinese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.	GSK3858279 Japanese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.	Caucasian Placebo n=4 Participants Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.	Chinese Placebo n=3 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.	Japanese Placebo n=4 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.	Total n=31 Participants Total of all reporting groups
Age, Customized 20 - 65 (years of age)	6 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	4 Participants n=4 Participants	3 Participants n=21 Participants	4 Participants n=8 Participants	31 Participants n=8 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	4 Participants n=8 Participants	30 Participants n=8 Participants
Race/Ethnicity, Customized ASIAN	0 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants	4 Participants n=8 Participants	21 Participants n=8 Participants
Race/Ethnicity, Customized WHITE	6 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	10 Participants n=8 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	GSK3858279 Caucasian n=6 Participants Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.	GSK3858279 Chinese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.	GSK3858279 Japanese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.	Caucasian Placebo n=4 Participants Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.	Chinese Placebo n=3 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.	Japanese Placebo n=4 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAE's) And Withdrawals Due to AE's SAE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAE's) And Withdrawals Due to AE's Withdrawals Due to AE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAE's) And Withdrawals Due to AE's AE	5 Participants	6 Participants	2 Participants	4 Participants	1 Participants	2 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	GSK3858279 Caucasian n=6 Participants Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.	GSK3858279 Chinese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.	GSK3858279 Japanese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.	Caucasian Placebo n=4 Participants Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.	Chinese Placebo n=3 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.	Japanese Placebo n=4 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Change From Baseline in Hematology Parameter of Platelet Count	2.8 Giga cells per liter (10^9/L) Standard Deviation 25.90	18.0 Giga cells per liter (10^9/L) Standard Deviation 18.81	-4.2 Giga cells per liter (10^9/L) Standard Deviation 12.27	7.0 Giga cells per liter (10^9/L) Standard Deviation 15.59	16.0 Giga cells per liter (10^9/L) Standard Deviation 39.60	-12.3 Giga cells per liter (10^9/L) Standard Deviation 6.51

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	GSK3858279 Caucasian n=6 Participants Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.	GSK3858279 Chinese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.	GSK3858279 Japanese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.	Caucasian Placebo n=4 Participants Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.	Chinese Placebo n=3 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.	Japanese Placebo n=4 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Change From Baseline in Hematology Parameter of Hemoglobin	-7.5 Gram Per Liter (g/L) Standard Deviation 13.79	-6.0 Gram Per Liter (g/L) Standard Deviation 10.42	-2.0 Gram Per Liter (g/L) Standard Deviation 10.79	-5.3 Gram Per Liter (g/L) Standard Deviation 7.37	-10.5 Gram Per Liter (g/L) Standard Deviation 16.26	-3.0 Gram Per Liter (g/L) Standard Deviation 3.61

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	GSK3858279 Caucasian n=6 Participants Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.	GSK3858279 Chinese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.	GSK3858279 Japanese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.	Caucasian Placebo n=4 Participants Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.	Chinese Placebo n=3 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.	Japanese Placebo n=4 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Change From Baseline in Hematology Parameter of Hematocrit	-0.027 Liter/liter (L/L) Standard Deviation 0.0367	-0.010 Liter/liter (L/L) Standard Deviation 0.0408	-0.005 Liter/liter (L/L) Standard Deviation 0.0259	-0.027 Liter/liter (L/L) Standard Deviation 0.0321	-0.035 Liter/liter (L/L) Standard Deviation 0.0495	-0.013 Liter/liter (L/L) Standard Deviation 0.0208

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	GSK3858279 Caucasian n=6 Participants Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.	GSK3858279 Chinese n=2 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.	GSK3858279 Japanese n=5 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.	Caucasian Placebo n=3 Participants Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.	Chinese Placebo n=2 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.	Japanese Placebo n=3 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
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 0.020	0.00 Giga cells per liter (10^9/L) Standard Deviation 0.000	0.00 Giga cells per liter (10^9/L) Standard Deviation 0.000	0.00 Giga cells per liter (10^9/L) Standard Deviation 0.00	-0.03 Giga cells per liter (10^9/L) Standard Deviation 0.035	0.00 Giga cells per liter (10^9/L) Standard Deviation 0.000
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	-0.03 Giga cells per liter (10^9/L) Standard Deviation 0.035	0.02 Giga cells per liter (10^9/L) Standard Deviation 0.135	-0.07 Giga cells per liter (10^9/L) Standard Deviation 0.115	0.03 Giga cells per liter (10^9/L) Standard Deviation 0.035	0.68 Giga cells per liter (10^9/L) Standard Deviation 1.098
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	0.10 Giga cells per liter (10^9/L) Standard Deviation 0.141	0.04 Giga cells per liter (10^9/L) Standard Deviation 0.261	0.03 Giga cells per liter (10^9/L) Standard Deviation 0.306	0.15 Giga cells per liter (10^9/L) Standard Deviation 0.212	-0.20 Giga cells per liter (10^9/L) Standard Deviation 0.361
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	0.05 Giga cells per liter (10^9/L) Standard Deviation 0.071	0.10 Giga cells per liter (10^9/L) Standard Deviation 0.122	-0.10 Giga cells per liter (10^9/L) Standard Deviation 0.265	0.05 Giga cells per liter (10^9/L) Standard Deviation 0.071	0.10 Giga cells per liter (10^9/L) Standard Deviation 0.100
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	-0.25 Giga cells per liter (10^9/L) Standard Deviation 0.212	0.54 Giga cells per liter (10^9/L) Standard Deviation 1.001	-0.97 Giga cells per liter (10^9/L) Standard Deviation 1.079	1.15 Giga cells per liter (10^9/L) Standard Deviation 1.061	0.07 Giga cells per liter (10^9/L) Standard Deviation 0.462

