Trial Outcomes & Findings for A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Ascending Intravenous Single Dose and Repeat Dose of GSK3342830 (NCT NCT02751424)

Last Updated: 2018-09-12

Results Overview

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, Requires hospitalization or prolongation of existing hospitalization, Results in disability/incapacity, Is a congenital anomaly/birth defect, medical judgement and is associated with liver injury or liver impartment. The number of participants with AEs and SAEs assessed in Part 1 (Single dose) of the study were reported.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

62 participants

Primary outcome timeframe

Up to Day 43

Results posted on

2018-09-12

Participant Flow

This is a first-time-in-human (FTIH), randomized, double-blind, placebo-controlled, dose-escalation study to determine the safety, tolerability \& pharmacokinetic (PK) profile of GSK3342830 after administration of single (Part 1) \& repeat (Part 2) IV doses in healthy adult participants (par.) \& single IV dose in healthy adult Japanese par. (Part 3).

A total of 62 par. were enrolled in the study. Part 1 comprised of 48 par. and 14 par. were enrolled in Part 2. No par. were enrolled in Part 3 as the study was terminated early per sponsor discretion.

Participant milestones

Participant milestones
Measure	GSK3342830 250 mg Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 milligram (mg),for 1 hour (hr) as a single intravenous (IV) infusion, on Day 1.	GSK3342830 500 mg Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.	GSK3342830 1000 mg TID Healthy adult participants in this repeat dose escalation cohort were administered GSK3342830 dose, in Part 2 as 1000 mg, as a single IV infusion on Day 1, three times a day (TID) IV infusions (approximately every 8 hrs) on Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14, and a single IV infusion on Day 15.	Placebo, Part 2 Healthy adult participants in this repeat dose escalation cohort were administered with matching placebo to GSK3342830 1000 mg TID, Single IV infusion on Day 1, TID IV infusions (approximately every 8 hrs) on Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14, and a single IV infusion on Day 15.
Part 1 STARTED	6	6	6	6	6	6	12	0	0
Part 1 COMPLETED	6	6	6	6	6	6	12	0	0
Part 1 NOT COMPLETED	0	0	0	0	0	0	0	0	0
Part 2 STARTED	0	0	0	0	0	0	0	11	3
Part 2 COMPLETED	0	0	0	0	0	0	0	6	3
Part 2 NOT COMPLETED	0	0	0	0	0	0	0	5	0

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK3342830 250 mg Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 milligram (mg),for 1 hour (hr) as a single intravenous (IV) infusion, on Day 1.	GSK3342830 500 mg Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.	GSK3342830 1000 mg TID Healthy adult participants in this repeat dose escalation cohort were administered GSK3342830 dose, in Part 2 as 1000 mg, as a single IV infusion on Day 1, three times a day (TID) IV infusions (approximately every 8 hrs) on Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14, and a single IV infusion on Day 15.	Placebo, Part 2 Healthy adult participants in this repeat dose escalation cohort were administered with matching placebo to GSK3342830 1000 mg TID, Single IV infusion on Day 1, TID IV infusions (approximately every 8 hrs) on Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14, and a single IV infusion on Day 15.
Part 2 Adverse Event	0	0	0	0	0	0	0	5	0

Baseline Characteristics

A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Ascending Intravenous Single Dose and Repeat Dose of GSK3342830

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK3342830 250 mg n=6 Participants Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.	GSK3342830 500 mg n=6 Participants Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 n=12 Participants Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.	GSK3342830 1000 mg TID n=11 Participants Healthy adult participants in this repeat dose escalation cohort were administered GSK3342830 dose, in Part 2 as 1000 mg, as a single IV infusion on Day 1, TID IV infusions (approximately every 8 hrs) on Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14, and a single IV infusion on Day 15.	Placebo, Part 2 n=3 Participants Healthy adult participants in this repeat dose escalation cohort were administered with matching placebo to GSK3342830 1000 mg TID, Single IV infusion on Day 1, TID IV infusions (approximately every 8 hrs) on Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14, and a single IV infusion on Day 15.	Total n=62 Participants Total of all reporting groups
Age, Continuous	23.2 Years STANDARD_DEVIATION 3.54 • n=5 Participants	22.8 Years STANDARD_DEVIATION 2.64 • n=7 Participants	32.2 Years STANDARD_DEVIATION 10.57 • n=5 Participants	25.5 Years STANDARD_DEVIATION 3.78 • n=4 Participants	30.2 Years STANDARD_DEVIATION 7.70 • n=21 Participants	21.0 Years STANDARD_DEVIATION 1.10 • n=10 Participants	28.3 Years STANDARD_DEVIATION 5.68 • n=115 Participants	27.1 Years STANDARD_DEVIATION 3.99 • n=6 Participants	22.3 Years STANDARD_DEVIATION 1.53 • n=6 Participants	26.4 Years STANDARD_DEVIATION 6.08 • n=64 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	6 Participants n=10 Participants	12 Participants n=115 Participants	11 Participants n=6 Participants	3 Participants n=6 Participants	62 Participants n=64 Participants
Race/Ethnicity, Customized White	6 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	4 Participants n=21 Participants	6 Participants n=10 Participants	10 Participants n=115 Participants	10 Participants n=6 Participants	2 Participants n=6 Participants	52 Participants n=64 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	4 Participants n=64 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	1 Participants n=6 Participants	1 Participants n=6 Participants	6 Participants n=64 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants
Race/Ethnicity, Customized Multiple	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants

PRIMARY outcome

Timeframe: Up to Day 43

Population: Safety population comprised of all participants who received at least 1 dose of study drug and had at least one post-dose safety assessment.

Outcome measures

Outcome measures
Measure	GSK3342830 250 mg n=6 Participants Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.	GSK3342830 500 mg n=6 Participants Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 n=12 Participants Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
Part 1: Number of Participants With Adverse Event (AE) and Serious Adverse Event (SAE) Any AE	5 Participants	4 Participants	6 Participants	5 Participants	5 Participants	4 Participants	11 Participants
Part 1: Number of Participants With Adverse Event (AE) and Serious Adverse Event (SAE) Any SAE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to Day 56

Population: Safety population.

