Trial Outcomes & Findings for Lipopolysaccharide (LPS) or Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Challenge Study on Healthy Subjects (NCT NCT03306589)

Last Updated: 2019-08-08

Results Overview

Blood samples were planned to be collected at indicated time-points for analysis of white blood cells. Baseline value is Session 2 Day 1. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

12 participants

Primary outcome timeframe

Baseline, Session 2: 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes, 9 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3

Results posted on

2019-08-08

Participant Flow

This study aimed to assess 2 models of systemic inflammatory response: exposure of healthy participants to systemic challenge with either Lipopolysaccharide (LPS) or Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF).

Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.

Participant milestones

Participant milestones
Measure	Part 1: LPS 0.5 ng/kg Participants were randomized to receive 0.5 nanogram/kilogram (ng/kg) LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: LPS 0.75 ng/kg Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: LPS 1 ng/kg Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: GM-CSF 60 µg/m^2 Participants were randomized to receive 60 microgram per meter square (µg/m\^2) GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection
Part 1 (69 Days) STARTED	2	4	2	4
Part 1 (69 Days) COMPLETED	2	4	2	4
Part 1 (69 Days) NOT COMPLETED	0	0	0	0
Part 2 (69 Days) STARTED	0	0	0	0
Part 2 (69 Days) COMPLETED	0	0	0	0
Part 2 (69 Days) NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lipopolysaccharide (LPS) or Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Challenge Study on Healthy Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: LPS 0.5 ng/kg n=2 Participants Participants were randomized to receive 0.5 nanogram/kilogram (ng/kg) LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: LPS 0.75 ng/kg n=4 Participants Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: LPS 1 ng/kg n=2 Participants Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: GM-CSF 60 µg/m^2 n=4 Participants Participants were randomized to receive 60 microgram per meter square (µg/m\^2) GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection	Part 2: Participants With LPS Participants were planned to be dosed with LPS (0.5 with possible escalation up to 4 ng/kg) during Part 2 of the study.	Part 2: Participants With GM-CSF Participants were planned to be dosed with GM-CSF (60 to a maximum of 480 µg/m\^2) during Part 2 of the study.	Total n=12 Participants Total of all reporting groups
Age, Continuous	23.5 Years STANDARD_DEVIATION 4.95 • n=5 Participants	35.5 Years STANDARD_DEVIATION 7.55 • n=7 Participants	31.5 Years STANDARD_DEVIATION 10.61 • n=5 Participants	33.5 Years STANDARD_DEVIATION 7.33 • n=4 Participants	—	—	32.2 Years STANDARD_DEVIATION 7.81 • n=115 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=115 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	—	—	12 Participants n=115 Participants
Race/Ethnicity, Customized White: WHITE/CAUCASIAN/EUROPEAN HERITAGE	2 Count of Participants n=5 Participants	4 Count of Participants n=7 Participants	2 Count of Participants n=5 Participants	4 Count of Participants n=4 Participants	—	—	12 Count of Participants n=115 Participants

PRIMARY outcome

Timeframe: Baseline, Session 2: -5, 10, 25, 40 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 2 hours 40 minutes,5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected at indicated timepoints for the analysis of primary soluble inflammatory mediators like TNF-alpha and IL-6 in blood. Latest pre-challenge LPS assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Each session was for three days. NA indicates that data was not available as standard deviation could not be calculated for a single participant. All participants who were randomized to receive the treatment (LPS or GM-CSF challenge) and received one dose of challenge agent were included in Safety Population.

Outcome measures

PRIMARY outcome

Timeframe: Baseline, Session 2 Day 1

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

The post-challenge urine samples were collected during session 2 after LPS challenge. In session 2, participants were encouraged to pass urine immediately before LPS challenge dose and urine voids were collected from after LPS until 12 hours post-LPS and the time of the urine collection were recorded as post-challenge 1 to 11. These samples were collected for measurement of tetranor-PGDM. Latest pre-challenge LPS assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. The data for normalized Tetranor PGDM was normalized by (Tetranor PGDM \[pg/mL\] divided by Creatinine \[milligram per deciliter\]) multiplied by 100. NA indicates that data was not available as standard deviation could not be calculated for a single participant.

Outcome measures

Outcome measures
Measure	Part 1: LPS 0.5 ng/kg n=2 Participants Participants were randomized to receive 0.5 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: LPS 0.75 ng/kg n=4 Participants Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: LPS 1 ng/kg n=2 Participants Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: GM-CSF 60 µg/m^2 Participants were randomized to receive 60 µg/m\^2 GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection
Part 1: Change From Baseline in Primary Soluble Inflammatory Mediators : Urinary Tetranor Prostaglandin D Metabolite (PGDM) LPS Arm Session2, Day1,Post challenge1, n=2, 4, 2	73.846 Picograms per milligram Standard Deviation 116.0073	-85.080 Picograms per milligram Standard Deviation 226.4168	134.806 Picograms per milligram Standard Deviation 166.6716	—
Part 1: Change From Baseline in Primary Soluble Inflammatory Mediators : Urinary Tetranor Prostaglandin D Metabolite (PGDM) LPS Arm Session2, Day1,Post challenge 2, n=2, 4, 2	99.438 Picograms per milligram Standard Deviation 112.5337	88.984 Picograms per milligram Standard Deviation 155.1855	276.788 Picograms per milligram Standard Deviation 134.7190	—
Part 1: Change From Baseline in Primary Soluble Inflammatory Mediators : Urinary Tetranor Prostaglandin D Metabolite (PGDM) LPS Arm Session2, Day1,Post challenge 3, n=2, 4, 2	32.006 Picograms per milligram Standard Deviation 88.2367	25.390 Picograms per milligram Standard Deviation 181.8009	200.337 Picograms per milligram Standard Deviation 183.9484	—
Part 1: Change From Baseline in Primary Soluble Inflammatory Mediators : Urinary Tetranor Prostaglandin D Metabolite (PGDM) LPS Arm Session2, Day1,Post challenge 4, n=2, 4, 2	-119.091 Picograms per milligram Standard Deviation 304.0503	-68.209 Picograms per milligram Standard Deviation 262.6169	140.482 Picograms per milligram Standard Deviation 108.7880	—
Part 1: Change From Baseline in Primary Soluble Inflammatory Mediators : Urinary Tetranor Prostaglandin D Metabolite (PGDM) LPS Arm Session2, Day1,Post challenge 5, n=1, 4, 2	112.355 Picograms per milligram Standard Deviation NA NA indicates that data was not available as standard deviation could not be calculated for a single participant.	-146.294 Picograms per milligram Standard Deviation 165.8587	184.263 Picograms per milligram Standard Deviation 262.9020	—
Part 1: Change From Baseline in Primary Soluble Inflammatory Mediators : Urinary Tetranor Prostaglandin D Metabolite (PGDM) LPS Arm Session2, Day1,Post challenge 6, n=0, 4, 1	—	-202.918 Picograms per milligram Standard Deviation 197.6455	-125.839 Picograms per milligram Standard Deviation NA NA indicates that data was not available as standard deviation could not be calculated for a single participant.	—
Part 1: Change From Baseline in Primary Soluble Inflammatory Mediators : Urinary Tetranor Prostaglandin D Metabolite (PGDM) LPS Arm Session2, Day1,Post challenge 7, n=0, 4, 1	—	-227.544 Picograms per milligram Standard Deviation 226.2006	6.336 Picograms per milligram Standard Deviation NA NA indicates that data was not available as standard deviation could not be calculated for a single participant.	—
Part 1: Change From Baseline in Primary Soluble Inflammatory Mediators : Urinary Tetranor Prostaglandin D Metabolite (PGDM) LPS Arm Session2, Day1,Post challenge 8, n=0, 3, 1	—	-144.855 Picograms per milligram Standard Deviation 53.7768	-117.672 Picograms per milligram Standard Deviation NA NA indicates that data was not available as standard deviation could not be calculated for a single participant.	—
Part 1: Change From Baseline in Primary Soluble Inflammatory Mediators : Urinary Tetranor Prostaglandin D Metabolite (PGDM) LPS Arm Session2, Day1,Post challenge 9, n=0, 2, 1	—	-147.066 Picograms per milligram Standard Deviation 39.8858	-30.861 Picograms per milligram Standard Deviation NA NA indicates that data was not available as standard deviation could not be calculated for a single participant.	—
Part 1: Change From Baseline in Primary Soluble Inflammatory Mediators : Urinary Tetranor Prostaglandin D Metabolite (PGDM) LPS Arm Session2, Day1,Post challenge 10, n=0, 1, 1	—	-172.982 Picograms per milligram Standard Deviation NA NA indicates that data was not available as standard deviation could not be calculated for a single participant.	-37.732 Picograms per milligram Standard Deviation NA NA indicates that data was not available as standard deviation could not be calculated for a single participant.	—
Part 1: Change From Baseline in Primary Soluble Inflammatory Mediators : Urinary Tetranor Prostaglandin D Metabolite (PGDM) LPS Arm Session2, Day1,Post challenge 11, n=0, 1, 1	—	-199.316 Picograms per milligram Standard Deviation NA NA indicates that data was not available as standard deviation could not be calculated for a single participant.	-78.792 Picograms per milligram Standard Deviation NA NA indicates that data was not available as standard deviation could not be calculated for a single participant.	—

PRIMARY outcome

Timeframe: Baseline, Session 2: -5, 10, 25, 40 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3

Population: Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.

Blood samples were planned to be collected at indicated timepoints for the analysis of primary soluble inflammatory mediators like TNF-alpha and IL-6 in blood. Latest pre-challenge LPS assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, Session 2 Day 1

Population: Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.

Urine samples were planned to be collected for analysis. Latest pre-challenge LPS assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, Session 2: 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes, 9 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3

Population: Safety Population.

Blood samples were collected at indicated time-points for analysis of white blood cells. Latest pre-challenge GM-CSF assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.

Outcome measures

Outcome measures
Measure	Part 1: LPS 0.5 ng/kg n=4 Participants Participants were randomized to receive 0.5 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: LPS 0.75 ng/kg Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: LPS 1 ng/kg Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: GM-CSF 60 µg/m^2 Participants were randomized to receive 60 µg/m\^2 GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection
Part 1: Change From Baseline in White Blood Cell Numbers in Blood: GM-CSF Session2, Day 1, 40 minutes	0.3754 Giga cells per liter Standard Deviation 2.78811	—	—	—
Part 1: Change From Baseline in White Blood Cell Numbers in Blood: GM-CSF Session2, Day 1, 2 hours 40 minutes	6.7609 Giga cells per liter Standard Deviation 2.94642	—	—	—
Part 1: Change From Baseline in White Blood Cell Numbers in Blood: GM-CSF Session2, Day 1, 5 hours 40 minutes	5.8083 Giga cells per liter Standard Deviation 1.11242	—	—	—
Part 1: Change From Baseline in White Blood Cell Numbers in Blood: GM-CSF Session2, Day 1, 9 hours 40 minutes	3.4558 Giga cells per liter Standard Deviation 0.82059	—	—	—
Part 1: Change From Baseline in White Blood Cell Numbers in Blood: GM-CSF Session2, Day 2, Pre-fluid sample	0.4224 Giga cells per liter Standard Deviation 1.01622	—	—	—
Part 1: Change From Baseline in White Blood Cell Numbers in Blood: GM-CSF Session2, Day 3, Pre-fluid sample	-0.0136 Giga cells per liter Standard Deviation 2.05134	—	—	—

PRIMARY outcome

Timeframe: Baseline, Session 2: 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes, 9 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3

Population: Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline; Session1: 48 hours on Day3; Session 2: 24 hours on Day 2 and 48 hours on Day 3

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blister samples were collected at indicated time-points for the analysis of soluble inflammatory mediators like IL-1 beta (b), Interferon-gamma (INFg), IL-6, IL-2, IL-8, Monocyte chemotactic protein-1 (MCP-1) and TNF-alpha. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.

Outcome measures

SECONDARY outcome

Timeframe: Baseline; Session1: 48 hours Day3; Session 2: 24 hours Day 2 and 48 hours Day 3

Population: Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.

Blister samples were planned to be collected at indicated time-points for the analysis of soluble inflammatory mediators like IL-1 beta, INFg, IL-6, IL-2, IL-8, MCP-1 and TNF-alpha. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Session 1: 48 hours Day 3. Session 2: 24 hours Day 2, 48 hours Day 3

Population: Safety Population.

Blister samples were collected at indicated time-points for analysis of blister volumes. . Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline.