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	GSK3858279 Caucasian n=6 Participants Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.	GSK3858279 Chinese n=4 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.	GSK3858279 Japanese n=6 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.	Caucasian Placebo n=3 Participants Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.	Chinese Placebo n=2 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.	Japanese Placebo n=3 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
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	1.3 Units per liter (U/L) Standard Deviation 6.34	-6.5 Units per liter (U/L) Standard Deviation 14.18	0.0 Units per liter (U/L) Standard Deviation 7.94	-3.0 Units per liter (U/L) Standard Deviation 8.49	-4.3 Units per liter (U/L) Standard Deviation 11.06
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 9.70	9.3 Units per liter (U/L) Standard Deviation 17.25	4.0 Units per liter (U/L) Standard Deviation 4.15	17.3 Units per liter (U/L) Standard Deviation 5.13	-3.0 Units per liter (U/L) Standard Deviation 5.66	-2.0 Units per liter (U/L) Standard Deviation 11.79
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	12.0 Units per liter (U/L) Standard Deviation 19.37	0.8 Units per liter (U/L) Standard Deviation 6.74	11.0 Units per liter (U/L) Standard Deviation 3.61	1.0 Units per liter (U/L) Standard Deviation 4.24	-1.3 Units per liter (U/L) Standard Deviation 3.06

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	GSK3858279 Caucasian n=6 Participants Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.	GSK3858279 Chinese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.	GSK3858279 Japanese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.	Caucasian Placebo n=4 Participants Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.	Chinese Placebo n=3 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.	Japanese Placebo n=4 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Change From Baseline in Clinical Chemistry Parameter of Total Protein	2.2 Gram Per Liter (g/L) Standard Deviation 1.94	2.5 Gram Per Liter (g/L) Standard Deviation 2.89	0.8 Gram Per Liter (g/L) Standard Deviation 4.45	0.3 Gram Per Liter (g/L) Standard Deviation 2.52	-0.5 Gram Per Liter (g/L) Standard Deviation 4.95	3.3 Gram Per Liter (g/L) Standard Deviation 1.53

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	GSK3858279 Caucasian n=6 Participants Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.	GSK3858279 Chinese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.	GSK3858279 Japanese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.	Caucasian Placebo n=4 Participants Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.	Chinese Placebo n=3 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.	Japanese Placebo n=4 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin	-5.3 micromole per liter (umol/L) Standard Deviation 3.88	-0.3 micromole per liter (umol/L) Standard Deviation 4.79	-1.5 micromole per liter (umol/L) Standard Deviation 3.73	-4.7 micromole per liter (umol/L) Standard Deviation 1.53	0.5 micromole per liter (umol/L) Standard Deviation 2.12	1.3 micromole per liter (umol/L) Standard Deviation 6.03

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	GSK3858279 Caucasian n=6 Participants Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.	GSK3858279 Chinese n=4 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.	GSK3858279 Japanese n=6 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.	Caucasian Placebo n=3 Participants Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.	Chinese Placebo n=2 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.	Japanese Placebo n=3 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Change From Baseline in Clinical Chemistry Parameter of Direct Bilirubin, Creatinine Direct Bilirubin,	-1.8 micromole per liter (umol/L) Standard Deviation 1.47	0.0 micromole per liter (umol/L) Standard Deviation 2.16	-0.3 micromole per liter (umol/L) Standard Deviation 0.82	-1.7 micromole per liter (umol/L) Standard Deviation 0.58	0.0 micromole per liter (umol/L) Standard Deviation 1.41	1.3 micromole per liter (umol/L) Standard Deviation 3.51
Change From Baseline in Clinical Chemistry Parameter of Direct Bilirubin, Creatinine Creatinine	1.8 micromole per liter (umol/L) Standard Deviation 8.86	-1.8 micromole per liter (umol/L) Standard Deviation 8.85	3.0 micromole per liter (umol/L) Standard Deviation 4.94	5.7 micromole per liter (umol/L) Standard Deviation 10.69	14.5 micromole per liter (umol/L) Standard Deviation 7.78	0.0 micromole per liter (umol/L) Standard Deviation 3.61