Outcome measures

Outcome measures
Measure	GSK3342830 250 mg n=11 Participants Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.	GSK3342830 500 mg n=3 Participants Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
Part 2: Number of Participants With AE and SAE Any AE	11 Participants	3 Participants	—	—	—	—	—
Part 2: Number of Participants With AE and SAE Any SAE	0 Participants	0 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to Day 2

Population: Safety population

Blood samples were collected and processed to measure the number of participants with abnormal platelet counts, red blood cells (RBC) count, white blood cells (WBC) count (absolute), hemoglobin, hematocrit, reticulocytes, total iron, total iron binding capacity (TIBC), ferritin, RBC indices (mean corpuscle volume \[MCV\], mean corpuscle hemoglobin \[MCH\] and mean corpuscle hemoglobin concentration \[MCHC\]) and differential WBC count (neutrophils, lymphocytes, monocytes, eosinophil's, and basophils). Participants with abnormalities of Grade 3 or higher have been reported.

Outcome measures

Outcome measures
Measure	GSK3342830 250 mg n=6 Participants Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.	GSK3342830 500 mg n=6 Participants Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 n=12 Participants Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
Part 1: Number of Participants With Abnormal Hematology Parameters as a Measure of Safety-Grade 3 or Higher	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to Day 15

Population: Safety population.

Blood samples were collected and processed to measure the number of participants with abnormal platelet counts, RBC count, WBC count (absolute), hemoglobin, hematocrit, reticulocytes, total iron, TIBC, ferritin, RBC indices MCV, MCH and MCHC and differential WBC count (neutrophils, lymphocytes, monocytes, eosinophils, and basophils). These were collected on Day 2, 5, 10 and Day 15, during Part 2 of the study. Part 2 is repeat dose escalation. Participants with abnormalities of Grade 3 or higher have been reported.

Outcome measures

Outcome measures
Measure	GSK3342830 250 mg n=11 Participants Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.	GSK3342830 500 mg n=3 Participants Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
Part 2: Number of Participants With Abnormal Hematology Parameters as a Measure of Safety-Grade 3 or Higher	0 Participants	0 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 2

Population: Safety population

Blood samples were collected and processed to measure the number of participants with abnormal blood urea nitrogen (BUN), creatinine, glucose, bicarbonate, sodium, potassium, chloride, calcium, aspartate aminotransferase (AST/SGOT), alanine aminotransferase (ALT/SGPT), alkaline phosphatase (ALP) levels, uric acid, total and direct bilirubin, total protein and albumin. These were collected on Day 1, during Part 1(single dose escalation) of the study. Participants with abnormalities Grade 3 or higher were reported.

Outcome measures

Outcome measures
Measure	GSK3342830 250 mg n=6 Participants Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.	GSK3342830 500 mg n=6 Participants Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 n=12 Participants Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
Part 1: Number of Participants With Abnormal Clinical Chemistry Parameters as a Measure of Safety-Grade 3 or Higher	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to Day 15

Population: Safety population

Blood samples were collected and processed to measure the number of participants with abnormal BUN, creat, glucose, bicarbonate, sodium, potassium, chloride, calcium, AST/SGOT, ALT/SGPT, ALP levels, uric acid, total and direct bilirubin, total protein and albumin. These were collected on Day 2, 5, 10 and Day 15 during Part 2 (repeat dose escalation), of the study. Participants with abnormalities Grade 3 or higher were reported.

Outcome measures

Outcome measures
Measure	GSK3342830 250 mg n=11 Participants Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.	GSK3342830 500 mg n=3 Participants Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
Part 2: Number of Participants With Abnormal Clinical Chemistry Parameters as a Measure of Safety-Grade 3 or Higher Serum Glucose	1 Participants	0 Participants	—	—	—	—	—
Part 2: Number of Participants With Abnormal Clinical Chemistry Parameters as a Measure of Safety-Grade 3 or Higher Serum or Plasma ALT	1 Participants	0 Participants	—	—	—	—	—
Part 2: Number of Participants With Abnormal Clinical Chemistry Parameters as a Measure of Safety-Grade 3 or Higher Serum or Plasma albumin	1 Participants	0 Participants	—	—	—	—	—
Part 2: Number of Participants With Abnormal Clinical Chemistry Parameters as a Measure of Safety-Grade 3 or Higher Serum or Plasma ALP	0 Participants	0 Participants	—	—	—	—	—
Part 2: Number of Participants With Abnormal Clinical Chemistry Parameters as a Measure of Safety-Grade 3 or Higher Serum or Plasma AST	2 Participants	0 Participants	—	—	—	—	—
Part 2: Number of Participants With Abnormal Clinical Chemistry Parameters as a Measure of Safety-Grade 3 or Higher Serum or Plasma Calcium	0 Participants	0 Participants	—	—	—	—	—
Part 2: Number of Participants With Abnormal Clinical Chemistry Parameters as a Measure of Safety-Grade 3 or Higher Serum or Plasma Chloride	0 Participants	0 Participants	—	—	—	—	—
Part 2: Number of Participants With Abnormal Clinical Chemistry Parameters as a Measure of Safety-Grade 3 or Higher Serum or Plasma Creat	0 Participants	0 Participants	—	—	—	—	—
Part 2: Number of Participants With Abnormal Clinical Chemistry Parameters as a Measure of Safety-Grade 3 or Higher Serum or Plasma Direct Bilirubin	2 Participants	0 Participants	—	—	—	—	—
Part 2: Number of Participants With Abnormal Clinical Chemistry Parameters as a Measure of Safety-Grade 3 or Higher Serum or Plasma Potassium	1 Participants	0 Participants	—	—	—	—	—
Part 2: Number of Participants With Abnormal Clinical Chemistry Parameters as a Measure of Safety-Grade 3 or Higher Serum or Plasma Protein	0 Participants	0 Participants	—	—	—	—	—
Part 2: Number of Participants With Abnormal Clinical Chemistry Parameters as a Measure of Safety-Grade 3 or Higher Serum or Plasma Sodium	1 Participants	0 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to Day 2

Population: Safety population.

An aliquot of the urine samples from first morning void urine samples was collected to analyze specific gravity, pH, glucose, protein, blood and ketone bodies by dipstick method, microscopic examination (if blood or protein is abnormal), albumin to creatinine ration (ACR), neutrophil gelatinase associated lipocalin (NGAL) and kidney injury molecule-1 (KIM-1). Urine samples were analyzed after the end of the study to verify if a clinical signal is detected. Urine samples were collected on Day 1 of Part 1 (Single-dose escalation) of the study.