Outcome measures

Outcome measures
Measure	Part 1: LPS 0.5 ng/kg n=2 Participants Participants were randomized to receive 0.5 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: LPS 0.75 ng/kg n=4 Participants Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: LPS 1 ng/kg n=2 Participants Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: GM-CSF 60 µg/m^2 n=4 Participants Participants were randomized to receive 60 µg/m\^2 GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection
Part 1: Absolute Values of Blister Volume Baseline	361.325 Microliter Standard Deviation 145.9115	156.638 Microliter Standard Deviation 112.1876	185.550 Microliter Standard Deviation 22.4860	230.425 Microliter Standard Deviation 146.2442
Part 1: Absolute Values of Blister Volume Session 1, Day 3, 48 hours	372.125 Microliter Standard Deviation 105.8892	188.625 Microliter Standard Deviation 128.1457	232.175 Microliter Standard Deviation 15.0967	216.775 Microliter Standard Deviation 141.8914
Part 1: Absolute Values of Blister Volume Session 2, Day 2, 24 hours	156.225 Microliter Standard Deviation 49.4621	102.838 Microliter Standard Deviation 64.6195	162.975 Microliter Standard Deviation 26.9054	105.363 Microliter Standard Deviation 60.7083
Part 1: Absolute Values of Blister Volume Session 2, Day 3, 48 hours	274.625 Microliter Standard Deviation 110.4147	164.100 Microliter Standard Deviation 104.8817	190.650 Microliter Standard Deviation 10.6066	108.313 Microliter Standard Deviation 79.5137

SECONDARY outcome

Timeframe: Baseline, Session 1: 48 hours Day 3. Session 2: 24 hours Day 2, 48 hours Day 3

Population: Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.

Blister samples were planned to be collected at indicated time-points for analysis of blister volumes. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Session 1: 48 hours Day 3. Session 2: 24 hours Day 2, 48 hours Day 3

Population: Safety Population. Only those participants with data available at the specified data points were analyzed.

Blister samples were collected at indicated time-points for analysis of white blood cell in blister. Latest pre-challenge LPS assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.

Outcome measures

Outcome measures
Measure	Part 1: LPS 0.5 ng/kg n=2 Participants Participants were randomized to receive 0.5 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: LPS 0.75 ng/kg n=4 Participants Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: LPS 1 ng/kg n=2 Participants Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: GM-CSF 60 µg/m^2 Participants were randomized to receive 60 µg/m\^2 GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection
Part 1: Change From Baseline in Cell Numbers in Blister Session 2, Day 3, 48 hours	586250.0 Cells per milliliter Standard Deviation 786656.29	-1316000.0 Cells per milliliter Standard Deviation 6556133.25	3275000.0 Cells per milliliter Standard Deviation 1216223.66	—
Part 1: Change From Baseline in Cell Numbers in Blister Session 1, Day 3, 48 hours	841250.0 Cells per milliliter Standard Deviation 171473.39	-1405000.0 Cells per milliliter Standard Deviation 6808193.03	667500.0 Cells per milliliter Standard Deviation 1375322.69	—
Part 1: Change From Baseline in Cell Numbers in Blister Session 2, Day 2, 24 hours	-298750.0 Cells per milliliter Standard Deviation 2137230.25	-936062.5 Cells per milliliter Standard Deviation 3258497.75	5447500.0 Cells per milliliter Standard Deviation 7124100.82	—

SECONDARY outcome

Timeframe: Baseline, Session 1: 48 hours Day 3. Session 2: 24 hours Day 2, 48 hours Day 3

Population: Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.

Blood samples were planned to be collected at indicated time-points for analysis of white blood cell in blister. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blister samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for monocytes in blister. Activation markers included Cluster of Differentiation (CD) 16, CD163, CD206, CD209, CD40, CD80, CD83, CD86 and Human Leukocyte Antigen - antigen D Related (HLA-DR). Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.

Outcome measures

SECONDARY outcome

Timeframe: Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3

Population: Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.

Blister samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blister samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for monocytes in blister like CD40+/CD80+. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.

Outcome measures

Outcome measures
Measure	Part 1: LPS 0.5 ng/kg n=2 Participants Participants were randomized to receive 0.5 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: LPS 0.75 ng/kg n=4 Participants Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: LPS 1 ng/kg n=2 Participants Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: GM-CSF 60 µg/m^2 n=4 Participants Participants were randomized to receive 60 µg/m\^2 GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection
Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Monocytes in Blister Session1,Day3, 48 hours, n=2, 4, 2, 4	0.1475 Ratio Standard Deviation 0.22981	0.2764 Ratio Standard Deviation 0.19587	0.0610 Ratio Standard Deviation 0.13294	-0.4060 Ratio Standard Deviation 0.82999
Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Monocytes in Blister Session2,Day2, 24 hours, n=2, 4, 2, 4	0.0925 Ratio Standard Deviation 0.15203	0.5062 Ratio Standard Deviation 0.70807	0.5108 Ratio Standard Deviation 0.67069	-0.0994 Ratio Standard Deviation 1.34749
Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Monocytes in Blister Session2,Day3, 48 hours, n=1, 4, 2, 3	-0.1210 Ratio Standard Deviation NA NA indicates that data was not available as standard deviation could not be calculated for a single participant.	0.3015 Ratio Standard Deviation 0.39252	0.1300 Ratio Standard Deviation 0.03748	-0.2698 Ratio Standard Deviation 1.09270

SECONDARY outcome

Timeframe: Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3

Population: Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline; Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blister samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for dendritic cells in blister. Activation markers included CD16, CD163, CD206, CD209, CD40, CD80, CD83, CD86 and HLA-DR. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.

Outcome measures

SECONDARY outcome

Timeframe: Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3

Population: Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blister samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for dendritic cells in blister like CD40+/CD80+. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.

Outcome measures

Outcome measures
Measure	Part 1: LPS 0.5 ng/kg n=2 Participants Participants were randomized to receive 0.5 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: LPS 0.75 ng/kg n=4 Participants Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: LPS 1 ng/kg n=2 Participants Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: GM-CSF 60 µg/m^2 n=4 Participants Participants were randomized to receive 60 µg/m\^2 GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection
Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Dendritic Cells in Blister Session1,Day3, 48 hours, n=2, 4, 2, 4	42.7675 Ratio Standard Deviation 5.32805	43.2094 Ratio Standard Deviation 6.81783	47.8100 Ratio Standard Deviation 4.17193	39.8453 Ratio Standard Deviation 6.60325
Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Dendritic Cells in Blister Session2,Day2, 24 hours, n=2, 4, 2, 4	2.7250 Ratio Standard Deviation 14.65125	0.0825 Ratio Standard Deviation 18.06488	0.0900 Ratio Standard Deviation 1.52735	6.7523 Ratio Standard Deviation 9.76233
Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Dendritic Cells in Blister Session2,Day3, 48 hours, n=1, 4, 2, 3	27.7000 Ratio Standard Deviation NA NA indicates that data was not available as standard deviation could not be calculated for a single participant.	42.6493 Ratio Standard Deviation 11.60035	42.5100 Ratio Standard Deviation 2.82843	38.4313 Ratio Standard Deviation 6.81975

SECONDARY outcome

Timeframe: Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3

Population: Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blister samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for macrophages in blister. Activation markers included CD16, CD163, CD206, CD209, CD40, CD80, CD83, CD86 and HLA-DR. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.

Outcome measures

SECONDARY outcome

Timeframe: Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3

Population: Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Part 1: LPS 0.5 ng/kg n=2 Participants Participants were randomized to receive 0.5 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: LPS 0.75 ng/kg n=4 Participants Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: LPS 1 ng/kg n=2 Participants Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: GM-CSF 60 µg/m^2 n=4 Participants Participants were randomized to receive 60 µg/m\^2 GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection
Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Macrophages in Blister Session1,Day3, 48 hours, n=2, 4, 2, 4	11.0475 Ratio Standard Deviation 9.89596	-1.2837 Ratio Standard Deviation 17.00275	21.8500 Ratio Standard Deviation 26.44579	-0.8938 Ratio Standard Deviation 20.18664
Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Macrophages in Blister Session2,Day3, 48 hours, n=1, 4, 2, 4	0.3500 Ratio Standard Deviation NA NA indicates that data was not available as standard deviation could not be calculated for a single participant.	-2.9838 Ratio Standard Deviation 10.58741	-8.9750 Ratio Standard Deviation 17.00592	-3.2238 Ratio Standard Deviation 27.65006
Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Macrophages in Blister Session2,Day2, 24 hours, n=2, 4, 2, 4	15.1225 Ratio Standard Deviation 35.88213	1.3537 Ratio Standard Deviation 22.85581	-16.0250 Ratio Standard Deviation 3.35876	9.1137 Ratio Standard Deviation 15.78332

SECONDARY outcome

Timeframe: Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3

Population: Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Session 2: -5, 10, 25, 40 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected at indicated timepoints for the analysis of primary soluble inflammatory mediators like IL-1 beta, INFg, IL-2, IL-8, and MCP-1 in blood. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.

Outcome measures

SECONDARY outcome

Timeframe: Baseline, Session 2: -5, 10, 25, 40 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3

Population: Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.

Blood samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Session 2: -5, 10, 25, 40 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3

Population: Safety Population.

Blood samples were collected at indicated time-points for the analysis of soluble inflammatory mediators like TNF-alpha, IL-6 and GM-CSF in blood. Latest pre-challenge GM-CSF assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.

Outcome measures

Outcome measures
Measure	Part 1: LPS 0.5 ng/kg n=4 Participants Participants were randomized to receive 0.5 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: LPS 0.75 ng/kg Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: LPS 1 ng/kg Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: GM-CSF 60 µg/m^2 Participants were randomized to receive 60 µg/m\^2 GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection
Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF: GM-CSF Arm GM-CSF, Session2,Day1,1 hour 10 minutes	145.793 Picograms per milliliter Standard Deviation 97.7248	—	—	—
Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF: GM-CSF Arm GM-CSF, Session2,Day1,2 hour 40 minutes	7.486 Picograms per milliliter Standard Deviation 9.9232	—	—	—
Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF: GM-CSF Arm GM-CSF, Session2,Day1,5 hour 40 minutes	0.000 Picograms per milliliter Standard Deviation 0.0000	—	—	—
Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF: GM-CSF Arm GM-CSF, Session2,Day2,Pre-fluid sampling	0.000 Picograms per milliliter Standard Deviation 0.0000	—	—	—
Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF: GM-CSF Arm GM-CSF, Session2,Day3,Pre-fluid sampling	0.000 Picograms per milliliter Standard Deviation 0.0000	—	—	—
Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF: GM-CSF Arm IL-6, Session2,Day1, -5 minutes	8.8136 Picograms per milliliter Standard Deviation 3.54771	—	—	—
Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF: GM-CSF Arm IL-6, Session2,Day1, 10 minutes	11.3851 Picograms per milliliter Standard Deviation 1.98376	—	—	—
Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF: GM-CSF Arm IL-6, Session2,Day1, 40 minutes	10.9359 Picograms per milliliter Standard Deviation 5.03738	—	—	—
Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF: GM-CSF Arm IL-6, Session2,Day1, 1hour 10minutes	6.8485 Picograms per milliliter Standard Deviation 3.17943	—	—	—
Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF: GM-CSF Arm IL-6, Session2,Day1, 1hour 40minutes	5.0334 Picograms per milliliter Standard Deviation 2.72854	—	—	—
Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF: GM-CSF Arm IL-6, Session2,Day3,Pre-fluid sample	-0.0324 Picograms per milliliter Standard Deviation 0.13824	—	—	—
Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF: GM-CSF Arm TNF-alpha, Session2,Day1, 10 minutes	2.4860 Picograms per milliliter Standard Deviation 0.70400	—	—	—
Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF: GM-CSF Arm TNF-alpha, Session2,Day1, 25 minutes	2.5475 Picograms per milliliter Standard Deviation 0.86898	—	—	—
Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF: GM-CSF Arm TNF-alpha, Session2,Day2, Pre-fluid sampling	0.5423 Picograms per milliliter Standard Deviation 0.50847	—	—	—
Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF: GM-CSF Arm TNF-alpha, Session2,Day3, Pre-fluid sampling	-0.1194 Picograms per milliliter Standard Deviation 0.55216	—	—	—
Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF: GM-CSF Arm TNF-alpha, Session2,Day1, -5 minutes	2.6740 Picograms per milliliter Standard Deviation 0.39814	—	—	—
Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF: GM-CSF Arm TNF-alpha, Session2,Day1, 40 minutes	2.2100 Picograms per milliliter Standard Deviation 0.99729	—	—	—
Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF: GM-CSF Arm TNF-alpha, Session2,Day1, 1 hour 10 minutes	2.1380 Picograms per milliliter Standard Deviation 0.90651	—	—	—
Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF: GM-CSF Arm TNF-alpha, Session2,Day1, 1 hour 40 minutes	1.9665 Picograms per milliliter Standard Deviation 1.19555	—	—	—
Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF: GM-CSF Arm TNF-alpha, Session2,Day1, 2 hour 40 minutes	1.6001 Picograms per milliliter Standard Deviation 0.80929	—	—	—
Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF: GM-CSF Arm TNF-alpha, Session2,Day1, 5 hour 40 minutes	0.9562 Picograms per milliliter Standard Deviation 0.63271	—	—	—
Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF: GM-CSF Arm GM-CSF, Session2,Day1, -5 minutes	1674.235 Picograms per milliliter Standard Deviation 635.9050	—	—	—
Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF: GM-CSF Arm GM-CSF, Session2,Day1, 10 minutes	1260.988 Picograms per milliliter Standard Deviation 850.1777	—	—	—
Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF: GM-CSF Arm GM-CSF, Session2,Day1, 25 minutes	624.895 Picograms per milliliter Standard Deviation 287.0075	—	—	—
Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF: GM-CSF Arm GM-CSF, Session2,Day1, 40 minutes	364.045 Picograms per milliliter Standard Deviation 218.4348	—	—	—
Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF: GM-CSF Arm GM-CSF, Session2,Day1,1 hour 40 minutes	52.158 Picograms per milliliter Standard Deviation 39.5878	—	—	—
Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF: GM-CSF Arm IL-6, Session2,Day1, 25 minutes	13.0699 Picograms per milliliter Standard Deviation 3.47569	—	—	—
Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF: GM-CSF Arm IL-6, Session2,Day1, 2hour 40minutes	2.6496 Picograms per milliliter Standard Deviation 1.56258	—	—	—
Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF: GM-CSF Arm IL-6, Session2,Day1, 5hour 40minutes	1.9135 Picograms per milliliter Standard Deviation 1.60586	—	—	—
Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF: GM-CSF Arm IL-6, Session2,Day2,Pre-fluid sample	1.2598 Picograms per milliliter Standard Deviation 1.72396	—	—	—