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	GSK3858279 Caucasian n=6 Participants Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.	GSK3858279 Chinese n=4 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.	GSK3858279 Japanese n=6 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.	Caucasian Placebo n=3 Participants Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.	Chinese Placebo n=2 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.	Japanese Placebo n=3 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Change From Baseline in Clinical Chemistry Parameter of Urea, Glucose, Potassium, Sodium Glucose	0.25 millimoles per liter (mmol/L) Standard Deviation 0.575	0.03 millimoles per liter (mmol/L) Standard Deviation 0.171	0.18 millimoles per liter (mmol/L) Standard Deviation 0.549	0.23 millimoles per liter (mmol/L) Standard Deviation 0.651	1.10 millimoles per liter (mmol/L) Standard Deviation 1.980	0.27 millimoles per liter (mmol/L) Standard Deviation 0.208
Change From Baseline in Clinical Chemistry Parameter of Urea, Glucose, Potassium, Sodium Potassium	0.00 millimoles per liter (mmol/L) Standard Deviation 0.400	-0.08 millimoles per liter (mmol/L) Standard Deviation 0.189	-0.15 millimoles per liter (mmol/L) Standard Deviation 0.302	0.33 millimoles per liter (mmol/L) Standard Deviation 0.115	-0.45 millimoles per liter (mmol/L) Standard Deviation 0.212	0.03 millimoles per liter (mmol/L) Standard Deviation 0.058
Change From Baseline in Clinical Chemistry Parameter of Urea, Glucose, Potassium, Sodium Sodium	1.8 millimoles per liter (mmol/L) Standard Deviation 0.98	-1.8 millimoles per liter (mmol/L) Standard Deviation 3.40	0.5 millimoles per liter (mmol/L) Standard Deviation 3.02	0.7 millimoles per liter (mmol/L) Standard Deviation 1.53	0.0 millimoles per liter (mmol/L) Standard Deviation 1.41	1.0 millimoles per liter (mmol/L) Standard Deviation 0.00
Change From Baseline in Clinical Chemistry Parameter of Urea, Glucose, Potassium, Sodium Urea	1.43 millimoles per liter (mmol/L) Standard Deviation 0.907	0.38 millimoles per liter (mmol/L) Standard Deviation 1.715	0.87 millimoles per liter (mmol/L) Standard Deviation 1.718	1.03 millimoles per liter (mmol/L) Standard Deviation 0.862	1.45 millimoles per liter (mmol/L) Standard Deviation 0.495	1.13 millimoles per liter (mmol/L) Standard Deviation 0.723