Outcome measures

Outcome measures
Measure	GSK3342830 250 mg n=6 Participants Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.	GSK3342830 500 mg n=6 Participants Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 n=12 Participants Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
Part 1: Number of Participants Having Abnormal Urine Parameters (Using Dipstick Test) as a Measure of Safety	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 2, 5, 10 and Day 15

Population: Safety population

An aliquot of the urine samples from first morning void urine samples was collected to analyze specific gravity, pH, glucose, protein, blood and ketone bodies by dipstick method, microscopic examination (if blood or protein is abnormal), ACR, NGAL and KIM-1. These urine samples were analyzed after the end of the study to verify if a clinical signal is detected. The samples were collected on Day 2, 5, 10, and Day 15 of Part 2 (Repeat dose escalation) of the study.

Outcome measures

Outcome measures
Measure	GSK3342830 250 mg n=11 Participants Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.	GSK3342830 500 mg n=3 Participants Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
Part 2: Number of Participants Having Abnormal Urine Parameters (Using Dipstick Test) as a Measure of Safety	0 Participants	0 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to Day 3

Population: Safety population

Triplicate 12-lead ECGs were obtained at least 5 minutes apart within 1 hr before dosing. Single ECGs were obtained at all other time points on Day 1 at 0.5 hr, 1 hr, 1.5 hr, 2, 3, 4, 6, 12 and 24 hr, Day 2 (36 hr) and Day 3 (48 hr) during Part 1 (single dose escalation phase) of the study. All the 12-lead ECGs were measured using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals.

Outcome measures

Outcome measures
Measure	GSK3342830 250 mg n=6 Participants Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.	GSK3342830 500 mg n=6 Participants Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 n=12 Participants Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
Part 1: Number of Participants With Electrocardiogram (ECG) Parameters of Potential Clinical Importance (PCI) Heart Rate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Electrocardiogram (ECG) Parameters of Potential Clinical Importance (PCI) PR Interval	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Electrocardiogram (ECG) Parameters of Potential Clinical Importance (PCI) QRS Duration	0 Participants	0 Participants	1 Participants	3 Participants	1 Participants	1 Participants	2 Participants
Part 1: Number of Participants With Electrocardiogram (ECG) Parameters of Potential Clinical Importance (PCI) QT Interval	1 Participants	2 Participants	1 Participants	0 Participants	0 Participants	1 Participants	2 Participants
Part 1: Number of Participants With Electrocardiogram (ECG) Parameters of Potential Clinical Importance (PCI) QTc (Bazett)	1 Participants	1 Participants	1 Participants	1 Participants	2 Participants	2 Participants	3 Participants
Part 1: Number of Participants With Electrocardiogram (ECG) Parameters of Potential Clinical Importance (PCI) QTc (Fridericia)	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Part 1: Number of Participants With Electrocardiogram (ECG) Parameters of Potential Clinical Importance (PCI) RR Interval	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to Day 16

Population: Safety population

Triplicate 12-lead ECGs were obtained at least 5 minutes apart within 1 hr before the start of infusion (pre-dose) on Day 1. Single ECGs were obtained at 0.5, 1, 1.5, 2, 3, 4, 6, and 12 hrs after the start of infusion on Day 1 and Day 15, within 1 hr before the start of the morning infusion on Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14, and in the morning on Day 16. All the 12-lead ECGs were measured using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals.

Outcome measures

Outcome measures
Measure	GSK3342830 250 mg n=11 Participants Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.	GSK3342830 500 mg n=3 Participants Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
Part 2: Number of Participants With ECG Parameters of PCI Heart Rate	0 Participants	0 Participants	—	—	—	—	—
Part 2: Number of Participants With ECG Parameters of PCI PR Interval	1 Participants	0 Participants	—	—	—	—	—
Part 2: Number of Participants With ECG Parameters of PCI QRS Duration	0 Participants	0 Participants	—	—	—	—	—
Part 2: Number of Participants With ECG Parameters of PCI QT Interval	1 Participants	2 Participants	—	—	—	—	—
Part 2: Number of Participants With ECG Parameters of PCI QTc (Bazett)	2 Participants	1 Participants	—	—	—	—	—
Part 2: Number of Participants With ECG Parameters of PCI QTc (Fridericia)	1 Participants	1 Participants	—	—	—	—	—
Part 2: Number of Participants With ECG Parameters of PCI RR Interval	0 Participants	0 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to Day 3

Population: Safety population

The vital sign includes systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate and temperature which were measured in a semi-supine position, where the participant had rested in the same position for at least 5 minutes. The number of participants with vital values, of PCI were reported. These were collected on Day 1 at pre-dose, 0.5 hr, 1 hr, 1.5 hr, 2, 3, 4, 6, 12 and 24 hr, Day 2 (36 hr) and Day 3 (48 hr) during Part 1 (single dose escalation phase) of the study.

Outcome measures

Outcome measures
Measure	GSK3342830 250 mg n=6 Participants Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.	GSK3342830 500 mg n=6 Participants Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 n=12 Participants Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
Part 1: Number of Participants With Vital Signs of Potential Clinical Importance (PCI) Systolic Blood Pressure	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Part 1: Number of Participants With Vital Signs of Potential Clinical Importance (PCI) Diastolic Blood Pressue	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Part 1: Number of Participants With Vital Signs of Potential Clinical Importance (PCI) Pulse rate	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Vital Signs of Potential Clinical Importance (PCI) Temperature	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Vital Signs of Potential Clinical Importance (PCI) Respiratory rate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to Day 16

Population: Safety population

The vitals for systolic, diastolic blood pressure, heart rate, respiratory rate and temperature were taken in a semi-supine position, where the participant had rested in the same position for atleast 5 minutes. The number of participants with vital values, of PCI were reported. These were collected from Day 1 to Day 16. Assessments were done within 1 hr before the start of infusion (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, and 12 hrs after the start of infusion on Days 1 and 15, within 1 hr before the start of the morning infusion and on Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14, and in the morning on Day 16.

Outcome measures

Outcome measures
Measure	GSK3342830 250 mg n=11 Participants Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.	GSK3342830 500 mg n=3 Participants Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
Part 2: Number of Participants With Vital Signs of PCI SBP	0 Participants	0 Participants	—	—	—	—	—
Part 2: Number of Participants With Vital Signs of PCI DBP	0 Participants	1 Participants	—	—	—	—	—
Part 2: Number of Participants With Vital Signs of PCI Pulse rate	1 Participants	0 Participants	—	—	—	—	—
Part 2: Number of Participants With Vital Signs of PCI Temperature	0 Participants	0 Participants	—	—	—	—	—
Part 2: Number of Participants With Vital Signs of PCI Respiratory rate	0 Participants	0 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 (pre-dose, 0.5 hr, 1 hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr, 48 hr post-dose

Population: The Pharmacokinetic (PK) Parameter Population included all participants in the PK population for whom valid and evaluable PK parameters were derived. PK Population is defined as all participants who received at least 1 dose of GSK3342830 and have evaluable PK data for GSK3342830.

