Arthritis, Rheumatoid
Conditions
Keywords
Inflammation, GM-CSF, LPS, Skin blisters, Healthy subjects, cantharidin
Brief summary
This exploratory study aims to assess exposure of healthy subjects to systemic challenge with either LPS or GM-CSF. This will be done by measuring inflammatory mediators and cellular activation markers both in circulation and in skin blisters induced by exposure to cantharidin (an agent that causes blisters). LPS is often used to induce inflammation whereas GM-CSF is a cytokine and a key mediator in inflammatory diseases. In this 2 parts study, subjects will have 2 sessions in each part. Part I of the study is a dose-exploration phase and part II will be a continuation phase to draw more precise outcomes. In session 1, subjects will be randomized to receive either LPS or GM-CSF and will have 2 blisters induced on each forearm followed by blood draws and a blister harvest on each forearm at 24 and 48 hours post-induction. After a minimum of 14 days blister healing period, subjects will return for session 2. In part I, Up to 6 cohorts will be tested and all cohorts will have 2 sessions. For Part I, initially Cohort 1 will proceed with session 1. After their blister healing period, Cohort 1 will return for their session 2 visit in two groups (Group A and Group B) on different days. Group A will be dosed on the same day (one with LPS and one with GM-CSF) and Group B will be dosed on a different day (one with LPS and one with GM-CSF) after group A. Dose-escalation in Cohort 2-6 will be continued until the well tolerated dose has been determined. The same dose will be administered to an additional Cohort in Part II and the same 2-session design will be used. Approximately 24-30 healthy subjects will be enrolled for the study and the total duration of the study for each subject will be approximately 13 weeks from screening to follow up.
Interventions
BIOLOGICALCantharidin
5 microliter (µL) of 0.2 percent Cantharidin solution (diluted in acetone) will be applied to all subjects on forearm by topical route.
BIOLOGICALLipopolysaccharide
0.5 to 4 ng/kg body weight of LPS formulated as suspension in normal saline will be administered to randomized subjects via intravenous (IV) route in dose-escalation manner.
5 to 15 µg/kg of GM-CSF will be administered to randomized subjects via subcutaneous (SC) route in the abdominal region in dose-escalation manner.
DRUGSaline Solution
0.9 percent sodium chloride will be administered via IV route to all subjects at a rate of 250 mL/hour for 4 hours prior to dosing with LPS and 8 hours after dosing with LPS.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
This will be an open label study and no masking will be performed.
Intervention model description
Subjects in 2 separate groups will be randomized to receive either LPS or GM-CSF at the same time.
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects must be 18 to 45 years of age inclusive, at the time of signing the informed consent. * Subjects who are overtly healthy as determined by medical evaluation including: medical history, physical examination, laboratory tests, and electrocardiogram (ECG). * Body mass index (BMI) within the range 19.0-30.0 kilogram per meter square (kg/m\^2) (inclusive). * All male subjects. All subjects must agree to use contraception during session 2 and refrain from donating sperm from session 2 to end of study (follow up 2 visits). * Capable of giving signed informed consent.
Exclusion criteria
* A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening. * A positive test for human immuno deficiency virus (HIV) antibody. * Persistent abnormal C-reactive protein/ white cell count (CRP/ WCC) levels at screening. * Abnormal liver function tests at screening. For healthy subjects: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase and bilirubin more than or equal to 1.5xupper limit of normal (ULN) (isolated bilirubin more than 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin less than 35 percent) at screening. * A positive pre-study drug/alcohol screen. * Current, or chronic history of (h/o): liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones), anaphylaxis, and /or anaphylactoid (resembling anaphylaxis) reactions; Cardiac, respiratory or renal disease (childhood asthma can be included); Sensitivity or severe allergic responses to any of the challenge agents or cantharidin, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or GlaxoSmithKline (GSK) Medical Monitor, contraindicates their participation; Vasovagal syncope; Surgery or significant trauma in 3 months leading to study enrolment; Relevant skin conditions (for example recent h/o eczema or recurrent eczema, keloid, skin allergies, psoriasis, atopic dermatitis, and vitiligo) which in the opinion of the investigator could pose safety issues or cause interference with study procedures; Sepsis or known coagulation disorders; Peripheral edema, lymphangitis, lymph edema, pleural or pericardial effusion; Respiratory conditions including but not limited to asthma, Chronic obstructive pulmonary disease (COPD), and bronchiectasis and any current respiratory infection. * Presence on either forearm of tattoos, naevi, hypertrophic scars, keloids, hyper or hypo-pigmentation. Subjects with very fair skin, very dark skin, excessive hair or any skin abnormalities that may, in the opinion of the Investigator, interfere with study assessments. * Unable to refrain from the use of prescription drugs taken on an intermittent (as needed) basis or non-prescription drugs; these include non-steroidal anti-inflammatory drugs (NSAIDs), vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to Day 1 of session 1 and continuing until the final follow up visit). * The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 90 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer) or currently in a study of an investigational device. * Previous exposure to LPS in a clinical research setting. Where participation in the study would result in donation of blood or blood products in excess of 500 milliliter (mL) within a 56-day period; Current smoker or former regular smoker within 6 months before the screening visit; Unwillingness or inability to follow the procedures outlined in the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Change From Baseline Primary Soluble Inflammatory Mediators in Blood: Tumor Necrosis Factor (TNF) Alpha and Interleukin (IL) 6 for LPS Arm | 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 | 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. |
| Part 1: Change From Baseline in Primary Soluble Inflammatory Mediators : Urinary Tetranor Prostaglandin D Metabolite (PGDM) LPS Arm | Baseline, Session 2 Day 1 | 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. |
| Part 2: Change From Baseline Primary Soluble Inflammatory Mediators in Blood: TNF Alpha and IL 6: LPS Arm | 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 | 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. |
| Part 2: Change From Baseline Primary Soluble Inflammatory Mediators : Urinary Tetranor PGDM: LPS Arm | Baseline, Session 2 Day 1 | 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. |
| Part 1: Change From Baseline in White Blood Cell Numbers in Blood: GM-CSF | 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 | 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. |
| Part 2: Change From Baseline in White Blood Cell Numbers in Blood: GM-CSF | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister | Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3 | 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. |
| Part 2:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister | Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3 | 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. |
| Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Monocytes in Blister | Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3 | 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. |
| Part 2:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Monocytes in Blister | Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3 | 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. |
| Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister | Baseline; Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3 | 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. |
| Part 2:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister | Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3 | 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. |
| Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Dendritic Cells in Blister | Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3 | 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. |
| Part 2:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Dendritic Cells in Blister | Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3 | 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. |
| Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister | Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3 | 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. |
| Part 2:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister | Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3 | 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. |
| Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Macrophages in Blister | Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3 | 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. |
| Part 2:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Macrophages in Blister | Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3 | 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. |
| Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | Baseline; Session1: 48 hours on Day3; Session 2: 24 hours on Day 2 and 48 hours on Day 3 | 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. |
| Part 2:Change From Baseline in Soluble Inflammatory Mediators in Blood | 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 | 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. |
| Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF: GM-CSF Arm | 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 | 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. |
| Part 2: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF for GM-CSF Arm | 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 | 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. |
| Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: C-reactive Protein (CRP) | Baseline; Session 2: Post challenge Day 1. Pre-fluid sample on Day 2 and Day 3 | 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. |
| Part 2: Change From Baseline in Soluble Inflammatory Mediators in Blood: CRP | Baseline; Session 2: Post challenge Day 1; Pre-fluid sample on Day 2 and Day 3 | 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. |
| Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | 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 | 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. |
| Part 2: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | 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 | 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. |
| Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | 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 | 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. |
| Part 2: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | 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 | 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. |
| Part 1: Change From Baseline in Circulating Leukocyte Numbers in Blood: LPS Arm | 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 | 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. |
| Part 2: Change From Baseline in Circulating Leukocyte Numbers in Blood: LPS Arm | 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 | 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. |
| Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | 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 | 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. |
| Part 2: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | Baseline; Session1: 48 hours Day3; Session 2: 24 hours Day 2 and 48 hours Day 3 | 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. |
| Part 1: Absolute Values of Blister Volume | Baseline, Session 1: 48 hours Day 3. Session 2: 24 hours Day 2, 48 hours Day 3 | 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. |
| Part 2: Absolute Values of Blister Volume | Baseline, Session 1: 48 hours Day 3. Session 2: 24 hours Day 2, 48 hours Day 3 | 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. |
| Part 1: Change From Baseline in Cell Numbers in Blister | Baseline, Session 1: 48 hours Day 3. Session 2: 24 hours Day 2, 48 hours Day 3 | 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. |
| Part 2: Change From Baseline in Cell Numbers in Blister | Baseline, Session 1: 48 hours Day 3. Session 2: 24 hours Day 2, 48 hours Day 3 | 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. |
Countries
United Kingdom
Participant flow
Recruitment details
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).
Pre-assignment details
Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 2 |
| 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. | 4 |
| 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. | 2 |
| 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 | 4 |
| 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. | 0 |
| 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. | 0 |
| Total | 12 |
Baseline characteristics
| Characteristic | Part 1: LPS 0.5 ng/kg | Part 1: LPS 0.75 ng/kg | Part 1: LPS 1 ng/kg | Part 1: GM-CSF 60 µg/m^2 | Total |
|---|---|---|---|---|---|
| Age, Continuous | 23.5 Years STANDARD_DEVIATION 4.95 | 35.5 Years STANDARD_DEVIATION 7.55 | 31.5 Years STANDARD_DEVIATION 10.61 | 33.5 Years STANDARD_DEVIATION 7.33 | 32.2 Years STANDARD_DEVIATION 7.81 |
| Race/Ethnicity, Customized White: WHITE/CAUCASIAN/EUROPEAN HERITAGE | 2 Count of Participants | 4 Count of Participants | 2 Count of Participants | 4 Count of Participants | 12 Count of Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 2 Participants | 4 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 4 | 0 / 2 | 0 / 4 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 2 / 2 | 4 / 4 | 2 / 2 | 3 / 4 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 2 | 0 / 4 | 0 / 2 | 0 / 4 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Part 1: Change From Baseline in Primary Soluble Inflammatory Mediators : Urinary Tetranor Prostaglandin D Metabolite (PGDM) LPS Arm
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: LPS 0.5 ng/kg | 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 | — |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.75 ng/kg | 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 | -146.294 Picograms per milligram | Standard Deviation 165.8587 |
| Part 1: LPS 0.75 ng/kg | 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 | -85.080 Picograms per milligram | Standard Deviation 226.4168 |
| Part 1: LPS 0.75 ng/kg | 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 | 88.984 Picograms per milligram | Standard Deviation 155.1855 |
| Part 1: LPS 0.75 ng/kg | 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 | 25.390 Picograms per milligram | Standard Deviation 181.8009 |
| Part 1: LPS 0.75 ng/kg | 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 | -68.209 Picograms per milligram | Standard Deviation 262.6169 |
| Part 1: LPS 0.75 ng/kg | 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 |
| Part 1: LPS 0.75 ng/kg | 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 |
| Part 1: LPS 0.75 ng/kg | 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 |
| Part 1: LPS 0.75 ng/kg | 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 |
| Part 1: LPS 0.75 ng/kg | 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 | — |
| Part 1: LPS 0.75 ng/kg | 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 | — |
| Part 1: LPS 1 ng/kg | 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 | -125.839 Picograms per milligram | — |
| Part 1: LPS 1 ng/kg | 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 | -30.861 Picograms per milligram | — |
| Part 1: LPS 1 ng/kg | 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 | 6.336 Picograms per milligram | — |
| Part 1: LPS 1 ng/kg | 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 | -78.792 Picograms per milligram | — |
| Part 1: LPS 1 ng/kg | 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 | 200.337 Picograms per milligram | Standard Deviation 183.9484 |
| Part 1: LPS 1 ng/kg | 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 | -117.672 Picograms per milligram | — |
| Part 1: LPS 1 ng/kg | 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 | 140.482 Picograms per milligram | Standard Deviation 108.788 |
| Part 1: LPS 1 ng/kg | 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 | 276.788 Picograms per milligram | Standard Deviation 134.719 |
| Part 1: LPS 1 ng/kg | 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 | 134.806 Picograms per milligram | Standard Deviation 166.6716 |
| Part 1: LPS 1 ng/kg | 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 | 184.263 Picograms per milligram | Standard Deviation 262.902 |
| Part 1: LPS 1 ng/kg | 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 | -37.732 Picograms per milligram | — |
Primary
Part 1: Change From Baseline in White Blood Cell Numbers in Blood: GM-CSF
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: LPS 0.5 ng/kg | 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: LPS 0.5 ng/kg | 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: LPS 0.5 ng/kg | 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: LPS 0.5 ng/kg | 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: LPS 0.5 ng/kg | 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: LPS 0.5 ng/kg | 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
Part 1: Change From Baseline Primary Soluble Inflammatory Mediators in Blood: Tumor Necrosis Factor (TNF) Alpha and Interleukin (IL) 6 for LPS Arm
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 16.5295 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 | — |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 | — |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.75 ng/kg | 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 | 15.4828 Picograms per milliliter | Standard Deviation 7.05404 |
| Part 1: LPS 0.75 ng/kg | 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 | 0.2798 Picograms per milliliter | Standard Deviation 0.12546 |
| Part 1: LPS 0.75 ng/kg | 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 | 0.2450 Picograms per milliliter | Standard Deviation 0.16048 |
| Part 1: LPS 0.75 ng/kg | 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 | 1.3623 Picograms per milliliter | Standard Deviation 0.8829 |
| Part 1: LPS 0.75 ng/kg | 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 | 8.7622 Picograms per milliliter | Standard Deviation 8.41234 |
| Part 1: LPS 0.75 ng/kg | 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 | 81.0629 Picograms per milliliter | Standard Deviation 104.23961 |
| Part 1: LPS 0.75 ng/kg | 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 | 193.7107 Picograms per milliliter | Standard Deviation 218.97996 |
| Part 1: LPS 0.75 ng/kg | 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 | 133.2063 Picograms per milliliter | Standard Deviation 92.47028 |
| Part 1: LPS 0.75 ng/kg | 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 | 2.5645 Picograms per milliliter | Standard Deviation 1.20737 |
| Part 1: LPS 0.75 ng/kg | 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 | 3.2880 Picograms per milliliter | Standard Deviation 2.52703 |
| Part 1: LPS 0.75 ng/kg | 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 | 0.5909 Picograms per milliliter | Standard Deviation 0.96127 |
| Part 1: LPS 0.75 ng/kg | 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 | -0.0726 Picograms per milliliter | Standard Deviation 0.14769 |
| Part 1: LPS 0.75 ng/kg | 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 | 2.3784 Picograms per milliliter | Standard Deviation 2.45156 |
| Part 1: LPS 0.75 ng/kg | 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 | 56.6529 Picograms per milliliter | Standard Deviation 51.91815 |
| Part 1: LPS 0.75 ng/kg | 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 | 157.5403 Picograms per milliliter | Standard Deviation 165.48643 |
| Part 1: LPS 0.75 ng/kg | 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 | 202.6136 Picograms per milliliter | Standard Deviation 215.3441 |
| Part 1: LPS 0.75 ng/kg | 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 | 147.3472 Picograms per milliliter | Standard Deviation 122.6801 |
| Part 1: LPS 0.75 ng/kg | 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 | 68.8879 Picograms per milliliter | Standard Deviation 24.42514 |
| Part 1: LPS 0.75 ng/kg | 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 | 1.2532 Picograms per milliliter | Standard Deviation 0.83802 |
| Part 1: LPS 0.75 ng/kg | 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 | 0.2951 Picograms per milliliter | Standard Deviation 0.39912 |
| Part 1: LPS 1 ng/kg | 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 | 0.0123 Picograms per milliliter | Standard Deviation 0.01746 |
| Part 1: LPS 1 ng/kg | 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 | 152.9415 Picograms per milliliter | Standard Deviation 60.31144 |
| Part 1: LPS 1 ng/kg | 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 | 32.3842 Picograms per milliliter | Standard Deviation 25.56374 |
| Part 1: LPS 1 ng/kg | 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 | 0.1391 Picograms per milliliter | Standard Deviation 0.15747 |
| Part 1: LPS 1 ng/kg | 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 | 115.6693 Picograms per milliliter | Standard Deviation 54.14279 |
| Part 1: LPS 1 ng/kg | 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 | 65.5675 Picograms per milliliter | Standard Deviation 36.0843 |
| Part 1: LPS 1 ng/kg | 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 | 0.6475 Picograms per milliliter | Standard Deviation 0.28268 |
| Part 1: LPS 1 ng/kg | 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 | 78.4734 Picograms per milliliter | Standard Deviation 38.13965 |
| Part 1: LPS 1 ng/kg | 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 | 51.8232 Picograms per milliliter | Standard Deviation 22.59507 |
| Part 1: LPS 1 ng/kg | 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 | -0.0126 Picograms per milliliter | Standard Deviation 0.01785 |
| Part 1: LPS 1 ng/kg | 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 | 44.3372 Picograms per milliliter | Standard Deviation 22.32753 |
| Part 1: LPS 1 ng/kg | 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 | 11.8672 Picograms per milliliter | Standard Deviation 3.39867 |
| Part 1: LPS 1 ng/kg | 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 | 6.4056 Picograms per milliliter | Standard Deviation 8.96887 |
| Part 1: LPS 1 ng/kg | 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 | 0.1542 Picograms per milliliter | Standard Deviation 0.21529 |
| Part 1: LPS 1 ng/kg | 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 | 1.8854 Picograms per milliliter | Standard Deviation 0.15615 |
| Part 1: LPS 1 ng/kg | 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 | 12.7647 Picograms per milliliter | Standard Deviation 13.08048 |
| Part 1: LPS 1 ng/kg | 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 | 0.3442 Picograms per milliliter | Standard Deviation 0.03336 |
| Part 1: LPS 1 ng/kg | 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 | 11.1378 Picograms per milliliter | Standard Deviation 4.74317 |
| Part 1: LPS 1 ng/kg | 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 | 84.6080 Picograms per milliliter | Standard Deviation 33.94449 |
| Part 1: LPS 1 ng/kg | 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 | 4.5141 Picograms per milliliter | Standard Deviation 2.09962 |
Primary
Part 2: Change From Baseline in White Blood Cell Numbers in Blood: GM-CSF
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.
Time frame: 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.
Primary
Part 2: Change From Baseline Primary Soluble Inflammatory Mediators in Blood: TNF Alpha and IL 6: LPS Arm
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.
Time frame: 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.
Primary
Part 2: Change From Baseline Primary Soluble Inflammatory Mediators : Urinary Tetranor PGDM: LPS Arm
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.