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	GSK3858279 Caucasian n=6 Participants Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.	GSK3858279 Chinese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.	GSK3858279 Japanese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.	Caucasian Placebo n=4 Participants Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.	Chinese Placebo n=3 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.	Japanese Placebo n=4 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
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	0 Participants	1 Participants	0 Participants	1 Participants	2 Participants
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	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density) Any Increase	6 Participants	7 Participants	7 Participants	4 Participants	3 Participants	4 Participants
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	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
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	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
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	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
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	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants
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	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
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	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
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	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
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	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
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	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
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	3 Participants	0 Participants	0 Participants	1 Participants	0 Participants
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	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
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	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants
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	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	GSK3858279 Caucasian n=6 Participants Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.	GSK3858279 Chinese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.	GSK3858279 Japanese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.	Caucasian Placebo n=4 Participants Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.	Chinese Placebo n=3 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.	Japanese Placebo n=4 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH) Any Increase	5 Participants	6 Participants	4 Participants	2 Participants	2 Participants	3 Participants
Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH) Increase to 6.5	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH) Increase to 7.0	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH) Increase to 7.5	1 Participants	2 Participants	2 Participants	0 Participants	2 Participants	2 Participants
Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH) Increase to 8.0	1 Participants	2 Participants	2 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH) Increase to 8.5	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	GSK3858279 Caucasian n=6 Participants Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.	GSK3858279 Chinese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.	GSK3858279 Japanese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.	Caucasian Placebo n=4 Participants Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.	Chinese Placebo n=3 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.	Japanese Placebo n=4 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Urobilinogen, Increase to TRACE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Bilirubin, Any Increase	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Bilirubin, Increase to TRACE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Bilirubin, Increase to 1+	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Bilirubin, Increase to 2+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Bilirubin, Increase to 3+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Bilirubin, Increase to 4+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Glucose, Any Increase	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Glucose, Increase to TRACE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Glucose, Increase to 1+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Glucose, Increase to 2+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Glucose, Increase to 3+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Glucose, Increase to 4+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Ketones, Any Increase	3 Participants	5 Participants	4 Participants	2 Participants	3 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Ketones, Increase to TRACE	3 Participants	5 Participants	3 Participants	2 Participants	3 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Ketones, Increase to 1+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Ketones, Increase to 2+	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Ketones, Increase to 3+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Ketones, Increase to 4+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Leukocyte Esterase, Any Increase	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Leukocyte Esterase, Increase to TRACE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Leukocyte Esterase, Increase to 1+	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Leukocyte Esterase, Increase to 2+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Leukocyte Esterase, Increase to 3+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Leukocyte Esterase, Increase to 4+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Nitrite, Any Increase	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Nitrite, Increase to POSITIVE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Occult Blood, Any Increase	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Occult Blood, Increase to TRACE	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Occult Blood, Increase to 1+	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Occult Blood, Increase to 2+	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Occult Blood, Increase to 3+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Occult Blood, Increase to 4+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Protein, Any Increase	2 Participants	2 Participants	2 Participants	1 Participants	0 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Protein, Increase to TRACE	2 Participants	1 Participants	2 Participants	1 Participants	0 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Protein, Increase to 1+	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Protein, Increase to 2+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Protein, Increase to 3+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Protein, Increase to 4+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Urobilinogen, Any Increase	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Urobilinogen, Increase to 1+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Urobilinogen, Increase to 2+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Urobilinogen, Increase to 3+	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Results by Dipstick Method Urobilinogen, Increase to 4+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	GSK3858279 Caucasian n=6 Participants Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.	GSK3858279 Chinese n=4 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.	GSK3858279 Japanese n=6 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.	Caucasian Placebo n=3 Participants Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.	Chinese Placebo n=2 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.	Japanese Placebo n=3 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
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 13.00	0.8 Millimetre of Mercury (mmHg) Standard Deviation 7.37	0.8 Millimetre of Mercury (mmHg) Standard Deviation 6.18	-1.0 Millimetre of Mercury (mmHg) Standard Deviation 7.21	5.0 Millimetre of Mercury (mmHg) Standard Deviation 5.66	0.0 Millimetre of Mercury (mmHg) Standard Deviation 5.00
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	4.0 Millimetre of Mercury (mmHg) Standard Deviation 2.00	3.5 Millimetre of Mercury (mmHg) Standard Deviation 8.24	1.3 Millimetre of Mercury (mmHg) Standard Deviation 4.73	8.5 Millimetre of Mercury (mmHg) Standard Deviation 12.02	-1.0 Millimetre of Mercury (mmHg) Standard Deviation 3.61

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	GSK3858279 Caucasian n=6 Participants Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.	GSK3858279 Chinese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.	GSK3858279 Japanese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.	Caucasian Placebo n=4 Participants Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.	Chinese Placebo n=3 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.	Japanese Placebo n=4 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Change From Baseline in Vital Signs: Pulse Rate	6.5 Beats per minute (bpm) Standard Deviation 11.74	16.0 Beats per minute (bpm) Standard Deviation 18.17	6.8 Beats per minute (bpm) Standard Deviation 11.58	6.7 Beats per minute (bpm) Standard Deviation 6.03	10.0 Beats per minute (bpm) Standard Deviation 1.41	4.3 Beats per minute (bpm) Standard Deviation 9.02

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	GSK3858279 Caucasian n=6 Participants Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.	GSK3858279 Chinese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.	GSK3858279 Japanese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.	Caucasian Placebo n=4 Participants Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.	Chinese Placebo n=3 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.	Japanese Placebo n=4 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Change From Baseline in Vital Signs: Body Temperature	0.07 Degree Celsius Standard Deviation 0.468	-0.03 Degree Celsius Standard Deviation 0.330	0.48 Degree Celsius Standard Deviation 0.436	-0.10 Degree Celsius Standard Deviation 0.500	0.00 Degree Celsius Standard Deviation 0.141	-0.03 Degree Celsius Standard Deviation 0.115

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	GSK3858279 Caucasian n=6 Participants Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.	GSK3858279 Chinese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.	GSK3858279 Japanese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.	Caucasian Placebo n=4 Participants Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.	Chinese Placebo n=3 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.	Japanese Placebo n=4 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Change From Baseline in Vital Signs: Respiratory Rate	-0.5 Breaths per minute Standard Deviation 1.76	-0.8 Breaths per minute Standard Deviation 0.96	-1.0 Breaths per minute Standard Deviation 1.67	-2.0 Breaths per minute Standard Deviation 2.00	-0.5 Breaths per minute Standard Deviation 2.12	-0.7 Breaths per minute Standard Deviation 2.31