AUC (0-t) is defined as AUC from time zero to the last quantifiable concentration after dosing. Blood samples were collected on Day 1 at indicated timepoints (pre-dose, 0.5 hr, 1hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr,3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr 24 hr, 36 hr and 48 hr post-dose. The Part 1 phase of the study comprised of single dosing of participants. Log untransformed values for AUC (0-t) have been presented.

Outcome measures

Outcome measures
Measure	GSK3342830 250 mg n=6 Participants Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.	GSK3342830 500 mg n=6 Participants Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
Part 1-Area Under the Plasma Concentration (AUC) From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Across All Treatments AUC(0-t) for GSK3342830	40.24 hour *microgram per milliliter Standard Deviation 5.9451	93.92 hour *microgram per milliliter Standard Deviation 11.849	171.3 hour *microgram per milliliter Standard Deviation 28.299	344.0 hour *microgram per milliliter Standard Deviation 30.312	672.9 hour *microgram per milliliter Standard Deviation 99.383	1039 hour *microgram per milliliter Standard Deviation 134.97	—

SECONDARY outcome

Timeframe: Day 1 (pre-dose, 0.5 hr, 1 hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr, 48hr post-dose

Population: PK Parameter Population

AUC (0-inf) is defined as AUC extrapolated from time zero to infinity. Blood samples were collected on Day 1 at indicated timepoints pre-dose, 0.5 hr, 1hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr,3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr 24 hr, 36 hr and 48 hr post-dose. This part 1 phase of the study comprised of single dosing of the participants. Log untransformed values for AUC (0-inf) have been presented.

Outcome measures

Outcome measures
Measure	GSK3342830 250 mg n=6 Participants Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.	GSK3342830 500 mg n=6 Participants Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
Part 1-AUC Pre Dose to Infinite (Inf) Time (AUC [0-inf]) of GSK3342830	42.08 hour *microgram per milliliter Standard Deviation 14.6	95.76 hour *microgram per milliliter Standard Deviation 12.5	172.5 hour *microgram per milliliter Standard Deviation 15.9	346.0 hour *microgram per milliliter Standard Deviation 9.2	671.6 hour *microgram per milliliter Standard Deviation 14.5	1038 hour *microgram per milliliter Standard Deviation 12.6	—

SECONDARY outcome

Timeframe: Day 1 (pre-dose, 0.5 hr, 1 hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr, 48 hr post-dose

Population: PK Parameter Population

Cmax was defined as the maximum concentration of drug GSK3342830, in plasma. Blood samples were collected on Day 1 at indicated timepoints pre-dose, 0.5 hr, 1hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr,3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr 24 hr, 36 hr and 48 hr post-dose. This part 1 phase of the study comprised of single dosing of the participants. Log untransformed values for Cmax have been presented.

Outcome measures

Outcome measures
Measure	GSK3342830 250 mg n=6 Participants Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.	GSK3342830 500 mg n=6 Participants Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
Part 1-Maximum Plasma Concentration (Cmax) of GSK3342830	16.37 Microgram per milliliter Standard Deviation 2.9161	35.09 Microgram per milliliter Standard Deviation 5.8409	71.11 Microgram per milliliter Standard Deviation 11.109	117.4 Microgram per milliliter Standard Deviation 41.338	242.4 Microgram per milliliter Standard Deviation 31.907	389.8 Microgram per milliliter Standard Deviation 31.010	—

SECONDARY outcome

Timeframe: Day 1 (pre-dose, 0.5 hr, 1 hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr, 48hr post-dose

Population: PK Parameter Population.

Tmax was defined as time required to achieve Cmax for drug GSK3342830, in plasma. Blood samples were collected on Day 1 at indicated timepoints pre-dose, 0.5 hr, 1hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr,3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr 24 hr, 36 hr and 48 hr post-dose. This part 1 phase of the study comprised of single dosing of the participants. Log untransformed values for tmax have been presented.

Outcome measures

Outcome measures
Measure	GSK3342830 250 mg n=6 Participants Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.	GSK3342830 500 mg n=6 Participants Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
Part 1-Time to Maximum Plasma Concentration (Tmax) of GSK3342830	1.042 hour Standard Deviation 0.1021	1.000 hour Standard Deviation 0.0000	1.000 hour Standard Deviation 0.0000	1.167 hour Standard Deviation 0.4082	1.000 hour Standard Deviation 0.0000	1.000 hour Standard Deviation 0.0000	—

SECONDARY outcome

Timeframe: Day 1 (pre-dose, 0.5 hr, 1 hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr, 48 hr post-dose

Population: PK Parameter Population

t ½ is defined as the time required by the drug to reduce to half its quantity. Blood samples were collected on Day 1 at indicated timepoints pre-dose, 0.5 hr, 1hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr,3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr 24 hr, 36 hr and 48 hr post-dose. This part 1 phase of the study comprised of single dosing of the participants. Log untransformed values for t1/2 have been presented.

Outcome measures

Outcome measures
Measure	GSK3342830 250 mg n=6 Participants Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.	GSK3342830 500 mg n=6 Participants Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
Part 1-Terminal Elimination Half-life (t1/2) of GSK3342830 in Plasma	1.860 hour Standard Deviation 0.19150	2.139 hour Standard Deviation 0.30026	2.295 hour Standard Deviation 0.22578	2.596 hour Standard Deviation 0.34939	2.465 hour Standard Deviation 0.33519	2.461 hour Standard Deviation 0.33327	—

SECONDARY outcome

Timeframe: Day 1 (pre-dose, 0.5 hr, 1 hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr, 48 hr post-dose

Population: PK Parameter Population

The systemic CL is a PK measure of volume of plasma from which the drug is removed per unit time. Blood samples were collected on Day 1 at indicated timepoints pre-dose, 0.5 hr, 1hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr,3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr 24 hr, 36 hr and 48 hr post-dose. This part 1 phase of the study comprised of single dosing of the participants. Log untransformed values for CL have been presented.