Time frame: Baseline, Session 2 Day 1
Population: Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.
Secondary
Part 1: Absolute Values of Blister Volume
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.
Time frame: Baseline, Session 1: 48 hours Day 3. Session 2: 24 hours Day 2, 48 hours Day 3
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: LPS 0.5 ng/kg | Part 1: Absolute Values of Blister Volume | Baseline | 361.325 Microliter | Standard Deviation 145.9115 |
| Part 1: LPS 0.5 ng/kg | Part 1: Absolute Values of Blister Volume | Session 1, Day 3, 48 hours | 372.125 Microliter | Standard Deviation 105.8892 |
| Part 1: LPS 0.5 ng/kg | Part 1: Absolute Values of Blister Volume | Session 2, Day 2, 24 hours | 156.225 Microliter | Standard Deviation 49.4621 |
| Part 1: LPS 0.5 ng/kg | Part 1: Absolute Values of Blister Volume | Session 2, Day 3, 48 hours | 274.625 Microliter | Standard Deviation 110.4147 |
| Part 1: LPS 0.75 ng/kg | Part 1: Absolute Values of Blister Volume | Session 1, Day 3, 48 hours | 188.625 Microliter | Standard Deviation 128.1457 |
| Part 1: LPS 0.75 ng/kg | Part 1: Absolute Values of Blister Volume | Session 2, Day 2, 24 hours | 102.838 Microliter | Standard Deviation 64.6195 |
| Part 1: LPS 0.75 ng/kg | Part 1: Absolute Values of Blister Volume | Session 2, Day 3, 48 hours | 164.100 Microliter | Standard Deviation 104.8817 |
| Part 1: LPS 0.75 ng/kg | Part 1: Absolute Values of Blister Volume | Baseline | 156.638 Microliter | Standard Deviation 112.1876 |
| Part 1: LPS 1 ng/kg | Part 1: Absolute Values of Blister Volume | Session 2, Day 2, 24 hours | 162.975 Microliter | Standard Deviation 26.9054 |
| Part 1: LPS 1 ng/kg | Part 1: Absolute Values of Blister Volume | Session 1, Day 3, 48 hours | 232.175 Microliter | Standard Deviation 15.0967 |
| Part 1: LPS 1 ng/kg | Part 1: Absolute Values of Blister Volume | Session 2, Day 3, 48 hours | 190.650 Microliter | Standard Deviation 10.6066 |
| Part 1: LPS 1 ng/kg | Part 1: Absolute Values of Blister Volume | Baseline | 185.550 Microliter | Standard Deviation 22.486 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Absolute Values of Blister Volume | Session 2, Day 3, 48 hours | 108.313 Microliter | Standard Deviation 79.5137 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Absolute Values of Blister Volume | Session 1, Day 3, 48 hours | 216.775 Microliter | Standard Deviation 141.8914 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Absolute Values of Blister Volume | Baseline | 230.425 Microliter | Standard Deviation 146.2442 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Absolute Values of Blister Volume | Session 2, Day 2, 24 hours | 105.363 Microliter | Standard Deviation 60.7083 |
Secondary
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 523.259 |
| Part 1: LPS 0.5 ng/kg | 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 171.12 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 341.179 |
| Part 1: LPS 0.5 ng/kg | 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 119.8546 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 900.854 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 | — |
| Part 1: LPS 0.75 ng/kg | 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 | 4155.674 Mean fluorescence intensity | Standard Deviation 893.4273 |
| Part 1: LPS 0.75 ng/kg | 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 | 1072.416 Mean fluorescence intensity | Standard Deviation 523.9965 |
| Part 1: LPS 0.75 ng/kg | 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 | 3368.105 Mean fluorescence intensity | Standard Deviation 953.2468 |
| Part 1: LPS 0.75 ng/kg | 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 | -49.4854 Mean fluorescence intensity | Standard Deviation 72.90224 |
| Part 1: LPS 0.75 ng/kg | 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 | 4689.54 Mean fluorescence intensity | Standard Deviation 1189.323 |
| Part 1: LPS 0.75 ng/kg | 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 | -409.187 Mean fluorescence intensity | Standard Deviation 1498.2826 |
| Part 1: LPS 0.75 ng/kg | 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 | 31657.05 Mean fluorescence intensity | Standard Deviation 11524.385 |
| Part 1: LPS 0.75 ng/kg | 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 | -696.70 Mean fluorescence intensity | Standard Deviation 1551.69 |
| Part 1: LPS 0.75 ng/kg | 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 | 3665.666 Mean fluorescence intensity | Standard Deviation 1565.6126 |
| Part 1: LPS 0.75 ng/kg | 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 | 7229.67 Mean fluorescence intensity | Standard Deviation 2733.004 |
| Part 1: LPS 0.75 ng/kg | 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 | -124.5144 Mean fluorescence intensity | Standard Deviation 79.57686 |
| Part 1: LPS 0.75 ng/kg | 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 | -1057.04 Mean fluorescence intensity | Standard Deviation 1641.526 |
| Part 1: LPS 0.75 ng/kg | 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 | -583.016 Mean fluorescence intensity | Standard Deviation 1305.3774 |
| Part 1: LPS 0.75 ng/kg | 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 | 208.225 Mean fluorescence intensity | Standard Deviation 339.7035 |
| Part 1: LPS 0.75 ng/kg | 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 | -3470.23 Mean fluorescence intensity | Standard Deviation 16869.569 |
| Part 1: LPS 0.75 ng/kg | 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 | 765.140 Mean fluorescence intensity | Standard Deviation 690.4086 |
| Part 1: LPS 0.75 ng/kg | 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 | 2806.835 Mean fluorescence intensity | Standard Deviation 741.907 |
| Part 1: LPS 0.75 ng/kg | 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 | 38.604 Mean fluorescence intensity | Standard Deviation 582.9139 |
| Part 1: LPS 0.75 ng/kg | 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 | 16282.97 Mean fluorescence intensity | Standard Deviation 22938.047 |
| Part 1: LPS 0.75 ng/kg | 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 | 297.936 Mean fluorescence intensity | Standard Deviation 605.5896 |
| Part 1: LPS 0.75 ng/kg | 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 | -91.1420 Mean fluorescence intensity | Standard Deviation 123.34114 |
| Part 1: LPS 0.75 ng/kg | 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 | 1403.000 Mean fluorescence intensity | Standard Deviation 754.2476 |
| Part 1: LPS 0.75 ng/kg | 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 | 235.293 Mean fluorescence intensity | Standard Deviation 200.9269 |
| Part 1: LPS 0.75 ng/kg | 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 | 668.512 Mean fluorescence intensity | Standard Deviation 634.0204 |
| Part 1: LPS 0.75 ng/kg | 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 | 17.354 Mean fluorescence intensity | Standard Deviation 257.3845 |
| Part 1: LPS 1 ng/kg | 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 | 480.50 Mean fluorescence intensity | Standard Deviation 11477.05 |
| Part 1: LPS 1 ng/kg | 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 | 44.500 Mean fluorescence intensity | Standard Deviation 90.5097 |
| Part 1: LPS 1 ng/kg | 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 | 62.750 Mean fluorescence intensity | Standard Deviation 48.4368 |
| Part 1: LPS 1 ng/kg | 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 | 186.250 Mean fluorescence intensity | Standard Deviation 254.912 |
| Part 1: LPS 1 ng/kg | 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 | -105.7500 Mean fluorescence intensity | Standard Deviation 107.83378 |
| Part 1: LPS 1 ng/kg | 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 | 267.2500 Mean fluorescence intensity | Standard Deviation 66.11448 |
| Part 1: LPS 1 ng/kg | 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 | -70.0000 Mean fluorescence intensity | Standard Deviation 101.11627 |
| Part 1: LPS 1 ng/kg | 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 | 1372.75 Mean fluorescence intensity | Standard Deviation 2325.321 |
| Part 1: LPS 1 ng/kg | 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 | -665.00 Mean fluorescence intensity | Standard Deviation 481.54 |
| Part 1: LPS 1 ng/kg | 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 | 198.75 Mean fluorescence intensity | Standard Deviation 150.26 |
| Part 1: LPS 1 ng/kg | 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 | -211.000 Mean fluorescence intensity | Standard Deviation 17.6777 |
| Part 1: LPS 1 ng/kg | 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 | 743.750 Mean fluorescence intensity | Standard Deviation 482.6004 |
| Part 1: LPS 1 ng/kg | 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 | 835.000 Mean fluorescence intensity | Standard Deviation 444.7702 |
| Part 1: LPS 1 ng/kg | 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 | 776.000 Mean fluorescence intensity | Standard Deviation 30.4056 |
| Part 1: LPS 1 ng/kg | 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 | -10.250 Mean fluorescence intensity | Standard Deviation 61.1647 |
| Part 1: LPS 1 ng/kg | 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 | 783.750 Mean fluorescence intensity | Standard Deviation 127.6328 |
| Part 1: LPS 1 ng/kg | 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 | 2924.250 Mean fluorescence intensity | Standard Deviation 510.1775 |
| Part 1: LPS 1 ng/kg | 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 | 2701.50 Mean fluorescence intensity | Standard Deviation 65.761 |
| Part 1: LPS 1 ng/kg | 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 | -184.00 Mean fluorescence intensity | Standard Deviation 373.352 |
| Part 1: LPS 1 ng/kg | 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 | 2750.50 Mean fluorescence intensity | Standard Deviation 421.436 |
| Part 1: LPS 1 ng/kg | 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 | -2661.75 Mean fluorescence intensity | Standard Deviation 19339.017 |
| Part 1: LPS 1 ng/kg | 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 | 1564.00 Mean fluorescence intensity | Standard Deviation 12854.494 |
| Part 1: LPS 1 ng/kg | 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 | 2366.000 Mean fluorescence intensity | Standard Deviation 72.832 |
| Part 1: LPS 1 ng/kg | 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 | -237.250 Mean fluorescence intensity | Standard Deviation 252.0836 |
| Part 1: LPS 1 ng/kg | 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 | 1407.250 Mean fluorescence intensity | Standard Deviation 331.9866 |
| Part 1: LPS 1 ng/kg | 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 | 2624.000 Mean fluorescence intensity | Standard Deviation 770.7464 |
| Part 1: LPS 1 ng/kg | 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 | -343.250 Mean fluorescence intensity | Standard Deviation 597.1517 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 923.024 Mean fluorescence intensity | Standard Deviation 560.8252 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 11902.82 Mean fluorescence intensity | Standard Deviation 17969.677 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 1822.510 Mean fluorescence intensity | Standard Deviation 1522.9886 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 1834.867 Mean fluorescence intensity | Standard Deviation 1573.3002 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 648.346 Mean fluorescence intensity | Standard Deviation 685.4282 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 19351.27 Mean fluorescence intensity | Standard Deviation 16136.948 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 1389.536 Mean fluorescence intensity | Standard Deviation 710.1286 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 95.101 Mean fluorescence intensity | Standard Deviation 191.7562 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 856.32 Mean fluorescence intensity | Standard Deviation 1654.671 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 3834.100 Mean fluorescence intensity | Standard Deviation 1511.6374 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 4998.865 Mean fluorescence intensity | Standard Deviation 1326.4663 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 3032.02 Mean fluorescence intensity | Standard Deviation 3183.213 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 2032.27 Mean fluorescence intensity | Standard Deviation 1708.909 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 225.589 Mean fluorescence intensity | Standard Deviation 233.9677 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 407.277 Mean fluorescence intensity | Standard Deviation 615.0693 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | -32.4464 Mean fluorescence intensity | Standard Deviation 30.09999 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 47.1343 Mean fluorescence intensity | Standard Deviation 60.71649 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 83.647 Mean fluorescence intensity | Standard Deviation 119.1684 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 3958.838 Mean fluorescence intensity | Standard Deviation 803.7564 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | -16.6220 Mean fluorescence intensity | Standard Deviation 31.7921 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 4132.68 Mean fluorescence intensity | Standard Deviation 2423.146 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 94.29 Mean fluorescence intensity | Standard Deviation 782.682 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 3936.29 Mean fluorescence intensity | Standard Deviation 2537.066 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 268.838 Mean fluorescence intensity | Standard Deviation 315.3551 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 3242.86 Mean fluorescence intensity | Standard Deviation 11323.629 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 3264.300 Mean fluorescence intensity | Standard Deviation 988.2407 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 293.485 Mean fluorescence intensity | Standard Deviation 249.0144 |
Secondary
Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD16+, Session2,Day1, 5 hour 40 minutes, n=2,4,2,4 | -1061.000 Mean fluorescence intensity | Standard Deviation 823.0723 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD83, Session2,Day1,2 hour 40 minutes, n=2, 4,2,4 | -26.500 Mean fluorescence intensity | Standard Deviation 246.7803 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD163+, Session2,Day1,2 hour 40 minutes, n=2,4,2,4 | -53.5000 Mean fluorescence intensity | Standard Deviation 31.81981 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD209+,Session2,Day2,Pre-fluid sampling,n=2,4, 2,4 | 6.5000 Mean fluorescence intensity | Standard Deviation 53.03301 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD206+,Session2,Day2, Pre-fluid sampling,n=2,2,2,4 | 8.500 Mean fluorescence intensity | Standard Deviation 57.2756 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD83, Session2,Day1,5 hour 40 minutes, n=2, 4,2,4 | -127.000 Mean fluorescence intensity | Standard Deviation 97.5807 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD209+,Session2,Day3, Pre-fluid sampling,n=2,4,2,4 | -64.5000 Mean fluorescence intensity | Standard Deviation 68.58936 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD40, Session2,Day2, Pre-fluid sampling,n=2,4, 2,4 | -93.0000 Mean fluorescence intensity | Standard Deviation 70.71068 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD206+, Session2,Day1,5 hour 40 minutes, n=2,2,2,4 | -54.500 Mean fluorescence intensity | Standard Deviation 106.7731 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | HLA-DR,Session2,Day2, Pre-fluid sampling,n=2,4,2,4 | -1449.00 Mean fluorescence intensity | Standard Deviation 1571.191 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD83,Session2,Day2, Pre-fluid sampling,n=2, 4,2,4 | -58.000 Mean fluorescence intensity | Standard Deviation 134.3503 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD16+,Session2,Day2, Pre-fluid sampling, n=2,4,2,4 | 135.500 Mean fluorescence intensity | Standard Deviation 446.1844 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD209+, Session2,Day1,2 hour 40 minutes, n=2,4,2,4 | -42.0000 Mean fluorescence intensity | Standard Deviation 16.97056 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD80, Session2,Day1,5 hour 40 minutes, n=2, 4,2,4 | -146.000 Mean fluorescence intensity | Standard Deviation 7.0711 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD83,Session2,Day3, Pre-fluid sampling,n=2, 4,2,4 | -241.500 Mean fluorescence intensity | Standard Deviation 103.9447 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD163+, Session2,Day1, 40 minutes, n=2,4,2,4 | 41.0000 Mean fluorescence intensity | Standard Deviation 65.05382 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD40, Session2,Day1,2 hour 40 minutes, n=2,4,2,4 | -248.5000 Mean fluorescence intensity | Standard Deviation 194.45436 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD206+, Session2,Day1,2 hour 40 minutes, n=2,2,2,4 | 570.500 Mean fluorescence intensity | Standard Deviation 164.7559 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD86+, Session2,Day1, 40 minutes, n=2, 4,2,4 | -93.5000 Mean fluorescence intensity | Standard Deviation 21.92031 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD40, Session2,Day1,5 hour 40 minutes, n=2,4,2,4 | -191.0000 Mean fluorescence intensity | Standard Deviation 22.62742 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD16+, Session2,Day1, 40 minutes, n=2, 4, 2,4 | -1492.500 Mean fluorescence intensity | Standard Deviation 1341.3816 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD209+, Session2,Day1, 40 minutes, n=2,4,2,4 | -46.5000 Mean fluorescence intensity | Standard Deviation 82.73149 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD86+, Session2,Day1,2 hour 40 minutes, n=2, 4,2,4 | 14.0000 Mean fluorescence intensity | Standard Deviation 250.3158 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD80,Session2,Day2, Pre-fluid sampling,n=2, 4,2,4 | 34.000 Mean fluorescence intensity | Standard Deviation 31.1127 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD40, Session2,Day3, Pre-fluid sampling,n=2, 4,2,4 | -359.9500 Mean fluorescence intensity | Standard Deviation 219.13239 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD206+, Session2,Day1, 40 minutes, n=2,2,2,4 | -75.000 Mean fluorescence intensity | Standard Deviation 130.1076 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD86+, Session2,Day1,5 hour 40 minutes, n=2, 4,2,4 | -54.5000 Mean fluorescence intensity | Standard Deviation 40.30509 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD163+, Session2,Day1,5 hour 40 minutes, n=2,4,2,4 | 28.0000 Mean fluorescence intensity | Standard Deviation 87.68124 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD80, Session2,Day1,2 hour 40 minutes, n=2,4,2,4 | -104.500 Mean fluorescence intensity | Standard Deviation 2.1213 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD40, Session2,Day1, 40 minutes, n=2,4,2,4 | -77.5000 Mean fluorescence intensity | Standard Deviation 105.35891 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD163+,Session2,Day3, Pre-fluid sampling,n=2,4,2,4 | 38.0000 Mean fluorescence intensity | Standard Deviation 50.91169 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD86+,Session2,Day2, Pre-fluid sampling,n=2, 4,2,4 | 41.5000 Mean fluorescence intensity | Standard Deviation 75.66043 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD80,Session2,Day3, Pre-fluid sampling,n=2, 4,2,4 | -47.500 Mean fluorescence intensity | Standard Deviation 2.1213 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD16+, Session2,Day1, 2 hour 40 minutes, n=2,4,2,4 | -1561.000 Mean fluorescence intensity | Standard Deviation 1359.0592 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | HLA-DR, Session2,Day1,5 hour 40 minutes, n=2,4,2,4 | -320.00 Mean fluorescence intensity | Standard Deviation 523.259 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD86+,Session2,Day3, Pre-fluid sampling,n=2, 4,2,4 | -91.0000 Mean fluorescence intensity | Standard Deviation 32.52691 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD206+,Session2,Day3, Pre-fluid sampling,n=2,2,2,4 | -87.500 Mean fluorescence intensity | Standard Deviation 89.8026 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD209+, Session2,Day1,5 hour 40 minutes, n=2,4,2,4 | -53.5000 Mean fluorescence intensity | Standard Deviation 28.99138 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD163+,Session2,Day2, Pre-fluid sampling,n=2,4,2,4 | -35.0000 Mean fluorescence intensity | Standard Deviation 35.35534 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | HLA-DR, Session2,Day1, 40 minutes, n=2, 4,2,4 | 445.50 Mean fluorescence intensity | Standard Deviation 434.871 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD83, Session2,Day1, 40 minutes, n=2, 4,2,4 | -225.000 Mean fluorescence intensity | Standard Deviation 31.1127 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD80, Session2,Day1, 