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	GSK3858279 Caucasian n=6 Participants Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.	GSK3858279 Chinese n=4 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.	GSK3858279 Japanese n=6 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.	Caucasian Placebo n=3 Participants Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.	Chinese Placebo n=2 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.	Japanese Placebo n=3 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
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	-4.000 milliseconds (msec) Standard Deviation 7.4486	-7.889 milliseconds (msec) Standard Deviation 21.1152	-15.778 milliseconds (msec) Standard Deviation 7.5817	-8.167 milliseconds (msec) Standard Deviation 4.4783	6.111 milliseconds (msec) Standard Deviation 12.6242
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	-2.083 milliseconds (msec) Standard Deviation 4.7561	-0.444 milliseconds (msec) Standard Deviation 8.8410	1.667 milliseconds (msec) Standard Deviation 6.2272	3.167 milliseconds (msec) Standard Deviation 3.5355	-3.667 milliseconds (msec) Standard Deviation 4.5092
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	-7.083 milliseconds (msec) Standard Deviation 15.8052	-18.056 milliseconds (msec) Standard Deviation 33.7859	-15.222 milliseconds (msec) Standard Deviation 16.4057	-21.333 milliseconds (msec) Standard Deviation 26.8701	-7.111 milliseconds (msec) Standard Deviation 14.6148
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	5.917 milliseconds (msec) Standard Deviation 8.7575	7.333 milliseconds (msec) Standard Deviation 8.8292	13.667 milliseconds (msec) Standard Deviation 9.5975	21.500 milliseconds (msec) Standard Deviation 17.2063	-2.444 milliseconds (msec) Standard Deviation 7.1518
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	1.583 milliseconds (msec) Standard Deviation 4.9319	-2.611 milliseconds (msec) Standard Deviation 15.3122	3.778 milliseconds (msec) Standard Deviation 11.4956	6.667 milliseconds (msec) Standard Deviation 20.2704	-4.111 milliseconds (msec) Standard Deviation 9.7144

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	GSK3858279 Caucasian n=6 Participants Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.	GSK3858279 Chinese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.	GSK3858279 Japanese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.	Caucasian Placebo Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.	Chinese Placebo Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.	Japanese Placebo Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
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	86412.2 day* nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 28.2	77742.0 day* nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 22.5	—	—	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	GSK3858279 Caucasian n=6 Participants Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.	GSK3858279 Chinese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.	GSK3858279 Japanese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.	Caucasian Placebo Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.	Chinese Placebo Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.	Japanese Placebo Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
AUC From Time Zero to the Last Measurable Concentration (0-t) Post-Dose of GSK3858279	88679.6 day*nanograms per milliliter (day*ng/mL) Geometric Coefficient of Variation 17.6	87201.8 day*nanograms per milliliter (day*ng/mL) Geometric Coefficient of Variation 29.1	77009.4 day*nanograms per milliliter (day*ng/mL) Geometric Coefficient of Variation 21.0	—	—	—

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Measure	GSK3858279 Caucasian n=6 Participants Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.	GSK3858279 Chinese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.	GSK3858279 Japanese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.	Caucasian Placebo Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.	Chinese Placebo Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.	Japanese Placebo Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Time of Occurrence of Last Quantifiable Concentration (Tlast) of GSK3858279	56.115 day Interval 41.83 to 84.92	56.062 day Interval 54.93 to 84.06	55.964 day Interval 14.01 to 58.01	—	—	—

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Measure	GSK3858279 Caucasian n=6 Participants Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.	GSK3858279 Chinese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.	GSK3858279 Japanese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.	Caucasian Placebo Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.	Chinese Placebo Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.	Japanese Placebo Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Maximum Observed Concentration (Cmax) of GSK3858279	9135.3 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 42.0	6851.4 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 41.4	8295.4 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 39.8	—	—	—