Outcome measures

Outcome measures
Measure	GSK3342830 250 mg n=6 Participants Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.	GSK3342830 500 mg n=6 Participants Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
Part 1-Total Systemic Clearance (CL) of GSK3342830 in Plasma	5.994 Liter per hour Standard Deviation 0.88869	5.255 Liter per hour Standard Deviation 0.63134	5.857 Liter per hour Standard Deviation 0.90413	5.801 Liter per hour Standard Deviation 0.55138	6.007 Liter per hour Standard Deviation 0.85700	5.819 Liter per hour Standard Deviation 0.70924	—

SECONDARY outcome

Timeframe: Day 1 (pre-dose, 0.5 hr, 1 hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr, 48 hr post-dose

Population: PK Parameter Population

Vss reflects the actual blood and tissue volume into which a drug is distributed and the relative binding of drug to protein in these spaces. Blood samples were collected on Day 1 at indicated timepoints pre-dose, 0.5 hr, 1hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr,3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr 24 hr, 36 hr and 48 hr post-dose. This part 1 phase of the study comprised of single dosing of the participants. Log untransformed values for Vss have been presented.

Outcome measures

Outcome measures
Measure	GSK3342830 250 mg n=6 Participants Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.	GSK3342830 500 mg n=6 Participants Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
Part 1-Steady-state Volume (Vss) of Distribution of GSK3342830 in Plasma	14.65 Liter Standard Deviation 2.6449	13.98 Liter Standard Deviation 2.2987	15.54 Liter Standard Deviation 2.4329	19.87 Liter Standard Deviation 11.115	16.63 Liter Standard Deviation 1.2716	15.61 Liter Standard Deviation 1.3961	—

SECONDARY outcome

Timeframe: Day 1 (pre-dose, 0.5 hr, 1 hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr, 48 hr post-dose

Population: PK parameter population

Urine samples were collected at indicated timepoints pre-dose and post dose. The Feu has been reported from 0 to 4, 4 to 8, 8 to 12, 12 to 24 and 24 to 48 hrs. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data is not available. The standard deviation could not be calculated as only single participant was present. Log untransformed values for Feu (t1-t2) have been presented.

Outcome measures

Outcome measures
Measure	GSK3342830 250 mg n=6 Participants Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.	GSK3342830 500 mg n=6 Participants Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
Part 1-Urinary Excretion Ratio Relative to Dose (Feu [t1-t2]) of GSK3342830 Feu (0-4) (n=6,6,6,6,6,6)	68.66 Percentage of excretion ratio Standard Deviation 10.456	83.01 Percentage of excretion ratio Standard Deviation 49.110	71.85 Percentage of excretion ratio Standard Deviation 23.591	59.29 Percentage of excretion ratio Standard Deviation 21.740	68.39 Percentage of excretion ratio Standard Deviation 5.8313	73.42 Percentage of excretion ratio Standard Deviation 8.3037	—
Part 1-Urinary Excretion Ratio Relative to Dose (Feu [t1-t2]) of GSK3342830 Feu (4-8) (n=6,6,6,6,6,6)	21.38 Percentage of excretion ratio Standard Deviation 6.2577	21.52 Percentage of excretion ratio Standard Deviation 2.7078	18.00 Percentage of excretion ratio Standard Deviation 4.3264	20.44 Percentage of excretion ratio Standard Deviation 1.3961	22.33 Percentage of excretion ratio Standard Deviation 7.1655	19.11 Percentage of excretion ratio Standard Deviation 2.5950	—
Part 1-Urinary Excretion Ratio Relative to Dose (Feu [t1-t2]) of GSK3342830 Feu (8-12) (n=6,6,6,6,6,6)	3.612 Percentage of excretion ratio Standard Deviation 0.48583	4.627 Percentage of excretion ratio Standard Deviation 1.0872	4.794 Percentage of excretion ratio Standard Deviation 0.68561	6.861 Percentage of excretion ratio Standard Deviation 3.7957	5.102 Percentage of excretion ratio Standard Deviation 1.5791	5.336 Percentage of excretion ratio Standard Deviation 1.9488	—
Part 1-Urinary Excretion Ratio Relative to Dose (Feu [t1-t2]) of GSK3342830 Feu (12-24) (n=6,6,6,6,6,6)	2.173 Percentage of excretion ratio Standard Deviation 1.0482	2.557 Percentage of excretion ratio Standard Deviation 0.68228	2.039 Percentage of excretion ratio Standard Deviation 0.82840	3.967 Percentage of excretion ratio Standard Deviation 4.3285	1.972 Percentage of excretion ratio Standard Deviation 1.0979	1.941 Percentage of excretion ratio Standard Deviation 0.91904	—
Part 1-Urinary Excretion Ratio Relative to Dose (Feu [t1-t2]) of GSK3342830 Feu (24-48) (n=1,1,6,6,6,6)	0.2132 Percentage of excretion ratio Standard Deviation NA NA indicates that data is not available. The standard deviation could not be calculated as only single participant was present.	0.2371 Percentage of excretion ratio Standard Deviation NA NA indicates that data is not available. The standard deviation could not be calculated as only single participant was present.	0.2036 Percentage of excretion ratio Standard Deviation 0.038871	0.2245 Percentage of excretion ratio Standard Deviation 0.067861	0.1720 Percentage of excretion ratio Standard Deviation 0.069232	0.1809 Percentage of excretion ratio Standard Deviation 0.057906	—

SECONDARY outcome

Timeframe: Day 1 (pre-dose, 0.5 hr, 1 hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr, 48hr post-dose

Population: PK Parameter Population

The renal clearance (CLr) is a PK measure of volume of drug is removed per unit time. Urine samples were collected at indicated timepoints pre-dose and post dose. This part 1 phase of the study comprised of single dosing of the participants. Log untransformed values for CLr have been presented.

Outcome measures

Outcome measures
Measure	GSK3342830 250 mg n=6 Participants Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.	GSK3342830 500 mg n=6 Participants Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
Part 1-Renal Clearance (CLr) of GSK3342830 in Urine	5.709 Liter per hour Standard Deviation 0.97041	5.696 Liter per hour Standard Deviation 1.9452	5.771 Liter per hour Standard Deviation 2.0146	5.229 Liter per hour Standard Deviation 0.32521	5.867 Liter per hour Standard Deviation 0.70267	5.837 Liter per hour Standard Deviation 0.98448	—

SECONDARY outcome

Timeframe: Day 1 (pre-dose, 0.5 hr, 1 hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr, 48hr post-dose

Population: PK Parameter Population

Ae is defined as amount of drug GSK3342830, excreted in urine. Urine samples were collected pre-dose (within a 24-hr period before dosing, may begin on Day -1) and 0 to 4, 4 to 8, 8 to 12, 12 to 24, and 24 to 48 hrs post-dose. Log untransformed values for Ae have been presented.