40 minutes, n=2, 4,2,4 | -4.000 Mean fluorescence intensity | Standard Deviation 72.1249 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | HLA-DR,Session2,Day3, Pre-fluid sampling,n=2,4,2,4 | -2292.50 Mean fluorescence intensity | Standard Deviation 416.486 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | HLA-DR, Session2,Day1,2 hour 40 minutes, n=2,4,2,4 | -2457.50 Mean fluorescence intensity | Standard Deviation 775.696 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD16+,Session2,Day3, Pre-fluid sampling, n=2,4,2,4 | -564.500 Mean fluorescence intensity | Standard Deviation 536.694 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | HLA-DR, Session2,Day1,2 hour 40 minutes, n=2,4,2,4 | -1417.49 Mean fluorescence intensity | Standard Deviation 1937.407 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | HLA-DR, Session2,Day1,5 hour 40 minutes, n=2,4,2,4 | -1744.11 Mean fluorescence intensity | Standard Deviation 2077.874 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD163+, Session2,Day1,2 hour 40 minutes, n=2,4,2,4 | -28.0153 Mean fluorescence intensity | Standard Deviation 33.20632 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | HLA-DR,Session2,Day2, Pre-fluid sampling,n=2,4,2,4 | 688.02 Mean fluorescence intensity | Standard Deviation 1710.854 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD40, Session2,Day1, 40 minutes, n=2,4,2,4 | 24.1702 Mean fluorescence intensity | Standard Deviation 96.21606 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD163+, Session2,Day1, 40 minutes, n=2,4,2,4 | -3.8803 Mean fluorescence intensity | Standard Deviation 39.59977 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | HLA-DR,Session2,Day3, Pre-fluid sampling,n=2,4,2,4 | -2030.80 Mean fluorescence intensity | Standard Deviation 2398.091 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD209+, Session2,Day1,2 hour 40 minutes, n=2,4,2,4 | -19.1610 Mean fluorescence intensity | Standard Deviation 8.8549 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD16+, Session2,Day1, 40 minutes, n=2, 4, 2,4 | -468.314 Mean fluorescence intensity | Standard Deviation 270.9419 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD16+,Session2,Day3, Pre-fluid sampling, n=2,4,2,4 | 1116.482 Mean fluorescence intensity | Standard Deviation 840.6096 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD16+, Session2,Day1, 2 hour 40 minutes, n=2,4,2,4 | -579.984 Mean fluorescence intensity | Standard Deviation 235.082 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD80, Session2,Day1,2 hour 40 minutes, n=2,4,2,4 | -95.364 Mean fluorescence intensity | Standard Deviation 66.7035 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD16+, Session2,Day1, 5 hour 40 minutes, n=2,4,2,4 | -530.365 Mean fluorescence intensity | Standard Deviation 208.1743 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD16+,Session2,Day2, Pre-fluid sampling, n=2,4,2,4 | 300.333 Mean fluorescence intensity | Standard Deviation 432.7904 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD80, Session2,Day1,5 hour 40 minutes, n=2, 4,2,4 | -85.528 Mean fluorescence intensity | Standard Deviation 66.3639 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD209+, Session2,Day1, 40 minutes, n=2,4,2,4 | 18.4320 Mean fluorescence intensity | Standard Deviation 55.78181 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD80,Session2,Day2, Pre-fluid sampling,n=2, 4,2,4 | 11.103 Mean fluorescence intensity | Standard Deviation 88.5547 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD40, Session2,Day1,5 hour 40 minutes, n=2,4,2,4 | -35.5593 Mean fluorescence intensity | Standard Deviation 26.02435 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD206+,Session2,Day3, Pre-fluid sampling,n=2,2,2,4 | -7.138 Mean fluorescence intensity | Standard Deviation 143.0385 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD80,Session2,Day3, Pre-fluid sampling,n=2, 4,2,4 | 82.987 Mean fluorescence intensity | Standard Deviation 84.8958 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD209+,Session2,Day3, Pre-fluid sampling,n=2,4,2,4 | -16.7770 Mean fluorescence intensity | Standard Deviation 8.10389 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD83, Session2,Day1, 40 minutes, n=2, 4,2,4 | 0.262 Mean fluorescence intensity | Standard Deviation 93.0741 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD209+,Session2,Day2,Pre-fluid sampling,n=2,4, 2,4 | -4.8983 Mean fluorescence intensity | Standard Deviation 19.52432 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD206+,Session2,Day2, Pre-fluid sampling,n=2,2,2,4 | 70.416 Mean fluorescence intensity | Standard Deviation 127.159 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD83, Session2,Day1,2 hour 40 minutes, n=2, 4,2,4 | -56.590 Mean fluorescence intensity | Standard Deviation 73.5714 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD83, Session2,Day1,5 hour 40 minutes, n=2, 4,2,4 | -54.265 Mean fluorescence intensity | Standard Deviation 56.5138 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD206+, Session2,Day1,5 hour 40 minutes, n=2,2,2,4 | -84.217 Mean fluorescence intensity | Standard Deviation 161.6658 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD83,Session2,Day2, Pre-fluid sampling,n=2, 4,2,4 | 125.239 Mean fluorescence intensity | Standard Deviation 117.8095 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD40, Session2,Day2, Pre-fluid sampling,n=2,4, 2,4 | 62.5378 Mean fluorescence intensity | Standard Deviation 130.98543 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD206+, Session2,Day1,2 hour 40 minutes, n=2,2,2,4 | -130.065 Mean fluorescence intensity | Standard Deviation 141.4567 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD83,Session2,Day3, Pre-fluid sampling,n=2, 4,2,4 | 142.101 Mean fluorescence intensity | Standard Deviation 59.5839 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD86+, Session2,Day1, 40 minutes, n=2, 4,2,4 | -101.1600 Mean fluorescence intensity | Standard Deviation 78.03703 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD209+, Session2,Day1,5 hour 40 minutes, n=2,4,2,4 | -3.8503 Mean fluorescence intensity | Standard Deviation 17.4856 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD206+, Session2,Day1, 40 minutes, n=2,2,2,4 | -140.156 Mean fluorescence intensity | Standard Deviation 160.101 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD86+, Session2,Day1,2 hour 40 minutes, n=2, 4,2,4 | -121.3668 Mean fluorescence intensity | Standard Deviation 68.34453 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD86+, Session2,Day1,5 hour 40 minutes, n=2, 4,2,4 | -94.3938 Mean fluorescence intensity | Standard Deviation 35.3743 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD40, Session2,Day3, Pre-fluid sampling,n=2, 4,2,4 | 108.3750 Mean fluorescence intensity | Standard Deviation 91.11295 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD163+,Session2,Day3, Pre-fluid sampling,n=2,4,2,4 | 175.6860 Mean fluorescence intensity | Standard Deviation 104.358 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD86+,Session2,Day2, Pre-fluid sampling,n=2, 4,2,4 | 126.1853 Mean fluorescence intensity | Standard Deviation 105.91022 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD40, Session2,Day1,2 hour 40 minutes, n=2,4,2,4 | -37.2498 Mean fluorescence intensity | Standard Deviation 30.55431 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD163+,Session2,Day2, Pre-fluid sampling,n=2,4,2,4 | 68.9850 Mean fluorescence intensity | Standard Deviation 76.56191 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD86+,Session2,Day3, Pre-fluid sampling,n=2, 4,2,4 | 117.9230 Mean fluorescence intensity | Standard Deviation 55.75943 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | HLA-DR, Session2,Day1, 40 minutes, n=2, 4,2,4 | 896.74 Mean fluorescence intensity | Standard Deviation 1309.134 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD163+, Session2,Day1,5 hour 40 minutes, n=2,4,2,4 | 13.7295 Mean fluorescence intensity | Standard Deviation 38.55623 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD80, Session2,Day1, 40 minutes, n=2, 4,2,4 | -35.839 Mean fluorescence intensity | Standard Deviation 78.4625 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | HLA-DR, Session2,Day1,5 hour 40 minutes, n=2,4,2,4 | -1604.00 Mean fluorescence intensity | Standard Deviation 3859.389 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD40, Session2,Day1, 40 minutes, n=2,4,2,4 | -17.1500 Mean fluorescence intensity | Standard Deviation 143.0477 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD40, Session2,Day1,2 hour 40 minutes, n=2,4,2,4 | -74.1500 Mean fluorescence intensity | Standard Deviation 35.14321 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD40, Session2,Day1,5 hour 40 minutes, n=2,4,2,4 | -55.0500 Mean fluorescence intensity | Standard Deviation 114.62201 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD40, Session2,Day2, Pre-fluid sampling,n=2,4, 2,4 | 135.5000 Mean fluorescence intensity | Standard Deviation 51.6188 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD40, Session2,Day3, Pre-fluid sampling,n=2, 4,2,4 | 152.5000 Mean fluorescence intensity | Standard Deviation 78.48885 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD80, Session2,Day1, 40 minutes, n=2, 4,2,4 | 666.250 Mean fluorescence intensity | Standard Deviation 1446.3869 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD80, Session2,Day1,2 hour 40 minutes, n=2,4,2,4 | -138.800 Mean fluorescence intensity | Standard Deviation 45.5377 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD80, Session2,Day1,5 hour 40 minutes, n=2, 4,2,4 | -139.800 Mean fluorescence intensity | Standard Deviation 25.7387 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD80,Session2,Day2, Pre-fluid sampling,n=2, 4,2,4 | 75.000 Mean fluorescence intensity | Standard Deviation 26.8701 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD80,Session2,Day3, Pre-fluid sampling,n=2, 4,2,4 | 113.500 Mean fluorescence intensity | Standard Deviation 16.2635 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD83, Session2,Day1, 40 minutes, n=2, 4,2,4 | 647.500 Mean fluorescence intensity | Standard Deviation 358.5031 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD83, Session2,Day1,2 hour 40 minutes, n=2, 4,2,4 | -17.500 Mean fluorescence intensity | Standard Deviation 309.0057 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD83, Session2,Day1,5 hour 40 minutes, n=2, 4,2,4 | -40.000 Mean fluorescence intensity | Standard Deviation 52.3259 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD83,Session2,Day2, Pre-fluid sampling,n=2, 4,2,4 | 243.500 Mean fluorescence intensity | Standard Deviation 153.4422 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD83,Session2,Day3, Pre-fluid sampling,n=2, 4,2,4 | 38.500 Mean fluorescence intensity | Standard Deviation 188.7975 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD86+, Session2,Day1, 40 minutes, n=2, 4,2,4 | 56.0000 Mean fluorescence intensity | Standard Deviation 29.69848 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD86+, Session2,Day1,2 hour 40 minutes, n=2, 4,2,4 | -144.5000 Mean fluorescence intensity | Standard Deviation 28.99138 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD86+, Session2,Day1,5 hour 40 minutes, n=2, 4,2,4 | -44.0000 Mean fluorescence intensity | Standard Deviation 214.96046 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD86+,Session2,Day2, Pre-fluid sampling,n=2, 4,2,4 | 194.5000 Mean fluorescence intensity | Standard Deviation 13.43503 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD86+,Session2,Day3, Pre-fluid sampling,n=2, 4,2,4 | 82.0000 Mean fluorescence intensity | Standard Deviation 94.75231 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | HLA-DR, Session2,Day1, 40 minutes, n=2, 4,2,4 | 41096.00 Mean fluorescence intensity | Standard Deviation 47912.141 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | HLA-DR, Session2,Day1,2 hour 40 minutes, n=2,4,2,4 | -5430.00 Mean fluorescence intensity | Standard Deviation 5929.797 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | HLA-DR,Session2,Day2, Pre-fluid sampling,n=2,4,2,4 | -2085.00 Mean fluorescence intensity | Standard Deviation 4775.799 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | HLA-DR,Session2,Day3, Pre-fluid sampling,n=2,4,2,4 | -6379.00 Mean fluorescence intensity | Standard Deviation 9237.643 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD16+, Session2,Day1, 40 minutes, n=2, 4, 2,4 | -1418.700 Mean fluorescence intensity | Standard Deviation 1089.3687 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD16+, Session2,Day1, 2 hour 40 minutes, n=2,4,2,4 | -1495.500 Mean fluorescence intensity | Standard Deviation 1535.1288 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD16+, Session2,Day1, 5 hour 40 minutes, n=2,4,2,4 | -1334.500 Mean fluorescence intensity | Standard Deviation 1035.9114 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD16+,Session2,Day2, Pre-fluid sampling, n=2,4,2,4 | 309.500 Mean fluorescence intensity | Standard Deviation 436.2849 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD16+,Session2,Day3, Pre-fluid sampling, n=2,4,2,4 | 984.000 Mean fluorescence intensity | Standard Deviation 130.1076 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD163+, Session2,Day1, 40 minutes, n=2,4,2,4 | -160.5000 Mean fluorescence intensity | Standard Deviation 152.02796 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD163+, Session2,Day1,2 hour 40 minutes, n=2,4,2,4 | -187.5500 Mean fluorescence intensity | Standard Deviation 156.34131 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD163+, Session2,Day1,5 hour 40 minutes, n=2,4,2,4 | -41.5000 Mean fluorescence intensity | Standard Deviation 101.11627 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD163+,Session2,Day2, Pre-fluid sampling,n=2,4,2,4 | 239.0000 Mean fluorescence intensity | Standard Deviation 11.31371 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD163+,Session2,Day3, Pre-fluid sampling,n=2,4,2,4 | 88.5000 Mean fluorescence intensity | Standard Deviation 27.57716 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD206+, Session2,Day1, 40 minutes, n=2,2,2,4 | 241.000 Mean fluorescence intensity | Standard Deviation 22.6274 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD206+, Session2,Day1,2 hour 40 minutes, n=2,2,2,4 | 124.000 Mean fluorescence intensity | Standard Deviation 229.1026 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD206+, Session2,Day1,5 hour 40 minutes, n=2,2,2,4 | 0.500 Mean fluorescence intensity | Standard Deviation 215.6676 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD206+,Session2,Day2, Pre-fluid sampling,n=2,2,2,4 | 193.000 Mean fluorescence intensity | Standard Deviation 190.9188 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD206+,Session2,Day3, Pre-fluid sampling,n=2,2,2,4 | 120.000 Mean fluorescence intensity | Standard Deviation 277.1859 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD209+, Session2,Day1, 40 minutes, n=2,4,2,4 | -105.6500 Mean fluorescence intensity | Standard Deviation 125.08719 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD209+, Session2,Day1,2 hour 40 minutes, n=2,4,2,4 | 226.5000 Mean fluorescence intensity | Standard Deviation 201.52543 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD209+, Session2,Day1,5 hour 40 minutes, n=2,4,2,4 | -42.8500 Mean fluorescence intensity | Standard Deviation 1.90919 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD209+,Session2,Day2,Pre-fluid sampling,n=2,4, 2,4 | 158.5000 Mean fluorescence intensity | Standard Deviation 65.76093 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD209+,Session2,Day3, Pre-fluid sampling,n=2,4,2,4 | -9.5000 Mean fluorescence intensity | Standard Deviation 58.68986 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | HLA-DR, Session2,Day1, 40 minutes, n=2, 4,2,4 | -2795.55 Mean fluorescence intensity | Standard Deviation 2243.871 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD40, Session2,Day3, Pre-fluid sampling,n=2, 4,2,4 | 5.2222 Mean fluorescence intensity | Standard Deviation 66.38351 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD163+, Session2,Day1,5 hour 40 minutes, n=2,4,2,4 | -12.9720 Mean fluorescence intensity | Standard Deviation 77.32898 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD163+, Session2,Day1, 9 hour 40 minutes,n=0,0,0,4 | -24.0198 Mean fluorescence intensity | Standard Deviation 66.75178 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD86+,Session2,Day3, Pre-fluid sampling,n=2, 4,2,4 | 15.2970 Mean fluorescence intensity | Standard Deviation 75.45627 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD86+,Session2,Day2, Pre-fluid sampling,n=2, 4,2,4 | 83.4098 Mean fluorescence intensity | Standard Deviation 63.1267 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD40, Session2,Day2, Pre-fluid sampling,n=2,4, 2,4 | 83.1860 Mean fluorescence intensity | Standard Deviation 92.90385 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD163+,Session2,Day2, Pre-fluid sampling,n=2,4,2,4 | -19.7730 Mean fluorescence intensity | Standard Deviation 57.0907 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD86+, Session2,Day1,9 hour 40 minutes,n=0,0,0,4 | 118.6338 Mean fluorescence intensity | Standard Deviation 49.28502 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD86+, Session2,Day1,5 hour 40 minutes, n=2, 4,2,4 | 106.9465 Mean fluorescence intensity | Standard Deviation 53.12949 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD40, Session2,Day1, 40 minutes, n=2,4,2,4 | -37.4720 Mean fluorescence intensity | Standard Deviation 29.7151 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD163+,Session2,Day3, Pre-fluid sampling,n=2,4,2,4 | -10.6642 Mean fluorescence intensity | Standard Deviation 38.84898 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD86+, Session2,Day1,2 hour 40 minutes, n=2, 4,2,4 | 30.0005 Mean fluorescence intensity | Standard Deviation 101.61342 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD86+, Session2,Day1, 40 minutes, n=2, 4,2,4 | 8.9678 Mean fluorescence intensity | Standard Deviation 29.2598 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD209+, Session2,Day1,5 hour 40 minutes, n=2,4,2,4 | -15.8723 Mean fluorescence intensity | Standard Deviation 25.15864 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD206+, Session2,Day1, 40 minutes, n=2,2,2,4 | 552.855 Mean fluorescence intensity | Standard Deviation 259.42 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD83,Session2,Day3, Pre-fluid sampling,n=2, 4,2,4 | -33.869 Mean fluorescence intensity | Standard Deviation 79.7178 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD83,Session2,Day2, Pre-fluid sampling,n=2, 4,2,4 | 72.982 Mean fluorescence intensity | Standard Deviation 123.0727 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD209+, Session2,Day1,9 hour 40 minutes,n=0,0,0,4 | -45.1118 Mean fluorescence intensity | Standard Deviation 38.63888 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD206+, Session2,Day1,2 hour 40 minutes, n=2,2,2,4 | 444.094 Mean fluorescence intensity | Standard Deviation 454.3525 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD83, Session2,Day1,9 hour 40 minutes,n=0,0,0,4 | 223.093 Mean fluorescence intensity | Standard Deviation 184.106 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD83, Session2,Day1,5 hour 40 minutes, n=2, 4,2,4 | -11.648 Mean fluorescence intensity | Standard Deviation 63.0964 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD40, Session2,Day1,9 hour 40 minutes,n=0,0,0,4 | 102.0438 Mean fluorescence intensity | Standard Deviation 67.79389 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD206+, Session2,Day1,5 hour 40 minutes, n=2,2,2,4 | 262.268 Mean fluorescence intensity | Standard Deviation 126.1299 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD206+, Session2,Day1,9 hour 40 minutes,n=0,0,0,4 | 275.423 Mean fluorescence intensity | Standard Deviation 163.9991 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD83, Session2,Day1,2 hour 40 minutes, n=2, 4,2,4 | 4.970 Mean fluorescence intensity | Standard Deviation 118.6525 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD83, Session2,Day1, 40 minutes, n=2, 4,2,4 | 8.260 Mean fluorescence intensity | Standard Deviation 38.7864 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD40, Session2,Day1,5 hour 40 minutes, n=2,4,2,4 | 78.3045 Mean fluorescence intensity | Standard Deviation 54.05275 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD206+,Session2,Day2, Pre-fluid sampling,n=2,2,2,4 | 164.064 Mean fluorescence intensity | Standard Deviation 33.1212 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD80,Session2,Day3, Pre-fluid sampling,n=2, 4,2,4 | 11.929 Mean fluorescence intensity | Standard Deviation 20.6629 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD80,Session2,Day2, Pre-fluid sampling,n=2, 4,2,4 | 36.587 Mean fluorescence intensity | Standard Deviation 15.1919 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD209+,Session2,Day3, Pre-fluid sampling,n=2,4,2,4 | -6.7250 Mean fluorescence intensity | Standard Deviation 35.83716 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD206+,Session2,Day3, Pre-fluid sampling,n=2,2,2,4 | 106.723 Mean fluorescence intensity | Standard Deviation 28.9729 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD80, Session2,Day1,9 hour 40 minutes, n=0,0,0,4 | 19.214 Mean fluorescence intensity | Standard Deviation 43.1702 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD80, Session2,Day1,5 hour 40 minutes, n=2, 4,2,4 | 22.829 Mean fluorescence intensity | Standard Deviation 39.2596 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD209+,Session2,Day2,Pre-fluid sampling,n=2,4, 2,4 | 46.9815 Mean fluorescence intensity | Standard Deviation 100.0642 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD209+, Session2,Day1, 40 minutes, n=2,4,2,4 | -6.6660 Mean fluorescence intensity | Standard Deviation 43.24876 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD16+, Session2,Day1,9 hour 40 minutes,n-0,0,0,4 | 265.065 Mean fluorescence intensity | Standard Deviation 334.2355 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD16+, Session2,Day1, 5 hour 40 minutes, n=2,4,2,4 | 171.104 Mean fluorescence intensity | Standard Deviation 275.2637 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD80, Session2,Day1,2 hour 40 minutes, n=2,4,2,4 | -15.964 Mean fluorescence intensity | Standard Deviation 41.2839 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD16+,Session2,Day2, Pre-fluid sampling, n=2,4,2,4 | 168.661 Mean fluorescence intensity | Standard Deviation 115.8827 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD16+, Session2,Day1, 2 hour 40 minutes, n=2,4,2,4 | -118.536 Mean fluorescence intensity | Standard Deviation 142.1664 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD16+, Session2,Day1, 40 minutes, n=2, 4, 2,4 | -215.981 Mean fluorescence intensity | Standard Deviation 31.8638 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD80, Session2,Day1, 40 minutes, n=2, 4,2,4 | -11.569 Mean fluorescence intensity | Standard Deviation 10.9548 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD16+,Session2,Day3, Pre-fluid sampling, n=2,4,2,4 | 4.757 Mean fluorescence intensity | Standard Deviation 149.9929 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | HLA-DR,Session2,Day3, Pre-fluid sampling,n=2,4,2,4 | 113.79 Mean fluorescence intensity | Standard Deviation 2769.699 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | HLA-DR,Session2,Day2, Pre-fluid sampling,n=2,4,2,4 | 800.49 Mean fluorescence intensity | Standard Deviation 2738.323 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD40, Session2,Day1,2 hour 40 minutes, n=2,4,2,4 | -11.0400 Mean fluorescence intensity | Standard Deviation 65.9971 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD163+, Session2,Day1, 40 minutes, n=2,4,2,4 | 58.3640 Mean fluorescence intensity | Standard Deviation 66.82273 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | HLA-DR, Session2,Day1,9 hour 40 minutes,n=0,0,0,4 | -943.38 Mean fluorescence intensity | Standard Deviation 4035.982 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | HLA-DR, Session2,Day1,5 hour 40 minutes, n=2,4,2,4 | -1347.06 Mean fluorescence intensity | Standard Deviation 2935.54 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD209+, Session2,Day1,2 hour 40 minutes, n=2,4,2,4 | -19.5825 Mean fluorescence intensity | Standard Deviation 32.92128 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | CD163+, Session2,Day1,2 hour 40 minutes, n=2,4,2,4 | 47.3110 Mean fluorescence intensity | Standard Deviation 48.31955 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood | HLA-DR, Session2,Day1,2 hour 40 minutes, n=2,4,2,4 | -1430.37 Mean fluorescence intensity | Standard Deviation 2743.193 |
Secondary
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: LPS 0.5 ng/kg | 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 1119.35 |
| Part 1: LPS 0.5 ng/kg | 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 20.86 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 215.314 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 | — |
| Part 1: LPS 0.75 ng/kg | 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 | -1275.50 Mean fluorescence intensity | Standard Deviation 3073.903 |
| Part 1: LPS 0.75 ng/kg | 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 | 4510.75 Mean fluorescence intensity | Standard Deviation 7162.125 |
| Part 1: LPS 0.75 ng/kg | 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 | -2948.25 Mean fluorescence intensity | Standard Deviation 3659.787 |
| Part 1: LPS 0.75 ng/kg | 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 | -6203.50 Mean fluorescence intensity | Standard Deviation 13105.657 |
| Part 1: LPS 0.75 ng/kg | 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 | 400.500 Mean fluorescence intensity | Standard Deviation 455.9359 |
| Part 1: LPS 0.75 ng/kg | 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 | 48.250 Mean fluorescence intensity | Standard Deviation 163.7506 |
| Part 1: LPS 0.75 ng/kg | 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 | 411.000 Mean fluorescence intensity | Standard Deviation 524.8443 |
| Part 1: LPS 0.75 ng/kg | 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 | 564.00 Mean fluorescence intensity | Standard Deviation 2911.625 |
| Part 1: LPS 0.75 ng/kg | 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 | -2542.63 Mean fluorescence intensity | Standard Deviation 4084.922 |
| Part 1: LPS 0.75 ng/kg | 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 | 458.88 Mean fluorescence intensity | Standard Deviation 1827.032 |
| Part 1: LPS 0.75 ng/kg | 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 | 21.63 Mean fluorescence intensity | Standard Deviation 1282.82 |
| Part 1: LPS 0.75 ng/kg | 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 | -236.13 Mean fluorescence intensity | Standard Deviation 1413.395 |
| Part 1: LPS 0.75 ng/kg | 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 | 198.00 Mean fluorescence intensity | Standard Deviation 1021.994 |
| Part 1: LPS 0.75 ng/kg | 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 | -43.38 Mean fluorescence intensity | Standard Deviation 837.351 |
| Part 1: LPS 0.75 ng/kg | 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 | -166.13 Mean fluorescence intensity | Standard Deviation 503.207 |
| Part 1: LPS 0.75 ng/kg | 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 | 1193.63 Mean fluorescence intensity | Standard Deviation 1486.267 |
| Part 1: LPS 0.75 ng/kg | 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 | 353.63 Mean fluorescence intensity | Standard Deviation 2446.46 |
| Part 1: LPS 0.75 ng/kg | 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 | -114.50 Mean fluorescence intensity | Standard Deviation 615.327 |
| Part 1: LPS 0.75 ng/kg | 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 | -556.88 Mean fluorescence intensity | Standard Deviation 1063.877 |
| Part 1: LPS 0.75 ng/kg | 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 | 1243.25 Mean fluorescence intensity | Standard Deviation 3307.491 |
| Part 1: LPS 0.75 ng/kg | 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 | -1046.38 Mean fluorescence intensity | Standard Deviation 561.034 |
| Part 1: LPS 0.75 ng/kg | 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 | 577.50 Mean fluorescence intensity | Standard Deviation 1141.719 |
| Part 1: LPS 0.75 ng/kg | 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 | 674.50 Mean fluorescence intensity | Standard Deviation 1496.032 |
| Part 1: LPS 0.75 ng/kg | 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 | 1692.50 Mean fluorescence intensity | Standard Deviation 1687.192 |
| Part 1: LPS 0.75 ng/kg | 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 | -7695.38 Mean fluorescence intensity | Standard Deviation 19317.582 |
| Part 1: LPS 0.75 ng/kg | 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 | 13061.88 Mean fluorescence intensity | Standard Deviation 29527.416 |
| Part 1: LPS 0.75 ng/kg | 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 | -20377.25 Mean fluorescence intensity | Standard Deviation 25175.815 |
| Part 1: LPS 1 ng/kg | 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 | 181.75 Mean fluorescence intensity | Standard Deviation 506.642 |
| Part 1: LPS 1 ng/kg | 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 | -691.50 Mean fluorescence intensity | Standard Deviation 542.351 |
| Part 1: LPS 1 ng/kg | 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 | -480.25 Mean fluorescence intensity | Standard Deviation 925.956 |
| Part 1: LPS 1 ng/kg | 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 | 5372.75 Mean fluorescence intensity | Standard Deviation 235.113 |
| Part 1: LPS 1 ng/kg | 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 | 1403.75 Mean fluorescence intensity | Standard Deviation 3760.04 |
| Part 1: LPS 1 ng/kg | 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 | 719.250 Mean fluorescence intensity | Standard Deviation 63.9932 |
| Part 1: LPS 1 ng/kg | 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 | -1136.25 Mean fluorescence intensity | Standard Deviation 1490.935 |
| Part 1: LPS 1 ng/kg | 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 | 6003.75 Mean fluorescence intensity | Standard Deviation 17276.386 |
| Part 1: LPS 1 ng/kg | 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 | -1686.50 Mean fluorescence intensity | Standard Deviation 2957.121 |
| Part 1: LPS 1 ng/kg | 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 | 415.250 Mean fluorescence intensity | Standard Deviation 142.482 |
| Part 1: LPS 1 ng/kg | 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 | 2522.00 Mean fluorescence intensity | Standard Deviation 1359.766 |
| Part 1: LPS 1 ng/kg | 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 | 2690.50 Mean fluorescence intensity | Standard Deviation 4319.008 |
| Part 1: LPS 1 ng/kg | 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 | 270.250 Mean fluorescence intensity | Standard Deviation 97.9343 |
| Part 1: LPS 1 ng/kg | 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 | -8397.75 Mean fluorescence intensity | Standard Deviation 19009.505 |
| Part 1: LPS 1 ng/kg | 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 | 745.75 Mean fluorescence intensity | Standard Deviation 496.743 |
| Part 1: LPS 1 ng/kg | 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 | 1273.75 Mean fluorescence intensity | Standard Deviation 3391.638 |
| Part 1: LPS 1 ng/kg | 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 | 2311.50 Mean fluorescence intensity | Standard Deviation 1262.186 |
| Part 1: LPS 1 ng/kg | 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 | -3286.25 Mean fluorescence intensity | Standard Deviation 947.17 |
| Part 1: LPS 1 ng/kg | 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 | -2193.50 Mean fluorescence intensity | Standard Deviation 543.765 |
| Part 1: LPS 1 ng/kg | 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 | -329.75 Mean fluorescence intensity | Standard Deviation 197.636 |
| Part 1: LPS 1 ng/kg | 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 | -333.00 Mean fluorescence intensity | Standard Deviation 416.486 |
| Part 1: LPS 1 ng/kg | 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 | 1672.25 Mean fluorescence intensity | Standard Deviation 1038.386 |
| Part 1: LPS 1 ng/kg | 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 | -1329.50 Mean fluorescence intensity | Standard Deviation 1668.065 |
| Part 1: LPS 1 ng/kg | 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 | 1607.75 Mean fluorescence intensity | Standard Deviation 1283.752 |
| Part 1: LPS 1 ng/kg | 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 | -3449.75 Mean fluorescence intensity | Standard Deviation 1895.4 |
| Part 1: LPS 1 ng/kg | 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 | 371.75 Mean fluorescence intensity | Standard Deviation 1282.338 |
| Part 1: LPS 1 ng/kg | 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 | -955.75 Mean fluorescence intensity | Standard Deviation 1183.343 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 890.88 Mean fluorescence intensity | Standard Deviation 2206.644 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 12596.63 Mean fluorescence intensity | Standard Deviation 16264.004 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 3426.13 Mean fluorescence intensity | Standard Deviation 4547.393 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 517.50 Mean fluorescence intensity | Standard Deviation 5171.981 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | -1668.63 Mean fluorescence intensity | Standard Deviation 2068.363 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | -70.50 Mean fluorescence intensity | Standard Deviation 1739.426 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 789.513 Mean fluorescence intensity | Standard Deviation 825.7539 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | -3653.63 Mean fluorescence intensity | Standard Deviation 5345.655 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | -570.75 Mean fluorescence intensity | Standard Deviation 3118.314 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 304.88 Mean fluorescence intensity | Standard Deviation 2126.019 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 2835.13 Mean fluorescence intensity | Standard Deviation 2917.207 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 11460.13 Mean fluorescence intensity | Standard Deviation 56951.939 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 28.25 Mean fluorescence intensity | Standard Deviation 2057.408 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 1215.88 Mean fluorescence intensity | Standard Deviation 2013.518 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 169.750 Mean fluorescence intensity | Standard Deviation 160.706 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 5641.13 Mean fluorescence intensity | Standard Deviation 4969.374 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 36041.13 Mean fluorescence intensity | Standard Deviation 33139.756 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | -744.88 Mean fluorescence intensity | Standard Deviation 3479.863 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | -2622.75 Mean fluorescence intensity | Standard Deviation 3423.992 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | -5724.25 Mean fluorescence intensity | Standard Deviation 49407.676 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | -734.88 Mean fluorescence intensity | Standard Deviation 5799.935 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | -842.63 Mean fluorescence intensity | Standard Deviation 1505.636 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 723.125 Mean fluorescence intensity | Standard Deviation 717.7969 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | -2607.25 Mean fluorescence intensity | Standard Deviation 6559.21 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | -1010.00 Mean fluorescence intensity | Standard Deviation 5492.201 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 918.75 Mean fluorescence intensity | Standard Deviation 1945.597 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | -59.50 Mean fluorescence intensity | Standard Deviation 536.615 |
Secondary
Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 291.328 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 195.515 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 | — |
| Part 1: LPS 0.75 ng/kg | 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 | -773.455 Mean fluorescence intensity | Standard Deviation 383.3063 |
| Part 1: LPS 0.75 ng/kg | 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 | -51.662 Mean fluorescence intensity | Standard Deviation 369.1392 |
| Part 1: LPS 0.75 ng/kg | 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 | -6.274 Mean fluorescence intensity | Standard Deviation 238.7732 |
| Part 1: LPS 0.75 ng/kg | 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 | 63.622 Mean fluorescence intensity | Standard Deviation 309.3805 |
| Part 1: LPS 0.75 ng/kg | 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 | -9344.96 Mean fluorescence intensity | Standard Deviation 2661.368 |
| Part 1: LPS 0.75 ng/kg | 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 | -60.255 Mean fluorescence intensity | Standard Deviation 174.9309 |
| Part 1: LPS 0.75 ng/kg | 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 | 342.798 Mean fluorescence intensity | Standard Deviation 181.3639 |
| Part 1: LPS 0.75 ng/kg | 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 | 312.288 Mean fluorescence intensity | Standard Deviation 458.1399 |
| Part 1: LPS 0.75 ng/kg | 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 | 44.949 Mean fluorescence intensity | Standard Deviation 222.8885 |
| Part 1: LPS 0.75 ng/kg | 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 | 131.238 Mean fluorescence intensity | Standard Deviation 104.7629 |
| Part 1: LPS 0.75 ng/kg | 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 | 50.962 Mean fluorescence intensity | Standard Deviation 31.2323 |
| Part 1: LPS 0.75 ng/kg | 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 | 247.858 Mean fluorescence intensity | Standard Deviation 249.5824 |
| Part 1: LPS 0.75 ng/kg | 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 | -26.379 Mean fluorescence intensity | Standard Deviation 183.4741 |
| Part 1: LPS 0.75 ng/kg | 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 | 767.291 Mean fluorescence intensity | Standard Deviation 469.9624 |
| Part 1: LPS 0.75 ng/kg | 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 | 324.662 Mean fluorescence intensity | Standard Deviation 223.8334 |
| Part 1: LPS 0.75 ng/kg | 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 | 507.721 Mean fluorescence intensity | Standard Deviation 375.747 |
| Part 1: LPS 0.75 ng/kg | 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 | -816.619 Mean fluorescence intensity | Standard Deviation 242.1554 |
| Part 1: LPS 0.75 ng/kg | 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 | 710.660 Mean fluorescence intensity | Standard Deviation 645.7405 |
| Part 1: LPS 0.75 ng/kg | 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 | -3291.05 Mean fluorescence intensity | Standard Deviation 4596.102 |
| Part 1: LPS 0.75 ng/kg | 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 | 1256.721 Mean fluorescence intensity | Standard Deviation 676.3278 |
| Part 1: LPS 0.75 ng/kg | 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 | 585.093 Mean fluorescence intensity | Standard Deviation 238.4787 |
| Part 1: LPS 0.75 ng/kg | 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 | 304.409 Mean fluorescence intensity | Standard Deviation 387.9039 |
| Part 1: LPS 0.75 ng/kg | 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 | -10329.79 Mean fluorescence intensity | Standard Deviation 4408.08 |
| Part 1: LPS 0.75 ng/kg | 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 | -241.591 Mean fluorescence intensity | Standard Deviation 286.2295 |
| Part 1: LPS 0.75 ng/kg | 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 | -562.71 Mean fluorescence intensity | Standard Deviation 207.541 |
| Part 1: LPS 1 ng/kg | 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 | -292.250 Mean fluorescence intensity | Standard Deviation 16.617 |
| Part 1: LPS 1 ng/kg | 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 | 314.000 Mean fluorescence intensity | Standard Deviation 129.4005 |
| Part 1: LPS 1 ng/kg | 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 | 711.250 Mean fluorescence intensity | Standard Deviation 942.9269 |
| Part 1: LPS 1 ng/kg | 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 | 438.250 Mean fluorescence intensity | Standard Deviation 329.1582 |
| Part 1: LPS 1 ng/kg | 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 | 663.750 Mean fluorescence intensity | Standard Deviation 149.5531 |
| Part 1: LPS 1 ng/kg | 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 | 460.500 Mean fluorescence intensity | Standard Deviation 120.2082 |
| Part 1: LPS 1 ng/kg | 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 | 978.750 Mean fluorescence intensity | Standard Deviation 426.7389 |
| Part 1: LPS 1 ng/kg | 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 | 3188.75 Mean fluorescence intensity | Standard Deviation 5879.946 |
| Part 1: LPS 1 ng/kg | 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 | -1224.50 Mean fluorescence intensity | Standard Deviation 1317.34 |
| Part 1: LPS 1 ng/kg | 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 | -1812.25 Mean fluorescence intensity | Standard Deviation 1074.449 |
| Part 1: LPS 1 ng/kg | 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 | 377.500 Mean fluorescence intensity | Standard Deviation 457.4981 |
| Part 1: LPS 1 ng/kg | 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 | 982.250 Mean fluorescence intensity | Standard Deviation 601.3943 |