SECONDARY outcome

Timeframe: Baseline, Session 2: -5, 10, 25, 40 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3

Population: Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.

Blood samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge GM-CSF assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline; Session 2: Post challenge Day 1. Pre-fluid sample on Day 2 and Day 3

Population: Safety Population.

Blood samples were collected at indicated time-points for the analysis of soluble inflammatory mediators like CRP in blood. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.

Outcome measures

Outcome measures
Measure	Part 1: LPS 0.5 ng/kg n=2 Participants Participants were randomized to receive 0.5 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: LPS 0.75 ng/kg n=4 Participants Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: LPS 1 ng/kg n=2 Participants Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: GM-CSF 60 µg/m^2 n=4 Participants Participants were randomized to receive 60 µg/m\^2 GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection
Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: C-reactive Protein (CRP) Session2,Day 2, Pre-fluid sample	7.50 Milligrams per liter Standard Deviation 4.667	21.80 Milligrams per liter Standard Deviation 2.380	18.55 Milligrams per liter Standard Deviation 4.455	5.80 Milligrams per liter Standard Deviation 1.623
Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: C-reactive Protein (CRP) Session2,Day1, Post-challenge	0.20 Milligrams per liter Standard Deviation 3.111	2.75 Milligrams per liter Standard Deviation 0.624	2.40 Milligrams per liter Standard Deviation 0.990	1.53 Milligrams per liter Standard Deviation 0.457
Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: C-reactive Protein (CRP) Session2,Day 3, Pre-fluid sample	1.50 Milligrams per liter Standard Deviation 3.111	10.65 Milligrams per liter Standard Deviation 0.968	8.45 Milligrams per liter Standard Deviation 0.636	2.25 Milligrams per liter Standard Deviation 0.451

SECONDARY outcome

Timeframe: Baseline; Session 2: Post challenge Day 1; Pre-fluid sample on Day 2 and Day 3

Population: Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline; Session 2: 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes, 9 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for monocytes in blood. Activation markers included CD16, CD163, CD206, CD209, CD40, CD80, CD83, CD86 and HLA-DR. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.

Outcome measures

SECONDARY outcome

Timeframe: Baseline, Session 2: 40 minutes, 2 hour 40 minutes, 5 hour 40 minutes,9hours 40 minutes on Day 1; Pre-fluid sample on Day 2 and Day 3

Population: Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Session 2: 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes, 9 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for dendritic cells in blood. Activation markers included CD16, CD163, CD206, CD209, CD40, CD80, CD83, CD86 and HLA-DR. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.

Outcome measures

SECONDARY outcome

Timeframe: Baseline, Session 2: 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes, 9 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3

Population: Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline; Session 2: 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3

Population: Safety Population.

Blood samples were collected at indicated time-points for analysis of leukocyte. Latest pre-challenge assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.

Outcome measures

Outcome measures
Measure	Part 1: LPS 0.5 ng/kg n=2 Participants Participants were randomized to receive 0.5 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: LPS 0.75 ng/kg n=4 Participants Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: LPS 1 ng/kg n=2 Participants Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: GM-CSF 60 µg/m^2 Participants were randomized to receive 60 µg/m\^2 GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection
Part 1: Change From Baseline in Circulating Leukocyte Numbers in Blood: LPS Arm Session2, Day 1, 40 minutes	-358893.71 Cells per milliliter Standard Deviation 1002862.023	-1477705.00 Cells per milliliter Standard Deviation 811560.729	-2065961.83 Cells per milliliter Standard Deviation 1083290.576	—
Part 1: Change From Baseline in Circulating Leukocyte Numbers in Blood: LPS Arm Session2, Day 1, 2 hours 40 minutes	3347754.14 Cells per milliliter Standard Deviation 1701524.775	2423233.00 Cells per milliliter Standard Deviation 2047535.993	5224467.23 Cells per milliliter Standard Deviation 800613.402	—
Part 1: Change From Baseline in Circulating Leukocyte Numbers in Blood: LPS Arm Session2, Day 1, 5 hours 40 minutes	2116748.36 Cells per milliliter Standard Deviation 3209541.020	4511414.25 Cells per milliliter Standard Deviation 3044446.191	3641780.22 Cells per milliliter Standard Deviation 1458532.473	—
Part 1: Change From Baseline in Circulating Leukocyte Numbers in Blood: LPS Arm Session2, Day 2, Pre-fluid sample	-447452.27 Cells per milliliter Standard Deviation 101410.586	881299.75 Cells per milliliter Standard Deviation 1640158.830	442226.68 Cells per milliliter Standard Deviation 232936.722	—
Part 1: Change From Baseline in Circulating Leukocyte Numbers in Blood: LPS Arm Session2, Day 3, Pre-fluid sample	-169328.51 Cells per milliliter Standard Deviation 21593.240	-93685.25 Cells per milliliter Standard Deviation 1383413.608	75348.31 Cells per milliliter Standard Deviation 927892.867	—

SECONDARY outcome

Timeframe: Baseline; Session 2: 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3

Population: Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.

Blood samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.

Outcome measures

Outcome data not reported

Adverse Events

Part 1: LPS 0.5 ng/kg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 1: LPS 0.75 ng/kg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part 1: LPS 1 ng/kg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 1: GM-CSF 60 µg/m^2

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 2: Participants With LPS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 2: Participants With GM-CSF

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Part 1: LPS 0.5 ng/kg n=2 participants at risk Participants were randomized to receive 0.5 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: LPS 0.75 ng/kg n=4 participants at risk Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: LPS 1 ng/kg n=2 participants at risk Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: GM-CSF 60 µg/m^2 n=4 participants at risk Participants were randomized to receive 60 µg/m\^2 GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection.	Part 2: Participants With LPS Participants were planned to be dosed with LPS (0.5 with possible escalation up to 4 ng/kg) during Part 2 of the study	Part 2: Participants With GM-CSF Participants were planned to be dosed with GM-CSF (60 to a maximum dose of 480 µg/m\^2) during Part 2 of the study.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/4 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/4 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/4 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/4 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	50.0% 1/2 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/4 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/4 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	50.0% 1/2 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/4 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/4 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	50.0% 1/2 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/4 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.
Gastrointestinal disorders Abdominal pain	0.00% 0/2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/4 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	50.0% 1/2 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/4 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.
Gastrointestinal disorders Toothache	0.00% 0/2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/4 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.
Investigations Alanine aminotransferase increased	50.0% 1/2 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/4 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/4 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.
Investigations Blood creatinine increased	50.0% 1/2 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/4 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/4 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.
Skin and subcutaneous tissue disorders Blister	0.00% 0/2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/4 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	50.0% 1/2 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.
Cardiac disorders Tachycardia	50.0% 1/2 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/4 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/4 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.
Injury, poisoning and procedural complications Contusion	0.00% 0/2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/4 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.
Vascular disorders Hot flush	0.00% 0/2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/4 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	50.0% 1/2 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/4 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.
Infections and infestations Nasopharyngitis	50.0% 1/2 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	50.0% 2/4 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	50.0% 1/2 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/4 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.
General disorders Chills	0.00% 0/2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	100.0% 4/4 • Number of events 4 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	100.0% 2/2 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/4 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.
General disorders Chest discomfort	0.00% 0/2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.
General disorders Fatigue	0.00% 0/2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/4 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.
General disorders Feeling cold	0.00% 0/2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/4 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.
Nervous system disorders Headache	0.00% 0/2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	50.0% 2/4 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	100.0% 2/2 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.
Nervous system disorders Presyncope	0.00% 0/2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/4 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.
Infections and infestations Folliculitis	0.00% 0/2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/4 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	50.0% 1/2 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/4 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.
Infections and infestations Tooth abscess	0.00% 0/2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/4 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	50.0% 1/2 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	0.00% 0/4 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.	— 0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study. AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.