Outcome measures

Outcome measures
Measure	GSK3342830 250 mg n=6 Participants Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.	GSK3342830 500 mg n=6 Participants Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg n=6 Participants The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
Part 1-Amount Excreted in Urine (Ae) of GSK3342830 in Urine	239.6 Milligram Standard Deviation 38.250	558.7 Milligram Standard Deviation 260.49	968.9 Milligram Standard Deviation 216.28	1816 Milligram Standard Deviation 189.65	3919 Milligram Standard Deviation 117.58	5999 Milligram Standard Deviation 413.23	—

SECONDARY outcome

Timeframe: Day 1 (pre-dose, 0.5 hr, 1 hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr, 48hr post-dose

Population: PK Parameter Population

Blood samples were collected at Day 1 (pre-dose, 0.5 hr, 1 hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr, 48hr post-dose. Dose proportionality was assessed for AUC(0-inf) and Cmax after single dose administration. AUC(0-inf) was selected as the AUC exposure measure as it is the default AUC parameter for single dose administration and the observed data permitted its calculation.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 (pre-dose, 0.5 hr, 1 hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr, 48hr post-dose

Population: PK Parameter Population

Blood samples were collected at Day 1 (pre-dose, 0.5 hr, 1 hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr, 48 hr post-dose. The data for estimate slope for log dose, has been reported.

Outcome measures

Outcome measures
Measure	GSK3342830 250 mg n=36 Participants Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.	GSK3342830 500 mg Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
Part 1:Dose Proportionality: AUC (0-inf)	0.988 hour*microgram per milliliter Standard Error 0.0198	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 (pre-dose, 0.5 hr, 1 hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr, 48hr post-dose

Population: PK Parameter Population

Blood samples were collected at Day 1 (pre-dose, 0.5 hr, 1 hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr, 48hr post-dose. The data for estimate slope for log dose, has been reported.

Outcome measures

Outcome measures
Measure	GSK3342830 250 mg n=36 Participants Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.	GSK3342830 500 mg Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
Part 1:Dose Proportionality: Cmax	0.968 microgram per milliliter Standard Error 0.0384	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hr post-dose at Day 1. Pre-dose on Day 3, 6, 9, 12, and 13. Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hr post-dose at Day 15

Population: PK Parameter Population

AUC (0-inf), was defined as AUC extrapolated from time zero to infinity Day 1 at pre-dose (15 minutes) and 0.5 hr, 1 hr (end of infusion), 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hrs after start of infusion. Single pre-dose samples on mornings of Days 3, 6, 9, 12, and 13. Serial samples (Day 15) time points: pre-dose (15 minutes) and 0.5 hr, 1 (end of infusion), 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hrs after start of infusion. The untransformed values for AUC(0-inf) have been presented.

Outcome measures

Outcome measures
Measure	GSK3342830 250 mg n=11 Participants Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.	GSK3342830 500 mg Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
Part 2-AUC (0-inf) of GSK3342830	156.5 hour *microgram per milliliter Standard Deviation 24.756	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hr, post-dose at Day 1. Pre-dose on Day 3, 6, 9, 12, and 13. Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hr post-dose at Day 15

Population: PK Parameter Population.

Cmax was defined as the maximum concentration of drug GSK3342830, in plasma. It was collected at Day 1 at pre-dose (15 minutes) and 0.5 hr, 1 hr (end of infusion), 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hrs after start of infusion. Single pre-dose samples on mornings of Days 3, 6, 9, 12, and 13. Serial samples (Day 15) time points: pre-dose (15 minutes) and 0.5 hr, 1 (end of infusion), 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hrs after start of infusion.

Outcome measures

Outcome measures
Measure	GSK3342830 250 mg n=11 Participants Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.	GSK3342830 500 mg Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
Part 2-Cmax of GSK3342830	60.25 microgram per milliliter Standard Deviation 10.875	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 h post-dose at Day 1. Pre-dose on Day 3, 6, 9, 12, and 13. Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 h post-dose at Day 15

Population: PK Parameter Population

Tmax was defined as time required to achieve Cmax for drug GSK3342830, in plasma. It was collected at Day 1 at pre-dose (15 minutes) and 0.5 hr, 1 hr (end of infusion), 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hrs after start of infusion. Single pre-dose samples on mornings of Days 3, 6, 9, 12, and 13. Serial samples (Day 15) time points: pre-dose (15 minutes) and 0.5 hr, 1 (end of infusion), 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hrs after start of infusion.

Outcome measures

Outcome measures
Measure	GSK3342830 250 mg n=11 Participants Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.	GSK3342830 500 mg Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
Part 2-Tmax of GSK3342830	1.023 hour Standard Deviation 0.0754	—	—	—	—	—	—

SECONDARY outcome

Population: PK Parameter Population

t ½ is defined as the time required by the drug to reduce to half its quantity. Blood samples were collected at Day 1 at pre-dose (15 minutes) and 0.5 hr, 1 hr (end of infusion), 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hrs after start of infusion. Single pre-dose samples on mornings of Days 3, 6, 9, 12, and 13. Serial samples (Day 15) time points: pre-dose (15 minutes) and 0.5 hr, 1 (end of infusion), 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hrs after start of infusion.

Outcome measures

Outcome measures
Measure	GSK3342830 250 mg n=11 Participants Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.	GSK3342830 500 mg Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
Part 2-Terminal t1/2 of GSK3342830 in Plasma	2.171 hour Standard Deviation 0.21459	—	—	—	—	—	—

SECONDARY outcome

Population: PK Parameter Population

The systemic CL is a PK measure of volume of plasma from which the drug is removed per unit time. The blood samples of 3 mL were collected at Day 1 at pre-dose (15 minutes) and 0.5 hr, 1 hr (end of infusion), 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hrs after start of infusion. Single pre-dose samples on mornings of Days 3, 6, 9, 12, and 13. Serial samples (Day 15) time points: pre-dose (15 minutes) and 0.5 hr, 1 (end of infusion), 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hrs after start of infusion.

Outcome measures

Outcome measures
Measure	GSK3342830 250 mg n=11 Participants Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.	GSK3342830 500 mg Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
Part 2-Total CL of GSK3342830 in Plasma	6.552 Liter per hour Standard Deviation 1.1567	—	—	—	—	—	—

SECONDARY outcome

Population: PK Parameter Population

Vss reflects the actual blood and tissue volume into which a drug is distributed and the relative binding of drug to protein in these spaces. The blood samples of 3 mL were collected at Day 1 at pre-dose (15 minutes) and 0.5 hr, 1 hr (end of infusion), 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hrs after start of infusion. Single pre-dose samples on mornings of Days 3, 6, 9, 12, and 13. Serial samples (Day 15) time points: pre-dose (15 minutes) and 0.5 hr, 1 (end of infusion), 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hrs after start of infusion.

Outcome measures

Outcome measures
Measure	GSK3342830 250 mg n=11 Participants Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.	GSK3342830 500 mg Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
Part 2- Vss of Distribution of GSK3342830 in Plasma	17.04 Liter Standard Deviation 3.2541	—	—	—	—	—	—

SECONDARY outcome

Population: PK Parameter Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)

The Feu has been reported from 0 to 4, 4 to 8, 8 to 12, 12 to 24 and 24 to 48 hrs. These were collected in opaque bottles at pre-dose (within a 24-hr period before dosing, may begin on Day -1) and 0 to 4, 4 to 8, 8 to 12, 12 to 24, and 24 to 48 hrs post-dose.

Outcome measures

Outcome measures
Measure	GSK3342830 250 mg n=11 Participants Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.	GSK3342830 500 mg Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
Part 2-Urinary Excretion Ratio Relative to Dose Feu (t1-t2) of GSK3342830 Day 1 Feu (0-8), n=11	90.39 Percentage of excretion ratio Standard Deviation 5.9551	—	—	—	—	—	—
Part 2-Urinary Excretion Ratio Relative to Dose Feu (t1-t2) of GSK3342830 Day 1 Feu (8-24), n= 11	4.855 Percentage of excretion ratio Standard Deviation 1.3990	—	—	—	—	—	—
Part 2-Urinary Excretion Ratio Relative to Dose Feu (t1-t2) of GSK3342830 Day 15, Feu (0-8), n=6	89.80 Percentage of excretion ratio Standard Deviation 19.319	—	—	—	—	—	—
Part 2-Urinary Excretion Ratio Relative to Dose Feu (t1-t2) of GSK3342830 Day 15, Feu (8-24), n=6	4.530 Percentage of excretion ratio Standard Deviation 2.9358	—	—	—	—	—	—

SECONDARY outcome

Population: PK Parameter Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected on Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 h post-dose at Day 1. Pre-dose on Day 3, 6, 9, 12, and 13. Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 h post-dose at Day 15. The untransformed values for Ctau have been presented.

Outcome measures

Outcome measures
Measure	GSK3342830 250 mg n=11 Participants Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.	GSK3342830 500 mg Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
Part 2- Trough Concentration (Ctau) Day 1 (n=11)	3.366 microgram per milliliter Standard Deviation 0.82694	—	—	—	—	—	—
Part 2- Trough Concentration (Ctau) Day 15 (n=6)	3.059 microgram per milliliter Standard Deviation 0.55052	—	—	—	—	—	—

SECONDARY outcome

Population: PK Parameter Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

The renal CLr is a PK measure of volume of plasma from which the drug is removed per unit time.These were collected in opaque bottles on Day 1 and Day 15 at (Pre-dose, 0 to 8 and 8 to 24 hrs post-dose). The untransformed values for CLr have been presented.

Outcome measures

Outcome measures
Measure	GSK3342830 250 mg n=11 Participants Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.	GSK3342830 500 mg Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
Part 2-CLr of GSK3342830 in Urine Day 1 (n=11)	6.261 Liter per hour Standard Deviation 1.3406	—	—	—	—	—	—
Part 2-CLr of GSK3342830 in Urine Day 15 (n=6)	6.174 Liter per hour Standard Deviation 1.3504	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 and Day 15 at (Pre-dose, 0 to 8 and 8 to 24 hrs post-dose)

Population: PK Parameter Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Ae defines as the amount of drug GSK3342830, excreted in urine. These were collected in opaque bottles on Day 1 and Day 15 at (Pre-dose, 0 to 8 and 8 to 24 hrs post-dose). The untransformed values for Ae have been presented.

Outcome measures

Outcome measures
Measure	GSK3342830 250 mg n=11 Participants Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.	GSK3342830 500 mg Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
Part 2- Ae of GSK3342830 in Urine Day 1 (n=11)	952.4 milligram Standard Deviation 61.274	—	—	—	—	—	—
Part 2- Ae of GSK3342830 in Urine Day 15 (n=6)	964.9 milligram Standard Deviation 223.30	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 (pre-dose, 0.5 hr, 1 hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr, 48hr post-dose

Population: PK Parameter Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

It was defined as Area Under the Concentration-time Curve From Time Zero (Pre-dose) to the time of the last measureable concentration. Blood samples were collected on Day 1 at indicated timepoints pre-dose, 0.5 hr, 1hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr,3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr 24 hr, 36 hr and 48 hr post-dose. Log untransformed values for AUC (0 to tau) have been presented.

Outcome measures

Outcome measures
Measure	GSK3342830 250 mg n=11 Participants Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.	GSK3342830 500 mg Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
Part 2: AUC From Time Zero to Last Measurable Concentration AUC (0- Tau) Day 1 (n=11)	145.6 hour*microgram per milliliter Standard Deviation 23.344	—	—	—	—	—	—
Part 2: AUC From Time Zero to Last Measurable Concentration AUC (0- Tau) Day 15 (n=6)	156.1 hour*microgram per milliliter Standard Deviation 14.612	—	—	—	—	—	—

SECONDARY outcome

Population: PK Parameter Population

Blood samples were collected at Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hr post-dose at Day 1. Pre-dose on Day 3, 6, 9, 12, and 13. Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hr post-dose at Day 15. Data cannot be summarized because only 1 dose level studied so dose proportionality analysis cannot be performed as no comparison can be conducted.

Outcome measures

Outcome data not reported

SECONDARY outcome

Population: PK Parameter Population.

The accumulation ratio has been reported. Sampling was done at Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 h post-dose at Day 1. Pre-dose on Day 3, 6, 9, 12, and 13. Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 h post-dose at Day 15. Data cannot be summarized because only 1 dose level studied so dose proportionality analysis cannot be performed as no comparison can be conducted.

Outcome measures

Outcome measures
Measure	GSK3342830 250 mg n=6 Participants Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.	GSK3342830 500 mg Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
Part 2: Observed Accumulation Ratio (Ro) Based on AUC and Cmax of GSK3342830 After Administration of Repeat IV Doses, as Data Permit	1.117 Ratio Standard Deviation 0.16167	—	—	—	—	—	—

SECONDARY outcome

Population: PK Parameter Population

Sampling was done at Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 h post-dose at Day 1. Pre-dose on Day 3, 6, 9, 12, and 13. Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 h post-dose at Day 15. Since the study was terminated early, data is only available for one dose level for Part 2. Some subjects have only partial data and were not dosed on Day 15.

Outcome measures

Outcome measures
Measure	GSK3342830 250 mg n=6 Participants Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.	GSK3342830 500 mg Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
Part 2: Steady-state Ratio (Rss) of GSK3342830 to Assess Time Invariance, as Data Permit	1.033 Ratio Standard Deviation 0.14336	—	—	—	—	—	—

SECONDARY outcome

Population: PK Parameter Population

Sampling was done at Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 h post-dose at Day 1. Pre-dose on Day 3, 6, 9, 12, and 13. Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 h post-dose at Day 15. The untransformed values for Ctau have been presented.

Outcome measures

Outcome measures
Measure	GSK3342830 250 mg n=11 Participants Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.	GSK3342830 500 mg Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
Part 2: Trough Plasma Concentrations at the End of the Dosing Interval (Ctau) to Assess the Achievement of Steady-state of GSK3342830 After Administration of Repeat IV Doses, as Data Permit Day 1 (n=11)	3.366 microgram per milliliter Standard Deviation 0.82694	—	—	—	—	—	—
Part 2: Trough Plasma Concentrations at the End of the Dosing Interval (Ctau) to Assess the Achievement of Steady-state of GSK3342830 After Administration of Repeat IV Doses, as Data Permit Day 15 (n=6)	3.059 microgram per milliliter Standard Deviation 0.55052	—	—	—	—	—	—

Adverse Events

GSK3342830 250 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

GSK3342830 500 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

GSK3342830 1000 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

GSK3342830 2000 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

GSK3342830 4000 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

GSK3342830 6000 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo, Part 1

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

GSK3342830 1000 mg TID

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo, Part 2

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	GSK3342830 250 mg n=6 participants at risk Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg,for 1 hr, as a single IV infusion, on Day 1.	GSK3342830 500 mg n=6 participants at risk Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 1000 mg n=6 participants at risk The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 2000 mg n=6 participants at risk The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 4000 mg n=6 participants at risk The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.	GSK3342830 6000 mg n=6 participants at risk The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.	Placebo, Part 1 n=12 participants at risk Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.	GSK3342830 1000 mg TID n=11 participants at risk Healthy adult participants in this repeat dose escalation cohort were administered GSK3342830 dose, in Part 2 as 1000 mg, as a single IV infusion on Day 1, TID, IV infusions (approximately every 8 hrs) on Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14, and a single IV infusion on Day 15.	Placebo, Part 2 n=3 participants at risk Healthy adult participants in this repeat dose escalation cohort were administered with matching placebo to GSK3342830 1000 mg TID, Single IV infusion on Day 1, TID IV infusions (approximately every 8 hrs) on Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14, and a single IV infusion on Day 15.
General disorders Infusion site extravasation	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	33.3% 1/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
General disorders Catheter site pain	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	16.7% 1/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	33.3% 2/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	33.3% 2/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	50.0% 3/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	16.7% 2/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	63.6% 7/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	66.7% 2/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
General disorders Application site dermatitis	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	50.0% 3/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	8.3% 1/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
General disorders Application site reaction	33.3% 2/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	16.7% 1/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
Nervous system disorders Headache	33.3% 2/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	16.7% 1/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	16.7% 1/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	33.3% 2/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	16.7% 1/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	50.0% 6/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	63.6% 7/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
Gastrointestinal disorders Diarrhoea	16.7% 1/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	16.7% 1/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	16.7% 1/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	18.2% 2/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	33.3% 1/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
Respiratory, thoracic and mediastinal disorders Cough	16.7% 1/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	16.7% 1/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	16.7% 1/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	18.2% 2/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	33.3% 1/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
Renal and urinary disorders Urine odour abnormal	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	50.0% 3/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	9.1% 1/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
Skin and subcutaneous tissue disorders Blister	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	8.3% 1/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	8.3% 1/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	8.3% 1/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
Skin and subcutaneous tissue disorders Dyshidrotic eczema	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	16.7% 1/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
Infections and infestations Pharyngitis	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	16.7% 1/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	33.3% 1/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
Infections and infestations Upper respiratory tract infection	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	16.7% 1/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	8.3% 1/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
Musculoskeletal and connective tissue disorders Pain in extremity	16.7% 1/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	9.1% 1/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	8.3% 1/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	8.3% 1/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	8.3% 1/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	27.3% 3/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
General disorders Catheter site erythema	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	27.3% 3/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	33.3% 1/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
General disorders Fatigue	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	27.3% 3/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
General disorders Pyrexia	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	27.3% 3/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
General disorders Catheter site bruise	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	66.7% 2/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
General disorders Catheter site related reaction	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	9.1% 1/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	33.3% 1/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
General disorders Catheter site inflammation	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	9.1% 1/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
General disorders Chills	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	9.1% 1/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
General disorders Extravasation	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	9.1% 1/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
General disorders Feeling hot	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	9.1% 1/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
General disorders Peripheral swelling	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	9.1% 1/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
Nervous system disorders Dizziness	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	33.3% 1/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
Gastrointestinal disorders Nausea	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	9.1% 1/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	33.3% 1/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	9.1% 1/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	9.1% 1/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	9.1% 1/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
Gastrointestinal disorders Flatulence	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	9.1% 1/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	27.3% 3/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	9.1% 1/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	9.1% 1/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	33.3% 1/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	18.2% 2/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
Respiratory, thoracic and mediastinal disorders Nasal obstruction	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	9.1% 1/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
Injury, poisoning and procedural complications Scratch	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	9.1% 1/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	33.3% 1/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	9.1% 1/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	33.3% 1/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
Injury, poisoning and procedural complications Contusion	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	9.1% 1/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
Infections and infestations Metapneumovirus infection	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	9.1% 1/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	33.3% 1/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
Infections and infestations Rhinitis	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	9.1% 1/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
Infections and infestations Viral infection	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	9.1% 1/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	9.1% 1/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	33.3% 1/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	9.1% 1/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
Cardiac disorders Tachycardia	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	33.3% 1/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
Ear and labyrinth disorders Vertigo	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	33.3% 1/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
Hepatobiliary disorders Hepatitis	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	9.1% 1/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
Vascular disorders Phlebitis	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	9.1% 1/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/6 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/12 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	9.1% 1/11 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.	0.00% 0/3 • SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56 Safety population was used and on-treatment AEs and SAEs were reported.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

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