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Measure	GSK3858279 Caucasian n=6 Participants Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.	GSK3858279 Chinese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.	GSK3858279 Japanese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.	Caucasian Placebo Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.	Chinese Placebo Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.	Japanese Placebo Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Time of Occurrence of Cmax (Tmax) of GSK3858279	2.004 day Interval 1.5 to 7.03	3.919 day Interval 1.5 to 7.18	3.217 day Interval 1.0 to 4.15	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	GSK3858279 Caucasian n=6 Participants Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.	GSK3858279 Chinese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.	GSK3858279 Japanese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.	Caucasian Placebo n=4 Participants Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.	Chinese Placebo n=3 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.	Japanese Placebo n=4 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Percentage Change From Baseline in Free CCL17 Day 15, Percent change	60.524 Percent change (%) Interval 46.235 to 73.216	50.249 Percent change (%) Interval 34.215 to 66.232	59.183 Percent change (%) Interval 44.561 to 72.343	7.528 Percent change (%) Interval 0.067 to 90.873	0.528 Percent change (%) Free CCL17 values below the Lower limit of quantification (LLQ) are imputed to be (1/2) \*LLQ = 0.1. If more than 30% of values have been imputed at any timepoint for a treatment group, then CI has not been calculated due to the high proportion of non-quantifiable (NQ) values that have been imputed which may affect the CI values.	0.787 Percent change (%) Free CCL17 values below the Lower limit of quantification (LLQ) are imputed to be (1/2) \*LLQ = 0.1. If more than 30% of values have been imputed at any timepoint for a treatment group, then CI has not been calculated due to the high proportion of non-quantifiable (NQ) values that have been imputed which may affect the CI values.
Percentage Change From Baseline in Free CCL17 Day 29, Percent change	0.529 Percent change (%) Free CCL17 values below the Lower limit of quantification (LLQ) are imputed to be (1/2) \*LLQ = 0.1. If more than 30% of values have been imputed at any timepoint for a treatment group, then CI has not been calculated due to the high proportion of non-quantifiable (NQ) values that have been imputed which may affect the CI values.	0.165 Percent change (%) Free CCL17 values below the Lower limit of quantification (LLQ) are imputed to be (1/2) \*LLQ = 0.1. If more than 30% of values have been imputed at any timepoint for a treatment group, then CI has not been calculated due to the high proportion of non-quantifiable (NQ) values that have been imputed which may affect the CI values.	0.606 Percent change (%) Free CCL17 values below the Lower limit of quantification (LLQ) are imputed to be (1/2) \*LLQ = 0.1. If more than 30% of values have been imputed at any timepoint for a treatment group, then CI has not been calculated due to the high proportion of non-quantifiable (NQ) values that have been imputed which may affect the CI values.	3.665 Percent change (%) Free CCL17 values below the Lower limit of quantification (LLQ) are imputed to be (1/2) \*LLQ = 0.1. If more than 30% of values have been imputed at any timepoint for a treatment group, then CI has not been calculated due to the high proportion of non-quantifiable (NQ) values that have been imputed which may affect the CI values.	0.316 Percent change (%) Free CCL17 values below the Lower limit of quantification (LLQ) are imputed to be (1/2) \*LLQ = 0.1. If more than 30% of values have been imputed at any timepoint for a treatment group, then CI has not been calculated due to the high proportion of non-quantifiable (NQ) values that have been imputed which may affect the CI values.	0.558 Percent change (%) Free CCL17 values below the Lower limit of quantification (LLQ) are imputed to be (1/2) \*LLQ = 0.1. If more than 30% of values have been imputed at any timepoint for a treatment group, then CI has not been calculated due to the high proportion of non-quantifiable (NQ) values that have been imputed which may affect the CI values.
Percentage Change From Baseline in Free CCL17 Day 8, Percent change	89.715 Percent change (%) Interval 87.619 to 91.49	85.825 Percent change (%) Interval 81.308 to 89.393	88.461 Percent change (%) Interval 83.293 to 92.181	22.353 Percent change (%) Interval 7.695 to 49.851	0.452 Percent change (%) Free CCL17 values below the Lower limit of quantification (LLQ) are imputed to be (1/2) \*LLQ = 0.1. If more than 30% of values have been imputed at any timepoint for a treatment group, then CI has not been calculated due to the high proportion of non-quantifiable (NQ) values that have been imputed which may affect the CI values.	0.863 Percent change (%) Free CCL17 values below the Lower limit of quantification (LLQ) are imputed to be (1/2) \*LLQ = 0.1. If more than 30% of values have been imputed at any timepoint for a treatment group, then CI has not been calculated due to the high proportion of non-quantifiable (NQ) values that have been imputed which may affect the CI values.
Percentage Change From Baseline in Free CCL17 Day 57, Percent change	1.380 Percent change (%) Free CCL17 values below the Lower limit of quantification (LLQ) are imputed to be (1/2) \*LLQ = 0.1. If more than 30% of values have been imputed at any timepoint for a treatment group, then CI has not been calculated due to the high proportion of non-quantifiable (NQ) values that have been imputed which may affect the CI values.	0.100 Percent change (%) Free CCL17 values below the Lower limit of quantification (LLQ) are imputed to be (1/2) \*LLQ = 0.1. If more than 30% of values have been imputed at any timepoint for a treatment group, then CI has not been calculated due to the high proportion of non-quantifiable (NQ) values that have been imputed which may affect the CI values.	0.527 Percent change (%) Free CCL17 values below the Lower limit of quantification (LLQ) are imputed to be (1/2) \*LLQ = 0.1. If more than 30% of values have been imputed at any timepoint for a treatment group, then CI has not been calculated due to the high proportion of non-quantifiable (NQ) values that have been imputed which may affect the CI values.	14.136 Percent change (%) Interval 1.811 to 59.507	1.416 Percent change (%) Free CCL17 values below the Lower limit of quantification (LLQ) are imputed to be (1/2) \*LLQ = 0.1. If more than 30% of values have been imputed at any timepoint for a treatment group, then CI has not been calculated due to the high proportion of non-quantifiable (NQ) values that have been imputed which may affect the CI values.	2.875 Percent change (%) Interval 0.069 to 55.775