| Part 1: LPS 1 ng/kg | 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 | 1330.250 Mean fluorescence intensity | Standard Deviation 491.7928 |
| Part 1: LPS 1 ng/kg | 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 | 7.500 Mean fluorescence intensity | Standard Deviation 108.8944 |
| Part 1: LPS 1 ng/kg | 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 | 116.500 Mean fluorescence intensity | Standard Deviation 64.3467 |
| Part 1: LPS 1 ng/kg | 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 | -8.250 Mean fluorescence intensity | Standard Deviation 42.0729 |
| Part 1: LPS 1 ng/kg | 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 | 404.500 Mean fluorescence intensity | Standard Deviation 137.8858 |
| Part 1: LPS 1 ng/kg | 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 | 44.250 Mean fluorescence intensity | Standard Deviation 158.0384 |
| Part 1: LPS 1 ng/kg | 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 | 254.000 Mean fluorescence intensity | Standard Deviation 77.7817 |
| Part 1: LPS 1 ng/kg | 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 | -373.250 Mean fluorescence intensity | Standard Deviation 578.7669 |
| Part 1: LPS 1 ng/kg | 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 | 791.500 Mean fluorescence intensity | Standard Deviation 1207.0313 |
| Part 1: LPS 1 ng/kg | 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 | -328.250 Mean fluorescence intensity | Standard Deviation 171.4734 |
| Part 1: LPS 1 ng/kg | 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 | -319.750 Mean fluorescence intensity | Standard Deviation 71.7713 |
| Part 1: LPS 1 ng/kg | 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 | 103.750 Mean fluorescence intensity | Standard Deviation 15.9099 |
| Part 1: LPS 1 ng/kg | 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 | -7267.75 Mean fluorescence intensity | Standard Deviation 11655.595 |
| Part 1: LPS 1 ng/kg | 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 | -2229.25 Mean fluorescence intensity | Standard Deviation 4812.922 |
| Part 1: LPS 1 ng/kg | 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 | -9340.00 Mean fluorescence intensity | Standard Deviation 10061.422 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 436.294 Mean fluorescence intensity | Standard Deviation 350.2183 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 8884.70 Mean fluorescence intensity | Standard Deviation 15377.757 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | -529.900 Mean fluorescence intensity | Standard Deviation 854.9675 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 76.408 Mean fluorescence intensity | Standard Deviation 149.4601 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 2161.950 Mean fluorescence intensity | Standard Deviation 1465.6418 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 10097.91 Mean fluorescence intensity | Standard Deviation 12898.982 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | -497.468 Mean fluorescence intensity | Standard Deviation 327.7072 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 1386.776 Mean fluorescence intensity | Standard Deviation 1523.3802 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 753.682 Mean fluorescence intensity | Standard Deviation 482.3904 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 174.016 Mean fluorescence intensity | Standard Deviation 226.3189 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 6.398 Mean fluorescence intensity | Standard Deviation 418.6691 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 613.37 Mean fluorescence intensity | Standard Deviation 1127.116 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 9194.06 Mean fluorescence intensity | Standard Deviation 4046.382 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 1295.95 Mean fluorescence intensity | Standard Deviation 1671.924 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | -97.004 Mean fluorescence intensity | Standard Deviation 1081.7203 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 713.995 Mean fluorescence intensity | Standard Deviation 519.242 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 122.859 Mean fluorescence intensity | Standard Deviation 88.9027 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 94.943 Mean fluorescence intensity | Standard Deviation 140.1057 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | -2543.35 Mean fluorescence intensity | Standard Deviation 3800.276 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 401.521 Mean fluorescence intensity | Standard Deviation 43.5362 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 367.626 Mean fluorescence intensity | Standard Deviation 245.5936 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | -824.574 Mean fluorescence intensity | Standard Deviation 521.901 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 44.488 Mean fluorescence intensity | Standard Deviation 94.3934 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 316.762 Mean fluorescence intensity | Standard Deviation 145.7658 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 279.814 Mean fluorescence intensity | Standard Deviation 332.5659 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 280.947 Mean fluorescence intensity | Standard Deviation 870.135 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 236.171 Mean fluorescence intensity | Standard Deviation 304.2282 |
Secondary
Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD80, Session2,Day1,5 hour 40 minutes, n=2, 4,2,4 | -80.5000 Mean fluorescence intensity | Standard Deviation 27.57716 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD206+, Session2,Day1,2 hour 40 minutes, n=2,2,2,4 | 1011.000 Mean fluorescence intensity | Standard Deviation 2743.5743 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD83, Session2,Day1,2 hour 40 minutes, n=2, 4,2,4 | 254.500 Mean fluorescence intensity | Standard Deviation 866.2058 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | HLA-DR,Session2,Day2, Pre-fluid sampling,n=2,4,2,4 | -171.000 Mean fluorescence intensity | Standard Deviation 835.8002 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD86+,Session2,Day2, Pre-fluid sampling,n=2, 4,2,4 | 32.5000 Mean fluorescence intensity | Standard Deviation 88.38835 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD206+, Session2,Day1,5 hour 40 minutes, n=2,2,2,4 | -388.500 Mean fluorescence intensity | Standard Deviation 74.2462 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | HLA-DR,Session2,Day3, Pre-fluid sampling,n=2,4,2,4 | -957.500 Mean fluorescence intensity | Standard Deviation 514.0666 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD16+,Session2,Day2, Pre-fluid sampling, n=2,4,2,4 | 125.5000 Mean fluorescence intensity | Standard Deviation 47.37615 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD40, Session2,Day2, Pre-fluid sampling,n=2,4, 2,4 | 29.5000 Mean fluorescence intensity | Standard Deviation 86.97413 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD86+, Session2,Day1,5 hour 40 minutes, n=2, 4,2,4 | -130.0000 Mean fluorescence intensity | Standard Deviation 65.05382 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD206+,Session2,Day2, Pre-fluid sampling,n=2,2,2,4 | 423.000 Mean fluorescence intensity | Standard Deviation 196.5757 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD80,Session2,Day2, Pre-fluid sampling,n=2, 4,2,4 | 46.0000 Mean fluorescence intensity | Standard Deviation 7.07107 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | HLA-DR, Session2,Day1,2 hour 40 minutes, n=2,4,2,4 | -706.000 Mean fluorescence intensity | Standard Deviation 1269.9638 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD163+, Session2,Day1,5 hour 40 minutes, n=2,4,2,4 | -363.500 Mean fluorescence intensity | Standard Deviation 112.43 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD206+,Session2,Day3, Pre-fluid sampling,n=2,4,2,4 | -496.500 Mean fluorescence intensity | Standard Deviation 422.1427 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD83, Session2,Day1, 40 minutes, n=2, 4,2,4 | -360.500 Mean fluorescence intensity | Standard Deviation 676.7012 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD16+, Session2,Day1, 2 hour 40 minutes, n=2,4,2,4 | -128.9500 Mean fluorescence intensity | Standard Deviation 131.45115 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD86+, Session2,Day1,2 hour 40 minutes, n=2, 4,2,4 | 15.5000 Mean fluorescence intensity | Standard Deviation 191.62594 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD209+, Session2,Day1, 40 minutes, n=2,4,2,4 | 15.800 Mean fluorescence intensity | Standard Deviation 109.6016 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD16+, Session2,Day1, 5 hour 40 minutes, n=2,4,2,4 | -130.1500 Mean fluorescence intensity | Standard Deviation 78.98383 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD80, Session2,Day1, 40 minutes, n=2, 4,2,4 | -56.0000 Mean fluorescence intensity | Standard Deviation 15.55635 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | HLA-DR, Session2,Day1, 40 minutes, n=2, 4,2,4 | -1701.500 Mean fluorescence intensity | Standard Deviation 96.8736 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD209+, Session2,Day1,2 hour 40 minutes, n=2,4,2,4 | -78.650 Mean fluorescence intensity | Standard Deviation 39.103 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD163+,Session2,Day2, Pre-fluid sampling,n=2,4,2,4 | 4.500 Mean fluorescence intensity | Standard Deviation 19.0919 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD16+,Session2,Day3, Pre-fluid sampling, n=2,4,2,4 | -24.5000 Mean fluorescence intensity | Standard Deviation 40.30509 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD86+, Session2,Day1, 40 minutes, n=2, 4,2,4 | -93.5000 Mean fluorescence intensity | Standard Deviation 17.67767 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD209+, Session2,Day1,5 hour 40 minutes, n=2,4,2,4 | 17.350 Mean fluorescence intensity | Standard Deviation 123.2487 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD83, Session2,Day1,5 hour 40 minutes, n=2, 4,2,4 | -441.500 Mean fluorescence intensity | Standard Deviation 844.9926 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD163+, Session2,Day1,2 hour 40 minutes, n=2,4,2,4 | -499.500 Mean fluorescence intensity | Standard Deviation 147.7853 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD16+, Session2,Day1, 40 minutes, n=2, 4, 2,4 | -117.5000 Mean fluorescence intensity | Standard Deviation 55.86144 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD83,Session2,Day3, Pre-fluid sampling,n=2, 4,2,4 | -547.000 Mean fluorescence intensity | Standard Deviation 687.3078 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD209+,Session2,Day2,Pre-fluid sampling,n=2,4, 2,4 | 36.450 Mean fluorescence intensity | Standard Deviation 150.6845 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD163+,Session2,Day3, Pre-fluid sampling,n=2,4,2,4 | -66.000 Mean fluorescence intensity | Standard Deviation 8.4853 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD80, Session2,Day1,2 hour 40 minutes, n=2,4,2,4 | -48.5000 Mean fluorescence intensity | Standard Deviation 85.55992 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD40, Session2,Day1,5 hour 40 minutes, n=2,4,2,4 | -136.5000 Mean fluorescence intensity | Standard Deviation 48.79037 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD209+,Session2,Day3, Pre-fluid sampling,n=2,4,2,4 | -30.630 Mean fluorescence intensity | Standard Deviation 180.9203 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD86+,Session2,Day3, Pre-fluid sampling,n=2, 4,2,4 | -60.5000 Mean fluorescence intensity | Standard Deviation 37.47666 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | HLA-DR, Session2,Day1,5 hour 40 minutes, n=2,4,2,4 | -1452.000 Mean fluorescence intensity | Standard Deviation 366.2813 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD83,Session2,Day2, Pre-fluid sampling,n=2, 4,2,4 | -32.000 Mean fluorescence intensity | Standard Deviation 394.5656 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD40, Session2,Day1, 40 minutes, n=2,4,2,4 | -96.5000 Mean fluorescence intensity | Standard Deviation 111.01576 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD206+, Session2,Day1, 40 minutes, n=2,3,2,4 | -502.500 Mean fluorescence intensity | Standard Deviation 171.8269 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD163+, Session2,Day1, 40 minutes, n=2,4,2,4 | -371.000 Mean fluorescence intensity | Standard Deviation 199.4041 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD40, Session2,Day3, Pre-fluid sampling,n=2, 4,2,4 | -184.5000 Mean fluorescence intensity | Standard Deviation 20.5061 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD40, Session2,Day1,2 hour 40 minutes, n=2,4,2,4 | -84.0000 Mean fluorescence intensity | Standard Deviation 263.04372 |
| Part 1: LPS 0.5 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD80,Session2,Day3, Pre-fluid sampling,n=2, 4,2,4 | 45.5000 Mean fluorescence intensity | Standard Deviation 78.48885 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD40, Session2,Day1,2 hour 40 minutes, n=2,4,2,4 | -34.9520 Mean fluorescence intensity | Standard Deviation 59.47287 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD40, Session2,Day1,5 hour 40 minutes, n=2,4,2,4 | -3.5480 Mean fluorescence intensity | Standard Deviation 23.88276 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD83, Session2,Day1,2 hour 40 minutes, n=2, 4,2,4 | -192.732 Mean fluorescence intensity | Standard Deviation 586.9635 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD40, Session2,Day2, Pre-fluid sampling,n=2,4, 2,4 | 76.4310 Mean fluorescence intensity | Standard Deviation 173.35366 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD16+, Session2,Day1, 40 minutes, n=2, 4, 2,4 | -10.5565 Mean fluorescence intensity | Standard Deviation 50.64061 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD83, Session2,Day1, 40 minutes, n=2, 4,2,4 | -509.522 Mean fluorescence intensity | Standard Deviation 743.2824 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD40, Session2,Day3, Pre-fluid sampling,n=2, 4,2,4 | -8.5503 Mean fluorescence intensity | Standard Deviation 56.03828 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | HLA-DR, Session2,Day1,2 hour 40 minutes, n=2,4,2,4 | -3133.030 Mean fluorescence intensity | Standard Deviation 1601.2468 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD80, Session2,Day1, 40 minutes, n=2, 4,2,4 | 22.5760 Mean fluorescence intensity | Standard Deviation 29.07877 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD80,Session2,Day3, Pre-fluid sampling,n=2, 4,2,4 | 11.4885 Mean fluorescence intensity | Standard Deviation 25.25635 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD80, Session2,Day1,2 hour 40 minutes, n=2,4,2,4 | -14.4080 Mean fluorescence intensity | Standard Deviation 34.73965 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD163+, Session2,Day1,2 hour 40 minutes, n=2,4,2,4 | -902.203 Mean fluorescence intensity | Standard Deviation 205.5423 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD80, Session2,Day1,5 hour 40 minutes, n=2, 4,2,4 | -28.4175 Mean fluorescence intensity | Standard Deviation 31.59217 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD80,Session2,Day2, Pre-fluid sampling,n=2, 4,2,4 | 33.8863 Mean fluorescence intensity | Standard Deviation 44.87592 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD163+, Session2,Day1,5 hour 40 minutes, n=2,4,2,4 | -694.390 Mean fluorescence intensity | Standard Deviation 222.5211 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | HLA-DR, Session2,Day1, 40 minutes, n=2, 4,2,4 | -3036.438 Mean fluorescence intensity | Standard Deviation 1102.3399 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD163+,Session2,Day2, Pre-fluid sampling,n=2,4,2,4 | 146.403 Mean fluorescence intensity | Standard Deviation 737.3912 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD16+, Session2,Day1, 5 hour 40 minutes, n=2,4,2,4 | -35.3433 Mean fluorescence intensity | Standard Deviation 40.19923 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD86+,Session2,Day3, Pre-fluid sampling,n=2, 4,2,4 | 20.5612 Mean fluorescence intensity | Standard Deviation 21.58116 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD163+,Session2,Day3, Pre-fluid sampling,n=2,4,2,4 | 3.801 Mean fluorescence intensity | Standard Deviation 244.5535 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | HLA-DR,Session2,Day3, Pre-fluid sampling,n=2,4,2,4 | -978.224 Mean fluorescence intensity | Standard Deviation 661.5084 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD206+, Session2,Day1, 40 minutes, n=2,3,2,4 | -892.543 Mean fluorescence intensity | Standard Deviation 205.722 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | HLA-DR,Session2,Day2, Pre-fluid sampling,n=2,4,2,4 | 924.615 Mean fluorescence intensity | Standard Deviation 1288.5384 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD86+,Session2,Day2, Pre-fluid sampling,n=2, 4,2,4 | 43.1203 Mean fluorescence intensity | Standard Deviation 47.48816 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD206+, Session2,Day1,2 hour 40 minutes, n=2,2,2,4 | -583.485 Mean fluorescence intensity | Standard Deviation 672.1029 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD206+, Session2,Day1,5 hour 40 minutes, n=2,2,2,4 | -686.465 Mean fluorescence intensity | Standard Deviation 521.9367 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD86+, Session2,Day1,5 hour 40 minutes, n=2, 4,2,4 | -85.0973 Mean fluorescence intensity | Standard Deviation 32.66115 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD206+,Session2,Day2, Pre-fluid sampling,n=2,2,2,4 | -202.457 Mean fluorescence intensity | Standard Deviation 181.7519 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD16+,Session2,Day2, Pre-fluid sampling, n=2,4,2,4 | 162.8120 Mean fluorescence intensity | Standard Deviation 171.51836 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD86+, Session2,Day1,2 hour 40 minutes, n=2, 4,2,4 | -80.7150 Mean fluorescence intensity | Standard Deviation 36.89354 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD206+,Session2,Day3, Pre-fluid sampling,n=2,4,2,4 | -469.550 Mean fluorescence intensity | Standard Deviation 397.5609 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD209+, Session2,Day1, 40 minutes, n=2,4,2,4 | 4.001 Mean fluorescence intensity | Standard Deviation 37.3132 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | HLA-DR, Session2,Day1,5 hour 40 minutes, n=2,4,2,4 | -2242.108 Mean fluorescence intensity | Standard Deviation 1155.9978 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD86+, Session2,Day1, 40 minutes, n=2, 4,2,4 | -51.3590 Mean fluorescence intensity | Standard Deviation 54.09737 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD209+, Session2,Day1,2 hour 40 minutes, n=2,4,2,4 | -9.406 Mean fluorescence intensity | Standard Deviation 15.8402 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD209+, Session2,Day1,5 hour 40 minutes, n=2,4,2,4 | -17.622 Mean fluorescence intensity | Standard Deviation 25.5632 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD16+,Session2,Day3, Pre-fluid sampling, n=2,4,2,4 | -6.6285 Mean fluorescence intensity | Standard Deviation 33.04476 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD83,Session2,Day3, Pre-fluid sampling,n=2, 4,2,4 | -261.969 Mean fluorescence intensity | Standard Deviation 458.2399 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD209+,Session2,Day2,Pre-fluid sampling,n=2,4, 2,4 | -3.732 Mean fluorescence intensity | Standard Deviation 32.4741 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD16+, Session2,Day1, 2 hour 40 minutes, n=2,4,2,4 | -31.4965 Mean fluorescence intensity | Standard Deviation 41.99141 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD83,Session2,Day2, Pre-fluid sampling,n=2, 4,2,4 | 185.975 Mean fluorescence intensity | Standard Deviation 797.3145 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD209+,Session2,Day3, Pre-fluid sampling,n=2,4,2,4 | -7.759 Mean fluorescence intensity | Standard Deviation 29.9928 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD40, Session2,Day1, 40 minutes, n=2,4,2,4 | -36.2400 Mean fluorescence intensity | Standard Deviation 53.43955 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD83, Session2,Day1,5 hour 40 minutes, n=2, 4,2,4 | 136.272 Mean fluorescence intensity | Standard Deviation 346.4007 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD163+, Session2,Day1, 40 minutes, n=2,4,2,4 | -833.203 Mean fluorescence intensity | Standard Deviation 131.9463 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD40, Session2,Day1,5 hour 40 minutes, n=2,4,2,4 | -62.0000 Mean fluorescence intensity | Standard Deviation 117.37973 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD16+, Session2,Day1, 40 minutes, n=2, 4, 2,4 | -47.0000 Mean fluorescence intensity | Standard Deviation 39.59798 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD16+, Session2,Day1, 2 hour 40 minutes, n=2,4,2,4 | -76.6000 Mean fluorescence