Additional Information

GSK Reponse 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

Measure	Part 1: LPS 0.5 ng/kg n=2 Participants Participants were randomized to receive 0.5 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: LPS 0.75 ng/kg n=4 Participants Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: LPS 1 ng/kg n=2 Participants Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: GM-CSF 60 µg/m^2 Participants were randomized to receive 60 µg/m\^2 GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection
Part 1: Change From Baseline Primary Soluble Inflammatory Mediators in Blood: Tumor Necrosis Factor (TNF) Alpha and Interleukin (IL) 6 for LPS Arm IL-6, Session2,Day1, -5 minutes, n=2, 4, 2	2.4086 Picograms per milliliter Standard Deviation 0.09467	0.2798 Picograms per milliliter Standard Deviation 0.12546	-0.0126 Picograms per milliliter Standard Deviation 0.01785	—
Part 1: Change From Baseline Primary Soluble Inflammatory Mediators in Blood: Tumor Necrosis Factor (TNF) Alpha and Interleukin (IL) 6 for LPS Arm IL-6, Session2,Day1, 10 minutes, n=2, 4, 2	3.6460 Picograms per milliliter Standard Deviation 2.68681	0.2450 Picograms per milliliter Standard Deviation 0.16048	0.0123 Picograms per milliliter Standard Deviation 0.01746	—
Part 1: Change From Baseline Primary Soluble Inflammatory Mediators in Blood: Tumor Necrosis Factor (TNF) Alpha and Interleukin (IL) 6 for LPS Arm IL-6, Session2,Day1, 25 minutes, n=1, 4, 2	3.3141 Picograms per milliliter Standard Deviation NA NA indicates that data was not available as standard deviation could not be calculated for a single participant.	1.3623 Picograms per milliliter Standard Deviation 0.88290	1.8854 Picograms per milliliter Standard Deviation 0.15615	—
Part 1: Change From Baseline Primary Soluble Inflammatory Mediators in Blood: Tumor Necrosis Factor (TNF) Alpha and Interleukin (IL) 6 for LPS Arm IL-6, Session2,Day1, 40 minutes, n=2, 4, 2	10.8074 Picograms per milliliter Standard Deviation 9.22779	8.7622 Picograms per milliliter Standard Deviation 8.41234	11.8672 Picograms per milliliter Standard Deviation 3.39867	—
Part 1: Change From Baseline Primary Soluble Inflammatory Mediators in Blood: Tumor Necrosis Factor (TNF) Alpha and Interleukin (IL) 6 for LPS Arm IL-6, Session2,Day1, 1 hour 10 minutes, n=2, 4, 2	30.6395 Picograms per milliliter Standard Deviation 26.77767	81.0629 Picograms per milliliter Standard Deviation 104.23961	51.8232 Picograms per milliliter Standard Deviation 22.59507	—
Part 1: Change From Baseline Primary Soluble Inflammatory Mediators in Blood: Tumor Necrosis Factor (TNF) Alpha and Interleukin (IL) 6 for LPS Arm IL-6, Session2,Day1, 1 hour 40 minutes, n=2, 4, 2	41.3221 Picograms per milliliter Standard Deviation 35.42047	193.7107 Picograms per milliliter Standard Deviation 218.97996	65.5675 Picograms per milliliter Standard Deviation 36.08430	—
Part 1: Change From Baseline Primary Soluble Inflammatory Mediators in Blood: Tumor Necrosis Factor (TNF) Alpha and Interleukin (IL) 6 for LPS Arm IL-6, Session2,Day1, 2 hour 40 minutes, n=2, 4, 2	23.9321 Picograms per milliliter Standard Deviation 21.46574	133.2063 Picograms per milliliter Standard Deviation 92.47028	32.3842 Picograms per milliliter Standard Deviation 25.56374	—
Part 1: Change From Baseline Primary Soluble Inflammatory Mediators in Blood: Tumor Necrosis Factor (TNF) Alpha and Interleukin (IL) 6 for LPS Arm IL-6, Session2,Day1, 5 hour 40 minutes, n=2, 4, 2	5.6991 Picograms per milliliter Standard Deviation 0.68051	2.5645 Picograms per milliliter Standard Deviation 1.20737	4.5141 Picograms per milliliter Standard Deviation 2.09962	—
Part 1: Change From Baseline Primary Soluble Inflammatory Mediators in Blood: Tumor Necrosis Factor (TNF) Alpha and Interleukin (IL) 6 for LPS Arm IL-6, Session2,Day2, Pre-fluid sampling, n=2, 4, 2	17.8308 Picograms per milliliter Standard Deviation 16.52950	3.2880 Picograms per milliliter Standard Deviation 2.52703	0.3442 Picograms per milliliter Standard Deviation 0.03336	—
Part 1: Change From Baseline Primary Soluble Inflammatory Mediators in Blood: Tumor Necrosis Factor (TNF) Alpha and Interleukin (IL) 6 for LPS Arm IL-6, Session2,Day3, Pre-fluid sampling, n=2, 4, 2	-0.4610 Picograms per milliliter Standard Deviation 0.08488	0.5909 Picograms per milliliter Standard Deviation 0.96127	0.1542 Picograms per milliliter Standard Deviation 0.21529	—
Part 1: Change From Baseline Primary Soluble Inflammatory Mediators in Blood: Tumor Necrosis Factor (TNF) Alpha and Interleukin (IL) 6 for LPS Arm TNF alpha, Session2,Day1, -5 minutes, n=2, 4, 2	-0.2541 Picograms per milliliter Standard Deviation 0.33782	-0.0726 Picograms per milliliter Standard Deviation 0.14769	6.4056 Picograms per milliliter Standard Deviation 8.96887	—
Part 1: Change From Baseline Primary Soluble Inflammatory Mediators in Blood: Tumor Necrosis Factor (TNF) Alpha and Interleukin (IL) 6 for LPS Arm TNF alpha, Session2,Day1, 10 minutes, n=2, 4, 2	6.5720 Picograms per milliliter Standard Deviation 1.84896	2.3784 Picograms per milliliter Standard Deviation 2.45156	12.7647 Picograms per milliliter Standard Deviation 13.08048	—
Part 1: Change From Baseline Primary Soluble Inflammatory Mediators in Blood: Tumor Necrosis Factor (TNF) Alpha and Interleukin (IL) 6 for LPS Arm TNF alpha, Session2,Day1, 25 minutes, n=1, 4, 2	20.2469 Picograms per milliliter Standard Deviation NA NA indicates that data was not available as standard deviation could not be calculated for a single participant.	56.6529 Picograms per milliliter Standard Deviation 51.91815	84.6080 Picograms per milliliter Standard Deviation 33.94449	—
Part 1: Change From Baseline Primary Soluble Inflammatory Mediators in Blood: Tumor Necrosis Factor (TNF) Alpha and Interleukin (IL) 6 for LPS Arm TNF alpha, Session2,Day1, 40 minutes, n=2, 4, 2	52.1665 Picograms per milliliter Standard Deviation 37.61641	157.5403 Picograms per milliliter Standard Deviation 165.48643	152.9415 Picograms per milliliter Standard Deviation 60.31144	—
Part 1: Change From Baseline Primary Soluble Inflammatory Mediators in Blood: Tumor Necrosis Factor (TNF) Alpha and Interleukin (IL) 6 for LPS Arm TNF alpha, Session2,Day1, 1hour 10minutes, n=2,4,2	43.4949 Picograms per milliliter Standard Deviation 30.81434	202.6136 Picograms per milliliter Standard Deviation 215.34410	115.6693 Picograms per milliliter Standard Deviation 54.14279	—
Part 1: Change From Baseline Primary Soluble Inflammatory Mediators in Blood: Tumor Necrosis Factor (TNF) Alpha and Interleukin (IL) 6 for LPS Arm TNF alpha, Session2,Day1, 1hour 40minutes, n=2,4,2	34.3031 Picograms per milliliter Standard Deviation 20.26768	147.3472 Picograms per milliliter Standard Deviation 122.68010	78.4734 Picograms per milliliter Standard Deviation 38.13965	—
Part 1: Change From Baseline Primary Soluble Inflammatory Mediators in Blood: Tumor Necrosis Factor (TNF) Alpha and Interleukin (IL) 6 for LPS Arm TNF alpha, Session2,Day1, 2hour 40minutes, n=2,4,2	22.5571 Picograms per milliliter Standard Deviation 11.11988	68.8879 Picograms per milliliter Standard Deviation 24.42514	44.3372 Picograms per milliliter Standard Deviation 22.32753	—
Part 1: Change From Baseline Primary Soluble Inflammatory Mediators in Blood: Tumor Necrosis Factor (TNF) Alpha and Interleukin (IL) 6 for LPS Arm TNF alpha, Session2,Day1, 5hour 40minutes, n=2,4,2	5.0087 Picograms per milliliter Standard Deviation 2.65663	15.4828 Picograms per milliliter Standard Deviation 7.05404	11.1378 Picograms per milliliter Standard Deviation 4.74317	—
Part 1: Change From Baseline Primary Soluble Inflammatory Mediators in Blood: Tumor Necrosis Factor (TNF) Alpha and Interleukin (IL) 6 for LPS Arm TNF alpha, Session2,Day2,Pre-fluid sample, n=2,4,2	12.9279 Picograms per milliliter Standard Deviation 16.96994	1.2532 Picograms per milliliter Standard Deviation 0.83802	0.6475 Picograms per milliliter Standard Deviation 0.28268	—
Part 1: Change From Baseline Primary Soluble Inflammatory Mediators in Blood: Tumor Necrosis Factor (TNF) Alpha and Interleukin (IL) 6 for LPS Arm TNF alpha, Session2,Day3,Pre-fluid sample, n=2,4,2	0.2453 Picograms per milliliter Standard Deviation 0.29126	0.2951 Picograms per milliliter Standard Deviation 0.39912	0.1391 Picograms per milliliter Standard Deviation 0.15747	—

Measure	Part 1: LPS 0.5 ng/kg n=2 Participants Participants were randomized to receive 0.5 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: LPS 0.75 ng/kg n=4 Participants Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: LPS 1 ng/kg n=2 Participants Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: GM-CSF 60 µg/m^2 n=4 Participants Participants were randomized to receive 60 µg/m\^2 GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection
Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister IL-1b, Session1, Day 3, 48 hours, n=2, 2, 2,3	-30.9691 Picograms per milliliter Standard Deviation 3.58338	-41.5298 Picograms per milliliter Standard Deviation 149.67553	3.6243 Picograms per milliliter Standard Deviation 35.28147	35.4452 Picograms per milliliter Standard Deviation 48.42938
Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister IL-1b, Session2,Day2, 24 hours, n=2, 2, 2,1	-48.4241 Picograms per milliliter Standard Deviation 69.70779	-83.1670 Picograms per milliliter Standard Deviation 108.13325	7.9733 Picograms per milliliter Standard Deviation 19.49142	-0.3579 Picograms per milliliter Standard Deviation NA NA indicates that data was not available as standard deviation could not be calculated for a single participant.
Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister IL-1b, Session2,Day3, 48 hours, n=2, 2, 2,1	-51.0992 Picograms per milliliter Standard Deviation 46.78156	-81.6788 Picograms per milliliter Standard Deviation 130.42664	7.6783 Picograms per milliliter Standard Deviation 0.42508	-6.8302 Picograms per milliliter Standard Deviation NA NA indicates that data was not available as standard deviation could not be calculated for a single participant.
Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister IFNg, Session1,Day3, 48 hours, n=2, 0, 2, 0	32.5244 Picograms per milliliter Standard Deviation 28.81866	—	55.9575 Picograms per milliliter Standard Deviation 65.86745	—
Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister IFNg, Session2,Day2, 24 hours, n=2, 0, 2, 0	-3.8191 Picograms per milliliter Standard Deviation 6.06240	—	-4.5772 Picograms per milliliter Standard Deviation 7.20432	—
Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister IFNg, Session2,Day3, 48 hours, n=2, 0, 2, 0	0.6652 Picograms per milliliter Standard Deviation 2.58511	—	2.9556 Picograms per milliliter Standard Deviation 13.15578	—
Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister IL-2, Session1,Day3, 48 hours, n=2, 2, 2, 3	1.3470 Picograms per milliliter Standard Deviation 1.58747	-0.5699 Picograms per milliliter Standard Deviation 0.80595	0.1623 Picograms per milliliter Standard Deviation 0.22960	1.2444 Picograms per milliliter Standard Deviation 1.98677
Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister IL-2, Session2,Day2, 24 hours, n=2, 2, 2, 1	0.2525 Picograms per milliliter Standard Deviation 0.66014	0.1804 Picograms per milliliter Standard Deviation 0.58673	0.0000 Picograms per milliliter Standard Deviation 0.0000	0.0000 Picograms per milliliter Standard Deviation NA NA indicates that data was not available as standard deviation could not be calculated for a single participant.
Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister IL-2, Session2,Day3, 48 hours, n=2, 2, 2, 1	0.2451 Picograms per milliliter Standard Deviation 0.64975	2.1377 Picograms per milliliter Standard Deviation 2.64598	0.6968 Picograms per milliliter Standard Deviation 0.98543	2.1293 Picograms per milliliter Standard Deviation NA NA indicates that data was not available as standard deviation could not be calculated for a single participant.
Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister IL-6, Session1,Day3,48 hours, n=2, 0, 2, 0	-1588.01 Picograms per milliliter Standard Deviation 1379.357	—	1535.45 Picograms per milliliter Standard Deviation 3195.182	—
Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister IL-6, Session2,Day2, 24 hours, n=1, 0, 1, 0	-0.13 Picograms per milliliter Standard Deviation NA NA indicates that data was not available as standard deviation could not be calculated for a single participant.	—	-349.63 Picograms per milliliter Standard Deviation NA NA indicates that data was not available as standard deviation could not be calculated for a single participant.	—
Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister IL-6, Session2,Day3, 48 hours, n=1, 0, 2, 0	41.39 Picograms per milliliter Standard Deviation NA NA indicates that data was not available as standard deviation could not be calculated for a single participant.	—	-25.74 Picograms per milliliter Standard Deviation 864.740	—
Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister IL-8, Session1,Day3,48 hours, n=2, 0, 2, 0	-127550.93 Picograms per milliliter Standard Deviation 141294.871	—	-42387.41 Picograms per milliliter Standard Deviation 31786.992	—
Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister IL-8, Session2,Day2, 24 hours, n=2, 0, 2, 0	-31850.03 Picograms per milliliter Standard Deviation 186366.091	—	34295.91 Picograms per milliliter Standard Deviation 34575.984	—
Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister IL-8, Session2,Day3, 48 hours, n=2, 0, 2, 0	-126387.78 Picograms per milliliter Standard Deviation 140485.270	—	-42836.70 Picograms per milliliter Standard Deviation 30559.892	—
Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister MCP-1, Session1,Day3, 48 hours, n=2,4,2,4	-36463.42 Picograms per milliliter Standard Deviation 4187.967	-10520.93 Picograms per milliliter Standard Deviation 5858.889	-18336.31 Picograms per milliliter Standard Deviation 9925.681	-10284.38 Picograms per milliliter Standard Deviation 10327.369
Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister MCP-1, Session2,Day2, 24 hours, n=2,4,2,4	-2842.63 Picograms per milliliter Standard Deviation 19696.319	4723.83 Picograms per milliliter Standard Deviation 11253.334	18049.87 Picograms per milliliter Standard Deviation 1010.158	4299.94 Picograms per milliliter Standard Deviation 11160.896
Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister MCP-1, Session2,Day3, 48 hours, n=2,4,2,4	-18920.55 Picograms per milliliter Standard Deviation 2850.508	1077.95 Picograms per milliliter Standard Deviation 10014.723	-16980.85 Picograms per milliliter Standard Deviation 11928.656	-11416.80 Picograms per milliliter Standard Deviation 9587.163
Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister TNF alpha,Session1,Day3,48 hours, n=2,2,2,3	-69.1140 Picograms per milliliter Standard Deviation 31.11083	-98.8930 Picograms per milliliter Standard Deviation 55.29269	-16.0826 Picograms per milliliter Standard Deviation 17.76133	-33.5839 Picograms per milliliter Standard Deviation 62.80430
Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister TNF alpha,Session2,Day2, 24 hours, n=2,2,2,1	-25.3949 Picograms per milliliter Standard Deviation 68.42872	53.6996 Picograms per milliliter Standard Deviation 266.29344	34.8290 Picograms per milliliter Standard Deviation 63.07748	-29.6573 Picograms per milliliter Standard Deviation NA NA indicates that data was not available as standard deviation could not be calculated for a single participant.
Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister TNF alpha,Session2,Day3,48 hours, n=2,2,2,1	-83.6471 Picograms per milliliter Standard Deviation 72.97148	-110.6500 Picograms per milliliter Standard Deviation 52.29742	-10.5091 Picograms per milliliter Standard Deviation 18.47463	-51.9244 Picograms per milliliter Standard Deviation NA NA indicates that data was not available as standard deviation could not be calculated for a single participant.