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	GSK3858279 Caucasian n=6 Participants Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.	GSK3858279 Chinese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.	GSK3858279 Japanese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.	Caucasian Placebo n=4 Participants Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.	Chinese Placebo n=3 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.	Japanese Placebo n=4 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Cmax of Total CCL17 in Serum Following GSK3858279	68969.794 Picogram per milliliter (pg/mL) Geometric Coefficient of Variation 30.025	62648.760 Picogram per milliliter (pg/mL) Geometric Coefficient of Variation 29.529	55177.740 Picogram per milliliter (pg/mL) Geometric Coefficient of Variation 20.370	1661.847 Picogram per milliliter (pg/mL) Geometric Coefficient of Variation 31.284	733.904 Picogram per milliliter (pg/mL) Geometric Coefficient of Variation 4.084	621.421 Picogram per milliliter (pg/mL) Geometric Coefficient of Variation 61.396

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	GSK3858279 Caucasian n=6 Participants Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.	GSK3858279 Chinese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.	GSK3858279 Japanese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.	Caucasian Placebo n=4 Participants Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.	Chinese Placebo n=3 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.	Japanese Placebo n=4 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Tmax of Total CCL17 in Serum Following GSK3858279	9.333 day Standard Deviation 5.7155	14.000 day Standard Deviation 4.0415	8.571 day Standard Deviation 3.8668	57.000 day Standard Deviation 75.7276	1.083 day Standard Deviation 0.7217	26.313 day Standard Deviation 38.8659

SECONDARY outcome

Timeframe: Baseline (Day 1) and Days 56 Post dose

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

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

Outcome measures

Measure	GSK3858279 Caucasian n=6 Participants Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.	GSK3858279 Chinese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.	GSK3858279 Japanese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.	Caucasian Placebo n=4 Participants Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.	Chinese Placebo n=3 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.	Japanese Placebo n=4 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Maximum Fold Change in Total CCL17 in Serum Following GSK3858279 Administration	77.479 Fold Change Geometric Coefficient of Variation 4.674	113.436 Fold Change Geometric Coefficient of Variation 34.212	73.474 Fold Change Geometric Coefficient of Variation 58.664	1.155 Fold Change Geometric Coefficient of Variation 14.377	1.270 Fold Change Geometric Coefficient of Variation 3.027	1.383 Fold Change Geometric Coefficient of Variation 29.136

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	GSK3858279 Caucasian n=6 Participants Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.	GSK3858279 Chinese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.	GSK3858279 Japanese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.	Caucasian Placebo n=4 Participants Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.	Chinese Placebo n=3 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.	Japanese Placebo n=4 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Fold Increase in Total CCL17 in Serum Following GSK3858279 Administration Day 29	26.405 Fold Change Interval 22.124 to 31.515	61.250 Fold Change Interval 46.002 to 81.552	21.448 Fold Change Interval 9.707 to 47.388	0.971 Fold Change Interval 0.495 to 1.904	0.960 Fold Change Interval 0.881 to 1.046	1.145 Fold Change Interval 0.858 to 1.528
Fold Increase in Total CCL17 in Serum Following GSK3858279 Administration Day 57	7.049 Fold Change Interval 4.323 to 11.495	16.002 Fold Change Interval 11.436 to 22.391	5.056 Fold Change Interval 2.583 to 9.894	0.942 Fold Change Interval 0.682 to 1.301	0.867 Fold Change Interval 0.745 to 1.009	1.082 Fold Change Interval 0.798 to 1.468
Fold Increase in Total CCL17 in Serum Following GSK3858279 Administration Day 8	76.489 Fold Change Interval 70.87 to 82.552	93.537 Fold Change Interval 76.813 to 113.903	70.025 Fold Change Interval 42.278 to 115.981	0.866 Fold Change Interval 0.689 to 1.089	0.975 Fold Change Interval 0.75 to 1.268	1.025 Fold Change Interval 0.73 to 1.439
Fold Increase in Total CCL17 in Serum Following GSK3858279 Administration Day 15	61.874 Fold Change Interval 51.206 to 74.765	110.634 Fold Change Interval 81.785 to 149.659	56.857 Fold Change Interval 27.424 to 117.878	0.977 Fold Change Interval 0.678 to 1.409	1.000 Fold Change Interval 0.798 to 1.254	1.072 Fold Change Interval 0.819 to 1.403

SECONDARY outcome

Timeframe: Day 169

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

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.