intensity | Standard Deviation 69.29646 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD16+, Session2,Day1, 5 hour 40 minutes, n=2,4,2,4 | -94.3000 Mean fluorescence intensity | Standard Deviation 56.85139 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD16+,Session2,Day2, Pre-fluid sampling, n=2,4,2,4 | 427.5000 Mean fluorescence intensity | Standard Deviation 132.22897 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD16+,Session2,Day3, Pre-fluid sampling, n=2,4,2,4 | 142.5000 Mean fluorescence intensity | Standard Deviation 71.41778 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD163+, Session2,Day1, 40 minutes, n=2,4,2,4 | -721.000 Mean fluorescence intensity | Standard Deviation 131.5219 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD163+, Session2,Day1,2 hour 40 minutes, n=2,4,2,4 | -790.000 Mean fluorescence intensity | Standard Deviation 8.4853 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD163+, Session2,Day1,5 hour 40 minutes, n=2,4,2,4 | -522.500 Mean fluorescence intensity | Standard Deviation 112.43 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD163+,Session2,Day2, Pre-fluid sampling,n=2,4,2,4 | 22.500 Mean fluorescence intensity | Standard Deviation 225.5671 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD163+,Session2,Day3, Pre-fluid sampling,n=2,4,2,4 | -80.000 Mean fluorescence intensity | Standard Deviation 66.468 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD206+, Session2,Day1, 40 minutes, n=2,3,2,4 | 86.500 Mean fluorescence intensity | Standard Deviation 263.7508 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD206+, Session2,Day1,2 hour 40 minutes, n=2,2,2,4 | -293.500 Mean fluorescence intensity | Standard Deviation 102.5305 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD206+, Session2,Day1,5 hour 40 minutes, n=2,2,2,4 | 12.000 Mean fluorescence intensity | Standard Deviation 309.7128 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD206+,Session2,Day2, Pre-fluid sampling,n=2,2,2,4 | 273.000 Mean fluorescence intensity | Standard Deviation 407.2935 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD206+,Session2,Day3, Pre-fluid sampling,n=2,4,2,4 | -9.500 Mean fluorescence intensity | Standard Deviation 504.1671 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD209+, Session2,Day1, 40 minutes, n=2,4,2,4 | -9.700 Mean fluorescence intensity | Standard Deviation 200.1112 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD209+, Session2,Day1,2 hour 40 minutes, n=2,4,2,4 | -2.650 Mean fluorescence intensity | Standard Deviation 9.9702 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD209+, Session2,Day1,5 hour 40 minutes, n=2,4,2,4 | -44.250 Mean fluorescence intensity | Standard Deviation 85.9135 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD209+,Session2,Day2,Pre-fluid sampling,n=2,4, 2,4 | 174.850 Mean fluorescence intensity | Standard Deviation 143.8962 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD209+,Session2,Day3, Pre-fluid sampling,n=2,4,2,4 | 5.850 Mean fluorescence intensity | Standard Deviation 122.2588 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD40, Session2,Day1, 40 minutes, n=2,4,2,4 | 340.0000 Mean fluorescence intensity | Standard Deviation 53.74012 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD40, Session2,Day1,2 hour 40 minutes, n=2,4,2,4 | -97.0000 Mean fluorescence intensity | Standard Deviation 43.84062 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD40, Session2,Day2, Pre-fluid sampling,n=2,4, 2,4 | 1.0000 Mean fluorescence intensity | Standard Deviation 26.87006 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD40, Session2,Day3, Pre-fluid sampling,n=2, 4,2,4 | 1.5000 Mean fluorescence intensity | Standard Deviation 218.496 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD80, Session2,Day1, 40 minutes, n=2, 4,2,4 | 151.5000 Mean fluorescence intensity | Standard Deviation 36.06245 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD80, Session2,Day1,2 hour 40 minutes, n=2,4,2,4 | -43.0000 Mean fluorescence intensity | Standard Deviation 4.24264 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD80, Session2,Day1,5 hour 40 minutes, n=2, 4,2,4 | -112.9000 Mean fluorescence intensity | Standard Deviation 97.43931 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD80,Session2,Day2, Pre-fluid sampling,n=2, 4,2,4 | 48.0000 Mean fluorescence intensity | Standard Deviation 76.36753 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD80,Session2,Day3, Pre-fluid sampling,n=2, 4,2,4 | -5.5000 Mean fluorescence intensity | Standard Deviation 21.92031 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD83, Session2,Day1, 40 minutes, n=2, 4,2,4 | 341.000 Mean fluorescence intensity | Standard Deviation 1500.4806 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD83, Session2,Day1,2 hour 40 minutes, n=2, 4,2,4 | -157.500 Mean fluorescence intensity | Standard Deviation 96.8736 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD83, Session2,Day1,5 hour 40 minutes, n=2, 4,2,4 | 56.500 Mean fluorescence intensity | Standard Deviation 610.2332 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD83,Session2,Day2, Pre-fluid sampling,n=2, 4,2,4 | -312.000 Mean fluorescence intensity | Standard Deviation 417.193 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD83,Session2,Day3, Pre-fluid sampling,n=2, 4,2,4 | -618.500 Mean fluorescence intensity | Standard Deviation 1304.612 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD86+, Session2,Day1, 40 minutes, n=2, 4,2,4 | -35.0000 Mean fluorescence intensity | Standard Deviation 100.40916 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD86+, Session2,Day1,2 hour 40 minutes, n=2, 4,2,4 | -62.5000 Mean fluorescence intensity | Standard Deviation 40.30509 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD86+, Session2,Day1,5 hour 40 minutes, n=2, 4,2,4 | -11.5000 Mean fluorescence intensity | Standard Deviation 183.14066 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD86+,Session2,Day2, Pre-fluid sampling,n=2, 4,2,4 | 120.5000 Mean fluorescence intensity | Standard Deviation 44.54773 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD86+,Session2,Day3, Pre-fluid sampling,n=2, 4,2,4 | 35.5000 Mean fluorescence intensity | Standard Deviation 153.44217 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | HLA-DR, Session2,Day1, 40 minutes, n=2, 4,2,4 | -2247.000 Mean fluorescence intensity | Standard Deviation 1572.6055 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | HLA-DR, Session2,Day1,2 hour 40 minutes, n=2,4,2,4 | -1898.000 Mean fluorescence intensity | Standard Deviation 733.9768 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | HLA-DR, Session2,Day1,5 hour 40 minutes, n=2,4,2,4 | -1296.500 Mean fluorescence intensity | Standard Deviation 352.8463 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | HLA-DR,Session2,Day2, Pre-fluid sampling,n=2,4,2,4 | 2717.500 Mean fluorescence intensity | Standard Deviation 2687.7129 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | HLA-DR,Session2,Day3, Pre-fluid sampling,n=2,4,2,4 | -3.000 Mean fluorescence intensity | Standard Deviation 612.3545 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD40, Session2,Day1, 40 minutes, n=2,4,2,4 | -74.1970 Mean fluorescence intensity | Standard Deviation 70.63576 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD16+,Session2,Day3, Pre-fluid sampling, n=2,4,2,4 | -11.7065 Mean fluorescence intensity | Standard Deviation 24.07118 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD83, Session2,Day1,5 hour 40 minutes, n=2, 4,2,4 | -694.319 Mean fluorescence intensity | Standard Deviation 570.1803 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD83, Session2,Day1,9 hour 40 minutes,n=0,0,0,4 | 450.242 Mean fluorescence intensity | Standard Deviation 1654.9166 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD209+,Session2,Day3, Pre-fluid sampling,n=2,4,2,4 | 23.752 Mean fluorescence intensity | Standard Deviation 61.2399 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD209+,Session2,Day2,Pre-fluid sampling,n=2,4, 2,4 | 71.592 Mean fluorescence intensity | Standard Deviation 146.6326 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD16+,Session2,Day2, Pre-fluid sampling, n=2,4,2,4 | 42.9945 Mean fluorescence intensity | Standard Deviation 58.62985 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD83,Session2,Day2, Pre-fluid sampling,n=2, 4,2,4 | -72.629 Mean fluorescence intensity | Standard Deviation 223.2647 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD209+, Session2,Day1,9 hour 40 minutes,n=0,0,0,4 | -7.284 Mean fluorescence intensity | Standard Deviation 34.7539 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD209+, Session2,Day1,5 hour 40 minutes, n=2,4,2,4 | 10.936 Mean fluorescence intensity | Standard Deviation 32.9481 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD16+, Session2,Day1, 40 minutes, n=2, 4, 2,4 | -26.3505 Mean fluorescence intensity | Standard Deviation 10.83082 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD83,Session2,Day3, Pre-fluid sampling,n=2, 4,2,4 | -461.280 Mean fluorescence intensity | Standard Deviation 449.4745 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD209+, Session2,Day1,2 hour 40 minutes, n=2,4,2,4 | -10.000 Mean fluorescence intensity | Standard Deviation 17.4401 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD209+, Session2,Day1, 40 minutes, n=2,4,2,4 | -16.194 Mean fluorescence intensity | Standard Deviation 23.7386 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | HLA-DR, Session2,Day1,5 hour 40 minutes, n=2,4,2,4 | -126.436 Mean fluorescence intensity | Standard Deviation 774.0775 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD86+, Session2,Day1, 40 minutes, n=2, 4,2,4 | 22.1330 Mean fluorescence intensity | Standard Deviation 58.85301 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD206+,Session2,Day3, Pre-fluid sampling,n=2,4,2,4 | 11.054 Mean fluorescence intensity | Standard Deviation 268.4708 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD206+,Session2,Day2, Pre-fluid sampling,n=2,2,2,4 | 1724.197 Mean fluorescence intensity | Standard Deviation 901.9847 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | HLA-DR, Session2,Day1,9 hour 40 minutes,n=0,0,0,4 | 798.182 Mean fluorescence intensity | Standard Deviation 1011.1423 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD86+, Session2,Day1,2 hour 40 minutes, n=2, 4,2,4 | 7.4130 Mean fluorescence intensity | Standard Deviation 91.99398 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD206+, Session2,Day1,9 hour 40 minutes,n=0,0,0,4 | 2546.884 Mean fluorescence intensity | Standard Deviation 2810.2028 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD206+, Session2,Day1,5 hour 40 minutes, n=2,2,2,4 | 2051.872 Mean fluorescence intensity | Standard Deviation 858.1801 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD16+, Session2,Day1,9 hour 40 minutes,n-0,0,0,4 | -24.5510 Mean fluorescence intensity | Standard Deviation 13.98978 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD86+, Session2,Day1,5 hour 40 minutes, n=2, 4,2,4 | -77.6915 Mean fluorescence intensity | Standard Deviation 70.58944 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD86+, Session2,Day1,9 hour 40 minutes,n=0,0,0,4 | -58.9008 Mean fluorescence intensity | Standard Deviation 99.84882 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD206+, Session2,Day1,2 hour 40 minutes, n=2,2,2,4 | 1808.345 Mean fluorescence intensity | Standard Deviation 1763.3758 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD206+, Session2,Day1, 40 minutes, n=2,3,2,4 | 932.807 Mean fluorescence intensity | Standard Deviation 829.8233 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD16+, Session2,Day1, 5 hour 40 minutes, n=2,4,2,4 | -29.1195 Mean fluorescence intensity | Standard Deviation 15.07448 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD86+,Session2,Day2, Pre-fluid sampling,n=2, 4,2,4 | 27.5388 Mean fluorescence intensity | Standard Deviation 55.57075 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD163+,Session2,Day3, Pre-fluid sampling,n=2,4,2,4 | 63.254 Mean fluorescence intensity | Standard Deviation 54.8309 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD163+,Session2,Day2, Pre-fluid sampling,n=2,4,2,4 | -73.247 Mean fluorescence intensity | Standard Deviation 127.0624 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | HLA-DR,Session2,Day3, Pre-fluid sampling,n=2,4,2,4 | -549.404 Mean fluorescence intensity | Standard Deviation 673.4385 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD86+,Session2,Day3, Pre-fluid sampling,n=2, 4,2,4 | -17.0975 Mean fluorescence intensity | Standard Deviation 38.55065 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD163+, Session2,Day1, 9 hour 40 minutes,n-0,0,0,4 | -314.464 Mean fluorescence intensity | Standard Deviation 132.33 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD163+, Session2,Day1,5 hour 40 minutes, n=2,4,2,4 | -376.659 Mean fluorescence intensity | Standard Deviation 156.2613 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | HLA-DR,Session2,Day2, Pre-fluid sampling,n=2,4,2,4 | 904.203 Mean fluorescence intensity | Standard Deviation 1067.6177 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | HLA-DR, Session2,Day1, 40 minutes, n=2, 4,2,4 | -1240.116 Mean fluorescence intensity | Standard Deviation 874.3051 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD80, Session2,Day1,9 hour 40 minutes, n=0,0,0,4 | 13.1760 Mean fluorescence intensity | Standard Deviation 30.88285 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD80, Session2,Day1,5 hour 40 minutes, n=2, 4,2,4 | -5.9842 Mean fluorescence intensity | Standard Deviation 18.30542 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD163+, Session2,Day1,2 hour 40 minutes, n=2,4,2,4 | -426.253 Mean fluorescence intensity | Standard Deviation 144.1939 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD80,Session2,Day2, Pre-fluid sampling,n=2, 4,2,4 | 51.1900 Mean fluorescence intensity | Standard Deviation 44.73616 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD80, Session2,Day1,2 hour 40 minutes, n=2,4,2,4 | -11.1910 Mean fluorescence intensity | Standard Deviation 6.58469 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD80, Session2,Day1, 40 minutes, n=2, 4,2,4 | -10.8950 Mean fluorescence intensity | Standard Deviation 7.78157 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD163+, Session2,Day1, 40 minutes, n=2,4,2,4 | -511.618 Mean fluorescence intensity | Standard Deviation 152.8883 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD80,Session2,Day3, Pre-fluid sampling,n=2, 4,2,4 | 29.5018 Mean fluorescence intensity | Standard Deviation 31.07571 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD40, Session2,Day3, Pre-fluid sampling,n=2, 4,2,4 | -33.4253 Mean fluorescence intensity | Standard Deviation 54.35736 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD40, Session2,Day2, Pre-fluid sampling,n=2,4, 2,4 | 87.4498 Mean fluorescence intensity | Standard Deviation 34.37912 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD16+, Session2,Day1, 2 hour 40 minutes, n=2,4,2,4 | -26.6015 Mean fluorescence intensity | Standard Deviation 13.40656 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD83, Session2,Day1, 40 minutes, n=2, 4,2,4 | 268.284 Mean fluorescence intensity | Standard Deviation 705.8063 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD40, Session2,Day1,9 hour 40 minutes,n=0,0,0,4 | 36.2845 Mean fluorescence intensity | Standard Deviation 55.24688 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD40, Session2,Day1,5 hour 40 minutes, n=2,4,2,4 | -9.8278 Mean fluorescence intensity | Standard Deviation 40.48593 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | HLA-DR, Session2,Day1,2 hour 40 minutes, n=2,4,2,4 | -764.884 Mean fluorescence intensity | Standard Deviation 1616.7399 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD83, Session2,Day1,2 hour 40 minutes, n=2, 4,2,4 | 113.359 Mean fluorescence intensity | Standard Deviation 989.9087 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood | CD40, Session2,Day1,2 hour 40 minutes, n=2,4,2,4 | -36.8868 Mean fluorescence intensity | Standard Deviation 86.92683 |
Secondary
Part 1: Change From Baseline in Cell Numbers in Blister
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Numbers in Blister | Session 2, Day 2, 24 hours | -936062.5 Cells per milliliter | Standard Deviation 3258497.75 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Numbers in Blister | Session 1, Day 3, 48 hours | -1405000.0 Cells per milliliter | Standard Deviation 6808193.03 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Cell Numbers in Blister | Session 2, Day 3, 48 hours | -1316000.0 Cells per milliliter | Standard Deviation 6556133.25 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Numbers in Blister | Session 1, Day 3, 48 hours | 667500.0 Cells per milliliter | Standard Deviation 1375322.69 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Numbers in Blister | Session 2, Day 3, 48 hours | 3275000.0 Cells per milliliter | Standard Deviation 1216223.66 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Cell Numbers in Blister | Session 2, Day 2, 24 hours | 5447500.0 Cells per milliliter | Standard Deviation 7124100.82 |
Secondary
Part 1: Change From Baseline in Circulating Leukocyte Numbers in Blood: LPS Arm
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 3209541.02 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 21593.24 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Circulating Leukocyte Numbers in Blood: LPS Arm | Session2, Day 1, 5 hours 40 minutes | 4511414.25 Cells per milliliter | Standard Deviation 3044446.191 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Circulating Leukocyte Numbers in Blood: LPS Arm | Session2, Day 1, 40 minutes | -1477705.00 Cells per milliliter | Standard Deviation 811560.729 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Circulating Leukocyte Numbers in Blood: LPS Arm | Session2, Day 1, 2 hours 40 minutes | 2423233.00 Cells per milliliter | Standard Deviation 2047535.993 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Circulating Leukocyte Numbers in Blood: LPS Arm | Session2, Day 2, Pre-fluid sample | 881299.75 Cells per milliliter | Standard Deviation 1640158.83 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Circulating Leukocyte Numbers in Blood: LPS Arm | Session2, Day 3, Pre-fluid sample | -93685.25 Cells per milliliter | Standard Deviation 1383413.608 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Circulating Leukocyte Numbers in Blood: LPS Arm | Session2, Day 3, Pre-fluid sample | 75348.31 Cells per milliliter | Standard Deviation 927892.867 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Circulating Leukocyte Numbers in Blood: LPS Arm | Session2, Day 2, Pre-fluid sample | 442226.68 Cells per milliliter | Standard Deviation 232936.722 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Circulating Leukocyte Numbers in Blood: LPS Arm | Session2, Day 1, 40 minutes | -2065961.83 Cells per milliliter | Standard Deviation 1083290.576 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Circulating Leukocyte Numbers in Blood: LPS Arm | Session2, Day 1, 5 hours 40 minutes | 3641780.22 Cells per milliliter | Standard Deviation 1458532.473 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Circulating Leukocyte Numbers in Blood: LPS Arm | Session2, Day 1, 2 hours 40 minutes | 5224467.23 Cells per milliliter | Standard Deviation 800613.402 |
Secondary
Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 | — |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 0.0525 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 | — |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 | — |
| Part 1: LPS 0.5 ng/kg | 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 2.4761 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 | — |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 3.4277 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-8, Session2,Day1, 5 hour 40 minutes, n=2,3, 2,4 | 88.5574 Picograms per milliliter | Standard Deviation 24.0924 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-8, Session2,Day2, Pre-fluid sampling, n=2,3,2,4 | 8.7544 Picograms per milliliter | Standard Deviation 16.57327 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-8, Session2,Day3, Pre-fluid sampling, n=2,4,2,4 | 0.6465 Picograms per milliliter | Standard Deviation 2.78896 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | INFg, Session2,Day3, Pre-fluid sampling, n=2,4,2,4 | 1.5962 Picograms per milliliter | Standard Deviation 3.09933 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | MCP-1, Session2,Day1, -5 minutes, n=2, 4, 2,4 | 7.280 Picograms per milliliter | Standard Deviation 11.0662 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | MCP-1, Session2,Day1, 10 minutes, n=2, 4, 2,4 | 15.335 Picograms per milliliter | Standard Deviation 18.3588 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | INFg, Session2,Day1, 25 minutes, n=1, 4, 2, 4 | -0.3697 Picograms per milliliter | Standard Deviation 0.19518 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | MCP-1, Session2,Day1, 25 minutes, n=1, 4, 2,4 | 22.679 Picograms per milliliter | Standard Deviation 14.054 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | MCP-1, Session2,Day1, 40 minutes, n=2, 4, 2,4 | 108.005 Picograms per milliliter | Standard Deviation 54.218 |
| Part 1: LPS 0.75 ng/kg | 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 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | MCP-1, Session2,Day1, 1 hour 10 minutes, n=2,4,2,4 | 3281.560 Picograms per milliliter | Standard Deviation 2188.7631 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | MCP-1, Session2,Day1, 1 hour 40 minutes, n=2,4,2,4 | 5164.946 Picograms per milliliter | Standard Deviation 25.3073 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | MCP-1, Session2,Day1, 2 hour 40 minutes, n=2,4,2,4 | 5189.946 Picograms per milliliter | Standard Deviation 75.0973 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | MCP-1, Session2,Day1, 5 hour 40 minutes, n=2,4,2,4 | 588.424 Picograms per milliliter | Standard Deviation 384.1274 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-1b, Session2,Day1, 10 minutes, n=2, 4, 2,4 | 0.0008 Picograms per milliliter | Standard Deviation 0.0015 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | MCP-1, Session2,Day2,Pre-fluid sampling, n=2,4,2,4 | 38.016 Picograms per milliliter | Standard Deviation 54.7584 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | MCP-1, Session2,Day3,Pre-fluid sampling, n=2,4,2,4 | 28.822 Picograms per milliliter | Standard Deviation 23.2955 |
| Part 1: LPS 0.75 ng/kg | 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 0 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-1b, Session2,Day1, 40 minutes, n=2, 4, 2,4 | 0.0008 Picograms per milliliter | Standard Deviation 0.0015 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | INFg, Session2,Day1, 40 minutes, n=2, 4, 2, 4 | -0.4771 Picograms per milliliter | Standard Deviation 0.4199 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-1b, Session2,Day1, 1hour 10minutes, n=2,4,2,4 | 0.0008 Picograms per milliliter | Standard Deviation 0.0015 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-1b, Session2,Day1, 1hour 40minutes, n=2,4,2,4 | 0.1875 Picograms per milliliter | Standard Deviation 0.37303 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-1b, Session2,Day1, 2hour 40minutes, n=2,4,2,4 | 0.3194 Picograms per milliliter | Standard Deviation 0.41468 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-1b, Session2,Day1, 5hour 40minutes, n=2,4,2,4 | 0.0008 Picograms per milliliter | Standard Deviation 0.0015 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | INFg, Session2,Day1, 1 hour 10 minutes, n=2, 4,2,4 | 1.7673 Picograms per milliliter | Standard Deviation 1.80932 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-1b, Session2,Day2,Pre-fluid sample, n=2,4,2,4 | 0.0008 Picograms per milliliter | Standard Deviation 0.0015 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-1b, Session2,Day3,Pre-fluid sample, n=2,4,2,4 | 0.0008 Picograms per milliliter | Standard Deviation 0.0015 |
| Part 1: LPS 0.75 ng/kg | 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 |
| Part 1: LPS 0.75 ng/kg | 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 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | INFg, Session2,Day1, 1 hour 40 minutes, n=2, 4,2,4 | 6.5863 Picograms per milliliter | Standard Deviation 3.69982 |
| Part 1: LPS 0.75 ng/kg | 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 |
| Part 1: LPS 0.75 ng/kg | 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 |
| Part 1: LPS 0.75 ng/kg | 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 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | INFg, Session2,Day1, 10 minutes, n=2, 4, 2, 4 | -0.3298 Picograms per milliliter | Standard Deviation 0.20362 |
| Part 1: LPS 0.75 ng/kg | 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 |
| Part 1: LPS 0.75 ng/kg | 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 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | INFg, Session2,Day1, 2 hour 40 minutes, n=2, 4,2,4 | 8.7498 Picograms per milliliter | Standard Deviation 2.9773 |
| Part 1: LPS 0.75 ng/kg | 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 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-2, Session2,Day2, Pre-fluid sampling, n=2,4,2,4 | 0.0031 Picograms per milliliter | Standard Deviation 0.00625 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-2, Session2,Day3, Pre-fluid sampling, n=2,4,2,4 | 0.0031 Picograms per milliliter | Standard Deviation 0.00625 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-8, Session2,Day1, -5 minutes, n=2, 4, 2,4 | 0.0761 Picograms per milliliter | Standard Deviation 0.99505 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | INFg, Session2,Day1, 5 hour 40 minutes, n=2, 4,2,4 | 3.2672 Picograms per milliliter | Standard Deviation 1.86587 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-8, Session2,Day1, 10 minutes, n=2, 4, 2,4 | 0.0714 Picograms per milliliter | Standard Deviation 1.30027 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-8, Session2,Day1, 25 minutes, n=1, 4, 2,4 | 0.6814 Picograms per milliliter | Standard Deviation 1.2765 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | INFg, Session2,Day1, -5 minutes, n=2, 4, 2, 4 | -0.1278 Picograms per milliliter | Standard Deviation 0.23076 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-8, Session2,Day1, 40 minutes, n=2, 3, 2,4 | 9.3036 Picograms per milliliter | Standard Deviation 5.86829 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-8, Session2,Day1, 1 hour 10 minutes, n=2, 3,2,4 | 141.7558 Picograms per milliliter | Standard Deviation 104.21164 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | INFg, Session2,Day2, Pre-fluid sampling, n=2,4,2,4 | 0.7630 Picograms per milliliter | Standard Deviation 1.43167 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-8, Session2,Day1, 1 hour 40 minutes, n=2,3, 2,4 | 468.8635 Picograms per milliliter | Standard Deviation 296.06234 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-8, Session2,Day1, 2 hour 40 minutes, n=2,3, 2,4 | 340.0657 Picograms per milliliter | Standard Deviation 234.74182 |
| Part 1: LPS 1 ng/kg | 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 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | MCP-1, Session2,Day1, 40 minutes, n=2, 4, 2,4 | 273.261 Picograms per milliliter | Standard Deviation 29.0646 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-2, Session2,Day1, 1 hour 10 minutes, n=0, 4,2,4 | 0.0000 Picograms per milliliter | Standard Deviation 0 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-8, Session2,Day1, 5 hour 40 minutes, n=2,3, 2,4 | 19.5090 Picograms per milliliter | Standard Deviation 6.86764 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-8, Session2,Day1, 40 minutes, n=2, 3, 2,4 | 27.1507 Picograms per milliliter | Standard Deviation 3.96686 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-2, Session2,Day1, 1 hour 40 minutes, n=0, 4,2,2 | 0.0000 Picograms per milliliter | Standard Deviation 0 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | MCP-1, Session2,Day1, 5 hour 40 minutes, n=2,4,2,4 | 350.071 Picograms per milliliter | Standard Deviation 81.7289 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | MCP-1, Session2,Day1, 25 minutes, n=1, 4, 2,4 | 9.360 Picograms per milliliter | Standard Deviation 10.2709 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-2, Session2,Day1, 2 hour 40 minutes, n=0, 4,2,2 | 0.0000 Picograms per milliliter | Standard Deviation 0 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | MCP-1, Session2,Day1, 10 minutes, n=2, 4, 2,4 | -6.963 Picograms per milliliter | Standard Deviation 11.3479 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-8, Session2,Day1, 2 hour 40 minutes, n=2,3, 2,4 | 111.6155 Picograms per milliliter | Standard Deviation 118.63027 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-2, Session2,Day1, 5 hour 40 minutes, n=0, 4,2,2 | 0.0000 Picograms per milliliter | Standard Deviation 0 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | INFg, Session2,Day1, 2 hour 40 minutes, n=2, 4,2,4 | 15.7306 Picograms per milliliter | Standard Deviation 3.51048 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | MCP-1, Session2,Day1, 2 hour 40 minutes, n=2,4,2,4 | 6824.798 Picograms per milliliter | Standard Deviation 3014.633 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-8, Session2,Day1, 1 hour 10 minutes, n=2, 3,2,4 | 162.3033 Picograms per milliliter | Standard Deviation 42.93991 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-2, Session2,Day2, Pre-fluid sampling, n=2,4,2,4 | -0.0160 Picograms per milliliter | Standard Deviation 0 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | INFg, Session2,Day1, 10 minutes, n=2, 4, 2, 4 | -0.2355 Picograms per milliliter | Standard Deviation 0.28729 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | INFg, Session2,Day1, 25 minutes, n=1, 4, 2, 4 | -0.2432 Picograms per milliliter | Standard Deviation 0.30593 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-8, Session2,Day3, Pre-fluid sampling, n=2,4,2,4 | -0.8507 Picograms per milliliter | Standard Deviation 0.69264 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-2, Session2,Day3, Pre-fluid sampling, n=2,4,2,4 | -0.0160 Picograms per milliliter | Standard Deviation 0 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | MCP-1, Session2,Day1, 1 hour 40 minutes, n=2,4,2,4 | 6182.663 Picograms per milliliter | Standard Deviation 13.9688 |
| Part 1: LPS 1 ng/kg | 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 |
| Part 1: LPS 1 ng/kg | 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 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | INFg, Session2,Day1, 40 minutes, n=2, 4, 2, 4 | 0.1501 Picograms per milliliter | Standard Deviation 0.28816 |
| Part 1: LPS 1 ng/kg | 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 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | INFg, Session2,Day3, Pre-fluid sampling, n=2,4,2,4 | -2.6600 Picograms per milliliter | Standard Deviation 1.75306 |
| Part 1: LPS 1 ng/kg | 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 |
| Part 1: LPS 1 ng/kg | 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 |
| Part 1: LPS 1 ng/kg | 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 0 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-8, Session2,Day1, -5 minutes, n=2, 4, 2,4 | 0.1849 Picograms per milliliter | Standard Deviation 0.0802 |
| Part 1: LPS 1 ng/kg | 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 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-8, Session2,Day2, Pre-fluid sampling, n=2,3,2,4 | -1.3116 Picograms per milliliter | Standard Deviation 1.93618 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | INFg, Session2,Day1, -5 minutes, n=2, 4, 2, 4 | 0.0653 Picograms per milliliter | Standard Deviation 0.80201 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | MCP-1, Session2,Day1, 1 hour 10 minutes, n=2,4,2,4 | 2993.718 Picograms per milliliter | Standard Deviation 17.3345 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-1b, Session2,Day2,Pre-fluid sample, n=2,4,2,4 | -0.0030 Picograms per milliliter | Standard Deviation 0 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | INFg, Session2,Day1, 1 hour 10 minutes, n=2, 4,2,4 | 6.6083 Picograms per milliliter | Standard Deviation 0.78111 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | MCP-1, Session2,Day3,Pre-fluid sampling, n=2,4,2,4 | 8.210 Picograms per milliliter | Standard Deviation 9.0286 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-8, Session2,Day1, 1 hour 40 minutes, n=2,3, 2,4 | 229.6116 Picograms per milliliter | Standard Deviation 155.88116 |
| Part 1: LPS 1 ng/kg | 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 |
| Part 1: LPS 1 ng/kg | 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 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-8, Session2,Day1, 10 minutes, n=2, 4, 2,4 | 0.8613 Picograms per milliliter | Standard Deviation 0.83194 |
| Part 1: LPS 1 ng/kg | 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 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | MCP-1, Session2,Day2,Pre-fluid sampling, n=2,4,2,4 | -2.917 Picograms per milliliter | Standard Deviation 42.85 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | INFg, Session2,Day1, 5 hour 40 minutes, n=2, 4,2,4 | 5.0294 Picograms per milliliter | Standard Deviation 3.92184 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-2, Session2,Day1, 10 minutes, n=0, 4, 2,2 | 0.0000 Picograms per milliliter | Standard Deviation 0 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | INFg, Session2,Day2, Pre-fluid sampling, n=2,4,2,4 | -0.3514 Picograms per milliliter | Standard Deviation 1.05828 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-8, Session2,Day1, 25 minutes, n=1, 4, 2,4 | 3.0142 Picograms per milliliter | Standard Deviation 1.22739 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-2, Session2,Day1, 25 minutes, n=0, 4, 2,4 | 0.0000 Picograms per milliliter | Standard Deviation 0 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | INFg, Session2,Day1, 1 hour 40 minutes, n=2, 4,2,4 | 13.6809 Picograms per milliliter | Standard Deviation 3.56564 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | MCP-1, Session2,Day1, -5 minutes, n=2, 4, 2,4 | -12.078 Picograms per milliliter | Standard Deviation 6.4316 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | MCP-1, Session2,Day3,Pre-fluid sampling, n=2,4,2,4 | -15.571 Picograms per milliliter | Standard Deviation 25.0756 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | INFg, Session2,Day1, -5 minutes, n=2, 4, 2, 4 | 5.7255 Picograms per milliliter | Standard Deviation 1.85029 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | INFg, Session2,Day1, 10 minutes, n=2, 4, 2, 4 | 6.0071 Picograms per milliliter | Standard Deviation 1.26842 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | INFg, Session2,Day1, 25 minutes, n=1, 4, 2, 4 | 6.1605 Picograms per milliliter | Standard Deviation 1.77144 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | INFg, Session2,Day1, 40 minutes, n=2, 4, 2, 4 | 5.4142 Picograms per milliliter | Standard Deviation 2.07138 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | INFg, Session2,Day1, 1 hour 10 minutes, n=2, 4,2,4 | 4.9508 Picograms per milliliter | Standard Deviation 1.77082 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | INFg, Session2,Day1, 1 hour 40 minutes, n=2, 4,2,4 | 3.8804 Picograms per milliliter | Standard Deviation 2.00819 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | INFg, Session2,Day1, 2 hour 40 minutes, n=2, 4,2,4 | 2.7181 Picograms per milliliter | Standard Deviation 2.63053 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | INFg, Session2,Day1, 5 hour 40 minutes, n=2, 4,2,4 | 1.7041 Picograms per milliliter | Standard Deviation 1.64895 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | INFg, Session2,Day2, Pre-fluid sampling, n=2,4,2,4 | -3.0755 Picograms per milliliter | Standard Deviation 2.76516 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | INFg, Session2,Day3, Pre-fluid sampling, n=2,4,2,4 | -3.2817 Picograms per milliliter | Standard Deviation 2.72811 |
| Part 1: GM-CSF 60 µg/m^2 | 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 |
| Part 1: GM-CSF 60 µg/m^2 | 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 |
| Part 1: GM-CSF 60 µg/m^2 | 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 0 |
| Part 1: GM-CSF 60 µg/m^2 | 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 |
| Part 1: GM-CSF 60 µg/m^2 | 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 |
| Part 1: GM-CSF 60 µg/m^2 | 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 |
| Part 1: GM-CSF 60 µg/m^2 | 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 |
| Part 1: GM-CSF 60 µg/m^2 | 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 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-1b, Session2,Day2,Pre-fluid sample, n=2,4,2,4 | 0.0857 Picograms per milliliter | Standard Deviation 0.10517 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-1b, Session2,Day3,Pre-fluid sample, n=2,4,2,4 | -0.0015 Picograms per milliliter | Standard Deviation 0.00173 |
| Part 1: GM-CSF 60 µg/m^2 | 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 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-2, Session2,Day1, 10 minutes, n=0, 4, 2,2 | 0.0000 Picograms per milliliter | Standard Deviation 0 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-2, Session2,Day1, 25 minutes, n=0, 4, 2,4 | 0.0000 Picograms per milliliter | Standard Deviation 0 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-2, Session2,Day1, 1 hour 10 minutes, n=0, 4,2,4 | 0.0000 Picograms per milliliter | Standard Deviation 0 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-2, Session2,Day1, 1 hour 40 minutes, n=0, 4,2,2 | 0.0000 Picograms per milliliter | Standard Deviation 0 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-2, Session2,Day1, 2 hour 40 minutes, n=0, 4,2,2 | 0.0000 Picograms per milliliter | Standard Deviation 0 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-2, Session2,Day1, 5 hour 40 minutes, n=0, 4,2,2 | 0.0000 Picograms per milliliter | Standard Deviation 0 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-2, Session2,Day2, Pre-fluid sampling, n=2,4,2,4 | -0.0018 Picograms per milliliter | Standard Deviation 0.01645 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-2, Session2,Day3, Pre-fluid sampling, n=2,4,2,4 | -0.0018 Picograms per milliliter | Standard Deviation 0.01645 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-8, Session2,Day1, -5 minutes, n=2, 4, 2,4 | 83.1531 Picograms per milliliter | Standard Deviation 44.11662 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-8, Session2,Day1, 10 minutes, n=2, 4, 2,4 | 89.0123 Picograms per milliliter | Standard Deviation 48.41011 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-8, Session2,Day1, 25 minutes, n=1, 4, 2,4 | 86.4178 Picograms per milliliter | Standard Deviation 47.57975 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-8, Session2,Day1, 40 minutes, n=2, 3, 2,4 | 50.4514 Picograms per milliliter | Standard Deviation 20.49601 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-8, Session2,Day1, 1 hour 10 minutes, n=2, 3,2,4 | 76.6709 Picograms per milliliter | Standard Deviation 36.79748 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-8, Session2,Day1, 1 hour 40 minutes, n=2,3, 2,4 | 77.3493 Picograms per milliliter | Standard Deviation 73.83422 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-8, Session2,Day1, 2 hour 40 minutes, n=2,3, 2,4 | 126.3552 Picograms per milliliter | Standard Deviation 204.81735 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-8, Session2,Day1, 5 hour 40 minutes, n=2,3, 2,4 | 30.1483 Picograms per milliliter | Standard Deviation 10.71198 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-8, Session2,Day2, Pre-fluid sampling, n=2,3,2,4 | 33.5296 Picograms per milliliter | Standard Deviation 54.13468 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | IL-8, Session2,Day3, Pre-fluid sampling, n=2,4,2,4 | -2.0468 Picograms per milliliter | Standard Deviation 1.21979 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | MCP-1, Session2,Day1, -5 minutes, n=2, 4, 2,4 | 2702.736 Picograms per milliliter | Standard Deviation 1675.5428 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | MCP-1, Session2,Day1, 10 minutes, n=2, 4, 2,4 | 3692.647 Picograms per milliliter | Standard Deviation 1671.9037 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | MCP-1, Session2,Day1, 25 minutes, n=1, 4, 2,4 | 4354.050 Picograms per milliliter | Standard Deviation 1579.4757 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | MCP-1, Session2,Day1, 40 minutes, n=2, 4, 2,4 | 4218.511 Picograms per milliliter | Standard Deviation 1850.5204 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | MCP-1, Session2,Day1, 1 hour 10 minutes, n=2,4,2,4 | 4119.865 Picograms per milliliter | Standard Deviation 2047.793 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | MCP-1, Session2,Day1, 1 hour 40 minutes, n=2,4,2,4 | 2659.013 Picograms per milliliter | Standard Deviation 1778.3867 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | MCP-1, Session2,Day1, 2 hour 40 minutes, n=2,4,2,4 | 1405.284 Picograms per milliliter | Standard Deviation 603.0458 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | MCP-1, Session2,Day1, 5 hour 40 minutes, n=2,4,2,4 | 365.641 Picograms per milliliter | Standard Deviation 156.6637 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood | MCP-1, Session2,Day2,Pre-fluid sampling, n=2,4,2,4 | -14.427 Picograms per milliliter | Standard Deviation 32.743 |
| Part 1: GM-CSF 60 µg/m^2 | 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 |
Secondary
Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: C-reactive Protein (CRP)
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.
Time frame: Baseline; Session 2: Post challenge Day 1. Pre-fluid sample on Day 2 and Day 3
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: C-reactive Protein (CRP) | Session2,Day1, Post-challenge | 2.75 Milligrams per liter | Standard Deviation 0.624 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: C-reactive Protein (CRP) | Session2,Day 3, Pre-fluid sample | 10.65 Milligrams per liter | Standard Deviation 0.968 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: C-reactive Protein (CRP) | Session2,Day 2, Pre-fluid sample | 21.80 Milligrams per liter | Standard Deviation 2.38 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: C-reactive Protein (CRP) | Session2,Day 2, Pre-fluid sample | 18.55 Milligrams per liter | Standard Deviation 4.455 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: C-reactive Protein (CRP) | Session2,Day1, Post-challenge | 2.40 Milligrams per liter | Standard Deviation 0.99 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: C-reactive Protein (CRP) | Session2,Day 3, Pre-fluid sample | 8.45 Milligrams per liter | Standard Deviation 0.636 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: C-reactive Protein (CRP) | Session2,Day1, Post-challenge | 1.53 Milligrams per liter | Standard Deviation 0.457 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: C-reactive Protein (CRP) | Session2,Day 3, Pre-fluid sample | 2.25 Milligrams per liter | Standard Deviation 0.451 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: C-reactive Protein (CRP) | Session2,Day 2, Pre-fluid sample | 5.80 Milligrams per liter | Standard Deviation 1.623 |
Secondary
Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF: GM-CSF Arm
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: LPS 0.5 ng/kg | 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 635.905 |
| Part 1: LPS 0.5 ng/kg | 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: LPS 0.5 ng/kg | 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: LPS 0.5 ng/kg | 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: LPS 0.5 ng/kg | 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: LPS 0.5 ng/kg | 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: LPS 0.5 ng/kg | 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: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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: LPS 0.5 ng/kg | 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: LPS 0.5 ng/kg | 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: LPS 0.5 ng/kg | 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: LPS 0.5 ng/kg | 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: LPS 0.5 ng/kg | 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: LPS 0.5 ng/kg | 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: LPS 0.5 ng/kg | 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: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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: LPS 0.5 ng/kg | 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: LPS 0.5 ng/kg | 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 0.704 |
| Part 1: LPS 0.5 ng/kg | 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: LPS 0.5 ng/kg | 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: LPS 0.5 ng/kg | 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: LPS 0.5 ng/kg | 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: LPS 0.5 ng/kg | 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: LPS 0.5 ng/kg | 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: LPS 0.5 ng/kg | 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: LPS 0.5 ng/kg | 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 |
Secondary
Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Dendritic Cells in Blister
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 | — |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.75 ng/kg | 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 | 43.2094 Ratio | Standard Deviation 6.81783 |
| Part 1: LPS 0.75 ng/kg | 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 | 42.6493 Ratio | Standard Deviation 11.60035 |
| Part 1: LPS 0.75 ng/kg | 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 | 0.0825 Ratio | Standard Deviation 18.06488 |
| Part 1: LPS 1 ng/kg | 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 | 0.0900 Ratio | Standard Deviation 1.52735 |
| Part 1: LPS 1 ng/kg | 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 | 47.8100 Ratio | Standard Deviation 4.17193 |
| Part 1: LPS 1 ng/kg | 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 | 42.5100 Ratio | Standard Deviation 2.82843 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 39.8453 Ratio | Standard Deviation 6.60325 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 38.4313 Ratio | Standard Deviation 6.81975 |
| Part 1: GM-CSF 60 µg/m^2 | 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 | 6.7523 Ratio | Standard Deviation 9.76233 |
Secondary
Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Macrophages in Blister
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 | — |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Macrophages in Blister | Session1,Day3, 48 hours, n=2, 4, 2, 4 | -1.2837 Ratio | Standard Deviation 17.00275 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Macrophages in Blister | Session2,Day3, 48 hours, n=1, 4, 2, 4 | -2.9838 Ratio | Standard Deviation 10.58741 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Macrophages in Blister | Session2,Day2, 24 hours, n=2, 4, 2, 4 | 1.3537 Ratio | Standard Deviation 22.85581 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Macrophages in Blister | Session2,Day2, 24 hours, n=2, 4, 2, 4 | -16.0250 Ratio | Standard Deviation 3.35876 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Macrophages in Blister | Session1,Day3, 48 hours, n=2, 4, 2, 4 | 21.8500 Ratio | Standard Deviation 26.44579 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Macrophages in Blister | Session2,Day3, 48 hours, n=1, 4, 2, 4 | -8.9750 Ratio | Standard Deviation 17.00592 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Macrophages in Blister | Session1,Day3, 48 hours, n=2, 4, 2, 4 | -0.8938 Ratio | Standard Deviation 20.18664 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Macrophages in Blister | Session2,Day3, 48 hours, n=1, 4, 2, 4 | -3.2238 Ratio | Standard Deviation 27.65006 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Macrophages in Blister | Session2,Day2, 24 hours, n=2, 4, 2, 4 | 9.1137 Ratio | Standard Deviation 15.78332 |
Secondary
Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Monocytes in Blister
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 | — |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Monocytes in Blister | Session1,Day3, 48 hours, n=2, 4, 2, 4 | 0.2764 Ratio | Standard Deviation 0.19587 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Monocytes in Blister | Session2,Day3, 48 hours, n=1, 4, 2, 3 | 0.3015 Ratio | Standard Deviation 0.39252 |
| Part 1: LPS 0.75 ng/kg | Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Monocytes in Blister | Session2,Day2, 24 hours, n=2, 4, 2, 4 | 0.5062 Ratio | Standard Deviation 0.70807 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Monocytes in Blister | Session2,Day2, 24 hours, n=2, 4, 2, 4 | 0.5108 Ratio | Standard Deviation 0.67069 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Monocytes in Blister | Session1,Day3, 48 hours, n=2, 4, 2, 4 | 0.0610 Ratio | Standard Deviation 0.13294 |
| Part 1: LPS 1 ng/kg | Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Monocytes in Blister | Session2,Day3, 48 hours, n=1, 4, 2, 3 | 0.1300 Ratio | Standard Deviation 0.03748 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Monocytes in Blister | Session1,Day3, 48 hours, n=2, 4, 2, 4 | -0.4060 Ratio | Standard Deviation 0.82999 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Monocytes in Blister | Session2,Day3, 48 hours, n=1, 4, 2, 3 | -0.2698 Ratio | Standard Deviation 1.0927 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Monocytes in Blister | Session2,Day2, 24 hours, n=2, 4, 2, 4 | -0.0994 Ratio | Standard Deviation 1.34749 |
Secondary
Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: LPS 0.5 ng/kg | 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 | — |
| Part 1: LPS 0.5 ng/kg | 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 | — |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 6.0624 |
| Part 1: LPS 0.5 ng/kg | 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 140485.27 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.5 ng/kg | 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 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | IL-2, Session2,Day3, 48 hours, n=2, 2, 2, 1 | 2.1377 Picograms per milliliter | Standard Deviation 2.64598 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | MCP-1, Session1,Day3, 48 hours, n=2,4,2,4 | -10520.93 Picograms per milliliter | Standard Deviation 5858.889 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | IL-1b, Session2,Day2, 24 hours, n=2, 2, 2,1 | -83.1670 Picograms per milliliter | Standard Deviation 108.13325 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | MCP-1, Session2,Day3, 48 hours, n=2,4,2,4 | 1077.95 Picograms per milliliter | Standard Deviation 10014.723 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | IL-1b, Session2,Day3, 48 hours, n=2, 2, 2,1 | -81.6788 Picograms per milliliter | Standard Deviation 130.42664 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | MCP-1, Session2,Day2, 24 hours, n=2,4,2,4 | 4723.83 Picograms per milliliter | Standard Deviation 11253.334 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | IL-2, Session2,Day2, 24 hours, n=2, 2, 2, 1 | 0.1804 Picograms per milliliter | Standard Deviation 0.58673 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | TNF alpha,Session2,Day3,48 hours, n=2,2,2,1 | -110.6500 Picograms per milliliter | Standard Deviation 52.29742 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | IL-1b, Session1, Day 3, 48 hours, n=2, 2, 2,3 | -41.5298 Picograms per milliliter | Standard Deviation 149.67553 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | TNF alpha,Session1,Day3,48 hours, n=2,2,2,3 | -98.8930 Picograms per milliliter | Standard Deviation 55.29269 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | IL-2, Session1,Day3, 48 hours, n=2, 2, 2, 3 | -0.5699 Picograms per milliliter | Standard Deviation 0.80595 |
| Part 1: LPS 0.75 ng/kg | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | TNF alpha,Session2,Day2, 24 hours, n=2,2,2,1 | 53.6996 Picograms per milliliter | Standard Deviation 266.29344 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | IL-8, Session2,Day3, 48 hours, n=2, 0, 2, 0 | -42836.70 Picograms per milliliter | Standard Deviation 30559.892 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | IL-1b, Session1, Day 3, 48 hours, n=2, 2, 2,3 | 3.6243 Picograms per milliliter | Standard Deviation 35.28147 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | IL-1b, Session2,Day2, 24 hours, n=2, 2, 2,1 | 7.9733 Picograms per milliliter | Standard Deviation 19.49142 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | IL-1b, Session2,Day3, 48 hours, n=2, 2, 2,1 | 7.6783 Picograms per milliliter | Standard Deviation 0.42508 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | IFNg, Session1,Day3, 48 hours, n=2, 0, 2, 0 | 55.9575 Picograms per milliliter | Standard Deviation 65.86745 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | IFNg, Session2,Day2, 24 hours, n=2, 0, 2, 0 | -4.5772 Picograms per milliliter | Standard Deviation 7.20432 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | IFNg, Session2,Day3, 48 hours, n=2, 0, 2, 0 | 2.9556 Picograms per milliliter | Standard Deviation 13.15578 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | IL-2, Session1,Day3, 48 hours, n=2, 2, 2, 3 | 0.1623 Picograms per milliliter | Standard Deviation 0.2296 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | IL-2, Session2,Day2, 24 hours, n=2, 2, 2, 1 | 0.0000 Picograms per milliliter | Standard Deviation 0 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | IL-2, Session2,Day3, 48 hours, n=2, 2, 2, 1 | 0.6968 Picograms per milliliter | Standard Deviation 0.98543 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | IL-6, Session1,Day3,48 hours, n=2, 0, 2, 0 | 1535.45 Picograms per milliliter | Standard Deviation 3195.182 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | IL-6, Session2,Day2, 24 hours, n=1, 0, 1, 0 | -349.63 Picograms per milliliter | — |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | IL-6, Session2,Day3, 48 hours, n=1, 0, 2, 0 | -25.74 Picograms per milliliter | Standard Deviation 864.74 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | IL-8, Session1,Day3,48 hours, n=2, 0, 2, 0 | -42387.41 Picograms per milliliter | Standard Deviation 31786.992 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | IL-8, Session2,Day2, 24 hours, n=2, 0, 2, 0 | 34295.91 Picograms per milliliter | Standard Deviation 34575.984 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | MCP-1, Session1,Day3, 48 hours, n=2,4,2,4 | -18336.31 Picograms per milliliter | Standard Deviation 9925.681 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | MCP-1, Session2,Day2, 24 hours, n=2,4,2,4 | 18049.87 Picograms per milliliter | Standard Deviation 1010.158 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | MCP-1, Session2,Day3, 48 hours, n=2,4,2,4 | -16980.85 Picograms per milliliter | Standard Deviation 11928.656 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | TNF alpha,Session1,Day3,48 hours, n=2,2,2,3 | -16.0826 Picograms per milliliter | Standard Deviation 17.76133 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | TNF alpha,Session2,Day2, 24 hours, n=2,2,2,1 | 34.8290 Picograms per milliliter | Standard Deviation 63.07748 |
| Part 1: LPS 1 ng/kg | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | TNF alpha,Session2,Day3,48 hours, n=2,2,2,1 | -10.5091 Picograms per milliliter | Standard Deviation 18.47463 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | IL-2, Session2,Day3, 48 hours, n=2, 2, 2, 1 | 2.1293 Picograms per milliliter | — |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | IL-2, Session2,Day2, 24 hours, n=2, 2, 2, 1 | 0.0000 Picograms per milliliter | — |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | IL-1b, Session1, Day 3, 48 hours, n=2, 2, 2,3 | 35.4452 Picograms per milliliter | Standard Deviation 48.42938 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | TNF alpha,Session1,Day3,48 hours, n=2,2,2,3 | -33.5839 Picograms per milliliter | Standard Deviation 62.8043 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | IL-2, Session1,Day3, 48 hours, n=2, 2, 2, 3 | 1.2444 Picograms per milliliter | Standard Deviation 1.98677 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | IL-1b, Session2,Day3, 48 hours, n=2, 2, 2,1 | -6.8302 Picograms per milliliter | — |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | TNF alpha,Session2,Day3,48 hours, n=2,2,2,1 | -51.9244 Picograms per milliliter | — |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | TNF alpha,Session2,Day2, 24 hours, n=2,2,2,1 | -29.6573 Picograms per milliliter | — |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | MCP-1, Session2,Day2, 24 hours, n=2,4,2,4 | 4299.94 Picograms per milliliter | Standard Deviation 11160.896 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | MCP-1, Session1,Day3, 48 hours, n=2,4,2,4 | -10284.38 Picograms per milliliter | Standard Deviation 10327.369 |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | IL-1b, Session2,Day2, 24 hours, n=2, 2, 2,1 | -0.3579 Picograms per milliliter | — |
| Part 1: GM-CSF 60 µg/m^2 | Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister | MCP-1, Session2,Day3, 48 hours, n=2,4,2,4 | -11416.80 Picograms per milliliter | Standard Deviation 9587.163 |
Secondary
Part 2: Absolute Values of Blister Volume
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.
Time frame: 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.
Secondary
Part 2:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister
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.
Time frame: 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.
Secondary
Part 2: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood
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.
Time frame: 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.
Secondary
Part 2:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister
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.
Time frame: 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.
Secondary
Part 2:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister
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.
Time frame: 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.
Secondary
Part 2: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood
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.
Time frame: 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.
Secondary
Part 2: Change From Baseline in Cell Numbers in Blister
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.
Time frame: 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.
Secondary
Part 2: Change From Baseline in Circulating Leukocyte Numbers in Blood: LPS Arm
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.
Time frame: 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.
Secondary
Part 2:Change From Baseline in Soluble Inflammatory Mediators in Blood
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.
Time frame: 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.
Secondary
Part 2: Change From Baseline in Soluble Inflammatory Mediators in Blood: CRP
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.
Time frame: 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.
Secondary
Part 2: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF for GM-CSF Arm
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.
Time frame: 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.
Secondary
Part 2:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Dendritic Cells in Blister
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.
Time frame: 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.
Secondary
Part 2:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Macrophages in Blister
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.
Time frame: 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.
Secondary
Part 2:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Monocytes in Blister
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.
Time frame: 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.
Secondary
Part 2: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister
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.
Time frame: 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.