Measure	Part 1: LPS 0.5 ng/kg n=2 Participants Participants were randomized to receive 0.5 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: LPS 0.75 ng/kg n=4 Participants Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: LPS 1 ng/kg n=2 Participants Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: GM-CSF 60 µg/m^2 n=4 Participants Participants were randomized to receive 60 µg/m\^2 GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister CD40, Session2,Day2, 24 hours, n=2, 4, 2, 4	200.750 Mean fluorescence intensity Standard Deviation 211.7785	-60.255 Mean fluorescence intensity Standard Deviation 174.9309	116.500 Mean fluorescence intensity Standard Deviation 64.3467	436.294 Mean fluorescence intensity Standard Deviation 350.2183
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister CD40, Session2,Day3, 48 hours, n=1, 4, 2, 3	-167.500 Mean fluorescence intensity Standard Deviation NA NA indicates that data was not available as standard deviation could not be calculated for a single participant	-6.274 Mean fluorescence intensity Standard Deviation 238.7732	-8.250 Mean fluorescence intensity Standard Deviation 42.0729	236.171 Mean fluorescence intensity Standard Deviation 304.2282
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister CD80, Session1,Day3, 48 hours, n=2, 4, 2, 4	490.500 Mean fluorescence intensity Standard Deviation 236.1737	342.798 Mean fluorescence intensity Standard Deviation 181.3639	404.500 Mean fluorescence intensity Standard Deviation 137.8858	316.762 Mean fluorescence intensity Standard Deviation 145.7658
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister CD80, Session2,Day2, 24 hours, n=2, 4, 2, 4	155.250 Mean fluorescence intensity Standard Deviation 284.6105	50.962 Mean fluorescence intensity Standard Deviation 31.2323	44.250 Mean fluorescence intensity Standard Deviation 158.0384	44.488 Mean fluorescence intensity Standard Deviation 94.3934
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister CD80, Session2,Day3, 48 hours, n=2, 4, 2, 4	286.250 Mean fluorescence intensity Standard Deviation 14.4957	324.662 Mean fluorescence intensity Standard Deviation 223.8334	254.000 Mean fluorescence intensity Standard Deviation 77.7817	401.521 Mean fluorescence intensity Standard Deviation 43.5362
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister CD83, Session1,Day3, 48 hours, n=2, 4, 2, 4	-832.500 Mean fluorescence intensity Standard Deviation 89.8026	-816.619 Mean fluorescence intensity Standard Deviation 242.1554	-373.250 Mean fluorescence intensity Standard Deviation 578.7669	-824.574 Mean fluorescence intensity Standard Deviation 521.9010
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister CD83, Session2,Day2, 24 hours, n=2, 4, 2, 4	83.250 Mean fluorescence intensity Standard Deviation 361.6851	44.949 Mean fluorescence intensity Standard Deviation 222.8885	791.500 Mean fluorescence intensity Standard Deviation 1207.0313	280.947 Mean fluorescence intensity Standard Deviation 870.1350
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister CD83, Session2,Day3, 48 hours, n=2, 4, 2, 4	-978.250 Mean fluorescence intensity Standard Deviation 339.0577	-773.455 Mean fluorescence intensity Standard Deviation 383.3063	-328.250 Mean fluorescence intensity Standard Deviation 171.4734	-529.900 Mean fluorescence intensity Standard Deviation 854.9675
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister CD86+, Session1,Day3, 48 hours, n=2, 4, 2, 4	-439.750 Mean fluorescence intensity Standard Deviation 195.5150	-51.662 Mean fluorescence intensity Standard Deviation 369.1392	-319.750 Mean fluorescence intensity Standard Deviation 71.7713	-497.468 Mean fluorescence intensity Standard Deviation 327.7072
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister CD86+, Session2,Day2, 24 hours, n=2, 4, 2, 4	-275.500 Mean fluorescence intensity Standard Deviation 30.4056	-241.591 Mean fluorescence intensity Standard Deviation 286.2295	103.750 Mean fluorescence intensity Standard Deviation 15.9099	6.398 Mean fluorescence intensity Standard Deviation 418.6691
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister CD86+, Session2,Day3, 48 hours, n=2, 4, 2, 4	-723.250 Mean fluorescence intensity Standard Deviation 104.2983	312.288 Mean fluorescence intensity Standard Deviation 458.1399	-292.250 Mean fluorescence intensity Standard Deviation 16.6170	-97.004 Mean fluorescence intensity Standard Deviation 1081.7203
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister HLA-DR, Session1,Day3, 48 hours, n=2, 4, 2, 4	-5189.00 Mean fluorescence intensity Standard Deviation 2028.689	-3291.05 Mean fluorescence intensity Standard Deviation 4596.102	-7267.75 Mean fluorescence intensity Standard Deviation 11655.595	-2543.35 Mean fluorescence intensity Standard Deviation 3800.276
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister HLA-DR, Session2,Day2, 24 hours, n=2, 4, 2, 4	388.50 Mean fluorescence intensity Standard Deviation 3168.545	-9344.96 Mean fluorescence intensity Standard Deviation 2661.368	-2229.25 Mean fluorescence intensity Standard Deviation 4812.922	10097.91 Mean fluorescence intensity Standard Deviation 12898.982
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister HLA-DR, Session2,Day3, 48 hours, n=2, 4, 2, 4	-7846.25 Mean fluorescence intensity Standard Deviation 6101.978	-10329.79 Mean fluorescence intensity Standard Deviation 4408.080	-9340.00 Mean fluorescence intensity Standard Deviation 10061.422	8884.70 Mean fluorescence intensity Standard Deviation 15377.757
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister CD16+, Session1,Day3, 48 hours, n=2, 4, 2, 4	255.500 Mean fluorescence intensity Standard Deviation 343.6539	304.409 Mean fluorescence intensity Standard Deviation 387.9039	314.000 Mean fluorescence intensity Standard Deviation 129.4005	94.943 Mean fluorescence intensity Standard Deviation 140.1057
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister CD16+, Session2,Day2, 24 hours, n=2, 4, 2, 4	512.000 Mean fluorescence intensity Standard Deviation 515.4808	507.721 Mean fluorescence intensity Standard Deviation 375.7470	711.250 Mean fluorescence intensity Standard Deviation 942.9269	174.016 Mean fluorescence intensity Standard Deviation 226.3189
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister CD16+, Session2,Day3, 48 hours, n=2, 4, 2, 4	220.750 Mean fluorescence intensity Standard Deviation 228.0419	-26.379 Mean fluorescence intensity Standard Deviation 183.4741	438.250 Mean fluorescence intensity Standard Deviation 329.1582	279.814 Mean fluorescence intensity Standard Deviation 332.5659
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister CD163+, Session1,Day3, 48 hours, n=2, 4, 2, 4	1022.000 Mean fluorescence intensity Standard Deviation 291.3280	710.660 Mean fluorescence intensity Standard Deviation 645.7405	663.750 Mean fluorescence intensity Standard Deviation 149.5531	367.626 Mean fluorescence intensity Standard Deviation 245.5936
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister CD163+, Session2,Day2, 24 hours, n=2, 4, 2, 4	51.750 Mean fluorescence intensity Standard Deviation 217.4353	247.858 Mean fluorescence intensity Standard Deviation 249.5824	460.500 Mean fluorescence intensity Standard Deviation 120.2082	122.859 Mean fluorescence intensity Standard Deviation 88.9027
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister CD163+, Session2,Day3, 48 hours, n=2, 4, 2, 4	1173.750 Mean fluorescence intensity Standard Deviation 213.1927	585.093 Mean fluorescence intensity Standard Deviation 238.4787	978.750 Mean fluorescence intensity Standard Deviation 426.7389	713.995 Mean fluorescence intensity Standard Deviation 519.2420
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister CD206+, Session1,Day3, 48 hours, n=2, 2, 2, 4	849.00 Mean fluorescence intensity Standard Deviation 3251.277	-562.71 Mean fluorescence intensity Standard Deviation 207.541	3188.75 Mean fluorescence intensity Standard Deviation 5879.946	1295.95 Mean fluorescence intensity Standard Deviation 1671.924
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister CD206+, Session2,Day2, 24 hours, n=2, 0, 2, 4	119.50 Mean fluorescence intensity Standard Deviation 2805.093	—	-1224.50 Mean fluorescence intensity Standard Deviation 1317.340	9194.06 Mean fluorescence intensity Standard Deviation 4046.382
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister CD206+, Session2,Day3, 48 hours, n=2, 0, 2, 4	-1596.50 Mean fluorescence intensity Standard Deviation 823.779	—	-1812.25 Mean fluorescence intensity Standard Deviation 1074.449	613.37 Mean fluorescence intensity Standard Deviation 1127.116
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister CD209+, Session1,Day3,48 hours, n=2, 4, 2, 4	827.000 Mean fluorescence intensity Standard Deviation 478.7113	1256.721 Mean fluorescence intensity Standard Deviation 676.3278	377.500 Mean fluorescence intensity Standard Deviation 457.4981	753.682 Mean fluorescence intensity Standard Deviation 482.3904
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister CD209+, Session2,Day2, 24 hours, n=2, 4, 2, 4	166.750 Mean fluorescence intensity Standard Deviation 78.8424	63.622 Mean fluorescence intensity Standard Deviation 309.3805	982.250 Mean fluorescence intensity Standard Deviation 601.3943	1386.776 Mean fluorescence intensity Standard Deviation 1523.3802
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister CD209+, Session2,Day3, 48 hours, n=2, 4, 2, 4	577.750 Mean fluorescence intensity Standard Deviation 334.8151	767.291 Mean fluorescence intensity Standard Deviation 469.9624	1330.250 Mean fluorescence intensity Standard Deviation 491.7928	2161.950 Mean fluorescence intensity Standard Deviation 1465.6418
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister CD40, Session1,Day3, 48 hours, n=2, 4, 2, 4	124.750 Mean fluorescence intensity Standard Deviation 47.7297	131.238 Mean fluorescence intensity Standard Deviation 104.7629	7.500 Mean fluorescence intensity Standard Deviation 108.8944	76.408 Mean fluorescence intensity Standard Deviation 149.4601

Measure	Part 1: LPS 0.5 ng/kg n=2 Participants Participants were randomized to receive 0.5 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: LPS 0.75 ng/kg n=4 Participants Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: LPS 1 ng/kg n=2 Participants Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: GM-CSF 60 µg/m^2 n=4 Participants Participants were randomized to receive 60 µg/m\^2 GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister CD16+, Session1,Day3, 48 hours, n=2, 4, 2, 4	-31.250 Mean fluorescence intensity Standard Deviation 48.4368	668.512 Mean fluorescence intensity Standard Deviation 634.0204	44.500 Mean fluorescence intensity Standard Deviation 90.5097	83.647 Mean fluorescence intensity Standard Deviation 119.1684
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister CD16+, Session2,Day2, 24 hours, n=2, 4, 2, 4	284.750 Mean fluorescence intensity Standard Deviation 2.4749	235.293 Mean fluorescence intensity Standard Deviation 200.9269	62.750 Mean fluorescence intensity Standard Deviation 48.4368	225.589 Mean fluorescence intensity Standard Deviation 233.9677
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister CD16+, Session2,Day3, 48 hours, n=2, 4, 2, 4	154.000 Mean fluorescence intensity Standard Deviation 44.5477	208.225 Mean fluorescence intensity Standard Deviation 339.7035	186.250 Mean fluorescence intensity Standard Deviation 254.9120	268.838 Mean fluorescence intensity Standard Deviation 315.3551
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister CD163+, Session1,Day3, 48 hours, n=2, 4, 2, 4	-103.7500 Mean fluorescence intensity Standard Deviation 129.04699	-91.1420 Mean fluorescence intensity Standard Deviation 123.34114	-105.7500 Mean fluorescence intensity Standard Deviation 107.83378	-16.6220 Mean fluorescence intensity Standard Deviation 31.79210
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister CD163+, Session2,Day2, 24 hours, n=2, 4, 2, 4	-112.7500 Mean fluorescence intensity Standard Deviation 143.89623	-49.4854 Mean fluorescence intensity Standard Deviation 72.90224	267.2500 Mean fluorescence intensity Standard Deviation 66.11448	47.1343 Mean fluorescence intensity Standard Deviation 60.71649
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister CD163+, Session2,Day3, 48 hours, n=2, 4, 2, 4	-132.2500 Mean fluorescence intensity Standard Deviation 119.85460	-124.5144 Mean fluorescence intensity Standard Deviation 79.57686	-70.0000 Mean fluorescence intensity Standard Deviation 101.11627	-32.4464 Mean fluorescence intensity Standard Deviation 30.09999
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister CD206+, Session1,Day3, 48 hours, n=2, 2, 2, 4	-56.00 Mean fluorescence intensity Standard Deviation 601.041	-1057.04 Mean fluorescence intensity Standard Deviation 1641.526	1372.75 Mean fluorescence intensity Standard Deviation 2325.321	2032.27 Mean fluorescence intensity Standard Deviation 1708.909
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister CD206+, Session2,Day2, 24 hours, n=2, 0, 2, 4	-430.25 Mean fluorescence intensity Standard Deviation 1407.496	—	-665.00 Mean fluorescence intensity Standard Deviation 481.540	3032.02 Mean fluorescence intensity Standard Deviation 3183.213
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister CD206+, Session2,Day3, 48 hours, n=2, 0, 2, 4	4.00 Mean fluorescence intensity Standard Deviation 171.120	—	198.75 Mean fluorescence intensity Standard Deviation 150.260	856.32 Mean fluorescence intensity Standard Deviation 1654.671
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister CD209+, Session1,Day3,48 hours, n=2, 4, 2, 4	83.250 Mean fluorescence intensity Standard Deviation 15.2028	765.140 Mean fluorescence intensity Standard Deviation 690.4086	-211.000 Mean fluorescence intensity Standard Deviation 17.6777	95.101 Mean fluorescence intensity Standard Deviation 191.7562
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister CD209+, Session2,Day2, 24 hours, n=2, 4, 2, 4	79.750 Mean fluorescence intensity Standard Deviation 37.1231	38.604 Mean fluorescence intensity Standard Deviation 582.9139	743.750 Mean fluorescence intensity Standard Deviation 482.6004	1834.867 Mean fluorescence intensity Standard Deviation 1573.3002
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister CD209+, Session2,Day3, 48 hours, n=2, 4, 2, 4	101.750 Mean fluorescence intensity Standard Deviation 341.1790	297.936 Mean fluorescence intensity Standard Deviation 605.5896	835.000 Mean fluorescence intensity Standard Deviation 444.7702	1822.510 Mean fluorescence intensity Standard Deviation 1522.9886
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister CD40, Session1,Day3, 48 hours, n=2, 4, 2, 4	963.750 Mean fluorescence intensity Standard Deviation 110.6622	1403.000 Mean fluorescence intensity Standard Deviation 754.2476	776.000 Mean fluorescence intensity Standard Deviation 30.4056	923.024 Mean fluorescence intensity Standard Deviation 560.8252
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister CD40, Session2,Day2, 24 hours, n=2, 4, 2, 4	96.000 Mean fluorescence intensity Standard Deviation 266.5793	17.354 Mean fluorescence intensity Standard Deviation 257.3845	-10.250 Mean fluorescence intensity Standard Deviation 61.1647	293.485 Mean fluorescence intensity Standard Deviation 249.0144
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister CD40, Session2,Day3, 48 hours, n=1, 4, 2, 3	383.500 Mean fluorescence intensity Standard Deviation NA NA indicates that data was not available as standard deviation could not be calculated for a single participant.	1072.416 Mean fluorescence intensity Standard Deviation 523.9965	783.750 Mean fluorescence intensity Standard Deviation 127.6328	1389.536 Mean fluorescence intensity Standard Deviation 710.1286
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister CD80, Session1,Day3, 48 hours, n=2, 4, 2, 4	2609.000 Mean fluorescence intensity Standard Deviation 376.8879	4155.674 Mean fluorescence intensity Standard Deviation 893.4273	2366.000 Mean fluorescence intensity Standard Deviation 72.8320	4998.865 Mean fluorescence intensity Standard Deviation 1326.4663
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister HLA-DR, Session2,Day2, 24 hours, n=2, 4, 2, 4	-494.00 Mean fluorescence intensity Standard Deviation 1211.981	-3470.23 Mean fluorescence intensity Standard Deviation 16869.569	480.50 Mean fluorescence intensity Standard Deviation 11477.050	11902.82 Mean fluorescence intensity Standard Deviation 17969.677
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister CD80, Session2,Day2, 24 hours, n=2, 4, 2, 4	-130.000 Mean fluorescence intensity Standard Deviation 523.2590	-583.016 Mean fluorescence intensity Standard Deviation 1305.3774	-237.250 Mean fluorescence intensity Standard Deviation 252.0836	407.277 Mean fluorescence intensity Standard Deviation 615.0693
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister CD80, Session2,Day3, 48 hours, n=2, 4, 2, 4	1235.000 Mean fluorescence intensity Standard Deviation 603.8692	3665.666 Mean fluorescence intensity Standard Deviation 1565.6126	1407.250 Mean fluorescence intensity Standard Deviation 331.9866	3958.838 Mean fluorescence intensity Standard Deviation 803.7564
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister CD83, Session1,Day3, 48 hours, n=2, 4, 2, 4	2342.250 Mean fluorescence intensity Standard Deviation 423.2034	2806.835 Mean fluorescence intensity Standard Deviation 741.9070	2624.000 Mean fluorescence intensity Standard Deviation 770.7464	3834.100 Mean fluorescence intensity Standard Deviation 1511.6374
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister CD83, Session2,Day2, 24 hours, n=2, 4, 2, 4	-28.000 Mean fluorescence intensity Standard Deviation 656.9022	-409.187 Mean fluorescence intensity Standard Deviation 1498.2826	-343.250 Mean fluorescence intensity Standard Deviation 597.1517	648.346 Mean fluorescence intensity Standard Deviation 685.4282
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister CD83, Session2,Day3, 48 hours, n=2, 4, 2, 4	1199.500 Mean fluorescence intensity Standard Deviation 900.8540	3368.105 Mean fluorescence intensity Standard Deviation 953.2468	2924.250 Mean fluorescence intensity Standard Deviation 510.1775	3264.300 Mean fluorescence intensity Standard Deviation 988.2407
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister CD86+, Session1,Day3, 48 hours, n=2, 4, 2, 4	2590.75 Mean fluorescence intensity Standard Deviation 1485.278	4689.54 Mean fluorescence intensity Standard Deviation 1189.323	2701.50 Mean fluorescence intensity Standard Deviation 65.761	3936.29 Mean fluorescence intensity Standard Deviation 2537.066
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister CD86+, Session2,Day2, 24 hours, n=2, 4, 2, 4	-509.75 Mean fluorescence intensity Standard Deviation 345.422	-696.70 Mean fluorescence intensity Standard Deviation 1551.690	-184.00 Mean fluorescence intensity Standard Deviation 373.352	94.29 Mean fluorescence intensity Standard Deviation 782.682
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister CD86+, Session2,Day3, 48 hours, n=2, 4, 2, 4	1175.25 Mean fluorescence intensity Standard Deviation 980.404	7229.67 Mean fluorescence intensity Standard Deviation 2733.004	2750.50 Mean fluorescence intensity Standard Deviation 421.436	4132.68 Mean fluorescence intensity Standard Deviation 2423.146
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister HLA-DR, Session1,Day3, 48 hours, n=2, 4, 2, 4	1020.00 Mean fluorescence intensity Standard Deviation 2766.909	31657.05 Mean fluorescence intensity Standard Deviation 11524.385	-2661.75 Mean fluorescence intensity Standard Deviation 19339.017	3242.86 Mean fluorescence intensity Standard Deviation 11323.629
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister HLA-DR, Session2,Day3, 48 hours, n=2, 4, 2, 4	-4386.50 Mean fluorescence intensity Standard Deviation 911.461	16282.97 Mean fluorescence intensity Standard Deviation 22938.047	1564.00 Mean fluorescence intensity Standard Deviation 12854.494	19351.27 Mean fluorescence intensity Standard Deviation 16136.948

Measure	Part 1: LPS 0.5 ng/kg n=2 Participants Participants were randomized to receive 0.5 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: LPS 0.75 ng/kg n=4 Participants Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: LPS 1 ng/kg n=2 Participants Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: GM-CSF 60 µg/m^2 n=4 Participants Participants were randomized to receive 60 µg/m\^2 GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister CD40, Session2,Day3, 48 hours, n=1, 4, 2, 4	74.50 Mean fluorescence intensity Standard Deviation NA NA indicates that data was not available as standard deviation could not be calculated for a single participant.	-166.13 Mean fluorescence intensity Standard Deviation 503.207	-480.25 Mean fluorescence intensity Standard Deviation 925.956	-70.50 Mean fluorescence intensity Standard Deviation 1739.426
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister CD80, Session1,Day3, 48 hours, n=2, 4, 2, 4	884.00 Mean fluorescence intensity Standard Deviation 9.899	1193.63 Mean fluorescence intensity Standard Deviation 1486.267	1403.75 Mean fluorescence intensity Standard Deviation 3760.040	304.88 Mean fluorescence intensity Standard Deviation 2126.019
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister CD80, Session2,Day2, 24 hours, n=2, 4, 2, 4	1250.50 Mean fluorescence intensity Standard Deviation 1339.967	353.63 Mean fluorescence intensity Standard Deviation 2446.460	-1136.25 Mean fluorescence intensity Standard Deviation 1490.935	1215.88 Mean fluorescence intensity Standard Deviation 2013.518
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister CD80, Session2,Day3, 48 hours, n=2, 4, 2, 4	-84.75 Mean fluorescence intensity Standard Deviation 23.688	-114.50 Mean fluorescence intensity Standard Deviation 615.327	-1686.50 Mean fluorescence intensity Standard Deviation 2957.121	-744.88 Mean fluorescence intensity Standard Deviation 3479.863
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister CD83, Session1,Day3, 48 hours, n=2, 4, 2, 4	-1139.00 Mean fluorescence intensity Standard Deviation 477.297	-556.88 Mean fluorescence intensity Standard Deviation 1063.877	2522.00 Mean fluorescence intensity Standard Deviation 1359.766	-842.63 Mean fluorescence intensity Standard Deviation 1505.636
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister CD83, Session2,Day2, 24 hours, n=2, 4, 2, 4	420.50 Mean fluorescence intensity Standard Deviation 3235.014	1243.25 Mean fluorescence intensity Standard Deviation 3307.491	2690.50 Mean fluorescence intensity Standard Deviation 4319.008	918.75 Mean fluorescence intensity Standard Deviation 1945.597
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister CD83, Session2,Day3, 48 hours, n=2, 4, 2, 4	-1703.75 Mean fluorescence intensity Standard Deviation 15.203	-1046.38 Mean fluorescence intensity Standard Deviation 561.034	745.75 Mean fluorescence intensity Standard Deviation 496.743	-1668.63 Mean fluorescence intensity Standard Deviation 2068.363
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister CD86+, Session1,Day3, 48 hours, n=2, 4, 2, 4	792.50 Mean fluorescence intensity Standard Deviation 338.704	577.50 Mean fluorescence intensity Standard Deviation 1141.719	2311.50 Mean fluorescence intensity Standard Deviation 1262.186	28.25 Mean fluorescence intensity Standard Deviation 2057.408
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister CD86+, Session2,Day2, 24 hours, n=2, 4, 2, 4	381.25 Mean fluorescence intensity Standard Deviation 2896.663	674.50 Mean fluorescence intensity Standard Deviation 1496.032	-329.75 Mean fluorescence intensity Standard Deviation 197.636	-570.75 Mean fluorescence intensity Standard Deviation 3118.314
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister CD86+, Session2,Day3, 48 hours, n=2, 4, 2, 4	13.75 Mean fluorescence intensity Standard Deviation 285.318	1692.50 Mean fluorescence intensity Standard Deviation 1687.192	181.75 Mean fluorescence intensity Standard Deviation 506.642	517.50 Mean fluorescence intensity Standard Deviation 5171.981
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister HLA-DR, Session1,Day3, 48 hours, n=2, 4, 2, 4	3326.25 Mean fluorescence intensity Standard Deviation 1854.388	-7695.38 Mean fluorescence intensity Standard Deviation 19317.582	6003.75 Mean fluorescence intensity Standard Deviation 17276.386	-5724.25 Mean fluorescence intensity Standard Deviation 49407.676
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister HLA-DR, Session2,Day2, 24 hours, n=2, 4, 2, 4	7435.25 Mean fluorescence intensity Standard Deviation 35884.608	13061.88 Mean fluorescence intensity Standard Deviation 29527.416	1273.75 Mean fluorescence intensity Standard Deviation 3391.638	36041.13 Mean fluorescence intensity Standard Deviation 33139.756
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister HLA-DR, Session2,Day3, 48 hours, n=2, 4, 2, 4	-882.00 Mean fluorescence intensity Standard Deviation 1575.434	-20377.25 Mean fluorescence intensity Standard Deviation 25175.815	-8397.75 Mean fluorescence intensity Standard Deviation 19009.505	11460.13 Mean fluorescence intensity Standard Deviation 56951.939
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister CD16+, Session1,Day3, 48 hours, n=2, 4, 2, 4	-5027.00 Mean fluorescence intensity Standard Deviation 5289.866	4510.75 Mean fluorescence intensity Standard Deviation 7162.125	-3449.75 Mean fluorescence intensity Standard Deviation 1895.400	-2607.25 Mean fluorescence intensity Standard Deviation 6559.210
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister CD206+, Session2,Day3, 48 hours, n=2, 4, 2, 4	-1229.25 Mean fluorescence intensity Standard Deviation 973.332	-2542.63 Mean fluorescence intensity Standard Deviation 4084.922	-2193.50 Mean fluorescence intensity Standard Deviation 543.765	-2622.75 Mean fluorescence intensity Standard Deviation 3423.992
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister CD16+, Session2,Day2, 24 hours, n=2, 4, 2, 4	13111.25 Mean fluorescence intensity Standard Deviation 32672.929	-2948.25 Mean fluorescence intensity Standard Deviation 3659.787	5372.75 Mean fluorescence intensity Standard Deviation 235.113	-1010.00 Mean fluorescence intensity Standard Deviation 5492.201
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister CD16+, Session2,Day3, 48 hours, n=2, 4, 2, 4	-4621.75 Mean fluorescence intensity Standard Deviation 8382.397	-6203.50 Mean fluorescence intensity Standard Deviation 13105.657	-3286.25 Mean fluorescence intensity Standard Deviation 947.170	-3653.63 Mean fluorescence intensity Standard Deviation 5345.655
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister CD163+, Session1,Day3, 48 hours, n=2, 4, 2, 4	888.500 Mean fluorescence intensity Standard Deviation 292.0351	400.500 Mean fluorescence intensity Standard Deviation 455.9359	270.250 Mean fluorescence intensity Standard Deviation 97.9343	723.125 Mean fluorescence intensity Standard Deviation 717.7969
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister CD163+, Session2,Day2, 24 hours, n=2, 4, 2, 4	49.750 Mean fluorescence intensity Standard Deviation 215.3140	48.250 Mean fluorescence intensity Standard Deviation 163.7506	415.250 Mean fluorescence intensity Standard Deviation 142.4820	169.750 Mean fluorescence intensity Standard Deviation 160.7060
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister CD163+, Session2,Day3, 48 hours, n=2, 4, 2, 4	1012.000 Mean fluorescence intensity Standard Deviation 501.3387	411.000 Mean fluorescence intensity Standard Deviation 524.8443	719.250 Mean fluorescence intensity Standard Deviation 63.9932	789.513 Mean fluorescence intensity Standard Deviation 825.7539
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister CD206+, Session1,Day3, 48 hours, n=2, 4, 2, 4	81.00 Mean fluorescence intensity Standard Deviation 2206.173	-1275.50 Mean fluorescence intensity Standard Deviation 3073.903	-955.75 Mean fluorescence intensity Standard Deviation 1183.343	-734.88 Mean fluorescence intensity Standard Deviation 5799.935
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister CD206+, Session2,Day2, 24 hours, n=2, 4, 2, 4	4503.00 Mean fluorescence intensity Standard Deviation 9540.992	564.00 Mean fluorescence intensity Standard Deviation 2911.625	-1329.50 Mean fluorescence intensity Standard Deviation 1668.065	12596.63 Mean fluorescence intensity Standard Deviation 16264.004
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister CD209+, Session1,Day3,48 hours, n=2, 4, 2, 4	931.00 Mean fluorescence intensity Standard Deviation 505.581	458.88 Mean fluorescence intensity Standard Deviation 1827.032	-333.00 Mean fluorescence intensity Standard Deviation 416.486	890.88 Mean fluorescence intensity Standard Deviation 2206.644
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister CD209+, Session2,Day2, 24 hours, n=2, 4, 2, 4	474.75 Mean fluorescence intensity Standard Deviation 485.429	21.63 Mean fluorescence intensity Standard Deviation 1282.820	1672.25 Mean fluorescence intensity Standard Deviation 1038.386	5641.13 Mean fluorescence intensity Standard Deviation 4969.374
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister CD209+, Session2,Day3, 48 hours, n=2, 4, 2, 4	565.75 Mean fluorescence intensity Standard Deviation 840.396	-236.13 Mean fluorescence intensity Standard Deviation 1413.395	1607.75 Mean fluorescence intensity Standard Deviation 1283.752	2835.13 Mean fluorescence intensity Standard Deviation 2917.207
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister CD40, Session1,Day3, 48 hours, n=2, 4, 2, 4	593.25 Mean fluorescence intensity Standard Deviation 20.860	198.00 Mean fluorescence intensity Standard Deviation 1021.994	371.75 Mean fluorescence intensity Standard Deviation 1282.338	-59.50 Mean fluorescence intensity Standard Deviation 536.615
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister CD40, Session2,Day2, 24 hours, n=2, 4, 2, 4	1007.00 Mean fluorescence intensity Standard Deviation 1119.350	-43.38 Mean fluorescence intensity Standard Deviation 837.351	-691.50 Mean fluorescence intensity Standard Deviation 542.351	3426.13 Mean fluorescence intensity Standard Deviation 4547.393

Measure	Part 1: LPS 0.5 ng/kg n=2 Participants Participants were randomized to receive 0.5 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: LPS 0.75 ng/kg n=4 Participants Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: LPS 1 ng/kg n=2 Participants Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.	Part 1: GM-CSF 60 µg/m^2 n=4 Participants Participants were randomized to receive 60 µg/m\^2 GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood IL-8, Session2,Day1, -5 minutes, n=2, 4, 2,4	-1.4835 Picograms per milliliter Standard Deviation 2.97824	0.0761 Picograms per milliliter Standard Deviation 0.99505	0.1849 Picograms per milliliter Standard Deviation 0.08020	83.1531 Picograms per milliliter Standard Deviation 44.11662
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood INFg, Session2,Day1, -5 minutes, n=2, 4, 2, 4	-0.5636 Picograms per milliliter Standard Deviation 0.24961	-0.1278 Picograms per milliliter Standard Deviation 0.23076	0.0653 Picograms per milliliter Standard Deviation 0.80201	5.7255 Picograms per milliliter Standard Deviation 1.85029
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood INFg, Session2,Day1, 10 minutes, n=2, 4, 2, 4	-0.4140 Picograms per milliliter Standard Deviation 0.05250	-0.3298 Picograms per milliliter Standard Deviation 0.20362	-0.2355 Picograms per milliliter Standard Deviation 0.28729	6.0071 Picograms per milliliter Standard Deviation 1.26842
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood INFg, Session2,Day1, 25 minutes, n=1, 4, 2, 4	-0.6996 Picograms per milliliter Standard Deviation NA NA indicates that data was not available as standard deviation could not be calculated for a single participant.	-0.3697 Picograms per milliliter Standard Deviation 0.19518	-0.2432 Picograms per milliliter Standard Deviation 0.30593	6.1605 Picograms per milliliter Standard Deviation 1.77144
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood INFg, Session2,Day1, 40 minutes, n=2, 4, 2, 4	-0.6745 Picograms per milliliter Standard Deviation 0.26829	-0.4771 Picograms per milliliter Standard Deviation 0.41990	0.1501 Picograms per milliliter Standard Deviation 0.28816	5.4142 Picograms per milliliter Standard Deviation 2.07138
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood INFg, Session2,Day1, 1 hour 10 minutes, n=2, 4,2,4	1.8597 Picograms per milliliter Standard Deviation 2.47610	1.7673 Picograms per milliliter Standard Deviation 1.80932	6.6083 Picograms per milliliter Standard Deviation 0.78111	4.9508 Picograms per milliliter Standard Deviation 1.77082
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood INFg, Session2,Day1, 1 hour 40 minutes, n=2, 4,2,4	6.5709 Picograms per milliliter Standard Deviation 5.72091	6.5863 Picograms per milliliter Standard Deviation 3.69982	13.6809 Picograms per milliliter Standard Deviation 3.56564	3.8804 Picograms per milliliter Standard Deviation 2.00819
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood INFg, Session2,Day1, 2 hour 40 minutes, n=2, 4,2,4	9.1319 Picograms per milliliter Standard Deviation 7.94104	8.7498 Picograms per milliliter Standard Deviation 2.97730	15.7306 Picograms per milliliter Standard Deviation 3.51048	2.7181 Picograms per milliliter Standard Deviation 2.63053
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood INFg, Session2,Day1, 5 hour 40 minutes, n=2, 4,2,4	3.5927 Picograms per milliliter Standard Deviation 3.83382	3.2672 Picograms per milliliter Standard Deviation 1.86587	5.0294 Picograms per milliliter Standard Deviation 3.92184	1.7041 Picograms per milliliter Standard Deviation 1.64895
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood INFg, Session2,Day2, Pre-fluid sampling, n=2,4,2,4	-3.7611 Picograms per milliliter Standard Deviation 1.04373	0.7630 Picograms per milliliter Standard Deviation 1.43167	-0.3514 Picograms per milliliter Standard Deviation 1.05828	-3.0755 Picograms per milliliter Standard Deviation 2.76516
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood INFg, Session2,Day3, Pre-fluid sampling, n=2,4,2,4	-4.3628 Picograms per milliliter Standard Deviation 0.31014	1.5962 Picograms per milliliter Standard Deviation 3.09933	-2.6600 Picograms per milliliter Standard Deviation 1.75306	-3.2817 Picograms per milliliter Standard Deviation 2.72811
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood IL-1b, Session2,Day1, -5 minutes, n=2, 4, 2,4	0.0000 Picograms per milliliter Standard Deviation 0.0000	0.0000 Picograms per milliliter Standard Deviation 0.0000	0.0000 Picograms per milliliter Standard Deviation 0.0000	0.0000 Picograms per milliliter Standard Deviation 0.0000
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood IL-1b, Session2,Day1, 10 minutes, n=2, 4, 2,4	0.0000 Picograms per milliliter Standard Deviation 0.0000	0.0008 Picograms per milliliter Standard Deviation 0.00150	0.0000 Picograms per milliliter Standard Deviation 0.0000	0.0000 Picograms per milliliter Standard Deviation 0.0000
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood IL-1b, Session2,Day1, 25 minutes, n=1, 4, 2,4	0.0000 Picograms per milliliter Standard Deviation NA NA indicates that data was not available as standard deviation could not be calculated for a single participant.	0.0000 Picograms per milliliter Standard Deviation 0.00000	0.0000 Picograms per milliliter Standard Deviation 0.00000	0.0000 Picograms per milliliter Standard Deviation 0.00000
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood IL-1b, Session2,Day1, 40 minutes, n=2, 4, 2,4	0.0000 Picograms per milliliter Standard Deviation 0.00000	0.0008 Picograms per milliliter Standard Deviation 0.00150	0.0000 Picograms per milliliter Standard Deviation 0.00000	0.0000 Picograms per milliliter Standard Deviation 0.00000
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood IL-1b, Session2,Day1, 1hour 10minutes, n=2,4,2,4	0.0000 Picograms per milliliter Standard Deviation 0.00000	0.0008 Picograms per milliliter Standard Deviation 0.00150	0.0000 Picograms per milliliter Standard Deviation 0.00000	0.0000 Picograms per milliliter Standard Deviation 0.00000
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood IL-1b, Session2,Day1, 1hour 40minutes, n=2,4,2,4	0.0000 Picograms per milliliter Standard Deviation 0.00000	0.1875 Picograms per milliliter Standard Deviation 0.37303	0.0000 Picograms per milliliter Standard Deviation 0.00000	0.0000 Picograms per milliliter Standard Deviation 0.00000
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood IL-1b, Session2,Day1, 2hour 40minutes, n=2,4,2,4	0.0000 Picograms per milliliter Standard Deviation 0.00000	0.3194 Picograms per milliliter Standard Deviation 0.41468	0.0000 Picograms per milliliter Standard Deviation 0.00000	0.0000 Picograms per milliliter Standard Deviation 0.00000
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood IL-1b, Session2,Day1, 5hour 40minutes, n=2,4,2,4	0.0000 Picograms per milliliter Standard Deviation 0.00000	0.0008 Picograms per milliliter Standard Deviation 0.00150	0.0000 Picograms per milliliter Standard Deviation 0.00000	0.0000 Picograms per milliliter Standard Deviation 0.00000
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood IL-1b, Session2,Day2,Pre-fluid sample, n=2,4,2,4	0.2225 Picograms per milliliter Standard Deviation 0.31897	0.0008 Picograms per milliliter Standard Deviation 0.00150	-0.0030 Picograms per milliliter Standard Deviation 0.00000	0.0857 Picograms per milliliter Standard Deviation 0.10517
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood IL-1b, Session2,Day3,Pre-fluid sample, n=2,4,2,4	-0.0030 Picograms per milliliter Standard Deviation 0.00000	0.0008 Picograms per milliliter Standard Deviation 0.00150	-0.0030 Picograms per milliliter Standard Deviation 0.00000	-0.0015 Picograms per milliliter Standard Deviation 0.00173
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood IL-2, Session2,Day1, -5 minutes, n=0, 4, 2,4	—	0.0000 Picograms per milliliter Standard Deviation 0.00000	0.0000 Picograms per milliliter Standard Deviation 0.00000	0.0000 Picograms per milliliter Standard Deviation 0.00000
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood IL-2, Session2,Day1, 10 minutes, n=0, 4, 2,2	—	0.0031 Picograms per milliliter Standard Deviation 0.00625	0.0000 Picograms per milliliter Standard Deviation 0.00000	0.0000 Picograms per milliliter Standard Deviation 0.00000
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood IL-2, Session2,Day1, 40 minutes, n=0, 3, 2,2	—	0.0000 Picograms per milliliter Standard Deviation 0.00000	0.0000 Picograms per milliliter Standard Deviation 0.00000	0.0000 Picograms per milliliter Standard Deviation 0.00000
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood IL-2, Session2,Day1, 1 hour 10 minutes, n=0, 4,2,4	—	0.0031 Picograms per milliliter Standard Deviation 0.00625	0.0000 Picograms per milliliter Standard Deviation 0.00000	0.0000 Picograms per milliliter Standard Deviation 0.00000
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood IL-2, Session2,Day1, 1 hour 40 minutes, n=0, 4,2,2	—	0.0031 Picograms per milliliter Standard Deviation 0.00625	0.0000 Picograms per milliliter Standard Deviation 0.00000	0.0000 Picograms per milliliter Standard Deviation 0.00000
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood IL-2, Session2,Day1, 2 hour 40 minutes, n=0, 4,2,2	—	0.0031 Picograms per milliliter Standard Deviation 0.00625	0.0000 Picograms per milliliter Standard Deviation 0.00000	0.0000 Picograms per milliliter Standard Deviation 0.00000
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood IL-2, Session2,Day1, 5 hour 40 minutes, n=0, 4,2,2	—	0.0031 Picograms per milliliter Standard Deviation 0.00625	0.0000 Picograms per milliliter Standard Deviation 0.00000	0.0000 Picograms per milliliter Standard Deviation 0.00000
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood IL-2, Session2,Day2, Pre-fluid sampling, n=2,4,2,4	0.0000 Picograms per milliliter Standard Deviation 0.00000	0.0031 Picograms per milliliter Standard Deviation 0.00625	-0.0160 Picograms per milliliter Standard Deviation 0.00000	-0.0018 Picograms per milliliter Standard Deviation 0.01645
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood IL-2, Session2,Day3, Pre-fluid sampling, n=2,4,2,4	0.0000 Picograms per milliliter Standard Deviation 0.00000	0.0031 Picograms per milliliter Standard Deviation 0.00625	-0.0160 Picograms per milliliter Standard Deviation 0.00000	-0.0018 Picograms per milliliter Standard Deviation 0.01645
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood IL-8, Session2,Day1, 10 minutes, n=2, 4, 2,4	2.2890 Picograms per milliliter Standard Deviation 3.42770	0.0714 Picograms per milliliter Standard Deviation 1.30027	0.8613 Picograms per milliliter Standard Deviation 0.83194	89.0123 Picograms per milliliter Standard Deviation 48.41011
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood IL-8, Session2,Day1, 25 minutes, n=1, 4, 2,4	1.7998 Picograms per milliliter Standard Deviation NA NA indicates that data was not available as standard deviation could not be calculated for a single participant.	0.6814 Picograms per milliliter Standard Deviation 1.27650	3.0142 Picograms per milliliter Standard Deviation 1.22739	86.4178 Picograms per milliliter Standard Deviation 47.57975
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood IL-8, Session2,Day1, 40 minutes, n=2, 3, 2,4	9.4905 Picograms per milliliter Standard Deviation 1.93306	9.3036 Picograms per milliliter Standard Deviation 5.86829	27.1507 Picograms per milliliter Standard Deviation 3.96686	50.4514 Picograms per milliliter Standard Deviation 20.49601
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood MCP-1, Session2,Day1, -5 minutes, n=2, 4, 2,4	-1.984 Picograms per milliliter Standard Deviation 0.9353	7.280 Picograms per milliliter Standard Deviation 11.0662	-12.078 Picograms per milliliter Standard Deviation 6.4316	2702.736 Picograms per milliliter Standard Deviation 1675.5428
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood IL-8, Session2,Day1, 1 hour 10 minutes, n=2, 3,2,4	105.0587 Picograms per milliliter Standard Deviation 43.02522	141.7558 Picograms per milliliter Standard Deviation 104.21164	162.3033 Picograms per milliliter Standard Deviation 42.93991	76.6709 Picograms per milliliter Standard Deviation 36.79748
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood IL-8, Session2,Day1, 2 hour 40 minutes, n=2,3, 2,4	49.6247 Picograms per milliliter Standard Deviation 26.76026	340.0657 Picograms per milliliter Standard Deviation 234.74182	111.6155 Picograms per milliliter Standard Deviation 118.63027	126.3552 Picograms per milliliter Standard Deviation 204.81735
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood IL-8, Session2,Day1, 5 hour 40 minutes, n=2,3, 2,4	7.6772 Picograms per milliliter Standard Deviation 3.55867	88.5574 Picograms per milliliter Standard Deviation 24.09240	19.5090 Picograms per milliliter Standard Deviation 6.86764	30.1483 Picograms per milliliter Standard Deviation 10.71198
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood IL-8, Session2,Day2, Pre-fluid sampling, n=2,3,2,4	3.8330 Picograms per milliliter Standard Deviation 7.21699	8.7544 Picograms per milliliter Standard Deviation 16.57327	-1.3116 Picograms per milliliter Standard Deviation 1.93618	33.5296 Picograms per milliliter Standard Deviation 54.13468
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood IL-8, Session2,Day3, Pre-fluid sampling, n=2,4,2,4	-1.3819 Picograms per milliliter Standard Deviation 2.32148	0.6465 Picograms per milliliter Standard Deviation 2.78896	-0.8507 Picograms per milliliter Standard Deviation 0.69264	-2.0468 Picograms per milliliter Standard Deviation 1.21979
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood MCP-1, Session2,Day1, 10 minutes, n=2, 4, 2,4	1.716 Picograms per milliliter Standard Deviation 33.8987	15.335 Picograms per milliliter Standard Deviation 18.3588	-6.963 Picograms per milliliter Standard Deviation 11.3479	3692.647 Picograms per milliliter Standard Deviation 1671.9037
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood MCP-1, Session2,Day1, 25 minutes, n=1, 4, 2,4	-25.166 Picograms per milliliter Standard Deviation NA NA indicates that data was not available as standard deviation could not be calculated for a single participant.	22.679 Picograms per milliliter Standard Deviation 14.0540	9.360 Picograms per milliliter Standard Deviation 10.2709	4354.050 Picograms per milliliter Standard Deviation 1579.4757
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood MCP-1, Session2,Day1, 40 minutes, n=2, 4, 2,4	53.774 Picograms per milliliter Standard Deviation 44.7737	108.005 Picograms per milliliter Standard Deviation 54.2180	273.261 Picograms per milliliter Standard Deviation 29.0646	4218.511 Picograms per milliliter Standard Deviation 1850.5204
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood MCP-1, Session2,Day1, 1 hour 10 minutes, n=2,4,2,4	1092.558 Picograms per milliliter Standard Deviation 576.0879	3281.560 Picograms per milliliter Standard Deviation 2188.7631	2993.718 Picograms per milliliter Standard Deviation 17.3345	4119.865 Picograms per milliliter Standard Deviation 2047.7930
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood MCP-1, Session2,Day1, 1 hour 40 minutes, n=2,4,2,4	2521.255 Picograms per milliliter Standard Deviation 1886.7927	5164.946 Picograms per milliliter Standard Deviation 25.3073	6182.663 Picograms per milliliter Standard Deviation 13.9688	2659.013 Picograms per milliliter Standard Deviation 1778.3867
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood MCP-1, Session2,Day1, 2 hour 40 minutes, n=2,4,2,4	1449.223 Picograms per milliliter Standard Deviation 880.4065	5189.946 Picograms per milliliter Standard Deviation 75.0973	6824.798 Picograms per milliliter Standard Deviation 3014.6330	1405.284 Picograms per milliliter Standard Deviation 603.0458
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood MCP-1, Session2,Day1, 5 hour 40 minutes, n=2,4,2,4	126.224 Picograms per milliliter Standard Deviation 72.8644	588.424 Picograms per milliliter Standard Deviation 384.1274	350.071 Picograms per milliliter Standard Deviation 81.7289	365.641 Picograms per milliliter Standard Deviation 156.6637
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood MCP-1, Session2,Day2,Pre-fluid sampling, n=2,4,2,4	-0.963 Picograms per milliliter Standard Deviation 23.0612	38.016 Picograms per milliliter Standard Deviation 54.7584	-2.917 Picograms per milliliter Standard Deviation 42.8500	-14.427 Picograms per milliliter Standard Deviation 32.7430
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood MCP-1, Session2,Day3,Pre-fluid sampling, n=2,4,2,4	-12.333 Picograms per milliliter Standard Deviation 0.9485	28.822 Picograms per milliliter Standard Deviation 23.2955	8.210 Picograms per milliliter Standard Deviation 9.0286	-15.571 Picograms per milliliter Standard Deviation 25.0756
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood IL-2, Session2,Day1, 25 minutes, n=0, 4, 2,4	—	0.0031 Picograms per milliliter Standard Deviation 0.00625	0.0000 Picograms per milliliter Standard Deviation 0.00000	0.0000 Picograms per milliliter Standard Deviation 0.00000
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood IL-8, Session2,Day1, 1 hour 40 minutes, n=2,3, 2,4	214.1372 Picograms per milliliter Standard Deviation 181.31639	468.8635 Picograms per milliliter Standard Deviation 296.06234	229.6116 Picograms per milliliter Standard Deviation 155.88116	77.3493 Picograms per milliliter Standard Deviation 73.83422