Outcome measures

Measure	GSK3858279 Caucasian n=6 Participants Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.	GSK3858279 Chinese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.	GSK3858279 Japanese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.	Caucasian Placebo n=4 Participants Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.	Chinese Placebo n=3 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.	Japanese Placebo n=4 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Number of Participants With Pre-existing Anti-drug Antibodies (ADA's)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 169

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

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.

Outcome measures

Measure	GSK3858279 Caucasian n=6 Participants Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.	GSK3858279 Chinese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.	GSK3858279 Japanese n=7 Participants Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.	Caucasian Placebo n=4 Participants Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.	Chinese Placebo n=3 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.	Japanese Placebo n=4 Participants Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Number of Participants With Treatment-Emergent ADA's Over Time	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

GSK3858279 Caucasian

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

GSK3858279 Chinese

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

GSK3858279 Japanese

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Caucasian Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Chinese Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Japanese Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	GSK3858279 Caucasian n=6 participants at risk Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.	GSK3858279 Chinese n=7 participants at risk Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.	GSK3858279 Japanese n=7 participants at risk Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.	Caucasian Placebo n=4 participants at risk Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.	Chinese Placebo n=3 participants at risk Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.	Japanese Placebo n=4 participants at risk Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/6 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/7 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/7 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	25.0% 1/4 • Number of events 1 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/3 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/4 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study
Eye disorders Conjunctival hyperaemia	0.00% 0/6 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/7 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/7 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/4 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/3 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	25.0% 1/4 • Number of events 1 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study
Gastrointestinal disorders Dental caries	0.00% 0/6 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	14.3% 1/7 • Number of events 1 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/7 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/4 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/3 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/4 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study
Gastrointestinal disorders Diarrhoea	0.00% 0/6 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/7 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/7 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	25.0% 1/4 • Number of events 1 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/3 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/4 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study
General disorders Injection site bruising	16.7% 1/6 • Number of events 1 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/7 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/7 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/4 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/3 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/4 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study
General disorders Injection site pain	0.00% 0/6 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/7 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/7 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/4 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/3 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	25.0% 1/4 • Number of events 1 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study
Infections and infestations COVID-19	50.0% 3/6 • Number of events 3 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/7 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/7 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/4 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/3 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/4 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study
Infections and infestations Gastroenteritis	16.7% 1/6 • Number of events 1 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/7 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/7 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/4 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/3 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/4 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study
Infections and infestations Skin candida	0.00% 0/6 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/7 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/7 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	25.0% 1/4 • Number of events 1 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/3 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/4 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study
Infections and infestations Upper respiratory tract infection	0.00% 0/6 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	14.3% 1/7 • Number of events 1 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/7 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	50.0% 2/4 • Number of events 2 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/3 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/4 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study
Infections and infestations Viral upper respiratory tract infection	0.00% 0/6 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/7 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	14.3% 1/7 • Number of events 1 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/4 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/3 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/4 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study
Injury, poisoning and procedural complications Eyelid injury	16.7% 1/6 • Number of events 1 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/7 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/7 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/4 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/3 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/4 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study
Injury, poisoning and procedural complications Limb injury	0.00% 0/6 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/7 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/7 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/4 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/3 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	25.0% 1/4 • Number of events 1 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study
Investigations Alanine aminotransferase increased	0.00% 0/6 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/7 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	14.3% 1/7 • Number of events 1 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/4 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/3 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/4 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study
Investigations Aspartate aminotransferase increased	0.00% 0/6 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/7 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	14.3% 1/7 • Number of events 1 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/4 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/3 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/4 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/6 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	14.3% 1/7 • Number of events 1 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/7 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/4 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/3 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/4 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/6 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/7 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/7 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	25.0% 1/4 • Number of events 1 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/3 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/4 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study
Musculoskeletal and connective tissue disorders Tendonitis	16.7% 1/6 • Number of events 1 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/7 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/7 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/4 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/3 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/4 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study
Nervous system disorders Dizziness	16.7% 1/6 • Number of events 1 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	14.3% 1/7 • Number of events 1 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/7 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/4 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/3 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/4 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study
Nervous system disorders Sedation	0.00% 0/6 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	14.3% 1/7 • Number of events 1 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/7 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/4 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/3 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/4 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study
Psychiatric disorders Insomnia	0.00% 0/6 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	14.3% 1/7 • Number of events 1 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/7 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/4 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/3 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/4 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study
Renal and urinary disorders Nephrolithiasis	0.00% 0/6 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	14.3% 1/7 • Number of events 1 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/7 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/4 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/3 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/4 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/6 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/7 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/7 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/4 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	33.3% 1/3 • Number of events 1 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study	0.00% 0/4 • All AEs and SAEs were collected from the start of the study intervention up to Day 169. All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: GSKClinicalSupportHD@gsk.com

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER