SB-681323 IV for Subjects at Risk of Acute Lung Injury or ARDS

Assessment of the Anti-Inflammatory Activity, Efficacy and Safety of Intravenous SB-681323 in Subjects at Risk for Development of Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS).

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00996840

Enrollment

Registered

2009-10-16

Start date

2009-10-16

Completion date

2013-02-09

Last updated

2017-10-18

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

Conditions

Lung Injury, Acute

Keywords

dilmapimod, p38, SB-681323, Acute Lung Injury (ALI), Acute Respiratory Distress Syndrome (ARDS)

Brief summary

This is an early phase (Phase IIa), randomized, double-blind, parallel group, multi-centre study for subjects with trauma (physical injury) who are at risk for developing Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS). The primary purpose of the study is to evaluate the safety and tolerability of SB-681323, which is a potent, selective inhibitor of p38 alpha (MAPK) (prevents inflammation of tissue), in comparison to a placebo.

Detailed description

The acute respiratory distress syndrome (ARDS) is a form of severe lung injury (ALI) characterized by hypoxemic respiratory failure (the lungs are unable to absorb oxygen to the arterial blood) and non-cardiogenic pulmonary edema (accumulation of fluid in the lungs). The syndrome may be caused by direct or indirect injury to the lungs. It is associated with a mortality rate of up to 40-50%. There are no marketed pharmacologic therapies for this devastating syndrome. This study aims to assess the safety and tolerability of SB-681323, which is a potent, selective inhibitor of p38 alpha mitogen-activated protein kinase. The rationale behind the development of this drug is that there are elevated levels of circulating pro-inflammatory agents, such as cytokines which are biological agents that increase levels of inflammation in the lungs. These agents are part of an 'inflammatory loop' and it may be beneficial to the condition to dampen this loop. p38 mitogen activated protein kinase (MAPK) plays a major role in the regulation and activation of intracellular proteins which are subsequently involved in the regulation of the cytokines. The pathway is activated by 'stress', such as injury, causing the inflammation. Therefore, 'dampening' this system should reduce the level of inflammation. This study will investigate the anti-inflammatory activity, efficacy (effectiveness at achieving the desired effect) and safety of SB-681323. To measure the efficacy of the drug, biomarkers will be measured. Biomarkers are biological agents in the body that are effected by the presence of specific injury or inflammation and are directly or indirectly linked to a regulatory system of event in the body. They are used to measure for the presence and severity of the condition in question. This study will investigate biomarkers linked directly or indirectly to the p38 alpha regulatory mechanism/system. We will be measuring biomarkers such as serum inflammatory biomarkers, coagulation (blood clotting) system biomarkers, biomarkers of endothelial cell / neutrophil interaction and biomarkers of lung epithelial cell injury.

Interventions

DRUGSB-681323 Intravenous 3mg

3 mg SB-681323 Intravenous administration infused over 4 hours

DRUGSB-681323 Intravenous 7.5 mg

7.5 mg SB-681323 Intravenous administration infused over 24 hours

DRUGSB-681323 Intravenous 7.5mg

7.5 mg SB-681323 Intravenous administration infused over 4 hours

DRUGSB-681323 Intravenous 10mg

10 mg SB-681323 Intravenous administration infused over 24 hours

OTHERPlacebo

Placebo to match intervention

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

A subject will be eligible for inclusion in this study only if all of the following criteria apply: * Male or female, 18 - 80 years of age (inclusive) with major trauma admitted to the Intensive Care Unit (ICU). * Injury Severity score (ISS) \>16 to \<70 (exclusive) * A female subject is eligible to participate if she is of non-child-bearing potential or of: * Child-bearing potential and agrees to use one of the approved contraception methods (oral contraceptive, either combined or progesterone alone, injectable progesterone, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, intrauterine device (IUD) or intrauterine system (IUS) with less than 1% non-effectiveness, documented male partner sterilization, double barrier method, i.e. condom and occlusive cap plus spermicidal agent) for an appropriate period of time (as determined by the product label or investigator, if applicable. Female subjects must agree to use contraception until one week post-last dose, if applicable. * Male subjects must agree to use one of the approved contraception methods (abstinence, defined as sexual inactivity consistent with the preferred and usual lifestyle of the subject, condom during non-vaginal intercourse with any partner (male or female), condom and occlusive cap plus spermicidal agent during sexual intercourse with a female) if applicable. This criterion must be followed from the time of the first dose of study medication until one week post-last dose, if applicable. * BMI within the range 19.0 - 35.0 kg/m2 inclusive (clinical estimate of height and weight is acceptable). * The subject or legal decision maker is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. * QTcB or QTcF \< 450 msec; or QTc \< 480 msec in subjects with Bundle Branch Block. * The subject must be randomized into the study within 24-26 hours from the time of trauma.

Exclusion criteria

A subject will not be eligible for inclusion in this study if any of the following criteria apply: * Known positive Hepatitis B surface antigen or Hepatitis C antibody. * Known positive test for HIV antibody. * A known history of substance abuse, alcohol abuse, or regular alcohol consumption within 6 months of the study defined as: * an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males), or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). One unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine. * 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: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). * History of sensitivity to any of the study medications, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation. * Haemoglobin \< 7g/dL. * Pregnant females as determined by positive serum or urine hCG test prior to dosing. * Lactating females. * Unwillingness or inability to follow the procedures outlined in the protocol. * History of sensitivity to heparin or heparin-induced thrombocytopenia. * Diagnosis of ALI at admission. * Head trauma (Abbreviated Injury Score \[AIS\]\>3), liver trauma (AIS\>2), or trauma that in the opinion of the Principle Investigator or GSK medical monitor is deemed unsurvivable. * Known history of neuromuscular disease or cord injury at C5 or above. * Elevated ALT or AST \> 1.5 ULN. * History of bone marrow or solid organ transplant. * Known history of auto-immune disorder in which immunosuppressive agents, other than prednisone, were required within the last 6 weeks. * Known to be receiving oral or intravenous corticosteroids within 7 days of admission. * Subject with active tuberculosis or being treated for active tuberculosis. * Known history of malignancy within the past 5 years with the exception of successfully treated squamous cell or basal cell cancer of the skin. * Arterial blood pH less than 7.1 or serum HCO3 - \<15 before infusion is started. * Persistent cardiovascular instability requiring therapy with more than one vasopressor. * A patient will be excluded if in the judgement of the Principle Investigator or GSK medical monitor their participation could jeopardize the health of the subject or the integrity of the study.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Any Adverse Events (AE) and Serious Adverse Events (SAE)	Up to Follow-up (Day 7)	AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	For Cohort 1 and 3: Day 1, 4 h, Day 2, pre-dose, Day 3, pre-dose and 24 h and Follow up (Day 7); for Cohort 2 and 4: Day 2, pre-dose, Day 3, pre-dose and 24 h, and Follow up (Day 7)	Absolute values of SBP and DBP were reported.
Vital Parameter: Mean Heart Rate	For Cohort 1 and 3: Day 1, 4 h, Day 2, pre-dose, Day 3, pre-dose and 24 h and Follow up (Day 7); for Cohort 2 and 4: Day 2, pre-dose, Day 3, pre-dose and 24 h, and Follow up (Day 7)	Absolute values of mean heart rate were reported.
Vital Sign: Mean Percent Oxygen (O2) in Blood	For Cohort 1 and 3: Day 1, 4 h, Day 2, pre-dose, Day 3, pre-dose and 24 h and Follow up (Day 7); for Cohort 2 and 4: Day 2, pre-dose, Day 3, pre-dose and 24 h, and Follow up (Day 7)	Absolute values of mean percent O2 in blood were reported.
Vital Signs: Mean Oxygen Saturation (SaO2) Via Pulse Oximetry	For Cohort 1 and 3: Day 1, 4 h, Day 2, pre-dose, Day 3, pre-dose and 24 h; for Cohort 2 and 4: Day 2, pre-dose, and Day 3, pre-dose and 24 h	Assessment of SaO2 via pulse oximetry was planned for cohort 1 and 3 at Day 1 (4 h), Day 2 (pre-dose) and Day 3 (pre-dose and 24 h) and for cohort 2 and 4: Day 2 (pre-dose) and Day 3 (pre-dose and 24 h). However, the analyzable data was not collected for this parameter.
Vital Signs: Mean Level of Positive End Expiratory Pressure	For Cohort 1 and 3: Day 1, 4 h, Day 2, pre-dose, Day 3, pre-dose and 24 h; for Cohort 2 and 4: Day 2, pre-dose, and Day 3, pre-dose and 24 h	Assessment of level of positive end expiratory pressure was planned for cohort 1 and 3 at Day 1 (4 h), Day 2 (pre-dose) and Day 3 (pre-dose and 24 h) and for cohort 2 and 4: Day 2 (pre-dose) and Day 3 (pre-dose and 24 h). However, the analyzable data was not collected for this parameter.
Vital Signs: Mean Level of Peak and Plateau Ventilator Pressures	For Cohort 1 and 3: Day 1, 4 h, Day 2, pre-dose, Day 3, pre-dose and 24 h; for Cohort 2 and 4: Day 2, pre-dose, and Day 3, pre-dose and 24 h	Assessment of mean level of peak and plateau ventilator pressures was planned for cohort 1 and 3 at Day 1 (4 h), Day 2 (pre-dose) and Day 3 (pre-dose and 24 h) and for cohort 2 and 4: Day 2 (pre-dose) and Day 3 (pre-dose and 24 h). However, the analyzable data was not collected for this parameter.
Vital Signs: Mean Oxygen Requirement (FiO2) Via Pulse Oximetry	For Cohort 1 and 3: Day 1, 4 h, Day 2, pre-dose, Day 3, pre-dose and 24 h; for Cohort 2 and 4: Day 2, pre-dose, and Day 3, pre-dose and 24 h	Assessment of mean FiO2 via pulse oximetry was planned for cohort 1 and 3 at Day 1 (4 h), Day 2 (pre-dose) and Day 3 (pre-dose and 24 h) and for cohort 2 and 4: Day 2 (pre-dose) and Day 3 (pre-dose and 24 h). However, the analyzable data was not collected for this parameter.
Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow-up (Day 7)	12-lead ECGs were obtained at each timepoint during the study using an ECG machine that automatically calculated the heart rate and measures RR, PR, QRS, QT, and QTc intervals. Absolute mean values of PR, QRS, QT, and QTcB, QTcF, RR intervals were reported.
Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)	Mean hematology parameters including basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count, white blood cell count were reported. If sample for hematology test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.
Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)	Mean hematology parameters including hemoglobin, MCHC were reported. If sample for hematology test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.
Mean Hematology Parameters- Mean Corpuscle Hemoglobin	Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)	Hematology parameter mean corpuscle hemoglobin was reported. If sample for hematology test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.
Hematology Parameters-Mean Corpuscle Volume	Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)	Absolute values of mean corpuscle volume were reported. If sample for hematology test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.
Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)	Absolute values of reticulocytes and red blood cell count were reported. If sample for hematology test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.
Mean Clinical Chemistry Parameters- Albumin and Total Protein	Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)	Absolute values of albumin and total protein were reported. If sample for clinical chemistry test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.
Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)	Absolute values of alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase and gamma glutamyl transferase were reported. If sample for clinical chemistry test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.
Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)	Absolute values of direct bilirubin, total bilirubin, creatinine and uric acid were reported. If sample for clinical chemistry test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.
Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)	Absolute values of calcium, chloride, glucose, bicarbonate, potassium, sodium and Urea/BUN were reported. If sample for clinical chemistry test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.
Mean Clinical Chemistry Parameters-estradiol	Day 1 (pre-dose) and Day 3 (24 h)	Absolute values of Estradiol were reported. If sample for clinical chemistry test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.
Mean Clinical Chemistry Parameters-Blood pH at Screening	Screening	Absolute values of Blood pH at screening were reported as clinical chemistry parameter.

Secondary

Measure	Time frame	Description
Mean Serum CXCL8 (Interleuin-8) Levels	6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1	Serum samples were collected at 6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1. Mean absolute values of Serum CXCL8 (Interleuin-8) levels at these specified time points were reported.
Mean Serum C-Reactive Protein (CRP) Levels	6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1	Serum samples were collected at 6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1. Mean absolute values of serum CRP levels at these specified time points were reported.
Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I	6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1	Samples were collected at 6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1. Mean absolute values of soluble tumor necrosis factor receptors-I levels at these specified time points were reported.
Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels	6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1	Serum samples were collected at 6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1. Mean absolute values of MPO levels at these specified time points were reported.
Mean Area Under the Concentration-time Curve From Zero (Pre-dose) to 24 Hours (AUC0-24)	For cohort 1 and 3: Day 1 (pre-dose, 4, 4.25, 5, 6, 8, 12, 18h), Day 2 (pre-dose and 4h), Day 3 (0, 4, 24, 48h). For cohort 2 and 4: Day 1 (pre-dose), Day (pre-dose), Day 3 (pre-dose)	Absolute values of the mean AUC 0-24 of SB-681323 were reported. PK samples were collected for cohort 1 and 3 at Day 1 (pre-dose, 4, 4.25, 5, 6, 8, 12, 18h), Day 2 (pre-dose and 4h), Day 3 (0, 4, 24, 48h) and for cohort 2 and 4 at Day 1 (pre-dose), Day (pre-dose), Day 3 (pre-dose, 24h10minutes \[min\], 24h45min, 27, 34, 40, 80 h since doing on Day 3).
Mean Average Concentration (Cavg) of SB-681323	For cohort 1 and 3: Day 1 (pre-dose, 4, 4.25, 5, 6, 8, 12, 18h), Day 2 (pre-dose and 4h), Day 3 (0, 4, 24, 48h). For cohort 2 and 4: Day 1 (pre-dose), Day (pre-dose), Day 3 (pre-dose, 24h 10minutes [min], 24h 45min, 27, 34, 40, 80 h since doing on Day 3)	Absolute values of mean Cavg of SB-681323 were reported. PK samples were collected for cohort 1 and 3 at Day 1 (pre-dose, 4, 4.25, 5, 6, 8, 12, 18h), Day 2 (pre-dose and 4h), Day 3 (0, 4, 24, 48h) and for cohort 2 and 4 at Day 1 (pre-dose), Day (pre-dose), Day 3 (pre-dose, 24h 10 min, 24h 45min, 27, 34, 40, 80 h since doing on Day 3).
Maximum Observed Concentration (Cmax) of SB-681323	For cohort 1 and 3: Day 1 (pre-dose, 4, 4.25, 5, 6, 8, 12, 18h), Day 2 (pre-dose and 4h), Day 3 (0, 4, 24, 48h). For cohort 2 and 4: Day 1 (pre-dose), Day (pre-dose), Day 3 (pre-dose, 24h 10 min, 24h 45min, 27, 34, 40, 80 h since doing on Day 3)	Absolute values of the Cmax of SB-681323 were reported. PK samples were collected for cohort 1 and 3 at Day 1 (pre-dose, 4, 4.25, 5, 6, 8, 12, 18h), Day 2 (pre-dose and 4h), Day 3 (0, 4, 24, 48h) and for cohort 2 and 4 at Day 1 (pre-dose), Day (pre-dose), Day 3 (pre-dose, 24h 10 min, 24h 45min, 27, 34, 40, 80 h since doing on Day 3).
Mean Serum Interleukin-6 Levels	6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1	Serum samples were collected at 6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1. Mean absolute values of Serum interleukin-6 levels at these specified time oints were reported.

Countries

United States

Participant flow

Recruitment details

This study was conducted across 6 centers in the United States, with 5 centers actually enrolling participants. The first participant was enrolled on 16-October-2009 and the last participant completed the study on 09-February-2013.

Pre-assignment details

Seventy seven participants were randomized in the study and were included in All subject population.

Participants by arm

Arm	Count
Combined Placebo Eligible participants received matching placebo IV infusion over 4 h or 24 h for 3 days	20
Cohort 1-SB-681323, 3 mg, 4 h Eligible participants received SB-681323, 3 mg, IV infusion over 4h for 3 days	9
Cohort 2-SB-681323, 7.5 mg, 24 h Eligible participants received SB-681323, 7.5 mg, IV infusion over 24h for 3 days	12
Cohort 3-SB-681323, 7.5 mg, 4 h Eligible participants received SB-681323, 7.5 mg, IV infusion over 4h for 3 days	18
Cohort 4-SB-681323, 10 mg, 24 h Eligible participants received SB-681323, 10 mg, IV infusion over 24h for 3 days	18
Total	77

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004
Overall Study	Adverse Event	0	1	0	0	0
Overall Study	Physician Decision	0	0	1	1	2
Overall Study	Withdrawal by Subject	1	1	0	0	0

Baseline characteristics

Characteristic	Combined Placebo	Total	Cohort 4-SB-681323, 10 mg, 24 h	Cohort 3-SB-681323, 7.5 mg, 4 h	Cohort 2-SB-681323, 7.5 mg, 24 h	Cohort 1-SB-681323, 3 mg, 4 h
Age, Continuous	41.2 Years STANDARD_DEVIATION 17.7	42.7 Years STANDARD_DEVIATION 18.24	46.1 Years STANDARD_DEVIATION 21.8	44.1 Years STANDARD_DEVIATION 15.89	34.5 Years STANDARD_DEVIATION 15.61	47.4 Years STANDARD_DEVIATION 19.31
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	8 Participants	18 Participants	4 Participants	3 Participants	3 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	5 Participants	1 Participants	2 Participants	1 Participants	0 Participants
Race (NIH/OMB) White	11 Participants	53 Participants	13 Participants	12 Participants	8 Participants	9 Participants
Sex: Female, Male Female	3 Participants	16 Participants	5 Participants	4 Participants	1 Participants	3 Participants
Sex: Female, Male Male	17 Participants	61 Participants	13 Participants	14 Participants	11 Participants	6 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
deaths Total, all-cause mortality	0 / 20	0 / 9	0 / 12	0 / 18	0 / 18
other Total, other adverse events	18 / 20	7 / 9	10 / 12	16 / 18	14 / 18
serious Total, serious adverse events	1 / 20	1 / 9	1 / 12	4 / 18	0 / 18

Outcome results

Primary

Hematology Parameters-Mean Corpuscle Volume

Absolute values of mean corpuscle volume were reported. If sample for hematology test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.

Time frame: Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)

Population: All subject population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Combined Placebo	Hematology Parameters-Mean Corpuscle Volume	Mean Corpuscle Volume:Day 2, pre-dose	89.30 Femtoliter	Standard Deviation 4.024
Combined Placebo	Hematology Parameters-Mean Corpuscle Volume	Mean Corpuscle Volume: Day 3, pre-dose	89.85 Femtoliter	Standard Deviation 3.833
Combined Placebo	Hematology Parameters-Mean Corpuscle Volume	Mean Corpuscle Volume: Day 3, 24 h	89.41 Femtoliter	Standard Deviation 3.92
Combined Placebo	Hematology Parameters-Mean Corpuscle Volume	Mean Corpuscle Volume: Follow up (Day 7)	90.12 Femtoliter	Standard Deviation 3.43
Cohort 1-SB-681323, 3 mg, 4 h	Hematology Parameters-Mean Corpuscle Volume	Mean Corpuscle Volume:Day 2, pre-dose	89.59 Femtoliter	Standard Deviation 3.379
Cohort 1-SB-681323, 3 mg, 4 h	Hematology Parameters-Mean Corpuscle Volume	Mean Corpuscle Volume: Follow up (Day 7)	89.86 Femtoliter	Standard Deviation 2.738
Cohort 1-SB-681323, 3 mg, 4 h	Hematology Parameters-Mean Corpuscle Volume	Mean Corpuscle Volume: Day 3, pre-dose	89.70 Femtoliter	Standard Deviation 2.804
Cohort 1-SB-681323, 3 mg, 4 h	Hematology Parameters-Mean Corpuscle Volume	Mean Corpuscle Volume: Day 3, 24 h	89.96 Femtoliter	Standard Deviation 2.295
Cohort 2-SB-681323, 7.5 mg, 24 h	Hematology Parameters-Mean Corpuscle Volume	Mean Corpuscle Volume: Follow up (Day 7)	89.67 Femtoliter	Standard Deviation 3.869
Cohort 2-SB-681323, 7.5 mg, 24 h	Hematology Parameters-Mean Corpuscle Volume	Mean Corpuscle Volume: Day 3, pre-dose	89.00 Femtoliter	Standard Deviation 3.742
Cohort 2-SB-681323, 7.5 mg, 24 h	Hematology Parameters-Mean Corpuscle Volume	Mean Corpuscle Volume: Day 3, 24 h	89.50 Femtoliter	Standard Deviation 3.92
Cohort 2-SB-681323, 7.5 mg, 24 h	Hematology Parameters-Mean Corpuscle Volume	Mean Corpuscle Volume:Day 2, pre-dose	88.33 Femtoliter	Standard Deviation 3.367
Cohort 3-SB-681323, 7.5 mg, 4 h	Hematology Parameters-Mean Corpuscle Volume	Mean Corpuscle Volume:Day 2, pre-dose	89.15 Femtoliter	Standard Deviation 4.828
Cohort 3-SB-681323, 7.5 mg, 4 h	Hematology Parameters-Mean Corpuscle Volume	Mean Corpuscle Volume: Day 3, pre-dose	89.18 Femtoliter	Standard Deviation 4.375
Cohort 3-SB-681323, 7.5 mg, 4 h	Hematology Parameters-Mean Corpuscle Volume	Mean Corpuscle Volume: Follow up (Day 7)	90.43 Femtoliter	Standard Deviation 4.079
Cohort 3-SB-681323, 7.5 mg, 4 h	Hematology Parameters-Mean Corpuscle Volume	Mean Corpuscle Volume: Day 3, 24 h	89.45 Femtoliter	Standard Deviation 4.285
Cohort 4-SB-681323, 10 mg, 24 h	Hematology Parameters-Mean Corpuscle Volume	Mean Corpuscle Volume: Follow up (Day 7)	90.75 Femtoliter	Standard Deviation 3.115
Cohort 4-SB-681323, 10 mg, 24 h	Hematology Parameters-Mean Corpuscle Volume	Mean Corpuscle Volume: Day 3, 24 h	90.08 Femtoliter	Standard Deviation 2.51
Cohort 4-SB-681323, 10 mg, 24 h	Hematology Parameters-Mean Corpuscle Volume	Mean Corpuscle Volume: Day 3, pre-dose	90.48 Femtoliter	Standard Deviation 3.075
Cohort 4-SB-681323, 10 mg, 24 h	Hematology Parameters-Mean Corpuscle Volume	Mean Corpuscle Volume:Day 2, pre-dose	90.63 Femtoliter	Standard Deviation 2.809

Primary

Mean Clinical Chemistry Parameters- Albumin and Total Protein

Absolute values of albumin and total protein were reported. If sample for clinical chemistry test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.

Time frame: Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)

Population: All subject population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Combined Placebo	Mean Clinical Chemistry Parameters- Albumin and Total Protein	Albumin : Day 2, pre-dose	25.2 g/L	Standard Deviation 4.27
Combined Placebo	Mean Clinical Chemistry Parameters- Albumin and Total Protein	Albumin : Day 3, pre-dose	22.8 g/L	Standard Deviation 4.29
Combined Placebo	Mean Clinical Chemistry Parameters- Albumin and Total Protein	Albumin : Day 3, 24 h	22.4 g/L	Standard Deviation 3.99
Combined Placebo	Mean Clinical Chemistry Parameters- Albumin and Total Protein	Albumin : Follow up (Day 7)	22.4 g/L	Standard Deviation 6.34
Combined Placebo	Mean Clinical Chemistry Parameters- Albumin and Total Protein	Total Protein : Day 2, pre-dose	49.4 g/L	Standard Deviation 7.39
Combined Placebo	Mean Clinical Chemistry Parameters- Albumin and Total Protein	Total Protein : Day 3, pre-dose	47.8 g/L	Standard Deviation 8.01
Combined Placebo	Mean Clinical Chemistry Parameters- Albumin and Total Protein	Total Protein : Day 3, 24 h	51.4 g/L	Standard Deviation 7.09
Combined Placebo	Mean Clinical Chemistry Parameters- Albumin and Total Protein	Total Protein : Follow up (Day 7)	55.8 g/L	Standard Deviation 9.54
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Albumin and Total Protein	Albumin : Day 3, 24 h	24.1 g/L	Standard Deviation 4.56
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Albumin and Total Protein	Total Protein : Day 3, pre-dose	50.0 g/L	Standard Deviation 7.02
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Albumin and Total Protein	Albumin : Day 2, pre-dose	25.1 g/L	Standard Deviation 5.72
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Albumin and Total Protein	Albumin : Follow up (Day 7)	25.5 g/L	Standard Deviation 4.87
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Albumin and Total Protein	Albumin : Day 3, pre-dose	25.6 g/L	Standard Deviation 4.96
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Albumin and Total Protein	Total Protein : Follow up (Day 7)	55.6 g/L	Standard Deviation 4.27
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Albumin and Total Protein	Total Protein : Day 2, pre-dose	47.1 g/L	Standard Deviation 9.44
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Albumin and Total Protein	Total Protein : Day 3, 24 h	49.6 g/L	Standard Deviation 3.82
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Albumin and Total Protein	Total Protein : Day 3, 24 h	49.2 g/L	Standard Deviation 7.78
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Albumin and Total Protein	Total Protein : Follow up (Day 7)	50.3 g/L	Standard Deviation 8.66
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Albumin and Total Protein	Albumin : Follow up (Day 7)	21.6 g/L	Standard Deviation 4.74
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Albumin and Total Protein	Total Protein : Day 3, pre-dose	46.3 g/L	Standard Deviation 9.24
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Albumin and Total Protein	Albumin : Day 3, 24 h	22.7 g/L	Standard Deviation 4.85
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Albumin and Total Protein	Albumin : Day 3, pre-dose	22.6 g/L	Standard Deviation 5.45
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Albumin and Total Protein	Albumin : Day 2, pre-dose	23.7 g/L	Standard Deviation 3.69
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Albumin and Total Protein	Total Protein : Day 2, pre-dose	46.8 g/L	Standard Deviation 7.64
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Albumin and Total Protein	Albumin : Day 3, pre-dose	23.1 g/L	Standard Deviation 3.51
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Albumin and Total Protein	Albumin : Day 3, 24 h	22.6 g/L	Standard Deviation 3.9
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Albumin and Total Protein	Albumin : Follow up (Day 7)	22.0 g/L	Standard Deviation 3.86
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Albumin and Total Protein	Total Protein : Day 2, pre-dose	48.9 g/L	Standard Deviation 5.76
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Albumin and Total Protein	Total Protein : Day 3, pre-dose	47.1 g/L	Standard Deviation 3.82
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Albumin and Total Protein	Total Protein : Follow up (Day 7)	52.3 g/L	Standard Deviation 7.41
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Albumin and Total Protein	Albumin : Day 2, pre-dose	26.2 g/L	Standard Deviation 3.45
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Albumin and Total Protein	Total Protein : Day 3, 24 h	49.0 g/L	Standard Deviation 5
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Albumin and Total Protein	Albumin : Follow up (Day 7)	26.8 g/L	Standard Deviation 5.03
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Albumin and Total Protein	Total Protein : Follow up (Day 7)	58.5 g/L	Standard Deviation 8.55
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Albumin and Total Protein	Albumin : Day 3, 24 h	24.3 g/L	Standard Deviation 6.69
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Albumin and Total Protein	Total Protein : Day 3, 24 h	53.2 g/L	Standard Deviation 10.99
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Albumin and Total Protein	Albumin : Day 2, pre-dose	24.7 g/L	Standard Deviation 5.33
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Albumin and Total Protein	Total Protein : Day 3, pre-dose	52.7 g/L	Standard Deviation 11.24
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Albumin and Total Protein	Albumin : Day 3, pre-dose	25.1 g/L	Standard Deviation 6.06
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Albumin and Total Protein	Total Protein : Day 2, pre-dose	51.1 g/L	Standard Deviation 9.21

Primary

Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase

Absolute values of alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase and gamma glutamyl transferase were reported. If sample for clinical chemistry test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.

Time frame: Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)

Population: All subject population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Combined Placebo	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Aspartate Amino Transferase : Day 2, pre-dose	74.6 International units per liter (IU/L)	Standard Deviation 42.35
Combined Placebo	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Gamma Glutamyl Transferase : Day 3, 24 h	39.4 International units per liter (IU/L)	Standard Deviation 47.61
Combined Placebo	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Creatine Kinase : Day 2, pre-dose	3287.8 International units per liter (IU/L)	Standard Deviation 3333.83
Combined Placebo	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Aspartate Amino Transferase : Day 3, pre-dose	73.3 International units per liter (IU/L)	Standard Deviation 62.8
Combined Placebo	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Alkaline phosphatase : Day 3, 24 h	66.6 International units per liter (IU/L)	Standard Deviation 37.08
Combined Placebo	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Aspartate Amino Transferase : Follow up (Day 7)	57.9 International units per liter (IU/L)	Standard Deviation 46.83
Combined Placebo	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Aspartate Amino Transferase : Day 3, 24 h	77.5 International units per liter (IU/L)	Standard Deviation 93.43
Combined Placebo	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Alkaline phosphatase : Day 2, pre-dose	52.0 International units per liter (IU/L)	Standard Deviation 19.99
Combined Placebo	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Alkaline phosphatase : Follow up (Day 7)	89.3 International units per liter (IU/L)	Standard Deviation 57.58
Combined Placebo	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Gamma Glutamyl Transferase : Follow up (Day 7)	75.9 International units per liter (IU/L)	Standard Deviation 61.62
Combined Placebo	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Gamma Glutamyl Transferase : Day 3, pre-dose	27.3 International units per liter (IU/L)	Standard Deviation 23.02
Combined Placebo	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Alanine Amino Transferase : Day 2, pre-dose	51.1 International units per liter (IU/L)	Standard Deviation 26.48
Combined Placebo	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Alkaline phosphatase : Day 3, pre-dose	52.6 International units per liter (IU/L)	Standard Deviation 20.35
Combined Placebo	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Gamma Glutamyl Transferase : Day 2, pre-dose	25.2 International units per liter (IU/L)	Standard Deviation 20.05
Combined Placebo	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Alanine Amino Transferase : Day 3, pre-dose	43.1 International units per liter (IU/L)	Standard Deviation 18.64
Combined Placebo	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Creatine Kinase : Follow up (Day 7)	954.3 International units per liter (IU/L)	Standard Deviation 2023.51
Combined Placebo	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Alanine Amino Transferase : Day 3, 24 h	44.7 International units per liter (IU/L)	Standard Deviation 21.93
Combined Placebo	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Creatine Kinase : Day 3, 24 h	2527.4 International units per liter (IU/L)	Standard Deviation 5594.82
Combined Placebo	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Alanine Amino Transferase : Follow up (Day 7)	52.5 International units per liter (IU/L)	Standard Deviation 50.95
Combined Placebo	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Creatine Kinase : Day 3, pre-dose	2668.0 International units per liter (IU/L)	Standard Deviation 4149.97
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Alanine Amino Transferase : Day 3, 24 h	53.3 International units per liter (IU/L)	Standard Deviation 62.19
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Aspartate Amino Transferase : Day 2, pre-dose	57.1 International units per liter (IU/L)	Standard Deviation 28.41
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Alanine Amino Transferase : Day 2, pre-dose	37.8 International units per liter (IU/L)	Standard Deviation 26.63
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Alkaline phosphatase : Day 2, pre-dose	53.8 International units per liter (IU/L)	Standard Deviation 12.53
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Aspartate Amino Transferase : Follow up (Day 7)	64.9 International units per liter (IU/L)	Standard Deviation 31.73
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Gamma Glutamyl Transferase : Day 3, 24 h	31.3 International units per liter (IU/L)	Standard Deviation 22.68
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Aspartate Amino Transferase : Day 3, pre-dose	64.9 International units per liter (IU/L)	Standard Deviation 58.77
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Creatine Kinase : Follow up (Day 7)	503.8 International units per liter (IU/L)	Standard Deviation 725.49
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Creatine Kinase : Day 3, pre-dose	1183.8 International units per liter (IU/L)	Standard Deviation 944.8
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Aspartate Amino Transferase : Day 3, 24 h	81.3 International units per liter (IU/L)	Standard Deviation 79.91
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Alanine Amino Transferase : Day 3, pre-dose	43.4 International units per liter (IU/L)	Standard Deviation 48.84
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Alkaline phosphatase : Day 3, 24 h	76.0 International units per liter (IU/L)	Standard Deviation 44.67
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Gamma Glutamyl Transferase : Follow up (Day 7)	70.6 International units per liter (IU/L)	Standard Deviation 49.58
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Alkaline phosphatase : Day 3, pre-dose	73.1 International units per liter (IU/L)	Standard Deviation 45.57
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Gamma Glutamyl Transferase : Day 3, pre-dose	23.0 International units per liter (IU/L)	Standard Deviation 9.81
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Creatine Kinase : Day 2, pre-dose	1174.0 International units per liter (IU/L)	Standard Deviation 996.71
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Alkaline phosphatase : Follow up (Day 7)	118.1 International units per liter (IU/L)	Standard Deviation 58.77
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Creatine Kinase : Day 3, 24 h	1638.3 International units per liter (IU/L)	Standard Deviation 2178.26
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Alanine Amino Transferase : Follow up (Day 7)	77.4 International units per liter (IU/L)	Standard Deviation 58.39
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Gamma Glutamyl Transferase : Day 2, pre-dose	20.8 International units per liter (IU/L)	Standard Deviation 8.8
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Gamma Glutamyl Transferase : Day 3, pre-dose	25.4 International units per liter (IU/L)	Standard Deviation 15.36
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Alkaline phosphatase : Day 2, pre-dose	43.5 International units per liter (IU/L)	Standard Deviation 8.19
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Alkaline phosphatase : Day 3, pre-dose	48.6 International units per liter (IU/L)	Standard Deviation 11.07
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Alkaline phosphatase : Day 3, 24 h	53.5 International units per liter (IU/L)	Standard Deviation 13.19
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Alkaline phosphatase : Follow up (Day 7)	69.8 International units per liter (IU/L)	Standard Deviation 39.4
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Alanine Amino Transferase : Day 2, pre-dose	60.5 International units per liter (IU/L)	Standard Deviation 37.89
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Alanine Amino Transferase : Day 3, pre-dose	50.8 International units per liter (IU/L)	Standard Deviation 26.93
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Alanine Amino Transferase : Day 3, 24 h	49.1 International units per liter (IU/L)	Standard Deviation 21.82
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Alanine Amino Transferase : Follow up (Day 7)	117.8 International units per liter (IU/L)	Standard Deviation 158.33
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Aspartate Amino Transferase : Day 2, pre-dose	125.2 International units per liter (IU/L)	Standard Deviation 65.22
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Aspartate Amino Transferase : Day 3, pre-dose	90.5 International units per liter (IU/L)	Standard Deviation 44.66
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Aspartate Amino Transferase : Day 3, 24 h	84.9 International units per liter (IU/L)	Standard Deviation 37.84
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Aspartate Amino Transferase : Follow up (Day 7)	137.1 International units per liter (IU/L)	Standard Deviation 192.21
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Creatine Kinase : Day 2, pre-dose	4663.1 International units per liter (IU/L)	Standard Deviation 4797.79
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Creatine Kinase : Day 3, pre-dose	4418.9 International units per liter (IU/L)	Standard Deviation 5201.64
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Creatine Kinase : Day 3, 24 h	3342.3 International units per liter (IU/L)	Standard Deviation 2222.65
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Creatine Kinase : Follow up (Day 7)	1349.9 International units per liter (IU/L)	Standard Deviation 1296.97
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Gamma Glutamyl Transferase : Day 2, pre-dose	34.0 International units per liter (IU/L)	Standard Deviation 46.54
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Gamma Glutamyl Transferase : Day 3, 24 h	38.4 International units per liter (IU/L)	Standard Deviation 33.91
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Gamma Glutamyl Transferase : Follow up (Day 7)	48.3 International units per liter (IU/L)	Standard Deviation 41.93
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Aspartate Amino Transferase : Day 2, pre-dose	83.2 International units per liter (IU/L)	Standard Deviation 40.61
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Gamma Glutamyl Transferase : Day 3, 24 h	43.4 International units per liter (IU/L)	Standard Deviation 46.7
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Creatine Kinase : Day 2, pre-dose	2797.2 International units per liter (IU/L)	Standard Deviation 2022.44
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Alanine Amino Transferase : Follow up (Day 7)	42.2 International units per liter (IU/L)	Standard Deviation 21.73
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Creatine Kinase : Day 3, pre-dose	2307.0 International units per liter (IU/L)	Standard Deviation 1670.81
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Alanine Amino Transferase : Day 3, 24 h	34.3 International units per liter (IU/L)	Standard Deviation 15.14
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Creatine Kinase : Day 3, 24 h	1410.2 International units per liter (IU/L)	Standard Deviation 1417.5
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Alanine Amino Transferase : Day 3, pre-dose	37.5 International units per liter (IU/L)	Standard Deviation 15.91
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Alkaline phosphatase : Day 2, pre-dose	49.4 International units per liter (IU/L)	Standard Deviation 21.15
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Creatine Kinase : Follow up (Day 7)	602.1 International units per liter (IU/L)	Standard Deviation 476.66
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Alanine Amino Transferase : Day 2, pre-dose	45.4 International units per liter (IU/L)	Standard Deviation 22.67
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Gamma Glutamyl Transferase : Day 2, pre-dose	26.3 International units per liter (IU/L)	Standard Deviation 23.01
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Alkaline phosphatase : Follow up (Day 7)	94.5 International units per liter (IU/L)	Standard Deviation 59.93
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Alkaline phosphatase : Day 3, 24 h	60.6 International units per liter (IU/L)	Standard Deviation 34.38
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Gamma Glutamyl Transferase : Day 3, pre-dose	23.7 International units per liter (IU/L)	Standard Deviation 18.42
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Alkaline phosphatase : Day 3, pre-dose	50.8 International units per liter (IU/L)	Standard Deviation 26.85
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Aspartate Amino Transferase : Day 3, 24 h	53.1 International units per liter (IU/L)	Standard Deviation 29.14
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Aspartate Amino Transferase : Day 3, pre-dose	65.8 International units per liter (IU/L)	Standard Deviation 31.23
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Gamma Glutamyl Transferase : Follow up (Day 7)	86.7 International units per liter (IU/L)	Standard Deviation 90.58
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Aspartate Amino Transferase : Follow up (Day 7)	48.3 International units per liter (IU/L)	Standard Deviation 21.76
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Alkaline phosphatase : Day 3, pre-dose	55.6 International units per liter (IU/L)	Standard Deviation 18.92
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Alanine Amino Transferase : Follow up (Day 7)	59.1 International units per liter (IU/L)	Standard Deviation 52.41
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Alkaline phosphatase : Follow up (Day 7)	90.0 International units per liter (IU/L)	Standard Deviation 60.86
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Gamma Glutamyl Transferase : Follow up (Day 7)	45.6 International units per liter (IU/L)	Standard Deviation 46.01
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Creatine Kinase : Day 2, pre-dose	2527.8 International units per liter (IU/L)	Standard Deviation 2507.94
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Aspartate Amino Transferase : Day 3, pre-dose	62.3 International units per liter (IU/L)	Standard Deviation 29.7
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Alanine Amino Transferase : Day 3, 24 h	42.3 International units per liter (IU/L)	Standard Deviation 29.56
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Gamma Glutamyl Transferase : Day 3, 24 h	39.3 International units per liter (IU/L)	Standard Deviation 54.64
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Gamma Glutamyl Transferase : Day 2, pre-dose	17.3 International units per liter (IU/L)	Standard Deviation 11.67
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Creatine Kinase : Day 3, pre-dose	2418.9 International units per liter (IU/L)	Standard Deviation 3267.7
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Aspartate Amino Transferase : Follow up (Day 7)	65.6 International units per liter (IU/L)	Standard Deviation 59.8
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Alanine Amino Transferase : Day 3, pre-dose	41.4 International units per liter (IU/L)	Standard Deviation 32.89
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Alkaline phosphatase : Day 2, pre-dose	52.2 International units per liter (IU/L)	Standard Deviation 17.98
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Alkaline phosphatase : Day 3, 24 h	59.5 International units per liter (IU/L)	Standard Deviation 25.61
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Creatine Kinase : Day 3, 24 h	1227.8 International units per liter (IU/L)	Standard Deviation 1038.81
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Aspartate Amino Transferase : Day 2, pre-dose	81.4 International units per liter (IU/L)	Standard Deviation 53.72
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Alanine Amino Transferase : Day 2, pre-dose	53.8 International units per liter (IU/L)	Standard Deviation 49.17
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Aspartate Amino Transferase : Day 3, 24 h	71.9 International units per liter (IU/L)	Standard Deviation 66.7
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Gamma Glutamyl Transferase : Day 3, pre-dose	26.9 International units per liter (IU/L)	Standard Deviation 31.6
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase	Creatine Kinase : Follow up (Day 7)	366.4 International units per liter (IU/L)	Standard Deviation 329.52

Primary

Mean Clinical Chemistry Parameters-Blood pH at Screening

Absolute values of Blood pH at screening were reported as clinical chemistry parameter.

Time frame: Screening

Population: All subject population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Value (MEAN)	Dispersion
Combined Placebo	Mean Clinical Chemistry Parameters-Blood pH at Screening	7.358 pH Units	Standard Deviation 0.0738
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters-Blood pH at Screening	7.363 pH Units	Standard Deviation 0.0824
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters-Blood pH at Screening	7.358 pH Units	Standard Deviation 0.0354
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters-Blood pH at Screening	7.353 pH Units	Standard Deviation 0.0297
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters-Blood pH at Screening	7.373 pH Units	Standard Deviation 0.0527

Primary

Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)

Absolute values of calcium, chloride, glucose, bicarbonate, potassium, sodium and Urea/BUN were reported. If sample for clinical chemistry test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.

Time frame: Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)

Population: All subject population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Combined Placebo	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Glucose : Follow up (Day 7)	6.6115 Millimole per liter	Standard Deviation 1.95391
Combined Placebo	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Calcium : Day 2, pre-dose	1.9523 Millimole per liter	Standard Deviation 0.11501
Combined Placebo	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Potassium : Day 3, pre-dose	3.88 Millimole per liter	Standard Deviation 0.318
Combined Placebo	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Bicarbonate : Day 2, pre-dose	26.0 Millimole per liter	Standard Deviation 2.73
Combined Placebo	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Potassium : Day 2, pre-dose	4.22 Millimole per liter	Standard Deviation 0.558
Combined Placebo	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Bicarbonate : Day 3, pre-dose	27.2 Millimole per liter	Standard Deviation 1.96
Combined Placebo	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Urea/BUN : Day 3, pre-dose	3.4808 Millimole per liter	Standard Deviation 1.57061
Combined Placebo	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Bicarbonate : Follow up (Day 7)	27.3 Millimole per liter	Standard Deviation 2.75
Combined Placebo	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Bicarbonate : Day 3, 24 h	27.7 Millimole per liter	Standard Deviation 2.7
Combined Placebo	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Calcium : Follow up (Day 7)	2.0617 Millimole per liter	Standard Deviation 0.14021
Combined Placebo	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Calcium : Day 3, 24 h	1.9881 Millimole per liter	Standard Deviation 0.09701
Combined Placebo	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Chloride : Day 2, pre-dose	106.5 Millimole per liter	Standard Deviation 5.04
Combined Placebo	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Urea/BUN : Follow up (Day 7)	5.9938 Millimole per liter	Standard Deviation 5.08449
Combined Placebo	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Urea/BUN : Day 2, pre-dose	3.7664 Millimole per liter	Standard Deviation 2.13093
Combined Placebo	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Chloride : Day 3, pre-dose	106.3 Millimole per liter	Standard Deviation 5.66
Combined Placebo	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Calcium : Day 3, pre-dose	1.9523 Millimole per liter	Standard Deviation 0.10857
Combined Placebo	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Sodium : Follow up (Day 7)	139.6 Millimole per liter	Standard Deviation 5.96
Combined Placebo	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Chloride : Day 3, 24 h	104.6 Millimole per liter	Standard Deviation 5.12
Combined Placebo	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Sodium : Day 3, 24 h	138.2 Millimole per liter	Standard Deviation 4.15
Combined Placebo	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Chloride : Follow up (Day 7)	105.2 Millimole per liter	Standard Deviation 7.84
Combined Placebo	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Sodium : Day 3, pre-dose	138.0 Millimole per liter	Standard Deviation 3.91
Combined Placebo	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Glucose : Day 2, pre-dose	6.8028 Millimole per liter	Standard Deviation 2.22918
Combined Placebo	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Sodium : Day 2, pre-dose	137.1 Millimole per liter	Standard Deviation 3.61
Combined Placebo	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Glucose : Day 3, pre-dose	6.7889 Millimole per liter	Standard Deviation 1.93504
Combined Placebo	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Urea/BUN : Day 3, 24 h	4.1525 Millimole per liter	Standard Deviation 2.34164
Combined Placebo	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Potassium : Follow up (Day 7)	4.01 Millimole per liter	Standard Deviation 0.435
Combined Placebo	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Glucose : Day 3, 24 h	7.6575 Millimole per liter	Standard Deviation 4.44567
Combined Placebo	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Potassium : Day 3, 24 h	3.85 Millimole per liter	Standard Deviation 0.347
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Potassium : Follow up (Day 7)	4.01 Millimole per liter	Standard Deviation 0.473
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Sodium : Day 3, 24 h	137.9 Millimole per liter	Standard Deviation 3.48
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Glucose : Day 3, 24 h	6.2865 Millimole per liter	Standard Deviation 1.01307
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Potassium : Day 2, pre-dose	3.89 Millimole per liter	Standard Deviation 0.348
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Chloride : Day 3, 24 h	104.4 Millimole per liter	Standard Deviation 4.98
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Bicarbonate : Day 2, pre-dose	25.9 Millimole per liter	Standard Deviation 2.36
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Urea/BUN : Day 3, pre-dose	3.7485 Millimole per liter	Standard Deviation 3.85447
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Calcium : Day 3, pre-dose	1.9835 Millimole per liter	Standard Deviation 0.11158
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Bicarbonate : Follow up (Day 7)	27.3 Millimole per liter	Standard Deviation 2.49
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Glucose : Day 3, pre-dose	7.2094 Millimole per liter	Standard Deviation 1.67306
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Bicarbonate : Day 3, pre-dose	27.8 Millimole per liter	Standard Deviation 2.92
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Sodium : Day 3, pre-dose	138.4 Millimole per liter	Standard Deviation 3.29
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Calcium : Day 3, 24 h	2.0272 Millimole per liter	Standard Deviation 0.09312
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Bicarbonate : Day 3, 24 h	28.5 Millimole per liter	Standard Deviation 2.62
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Chloride : Follow up (Day 7)	101.8 Millimole per liter	Standard Deviation 4.59
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Calcium : Day 2, pre-dose	1.9274 Millimole per liter	Standard Deviation 0.12913
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Calcium : Follow up (Day 7)	2.0989 Millimole per liter	Standard Deviation 0.12612
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Urea/BUN : Follow up (Day 7)	6.0244 Millimole per liter	Standard Deviation 4.2087
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Glucose : Follow up (Day 7)	6.3698 Millimole per liter	Standard Deviation 0.55172
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Urea/BUN : Day 2, pre-dose	3.4361 Millimole per liter	Standard Deviation 3.16986
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Sodium : Day 2, pre-dose	136.3 Millimole per liter	Standard Deviation 3.45
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Chloride : Day 2, pre-dose	105.5 Millimole per liter	Standard Deviation 4.69
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Potassium : Day 3, 24 h	3.91 Millimole per liter	Standard Deviation 0.28
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Glucose : Day 2, pre-dose	8.0628 Millimole per liter	Standard Deviation 1.92721
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Sodium : Follow up (Day 7)	137.1 Millimole per liter	Standard Deviation 4.97
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Urea/BUN : Day 3, 24 h	4.3286 Millimole per liter	Standard Deviation 4.26883
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Chloride : Day 3, pre-dose	105.5 Millimole per liter	Standard Deviation 4.93
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Potassium : Day 3, pre-dose	3.96 Millimole per liter	Standard Deviation 0.267
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Urea/BUN : Day 2, pre-dose	4.3392 Millimole per liter	Standard Deviation 3.00056
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Calcium : Day 2, pre-dose	1.9098 Millimole per liter	Standard Deviation 0.11828
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Calcium : Day 3, pre-dose	1.9007 Millimole per liter	Standard Deviation 0.08411
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Calcium : Day 3, 24 h	1.9565 Millimole per liter	Standard Deviation 0.15138
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Calcium : Follow up (Day 7)	2.0005 Millimole per liter	Standard Deviation 0.15773
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Chloride : Day 2, pre-dose	107.5 Millimole per liter	Standard Deviation 3.62
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Chloride : Day 3, pre-dose	107.7 Millimole per liter	Standard Deviation 4.67
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Chloride : Day 3, 24 h	106.0 Millimole per liter	Standard Deviation 5.54
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Chloride : Follow up (Day 7)	106.2 Millimole per liter	Standard Deviation 5.13
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Glucose : Day 2, pre-dose	6.9690 Millimole per liter	Standard Deviation 1.03682
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Glucose : Day 3, pre-dose	6.2878 Millimole per liter	Standard Deviation 1.22124
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Glucose : Day 3, 24 h	6.1662 Millimole per liter	Standard Deviation 0.84863
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Glucose : Follow up (Day 7)	6.4139 Millimole per liter	Standard Deviation 1.50295
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Bicarbonate : Day 2, pre-dose	25.6 Millimole per liter	Standard Deviation 2.11
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Bicarbonate : Day 3, pre-dose	26.5 Millimole per liter	Standard Deviation 2.91
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Bicarbonate : Day 3, 24 h	27.3 Millimole per liter	Standard Deviation 3.86
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Bicarbonate : Follow up (Day 7)	28.3 Millimole per liter	Standard Deviation 1.91
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Potassium : Day 2, pre-dose	4.17 Millimole per liter	Standard Deviation 0.374
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Potassium : Day 3, pre-dose	4.15 Millimole per liter	Standard Deviation 0.491
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Potassium : Day 3, 24 h	3.93 Millimole per liter	Standard Deviation 0.442
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Potassium : Follow up (Day 7)	3.70 Millimole per liter	Standard Deviation 0.357
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Sodium : Day 2, pre-dose	136.7 Millimole per liter	Standard Deviation 3.44
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Sodium : Day 3, pre-dose	138.5 Millimole per liter	Standard Deviation 3.8
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Sodium : Day 3, 24 h	138.5 Millimole per liter	Standard Deviation 3.09
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Sodium : Follow up (Day 7)	140.2 Millimole per liter	Standard Deviation 5.22
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Urea/BUN : Day 3, pre-dose	4.9655 Millimole per liter	Standard Deviation 4.52265
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Urea/BUN : Day 3, 24 h	4.9683 Millimole per liter	Standard Deviation 6.06128
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Urea/BUN : Follow up (Day 7)	6.2313 Millimole per liter	Standard Deviation 7.18868
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Potassium : Follow up (Day 7)	3.99 Millimole per liter	Standard Deviation 0.405
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Sodium : Day 3, 24 h	138.4 Millimole per liter	Standard Deviation 3.86
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Potassium : Day 3, pre-dose	4.00 Millimole per liter	Standard Deviation 0.55
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Chloride : Day 3, pre-dose	105.9 Millimole per liter	Standard Deviation 5.89
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Glucose : Day 2, pre-dose	7.8763 Millimole per liter	Standard Deviation 2.30585
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Calcium : Day 2, pre-dose	1.9489 Millimole per liter	Standard Deviation 0.08889
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Sodium : Follow up (Day 7)	139.0 Millimole per liter	Standard Deviation 5.05
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Calcium : Day 3, pre-dose	1.9314 Millimole per liter	Standard Deviation 0.12383
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Chloride : Day 2, pre-dose	106.3 Millimole per liter	Standard Deviation 4.17
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Urea/BUN : Day 3, 24 h	5.4390 Millimole per liter	Standard Deviation 5.13095
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Calcium : Follow up (Day 7)	2.0386 Millimole per liter	Standard Deviation 0.11794
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Urea/BUN : Day 2, pre-dose	4.9385 Millimole per liter	Standard Deviation 3.44877
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Sodium : Day 2, pre-dose	136.7 Millimole per liter	Standard Deviation 2.97
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Potassium : Day 3, 24 h	3.91 Millimole per liter	Standard Deviation 0.496
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Calcium : Day 3, 24 h	1.9432 Millimole per liter	Standard Deviation 0.0912
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Chloride : Follow up (Day 7)	104.5 Millimole per liter	Standard Deviation 6.07
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Glucose : Follow up (Day 7)	6.9110 Millimole per liter	Standard Deviation 2.14454
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Bicarbonate : Day 3, 24 h	26.6 Millimole per liter	Standard Deviation 2.18
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Glucose : Day 3, pre-dose	7.8530 Millimole per liter	Standard Deviation 2.96473
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Bicarbonate : Day 3, pre-dose	26.5 Millimole per liter	Standard Deviation 3.47
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Sodium : Day 3, pre-dose	137.6 Millimole per liter	Standard Deviation 3.69
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Urea/BUN : Day 3, pre-dose	4.8510 Millimole per liter	Standard Deviation 3.92306
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Bicarbonate : Follow up (Day 7)	27.1 Millimole per liter	Standard Deviation 2.67
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Glucose : Day 3, 24 h	7.7192 Millimole per liter	Standard Deviation 3.27506
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Bicarbonate : Day 2, pre-dose	25.9 Millimole per liter	Standard Deviation 2.55
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Chloride : Day 3, 24 h	106.4 Millimole per liter	Standard Deviation 5.84
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Urea/BUN : Follow up (Day 7)	7.1610 Millimole per liter	Standard Deviation 8.27331
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Potassium : Day 2, pre-dose	4.10 Millimole per liter	Standard Deviation 0.468
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Bicarbonate : Day 2, pre-dose	25.6 Millimole per liter	Standard Deviation 2.2
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Glucose : Day 3, 24 h	6.0321 Millimole per liter	Standard Deviation 1.32273
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Calcium : Day 3, pre-dose	1.9887 Millimole per liter	Standard Deviation 0.15273
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Potassium : Day 3, pre-dose	3.99 Millimole per liter	Standard Deviation 0.376
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Glucose : Day 3, pre-dose	6.2530 Millimole per liter	Standard Deviation 0.98343
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Potassium : Day 3, 24 h	3.95 Millimole per liter	Standard Deviation 0.449
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Glucose : Day 2, pre-dose	7.3797 Millimole per liter	Standard Deviation 4.08342
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Potassium : Follow up (Day 7)	3.98 Millimole per liter	Standard Deviation 0.256
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Chloride : Follow up (Day 7)	102.2 Millimole per liter	Standard Deviation 3.15
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Sodium : Day 2, pre-dose	137.2 Millimole per liter	Standard Deviation 4.02
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Chloride : Day 3, 24 h	105.3 Millimole per liter	Standard Deviation 4.41
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Urea/BUN : Day 3, 24 h	4.8418 Millimole per liter	Standard Deviation 2.59399
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Sodium : Day 3, pre-dose	138.1 Millimole per liter	Standard Deviation 3.66
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Chloride : Day 3, pre-dose	105.7 Millimole per liter	Standard Deviation 4.25
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Calcium : Day 2, pre-dose	1.9655 Millimole per liter	Standard Deviation 0.13867
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Sodium : Day 3, 24 h	137.9 Millimole per liter	Standard Deviation 3.24
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Chloride : Day 2, pre-dose	105.3 Millimole per liter	Standard Deviation 4.75
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Sodium : Follow up (Day 7)	136.6 Millimole per liter	Standard Deviation 3.06
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Calcium : Follow up (Day 7)	2.0958 Millimole per liter	Standard Deviation 0.14441
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Urea/BUN : Day 2, pre-dose	4.6013 Millimole per liter	Standard Deviation 2.85045
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Calcium : Day 3, 24 h	2.0116 Millimole per liter	Standard Deviation 0.15132
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Bicarbonate : Day 3, pre-dose	25.7 Millimole per liter	Standard Deviation 2.69
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Urea/BUN : Follow up (Day 7)	5.3340 Millimole per liter	Standard Deviation 2.801
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Bicarbonate : Day 3, 24 h	25.3 Millimole per liter	Standard Deviation 2.59
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Potassium : Day 2, pre-dose	4.12 Millimole per liter	Standard Deviation 0.342
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Bicarbonate : Follow up (Day 7)	26.7 Millimole per liter	Standard Deviation 3.14
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Glucose : Follow up (Day 7)	6.2563 Millimole per liter	Standard Deviation 1.41547
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)	Urea/BUN : Day 3, pre-dose	4.6200 Millimole per liter	Standard Deviation 2.93162

Primary

Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid

Absolute values of direct bilirubin, total bilirubin, creatinine and uric acid were reported. If sample for clinical chemistry test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.

Time frame: Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)

Population: All subject population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Combined Placebo	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Total Bilirubin : Day 2, pre-dose	19.238 Micromol per liter	Standard Deviation 9.9071
Combined Placebo	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Direct Bilirubin : Day 3, pre-dose	4.590 Micromol per liter	Standard Deviation 1.9789
Combined Placebo	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Direct Bilirubin : Day 3, 24 h	5.890 Micromol per liter	Standard Deviation 4.0305
Combined Placebo	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Direct Bilirubin : Follow up (Day 7)	7.110 Micromol per liter	Standard Deviation 5.7923
Combined Placebo	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Direct Bilirubin : Day 2, pre-dose	4.500 Micromol per liter	Standard Deviation 1.6333
Combined Placebo	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Total Bilirubin : Day 3, pre-dose	18.126 Micromol per liter	Standard Deviation 6.1128
Combined Placebo	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Total Bilirubin : Day 3, 24 h	20.430 Micromol per liter	Standard Deviation 7.6574
Combined Placebo	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Total Bilirubin : Follow up (Day 7)	20.880 Micromol per liter	Standard Deviation 8.4271
Combined Placebo	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Creatinine : Day 2, pre-dose	76.6428 Micromol per liter	Standard Deviation 23.25282
Combined Placebo	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Creatinine : Day 3, pre-dose	71.1620 Micromol per liter	Standard Deviation 22.69678
Combined Placebo	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Creatinine : Day 3, 24 h	69.9756 Micromol per liter	Standard Deviation 22.20243
Combined Placebo	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Creatinine : Follow up (Day 7)	70.7200 Micromol per liter	Standard Deviation 25.41831
Combined Placebo	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Uric acid : Day 2, pre-dose	200.7450 Micromol per liter	Standard Deviation 79.77454
Combined Placebo	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Uric acid : Day 3, pre-dose	185.2802 Micromol per liter	Standard Deviation 76.68988
Combined Placebo	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Uric acid : Day 3, 24 h	190.6491 Micromol per liter	Standard Deviation 75.69201
Combined Placebo	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Uric acid : Follow up (Day 7)	174.4747 Micromol per liter	Standard Deviation 74.95979
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Uric acid : Day 3, pre-dose	202.9755 Micromol per liter	Standard Deviation 83.29855
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Creatinine : Day 3, pre-dose	80.2230 Micromol per liter	Standard Deviation 51.77845
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Creatinine : Day 2, pre-dose	83.4275 Micromol per liter	Standard Deviation 49.48807
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Uric acid : Day 3, 24 h	194.0535 Micromol per liter	Standard Deviation 90.4821
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Total Bilirubin : Follow up (Day 7)	24.581 Micromol per liter	Standard Deviation 15.2383
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Total Bilirubin : Day 2, pre-dose	17.314 Micromol per liter	Standard Deviation 8.7403
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Direct Bilirubin : Follow up (Day 7)	7.695 Micromol per liter	Standard Deviation 8.7671
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Direct Bilirubin : Day 3, pre-dose	4.275 Micromol per liter	Standard Deviation 1.5832
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Direct Bilirubin : Day 2, pre-dose	4.275 Micromol per liter	Standard Deviation 2.0438
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Uric acid : Day 2, pre-dose	207.4365 Micromol per liter	Standard Deviation 76.26689
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Total Bilirubin : Day 3, pre-dose	16.245 Micromol per liter	Standard Deviation 5.9937
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Direct Bilirubin : Day 3, 24 h	4.703 Micromol per liter	Standard Deviation 2.5446
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Uric acid : Follow up (Day 7)	171.0050 Micromol per liter	Standard Deviation 62.36289
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Creatinine : Follow up (Day 7)	71.8250 Micromol per liter	Standard Deviation 31.43842
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Creatinine : Day 3, 24 h	73.0405 Micromol per liter	Standard Deviation 45.07022
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Total Bilirubin : Day 3, 24 h	19.238 Micromol per liter	Standard Deviation 8.1112
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Uric acid : Day 3, pre-dose	202.7727 Micromol per liter	Standard Deviation 83.20631
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Direct Bilirubin : Follow up (Day 7)	26.030 Micromol per liter	Standard Deviation 58.4146
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Total Bilirubin : Day 2, pre-dose	24.717 Micromol per liter	Standard Deviation 16.4971
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Total Bilirubin : Day 3, pre-dose	20.520 Micromol per liter	Standard Deviation 14.7497
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Total Bilirubin : Day 3, 24 h	21.608 Micromol per liter	Standard Deviation 15.0494
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Total Bilirubin : Follow up (Day 7)	53.390 Micromol per liter	Standard Deviation 98.8728
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Uric acid : Day 3, 24 h	192.4989 Micromol per liter	Standard Deviation 95.58615
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Creatinine : Day 2, pre-dose	87.9982 Micromol per liter	Standard Deviation 34.95181
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Creatinine : Day 3, pre-dose	87.9178 Micromol per liter	Standard Deviation 53.40174
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Creatinine : Day 3, 24 h	89.7260 Micromol per liter	Standard Deviation 84.44314
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Creatinine : Follow up (Day 7)	85.9690 Micromol per liter	Standard Deviation 61.38913
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Uric acid : Day 2, pre-dose	194.1211 Micromol per liter	Standard Deviation 99.68084
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Direct Bilirubin : Day 2, pre-dose	8.705 Micromol per liter	Standard Deviation 11.6846
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Uric acid : Follow up (Day 7)	188.8490 Micromol per liter	Standard Deviation 106.199
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Direct Bilirubin : Day 3, pre-dose	6.995 Micromol per liter	Standard Deviation 7.2329
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Direct Bilirubin : Day 3, 24 h	7.773 Micromol per liter	Standard Deviation 10.634
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Creatinine : Day 3, pre-dose	87.4640 Micromol per liter	Standard Deviation 65.10727
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Uric acid : Follow up (Day 7)	221.4755 Micromol per liter	Standard Deviation 129.6427
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Creatinine : Day 3, 24 h	90.8960 Micromol per liter	Standard Deviation 91.11701
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Uric acid : Day 3, pre-dose	233.3715 Micromol per liter	Standard Deviation 101.89
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Creatinine : Follow up (Day 7)	98.7480 Micromol per liter	Standard Deviation 110.4008
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Total Bilirubin : Day 3, pre-dose	18.408 Micromol per liter	Standard Deviation 11.8245
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Uric acid : Day 2, pre-dose	246.5116 Micromol per liter	Standard Deviation 96.00019
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Direct Bilirubin : Follow up (Day 7)	10.964 Micromol per liter	Standard Deviation 22.214
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Direct Bilirubin : Day 2, pre-dose	5.985 Micromol per liter	Standard Deviation 6.925
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Direct Bilirubin : Day 3, 24 h	6.639 Micromol per liter	Standard Deviation 9.7463
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Total Bilirubin : Follow up (Day 7)	26.656 Micromol per liter	Standard Deviation 30.482
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Total Bilirubin : Day 2, pre-dose	15.675 Micromol per liter	Standard Deviation 8.8223
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Creatinine : Day 2, pre-dose	90.9538 Micromol per liter	Standard Deviation 66.75768
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Uric acid : Day 3, 24 h	222.8751 Micromol per liter	Standard Deviation 115.721
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Total Bilirubin : Day 3, 24 h	19.615 Micromol per liter	Standard Deviation 12.2882
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Direct Bilirubin : Day 3, pre-dose	6.840 Micromol per liter	Standard Deviation 9.5974
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Uric acid : Day 2, pre-dose	231.9720 Micromol per liter	Standard Deviation 76.04761
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Creatinine : Day 3, pre-dose	72.9560 Micromol per liter	Standard Deviation 31.73042
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Uric acid : Day 3, 24 h	247.0403 Micromol per liter	Standard Deviation 87.73096
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Total Bilirubin : Day 2, pre-dose	18.145 Micromol per liter	Standard Deviation 14.8048
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Direct Bilirubin : Day 3, pre-dose	3.420 Micromol per liter	Standard Deviation 2.2076
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Total Bilirubin : Follow up (Day 7)	22.978 Micromol per liter	Standard Deviation 22.7112
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Creatinine : Day 3, 24 h	78.1788 Micromol per liter	Standard Deviation 28.17353
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Uric acid : Follow up (Day 7)	253.7813 Micromol per liter	Standard Deviation 118.3352
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Total Bilirubin : Day 3, pre-dose	15.604 Micromol per liter	Standard Deviation 6.7214
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Creatinine : Day 2, pre-dose	80.1984 Micromol per liter	Standard Deviation 32.87944
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Direct Bilirubin : Day 2, pre-dose	3.306 Micromol per liter	Standard Deviation 1.6436
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Creatinine : Follow up (Day 7)	76.9080 Micromol per liter	Standard Deviation 35.07431
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Total Bilirubin : Day 3, 24 h	18.596 Micromol per liter	Standard Deviation 9.6505
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Uric acid : Day 3, pre-dose	226.4205 Micromol per liter	Standard Deviation 79.05205
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Direct Bilirubin : Follow up (Day 7)	9.120 Micromol per liter	Standard Deviation 16.4864
Cohort 4-SB-681323, 10 mg, 24 h	Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Direct Bilirubin : Day 3, 24 h	4.998 Micromol per liter	Standard Deviation 4.1572

Primary

Mean Clinical Chemistry Parameters-estradiol

Absolute values of Estradiol were reported. If sample for clinical chemistry test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.

Time frame: Day 1 (pre-dose) and Day 3 (24 h)

Population: All subject population. Only those participants available at the specified time points were analyzed. Data were not collected from participants in Cohort 2-SB-681323, 7.5 mg, 24 h, Cohort 3-SB-681323, 7.5 mg, 4 h, and Cohort 4-SB-681323, 10 mg, 24 h.

Arm	Measure	Value (MEAN)	Dispersion
Combined Placebo	Mean Clinical Chemistry Parameters-estradiol	165.150 Picomole per liter	—
Cohort 1-SB-681323, 3 mg, 4 h	Mean Clinical Chemistry Parameters-estradiol	210.108 Picomole per liter	Standard Deviation 100.836

Primary

Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals

12-lead ECGs were obtained at each timepoint during the study using an ECG machine that automatically calculated the heart rate and measures RR, PR, QRS, QT, and QTc intervals. Absolute mean values of PR, QRS, QT, and QTcB, QTcF, RR intervals were reported.

Time frame: Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow-up (Day 7)

Population: All subject population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Combined Placebo	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	PR Interval: Day 2, pre-dose	141.4 Milliseconds	Standard Deviation 14.35
Combined Placebo	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	PR Interval: Day 3, pre-dose	145.7 Milliseconds	Standard Deviation 20.73
Combined Placebo	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	PR Interval: Day 3, 24 h	137.0 Milliseconds	Standard Deviation 18.9
Combined Placebo	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	PR Interval: Follow up (Day 7)	133.9 Milliseconds	Standard Deviation 13.85
Combined Placebo	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QRS Duration: Day 2, pre-dose	89.8 Milliseconds	Standard Deviation 9.26
Combined Placebo	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QRS Duration: Day 3, pre-dose	90.5 Milliseconds	Standard Deviation 9.62
Combined Placebo	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QRS Duration: Day 3, 24 h	91.6 Milliseconds	Standard Deviation 10.48
Combined Placebo	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QRS Duration: Follow up (Day 7)	90.8 Milliseconds	Standard Deviation 9.39
Combined Placebo	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QT Interval: Day 2, pre-dose	338.7 Milliseconds	Standard Deviation 30.74
Combined Placebo	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QT Interval: Day 3, pre-dose	338.6 Milliseconds	Standard Deviation 34.99
Combined Placebo	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QT Interval: Day 3, 24 h	328.8 Milliseconds	Standard Deviation 35.13
Combined Placebo	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QT Interval: Follow up (Day 7)	346.7 Milliseconds	Standard Deviation 33.16
Combined Placebo	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QTcB Interval: Day 2, pre-dose	432.5 Milliseconds	Standard Deviation 28.82
Combined Placebo	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QTcB Interval: Day 3, pre-dose	424.4 Milliseconds	Standard Deviation 27.55
Combined Placebo	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QTcB Interval: Day 3, 24 h	425.8 Milliseconds	Standard Deviation 21.83
Combined Placebo	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QTcB Interval: Follow up (Day 7)	435.5 Milliseconds	Standard Deviation 32.08
Combined Placebo	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QTcF Interval: Day 2, pre-dose	398.3 Milliseconds	Standard Deviation 24.07
Combined Placebo	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QTcF Interval: Day 3, pre-dose	393.3 Milliseconds	Standard Deviation 27.85
Combined Placebo	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QTcF Interval: Day 3, 24 h	390.4 Milliseconds	Standard Deviation 24.77
Combined Placebo	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QTcF Interval: Follow up (Day 7)	403.4 Milliseconds	Standard Deviation 29.35
Combined Placebo	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	RR Interval: Day 2, pre-dose	622.0 Milliseconds	Standard Deviation 117.16
Combined Placebo	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	RR Interval: Day 3, pre-dose	640.1 Milliseconds	Standard Deviation 103.46
Combined Placebo	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	RR Interval: Day 3, 24 h	598.7 Milliseconds	Standard Deviation 99.54
Combined Placebo	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	RR Interval: Follow up (Day 7)	639.0 Milliseconds	Standard Deviation 103.45
Cohort 1-SB-681323, 3 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	RR Interval: Day 3, 24 h	675.1 Milliseconds	Standard Deviation 137.03
Cohort 1-SB-681323, 3 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QTcF Interval: Follow up (Day 7)	408.1 Milliseconds	Standard Deviation 11.78
Cohort 1-SB-681323, 3 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	RR Interval: Day 3, pre-dose	641.4 Milliseconds	Standard Deviation 137.62
Cohort 1-SB-681323, 3 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QT Interval: Day 3, 24 h	347.4 Milliseconds	Standard Deviation 28.93
Cohort 1-SB-681323, 3 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QTcF Interval: Day 3, pre-dose	410.5 Milliseconds	Standard Deviation 26.01
Cohort 1-SB-681323, 3 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QRS Duration: Day 3, 24 h	85.7 Milliseconds	Standard Deviation 7.7
Cohort 1-SB-681323, 3 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	PR Interval: Day 3, 24 h	146.9 Milliseconds	Standard Deviation 34.15
Cohort 1-SB-681323, 3 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QTcB Interval: Follow up (Day 7)	439.4 Milliseconds	Standard Deviation 15.3
Cohort 1-SB-681323, 3 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QT Interval: Follow up (Day 7)	352.5 Milliseconds	Standard Deviation 16.89
Cohort 1-SB-681323, 3 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QT Interval: Day 2, pre-dose	349.5 Milliseconds	Standard Deviation 29.89
Cohort 1-SB-681323, 3 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QTcF Interval: Day 3, 24 h	397.4 Milliseconds	Standard Deviation 14.85
Cohort 1-SB-681323, 3 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QTcF Interval: Day 2, pre-dose	399.4 Milliseconds	Standard Deviation 22.88
Cohort 1-SB-681323, 3 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	RR Interval: Day 2, pre-dose	677.5 Milliseconds	Standard Deviation 133.48
Cohort 1-SB-681323, 3 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QTcB Interval: Day 2, pre-dose	427.5 Milliseconds	Standard Deviation 27.91
Cohort 1-SB-681323, 3 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	PR Interval: Follow up (Day 7)	142.8 Milliseconds	Standard Deviation 24.33
Cohort 1-SB-681323, 3 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QRS Duration: Day 2, pre-dose	86.5 Milliseconds	Standard Deviation 10.78
Cohort 1-SB-681323, 3 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	PR Interval: Day 3, pre-dose	142.0 Milliseconds	Standard Deviation 22.33
Cohort 1-SB-681323, 3 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	PR Interval: Day 2, pre-dose	145.5 Milliseconds	Standard Deviation 21.21
Cohort 1-SB-681323, 3 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QTcB Interval: Day 3, pre-dose	443.4 Milliseconds	Standard Deviation 28.77
Cohort 1-SB-681323, 3 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QT Interval: Day 3, pre-dose	352.9 Milliseconds	Standard Deviation 36.2
Cohort 1-SB-681323, 3 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QRS Duration: Day 3, pre-dose	87.1 Milliseconds	Standard Deviation 8.86
Cohort 1-SB-681323, 3 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	RR Interval: Follow up (Day 7)	646.8 Milliseconds	Standard Deviation 74.52
Cohort 1-SB-681323, 3 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QRS Duration: Follow up (Day 7)	86.0 Milliseconds	Standard Deviation 8.42
Cohort 1-SB-681323, 3 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QTcB Interval: Day 3, 24 h	425.6 Milliseconds	Standard Deviation 18.45
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QTcF Interval: Follow up (Day 7)	395.5 Milliseconds	Standard Deviation 43.63
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QRS Duration: Follow up (Day 7)	88.5 Milliseconds	Standard Deviation 11.35
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QTcB Interval: Follow up (Day 7)	430.1 Milliseconds	Standard Deviation 43.76
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QRS Duration: Day 3, pre-dose	89.5 Milliseconds	Standard Deviation 10.66
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	RR Interval: Day 3, 24 h	665.8 Milliseconds	Standard Deviation 114.27
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QTcF Interval: Day 2, pre-dose	392.6 Milliseconds	Standard Deviation 36.62
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QTcF Interval: Day 3, 24 h	390.3 Milliseconds	Standard Deviation 22.25
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	PR Interval: Follow up (Day 7)	142.0 Milliseconds	Standard Deviation 16.54
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QTcF Interval: Day 3, pre-dose	391.5 Milliseconds	Standard Deviation 30.9
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QT Interval: Day 2, pre-dose	342.0 Milliseconds	Standard Deviation 61.77
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	RR Interval: Follow up (Day 7)	608.3 Milliseconds	Standard Deviation 98.05
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QT Interval: Day 3, pre-dose	351.3 Milliseconds	Standard Deviation 56.64
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QRS Duration: Day 2, pre-dose	86.8 Milliseconds	Standard Deviation 12.49
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	PR Interval: Day 3, 24 h	142.2 Milliseconds	Standard Deviation 24.93
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QT Interval: Day 3, 24 h	340.2 Milliseconds	Standard Deviation 31.64
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	RR Interval: Day 3, pre-dose	727.9 Milliseconds	Standard Deviation 210.54
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QT Interval: Follow up (Day 7)	335.0 Milliseconds	Standard Deviation 47.41
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QRS Duration: Day 3, 24 h	90.6 Milliseconds	Standard Deviation 8.85
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	PR Interval: Day 3, pre-dose	141.6 Milliseconds	Standard Deviation 27.43
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	RR Interval: Day 2, pre-dose	667.7 Milliseconds	Standard Deviation 219.26
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QTcB Interval: Day 2, pre-dose	422.0 Milliseconds	Standard Deviation 28.72
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QTcB Interval: Day 3, 24 h	418.5 Milliseconds	Standard Deviation 22.6
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QTcB Interval: Day 3, pre-dose	414.4 Milliseconds	Standard Deviation 22.33
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	PR Interval: Day 2, pre-dose	141.5 Milliseconds	Standard Deviation 17.8
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QRS Duration: Day 2, pre-dose	87.2 Milliseconds	Standard Deviation 13.34
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QRS Duration: Day 3, pre-dose	87.6 Milliseconds	Standard Deviation 14.56
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QRS Duration: Day 3, 24 h	88.3 Milliseconds	Standard Deviation 14.36
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	RR Interval: Day 2, pre-dose	635.5 Milliseconds	Standard Deviation 119.09
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QRS Duration: Follow up (Day 7)	85.4 Milliseconds	Standard Deviation 14.01
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QT Interval: Day 2, pre-dose	332.1 Milliseconds	Standard Deviation 34
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QT Interval: Day 3, pre-dose	342.5 Milliseconds	Standard Deviation 24.15
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QT Interval: Day 3, 24 h	336.5 Milliseconds	Standard Deviation 31.22
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QT Interval: Follow up (Day 7)	342.1 Milliseconds	Standard Deviation 37.14
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	RR Interval: Day 3, pre-dose	670.2 Milliseconds	Standard Deviation 115.37
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QTcB Interval: Day 2, pre-dose	418.6 Milliseconds	Standard Deviation 21.72
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QTcB Interval: Day 3, pre-dose	420.9 Milliseconds	Standard Deviation 26.99
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	RR Interval: Follow up (Day 7)	622.3 Milliseconds	Standard Deviation 105.38
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QTcB Interval: Day 3, 24 h	422.5 Milliseconds	Standard Deviation 22.33
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QTcB Interval: Follow up (Day 7)	434.7 Milliseconds	Standard Deviation 19.27
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QTcF Interval: Day 2, pre-dose	387.1 Milliseconds	Standard Deviation 22.19
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	RR Interval: Day 3, 24 h	639.0 Milliseconds	Standard Deviation 106.37
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QTcF Interval: Day 3, pre-dose	392.7 Milliseconds	Standard Deviation 21.41
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QTcF Interval: Day 3, 24 h	391.4 Milliseconds	Standard Deviation 22.27
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	PR Interval: Day 2, pre-dose	143.9 Milliseconds	Standard Deviation 30.54
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	PR Interval: Day 3, pre-dose	148.6 Milliseconds	Standard Deviation 23
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QTcF Interval: Follow up (Day 7)	401.0 Milliseconds	Standard Deviation 23.91
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	PR Interval: Day 3, 24 h	145.9 Milliseconds	Standard Deviation 21.21
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	PR Interval: Follow up (Day 7)	138.1 Milliseconds	Standard Deviation 26.91
Cohort 4-SB-681323, 10 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QTcB Interval: Follow up (Day 7)	440.3 Milliseconds	Standard Deviation 48.93
Cohort 4-SB-681323, 10 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QTcB Interval: Day 3, 24 h	429.6 Milliseconds	Standard Deviation 22.05
Cohort 4-SB-681323, 10 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QTcB Interval: Day 3, pre-dose	427.4 Milliseconds	Standard Deviation 31.17
Cohort 4-SB-681323, 10 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	PR Interval: Follow up (Day 7)	155.1 Milliseconds	Standard Deviation 22.63
Cohort 4-SB-681323, 10 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	PR Interval: Day 2, pre-dose	152.9 Milliseconds	Standard Deviation 20.98
Cohort 4-SB-681323, 10 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	RR Interval: Day 3, pre-dose	679.5 Milliseconds	Standard Deviation 140.86
Cohort 4-SB-681323, 10 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QTcB Interval: Day 2, pre-dose	416.2 Milliseconds	Standard Deviation 24.28
Cohort 4-SB-681323, 10 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QT Interval: Follow up (Day 7)	369.1 Milliseconds	Standard Deviation 45.58
Cohort 4-SB-681323, 10 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QRS Duration: Follow up (Day 7)	85.9 Milliseconds	Standard Deviation 10.16
Cohort 4-SB-681323, 10 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	PR Interval: Day 3, pre-dose	152.0 Milliseconds	Standard Deviation 25.88
Cohort 4-SB-681323, 10 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QRS Duration: Day 3, 24 h	88.4 Milliseconds	Standard Deviation 12.29
Cohort 4-SB-681323, 10 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QT Interval: Day 3, 24 h	358.0 Milliseconds	Standard Deviation 47.32
Cohort 4-SB-681323, 10 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QT Interval: Day 3, pre-dose	351.4 Milliseconds	Standard Deviation 48.51
Cohort 4-SB-681323, 10 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QRS Duration: Day 3, pre-dose	86.5 Milliseconds	Standard Deviation 12.11
Cohort 4-SB-681323, 10 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	PR Interval: Day 3, 24 h	160.7 Milliseconds	Standard Deviation 23.58
Cohort 4-SB-681323, 10 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QTcF Interval: Follow up (Day 7)	414.9 Milliseconds	Standard Deviation 45.44
Cohort 4-SB-681323, 10 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QT Interval: Day 2, pre-dose	365.1 Milliseconds	Standard Deviation 39.95
Cohort 4-SB-681323, 10 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	RR Interval: Day 2, pre-dose	780.8 Milliseconds	Standard Deviation 178.59
Cohort 4-SB-681323, 10 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	RR Interval: Day 3, 24 h	703.1 Milliseconds	Standard Deviation 171.59
Cohort 4-SB-681323, 10 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QTcF Interval: Day 3, pre-dose	400.0 Milliseconds	Standard Deviation 35.34
Cohort 4-SB-681323, 10 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QTcF Interval: Day 2, pre-dose	397.9 Milliseconds	Standard Deviation 24.09
Cohort 4-SB-681323, 10 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QRS Duration: Day 2, pre-dose	88.0 Milliseconds	Standard Deviation 12.63
Cohort 4-SB-681323, 10 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	QTcF Interval: Day 3, 24 h	403.7 Milliseconds	Standard Deviation 26.8
Cohort 4-SB-681323, 10 mg, 24 h	Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals	RR Interval: Follow up (Day 7)	709.0 Milliseconds	Standard Deviation 112.18

Primary

Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count

Mean hematology parameters including basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count, white blood cell count were reported. If sample for hematology test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.

Time frame: Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)

Population: All subject Population comprised of as all participant who received at least one dose of study medication. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Combined Placebo	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Lymphocytes: Follow up (Day 7)	1.4967 Giga cells per liter	Standard Deviation 0.53371
Combined Placebo	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Total Neutrophils: Day 3, pre-dose	8.3494 Giga cells per liter	Standard Deviation 2.81972
Combined Placebo	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Monocytes: Day 2, pre-dose	0.8503 Giga cells per liter	Standard Deviation 0.36457
Combined Placebo	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Total Neutrophils: Day 2, pre-dose	9.1607 Giga cells per liter	Standard Deviation 2.78517
Combined Placebo	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Monocytes: Day 3, pre-dose	0.7726 Giga cells per liter	Standard Deviation 0.35421
Combined Placebo	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	White blood cell count: Day 3, pre-dose	10.43 Giga cells per liter	Standard Deviation 3.482
Combined Placebo	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Monocytes: Follow up (Day 7)	1.1119 Giga cells per liter	Standard Deviation 0.50819
Combined Placebo	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Monocytes: Day 3, 24 h	0.8554 Giga cells per liter	Standard Deviation 0.32384
Combined Placebo	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Basophils: Follow up (Day 7)	0.0389 Giga cells per liter	Standard Deviation 0.0366
Combined Placebo	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	White blood cell count: Follow up (Day 7)	12.84 Giga cells per liter	Standard Deviation 3.894
Combined Placebo	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Basophils: Day 2, pre-dose	0.0305 Giga cells per liter	Standard Deviation 0.04196
Combined Placebo	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Eosinophils: Day 2, pre-dose	0.0968 Giga cells per liter	Standard Deviation 0.18817
Combined Placebo	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Basophils: Day 3, pre-dose	0.0291 Giga cells per liter	Standard Deviation 0.03036
Combined Placebo	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	White blood cell count: Day 2, pre-dose	11.17 Giga cells per liter	Standard Deviation 3.394
Combined Placebo	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Eosinophils: Day 3, pre-dose	0.1588 Giga cells per liter	Standard Deviation 0.18027
Combined Placebo	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Platelet count: Follow up (Day 7)	310.1 Giga cells per liter	Standard Deviation 87.28
Combined Placebo	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Eosinophils: Day 3, 24 h	0.2544 Giga cells per liter	Standard Deviation 0.18852
Combined Placebo	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Platelet count: Day 3, 24 h	172.0 Giga cells per liter	Standard Deviation 58.25
Combined Placebo	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Eosinophils: Follow up (Day 7)	0.3713 Giga cells per liter	Standard Deviation 0.29748
Combined Placebo	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Platelet count: Day 3, pre-dose	143.1 Giga cells per liter	Standard Deviation 54.62
Combined Placebo	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Lymphocytes: Day 2, pre-dose	1.2943 Giga cells per liter	Standard Deviation 0.68932
Combined Placebo	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	White blood cell count: Day 3, 24 h	10.26 Giga cells per liter	Standard Deviation 2.544
Combined Placebo	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Platelet count: Day 2, pre-dose	139.5 Giga cells per liter	Standard Deviation 46.84
Combined Placebo	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Lymphocytes: Day 3, pre-dose	1.2594 Giga cells per liter	Standard Deviation 0.59834
Combined Placebo	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Basophils: Day 3, 24 h	0.0239 Giga cells per liter	Standard Deviation 0.02062
Combined Placebo	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Total Neutrophils: Follow up (Day 7)	9.7596 Giga cells per liter	Standard Deviation 3.5318
Combined Placebo	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Lymphocytes: Day 3, 24 h	1.1146 Giga cells per liter	Standard Deviation 0.44206
Combined Placebo	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Total Neutrophils: Day 3, 24 h	8.0317 Giga cells per liter	Standard Deviation 2.21593
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Total Neutrophils: Day 3, pre-dose	6.8724 Giga cells per liter	Standard Deviation 2.39872
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	White blood cell count: Follow up (Day 7)	10.73 Giga cells per liter	Standard Deviation 3.973
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Platelet count: Day 3, 24 h	138.9 Giga cells per liter	Standard Deviation 28.15
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Total Neutrophils: Day 2, pre-dose	7.0729 Giga cells per liter	Standard Deviation 2.28843
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Total Neutrophils: Follow up (Day 7)	7.8463 Giga cells per liter	Standard Deviation 3.498
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Monocytes: Day 2, pre-dose	0.6670 Giga cells per liter	Standard Deviation 0.16724
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	White blood cell count: Day 3, pre-dose	8.55 Giga cells per liter	Standard Deviation 2.206
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Eosinophils: Day 3, 24 h	0.1538 Giga cells per liter	Standard Deviation 0.07558
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Monocytes: Follow up (Day 7)	0.9531 Giga cells per liter	Standard Deviation 0.45374
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Basophils: Day 2, pre-dose	0.0163 Giga cells per liter	Standard Deviation 0.01188
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Monocytes: Day 3, pre-dose	0.6564 Giga cells per liter	Standard Deviation 0.20882
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Lymphocytes: Day 3, 24 h	1.0406 Giga cells per liter	Standard Deviation 0.36407
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Platelet count: Day 3, pre-dose	124.5 Giga cells per liter	Standard Deviation 39.16
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Monocytes: Day 3, 24 h	0.6238 Giga cells per liter	Standard Deviation 0.16501
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Lymphocytes: Day 3, pre-dose	1.0103 Giga cells per liter	Standard Deviation 0.39949
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Eosinophils: Follow up (Day 7)	0.2866 Giga cells per liter	Standard Deviation 0.2512
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Basophils: Follow up (Day 7)	0.0314 Giga cells per liter	Standard Deviation 0.0234
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	White blood cell count: Day 3, 24 h	7.26 Giga cells per liter	Standard Deviation 1.859
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Basophils: Day 3, 24 h	0.0294 Giga cells per liter	Standard Deviation 0.02809
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	White blood cell count: Day 2, pre-dose	8.80 Giga cells per liter	Standard Deviation 2.48
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Platelet count: Day 2, pre-dose	109.6 Giga cells per liter	Standard Deviation 36.21
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Eosinophils: Day 2, pre-dose	0.0676 Giga cells per liter	Standard Deviation 0.07149
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Lymphocytes: Follow up (Day 7)	1.0611 Giga cells per liter	Standard Deviation 0.31455
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Lymphocytes: Day 2, pre-dose	0.9725 Giga cells per liter	Standard Deviation 0.4398
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Platelet count: Follow up (Day 7)	262.4 Giga cells per liter	Standard Deviation 76.44
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Total Neutrophils: Day 3, 24 h	5.4550 Giga cells per liter	Standard Deviation 2.0133
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Eosinophils: Day 3, pre-dose	0.0894 Giga cells per liter	Standard Deviation 0.06882
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Basophils: Day 3, pre-dose	0.0129 Giga cells per liter	Standard Deviation 0.00756
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	White blood cell count: Day 2, pre-dose	10.95 Giga cells per liter	Standard Deviation 3.028
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Basophils: Day 2, pre-dose	0.0208 Giga cells per liter	Standard Deviation 0.02843
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Basophils: Day 3, pre-dose	0.0209 Giga cells per liter	Standard Deviation 0.02737
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Basophils: Day 3, 24 h	0.0300 Giga cells per liter	Standard Deviation 0.02374
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Basophils: Follow up (Day 7)	0.0300 Giga cells per liter	Standard Deviation 0.02625
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Eosinophils: Day 2, pre-dose	0.0633 Giga cells per liter	Standard Deviation 0.07451
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Eosinophils: Day 3, pre-dose	0.0964 Giga cells per liter	Standard Deviation 0.10112
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Eosinophils: Day 3, 24 h	0.1400 Giga cells per liter	Standard Deviation 0.14365
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Eosinophils: Follow up (Day 7)	0.1900 Giga cells per liter	Standard Deviation 0.16445
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Lymphocytes: Day 2, pre-dose	1.0575 Giga cells per liter	Standard Deviation 0.49116
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Lymphocytes: Day 3, pre-dose	1.0582 Giga cells per liter	Standard Deviation 0.42171
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Lymphocytes: Day 3, 24 h	1.0067 Giga cells per liter	Standard Deviation 0.60161
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Lymphocytes: Follow up (Day 7)	1.0370 Giga cells per liter	Standard Deviation 0.50228
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Monocytes: Day 2, pre-dose	0.7900 Giga cells per liter	Standard Deviation 0.20432
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Monocytes: Day 3, pre-dose	0.5936 Giga cells per liter	Standard Deviation 0.24072
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Monocytes: Day 3, 24 h	0.7308 Giga cells per liter	Standard Deviation 0.23372
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Monocytes: Follow up (Day 7)	0.9030 Giga cells per liter	Standard Deviation 0.45314
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Total Neutrophils: Day 2, pre-dose	9.0225 Giga cells per liter	Standard Deviation 3.17595
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Total Neutrophils: Day 3, pre-dose	8.6555 Giga cells per liter	Standard Deviation 4.16819
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Total Neutrophils: Day 3, 24 h	7.7675 Giga cells per liter	Standard Deviation 2.93749
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Total Neutrophils: Follow up (Day 7)	9.4750 Giga cells per liter	Standard Deviation 3.26687
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Platelet count: Day 2, pre-dose	152.0 Giga cells per liter	Standard Deviation 60.65
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Platelet count: Day 3, pre-dose	152.4 Giga cells per liter	Standard Deviation 66.02
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Platelet count: Day 3, 24 h	177.3 Giga cells per liter	Standard Deviation 68.96
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Platelet count: Follow up (Day 7)	253.6 Giga cells per liter	Standard Deviation 84.79
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	White blood cell count: Day 3, pre-dose	10.38 Giga cells per liter	Standard Deviation 4.105
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	White blood cell count: Day 3, 24 h	9.68 Giga cells per liter	Standard Deviation 2.954
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	White blood cell count: Follow up (Day 7)	11.34 Giga cells per liter	Standard Deviation 3.312
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Total Neutrophils: Follow up (Day 7)	9.7576 Giga cells per liter	Standard Deviation 4.00884
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Platelet count: Day 3, 24 h	183.1 Giga cells per liter	Standard Deviation 53.62
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Total Neutrophils: Day 3, pre-dose	8.3912 Giga cells per liter	Standard Deviation 3.6453
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Eosinophils: Day 3, pre-dose	0.0746 Giga cells per liter	Standard Deviation 0.06376
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Lymphocytes: Day 2, pre-dose	1.3276 Giga cells per liter	Standard Deviation 0.57791
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Basophils: Day 2, pre-dose	0.0153 Giga cells per liter	Standard Deviation 0.01125
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Platelet count: Follow up (Day 7)	284.0 Giga cells per liter	Standard Deviation 84.37
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Basophils: Day 3, pre-dose	0.0176 Giga cells per liter	Standard Deviation 0.01562
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Eosinophils: Day 2, pre-dose	0.0331 Giga cells per liter	Standard Deviation 0.04319
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	White blood cell count: Day 3, 24 h	10.72 Giga cells per liter	Standard Deviation 3.694
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Basophils: Follow up (Day 7)	0.0345 Giga cells per liter	Standard Deviation 0.03965
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	White blood cell count: Day 2, pre-dose	11.67 Giga cells per liter	Standard Deviation 3.377
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Platelet count: Day 2, pre-dose	145.2 Giga cells per liter	Standard Deviation 52.96
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Total Neutrophils: Day 3, 24 h	8.4700 Giga cells per liter	Standard Deviation 3.4885
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Basophils: Day 3, 24 h	0.0284 Giga cells per liter	Standard Deviation 0.02762
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Eosinophils: Follow up (Day 7)	0.2390 Giga cells per liter	Standard Deviation 0.08483
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Lymphocytes: Follow up (Day 7)	1.3915 Giga cells per liter	Standard Deviation 0.72178
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Monocytes: Day 3, 24 h	0.8852 Giga cells per liter	Standard Deviation 0.33731
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Lymphocytes: Day 3, pre-dose	1.1462 Giga cells per liter	Standard Deviation 0.52784
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Monocytes: Day 3, pre-dose	0.8479 Giga cells per liter	Standard Deviation 0.54882
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Platelet count: Day 3, pre-dose	144.6 Giga cells per liter	Standard Deviation 44.73
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	White blood cell count: Day 3, pre-dose	10.47 Giga cells per liter	Standard Deviation 4.112
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Monocytes: Follow up (Day 7)	1.1811 Giga cells per liter	Standard Deviation 0.42979
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Lymphocytes: Day 3, 24 h	1.1936 Giga cells per liter	Standard Deviation 0.5019
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Monocytes: Day 2, pre-dose	0.9588 Giga cells per liter	Standard Deviation 0.53966
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Eosinophils: Day 3, 24 h	0.1345 Giga cells per liter	Standard Deviation 0.1256
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	White blood cell count: Follow up (Day 7)	13.60 Giga cells per liter	Standard Deviation 5.614
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Total Neutrophils: Day 2, pre-dose	9.4199 Giga cells per liter	Standard Deviation 2.80762
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Monocytes: Day 2, pre-dose	0.7246 Giga cells per liter	Standard Deviation 0.24992
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Lymphocytes: Day 3, 24 h	1.4288 Giga cells per liter	Standard Deviation 0.62231
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Basophils: Day 3, pre-dose	0.0279 Giga cells per liter	Standard Deviation 0.03191
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Total Neutrophils: Day 3, pre-dose	8.1779 Giga cells per liter	Standard Deviation 2.36852
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Lymphocytes: Day 3, pre-dose	1.1593 Giga cells per liter	Standard Deviation 0.55383
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Total Neutrophils: Day 3, 24 h	6.9604 Giga cells per liter	Standard Deviation 3.51501
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Lymphocytes: Day 2, pre-dose	1.5365 Giga cells per liter	Standard Deviation 0.83119
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Total Neutrophils: Follow up (Day 7)	8.4943 Giga cells per liter	Standard Deviation 4.71139
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Eosinophils: Follow up (Day 7)	0.1998 Giga cells per liter	Standard Deviation 0.14855
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Platelet count: Day 2, pre-dose	149.5 Giga cells per liter	Standard Deviation 45.73
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Eosinophils: Day 3, 24 h	0.1142 Giga cells per liter	Standard Deviation 0.07005
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	White blood cell count: Day 3, 24 h	9.78 Giga cells per liter	Standard Deviation 3.316
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Platelet count: Day 3, pre-dose	144.1 Giga cells per liter	Standard Deviation 39.33
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Eosinophils: Day 3, pre-dose	0.0664 Giga cells per liter	Standard Deviation 0.04955
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Basophils: Day 2, pre-dose	0.0258 Giga cells per liter	Standard Deviation 0.02134
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Platelet count: Day 3, 24 h	176.1 Giga cells per liter	Standard Deviation 44.35
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Eosinophils: Day 2, pre-dose	0.0724 Giga cells per liter	Standard Deviation 0.07411
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Platelet count: Follow up (Day 7)	300.6 Giga cells per liter	Standard Deviation 105.65
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Basophils: Follow up (Day 7)	0.0240 Giga cells per liter	Standard Deviation 0.02501
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	White blood cell count: Day 2, pre-dose	10.88 Giga cells per liter	Standard Deviation 3.068
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Basophils: Day 3, 24 h	0.0315 Giga cells per liter	Standard Deviation 0.0424
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Monocytes: Day 3, pre-dose	0.6957 Giga cells per liter	Standard Deviation 0.22589
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	White blood cell count: Follow up (Day 7)	11.18 Giga cells per liter	Standard Deviation 5.237
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Monocytes: Day 3, 24 h	0.6712 Giga cells per liter	Standard Deviation 0.29185
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Total Neutrophils: Day 2, pre-dose	8.2319 Giga cells per liter	Standard Deviation 2.78227
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Monocytes: Follow up (Day 7)	0.7591 Giga cells per liter	Standard Deviation 0.2303
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	Lymphocytes: Follow up (Day 7)	1.2835 Giga cells per liter	Standard Deviation 0.417
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count	White blood cell count: Day 3, pre-dose	10.36 Giga cells per liter	Standard Deviation 2.37

Primary

Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)

Mean hematology parameters including hemoglobin, MCHC were reported. If sample for hematology test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.

Time frame: Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)

Population: All subject population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Combined Placebo	Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	Hemoglobin : Day 2, pre-dose	100.8 Grams per liter (g/L)	Standard Deviation 17.05
Combined Placebo	Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	Hemoglobin : Day 3, pre-dose	90.6 Grams per liter (g/L)	Standard Deviation 15.27
Combined Placebo	Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	Hemoglobin : Day 3, 24 h	91.9 Grams per liter (g/L)	Standard Deviation 12.94
Combined Placebo	Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	Hemoglobin: follow up (Day 7)	94.1 Grams per liter (g/L)	Standard Deviation 14.97
Combined Placebo	Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	MCHC :Day 2, pre-dose	341.2 Grams per liter (g/L)	Standard Deviation 10.96
Combined Placebo	Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	MCHC : Day 3, pre-dose	337.4 Grams per liter (g/L)	Standard Deviation 9.3
Combined Placebo	Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	MCHC : Day 3, 24 h	338.2 Grams per liter (g/L)	Standard Deviation 9.33
Combined Placebo	Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	MCHC : Follow up (Day 7)	333.4 Grams per liter (g/L)	Standard Deviation 12.09
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	Hemoglobin : Day 3, 24 h	96.5 Grams per liter (g/L)	Standard Deviation 16.5
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	MCHC : Day 3, pre-dose	343.1 Grams per liter (g/L)	Standard Deviation 8.15
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	Hemoglobin : Day 2, pre-dose	97.0 Grams per liter (g/L)	Standard Deviation 16.27
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	Hemoglobin: follow up (Day 7)	103.5 Grams per liter (g/L)	Standard Deviation 16.42
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	Hemoglobin : Day 3, pre-dose	96.0 Grams per liter (g/L)	Standard Deviation 17.48
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	MCHC : Follow up (Day 7)	339.5 Grams per liter (g/L)	Standard Deviation 10.74
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	MCHC :Day 2, pre-dose	343.8 Grams per liter (g/L)	Standard Deviation 4.17
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	MCHC : Day 3, 24 h	342.9 Grams per liter (g/L)	Standard Deviation 6.9
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	MCHC : Day 3, 24 h	338.1 Grams per liter (g/L)	Standard Deviation 9.34
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	MCHC : Follow up (Day 7)	337.8 Grams per liter (g/L)	Standard Deviation 9.72
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	Hemoglobin: follow up (Day 7)	99.6 Grams per liter (g/L)	Standard Deviation 15.49
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	MCHC : Day 3, pre-dose	338.7 Grams per liter (g/L)	Standard Deviation 7.64
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	Hemoglobin : Day 3, 24 h	93.0 Grams per liter (g/L)	Standard Deviation 15.36
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	Hemoglobin : Day 3, pre-dose	93.7 Grams per liter (g/L)	Standard Deviation 19.4
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	Hemoglobin : Day 2, pre-dose	97.8 Grams per liter (g/L)	Standard Deviation 22.04
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	MCHC :Day 2, pre-dose	339.3 Grams per liter (g/L)	Standard Deviation 6.96
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	Hemoglobin : Day 3, pre-dose	82.9 Grams per liter (g/L)	Standard Deviation 9.29
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	Hemoglobin : Day 3, 24 h	84.7 Grams per liter (g/L)	Standard Deviation 9.73
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	Hemoglobin: follow up (Day 7)	88.8 Grams per liter (g/L)	Standard Deviation 8.93
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	MCHC :Day 2, pre-dose	339.1 Grams per liter (g/L)	Standard Deviation 9.43
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	MCHC : Day 3, pre-dose	339.1 Grams per liter (g/L)	Standard Deviation 7.43
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	MCHC : Follow up (Day 7)	331.1 Grams per liter (g/L)	Standard Deviation 11.89
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	Hemoglobin : Day 2, pre-dose	88.4 Grams per liter (g/L)	Standard Deviation 12.46
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	MCHC : Day 3, 24 h	336.4 Grams per liter (g/L)	Standard Deviation 10.03
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	Hemoglobin: follow up (Day 7)	99.2 Grams per liter (g/L)	Standard Deviation 16.36
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	MCHC : Follow up (Day 7)	342.5 Grams per liter (g/L)	Standard Deviation 9.28
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	Hemoglobin : Day 3, 24 h	95.1 Grams per liter (g/L)	Standard Deviation 19.37
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	MCHC : Day 3, 24 h	342.8 Grams per liter (g/L)	Standard Deviation 9.6
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	Hemoglobin : Day 2, pre-dose	97.2 Grams per liter (g/L)	Standard Deviation 20.4
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	MCHC : Day 3, pre-dose	341.2 Grams per liter (g/L)	Standard Deviation 8.73
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	Hemoglobin : Day 3, pre-dose	95.2 Grams per liter (g/L)	Standard Deviation 20.85
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)	MCHC :Day 2, pre-dose	343.6 Grams per liter (g/L)	Standard Deviation 10.63

Primary

Mean Hematology Parameters- Mean Corpuscle Hemoglobin

Hematology parameter mean corpuscle hemoglobin was reported. If sample for hematology test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.

Time frame: Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)

Population: All subject population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Combined Placebo	Mean Hematology Parameters- Mean Corpuscle Hemoglobin	Mean Corpuscle Hemoglobin: Day 2, pre-dose	30.46 Picogram (pg)	Standard Deviation 1.34
Combined Placebo	Mean Hematology Parameters- Mean Corpuscle Hemoglobin	Mean Corpuscle Hemoglobin: Day 3, pre-dose	30.21 Picogram (pg)	Standard Deviation 1.319
Combined Placebo	Mean Hematology Parameters- Mean Corpuscle Hemoglobin	Mean Corpuscle Hemoglobin: Day 3, 24 h	30.25 Picogram (pg)	Standard Deviation 1.359
Combined Placebo	Mean Hematology Parameters- Mean Corpuscle Hemoglobin	Mean Corpuscle Hemoglobin:Follow up (Day 7)	30.02 Picogram (pg)	Standard Deviation 1.141
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters- Mean Corpuscle Hemoglobin	Mean Corpuscle Hemoglobin: Day 2, pre-dose	30.74 Picogram (pg)	Standard Deviation 1.241
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters- Mean Corpuscle Hemoglobin	Mean Corpuscle Hemoglobin:Follow up (Day 7)	30.64 Picogram (pg)	Standard Deviation 1.308
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters- Mean Corpuscle Hemoglobin	Mean Corpuscle Hemoglobin: Day 3, pre-dose	30.78 Picogram (pg)	Standard Deviation 1.29
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters- Mean Corpuscle Hemoglobin	Mean Corpuscle Hemoglobin: Day 3, 24 h	30.80 Picogram (pg)	Standard Deviation 1.153
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters- Mean Corpuscle Hemoglobin	Mean Corpuscle Hemoglobin:Follow up (Day 7)	30.13 Picogram (pg)	Standard Deviation 1.234
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters- Mean Corpuscle Hemoglobin	Mean Corpuscle Hemoglobin: Day 3, pre-dose	30.22 Picogram (pg)	Standard Deviation 1.135
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters- Mean Corpuscle Hemoglobin	Mean Corpuscle Hemoglobin: Day 3, 24 h	30.33 Picogram (pg)	Standard Deviation 1.378
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters- Mean Corpuscle Hemoglobin	Mean Corpuscle Hemoglobin: Day 2, pre-dose	30.11 Picogram (pg)	Standard Deviation 1.262
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters- Mean Corpuscle Hemoglobin	Mean Corpuscle Hemoglobin: Day 2, pre-dose	30.18 Picogram (pg)	Standard Deviation 1.997
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters- Mean Corpuscle Hemoglobin	Mean Corpuscle Hemoglobin: Day 3, pre-dose	30.19 Picogram (pg)	Standard Deviation 1.771
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters- Mean Corpuscle Hemoglobin	Mean Corpuscle Hemoglobin:Follow up (Day 7)	29.82 Picogram (pg)	Standard Deviation 1.768
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters- Mean Corpuscle Hemoglobin	Mean Corpuscle Hemoglobin: Day 3, 24 h	30.06 Picogram (pg)	Standard Deviation 1.808
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters- Mean Corpuscle Hemoglobin	Mean Corpuscle Hemoglobin:Follow up (Day 7)	31.08 Picogram (pg)	Standard Deviation 1.415
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters- Mean Corpuscle Hemoglobin	Mean Corpuscle Hemoglobin: Day 3, 24 h	30.92 Picogram (pg)	Standard Deviation 1.274
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters- Mean Corpuscle Hemoglobin	Mean Corpuscle Hemoglobin: Day 3, pre-dose	30.77 Picogram (pg)	Standard Deviation 1.332
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters- Mean Corpuscle Hemoglobin	Mean Corpuscle Hemoglobin: Day 2, pre-dose	31.10 Picogram (pg)	Standard Deviation 1.16

Primary

Mean Hematology Parameters-reticulocytes, Red Blood Cell Count

Absolute values of reticulocytes and red blood cell count were reported. If sample for hematology test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.

Time frame: Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)

Population: All subject population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Combined Placebo	Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Reticulocytes : Day 2, pre-dose	0.0488 Trillion cells per liter (TI/L)	Standard Deviation 0.01974
Combined Placebo	Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Reticulocytes : Day 3, pre-dose	0.0554 Trillion cells per liter (TI/L)	Standard Deviation 0.01871
Combined Placebo	Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Reticulocytes : Day 3, 24 h	0.0662 Trillion cells per liter (TI/L)	Standard Deviation 0.02171
Combined Placebo	Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Reticulocytes : Follow up (Day 7)	0.0934 Trillion cells per liter (TI/L)	Standard Deviation 0.04509
Combined Placebo	Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Red Blood Cell count : Day 2, pre-dose	3.320 Trillion cells per liter (TI/L)	Standard Deviation 0.6164
Combined Placebo	Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Red Blood Cell count : Day 3, pre-dose	3.007 Trillion cells per liter (TI/L)	Standard Deviation 0.5787
Combined Placebo	Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Red Blood Cell count : Day 3, 24 h	3.054 Trillion cells per liter (TI/L)	Standard Deviation 0.522
Combined Placebo	Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Red Blood Cell count : Follow up (Day 7)	3.144 Trillion cells per liter (TI/L)	Standard Deviation 0.5268
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Reticulocytes : Day 3, 24 h	0.0592 Trillion cells per liter (TI/L)	Standard Deviation 0.02654
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Red Blood Cell count : Day 3, pre-dose	3.110 Trillion cells per liter (TI/L)	Standard Deviation 0.5001
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Reticulocytes : Day 2, pre-dose	0.0411 Trillion cells per liter (TI/L)	Standard Deviation 0.01902
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Reticulocytes : Follow up (Day 7)	0.0979 Trillion cells per liter (TI/L)	Standard Deviation 0.04134
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Reticulocytes : Day 3, pre-dose	0.0448 Trillion cells per liter (TI/L)	Standard Deviation 0.01903
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Red Blood Cell count : Follow up (Day 7)	3.379 Trillion cells per liter (TI/L)	Standard Deviation 0.4695
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Red Blood Cell count : Day 2, pre-dose	3.151 Trillion cells per liter (TI/L)	Standard Deviation 0.4434
Cohort 1-SB-681323, 3 mg, 4 h	Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Red Blood Cell count : Day 3, 24 h	3.128 Trillion cells per liter (TI/L)	Standard Deviation 0.4706
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Red Blood Cell count : Day 3, 24 h	3.071 Trillion cells per liter (TI/L)	Standard Deviation 0.5146
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Red Blood Cell count : Follow up (Day 7)	3.313 Trillion cells per liter (TI/L)	Standard Deviation 0.5365
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Reticulocytes : Follow up (Day 7)	0.0829 Trillion cells per liter (TI/L)	Standard Deviation 0.0517
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Red Blood Cell count : Day 3, pre-dose	3.103 Trillion cells per liter (TI/L)	Standard Deviation 0.6117
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Reticulocytes : Day 3, 24 h	0.0538 Trillion cells per liter (TI/L)	Standard Deviation 0.01876
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Reticulocytes : Day 3, pre-dose	0.0464 Trillion cells per liter (TI/L)	Standard Deviation 0.01284
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Reticulocytes : Day 2, pre-dose	0.0406 Trillion cells per liter (TI/L)	Standard Deviation 0.00863
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Red Blood Cell count : Day 2, pre-dose	3.253 Trillion cells per liter (TI/L)	Standard Deviation 0.6883
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Reticulocytes : Day 3, pre-dose	0.0474 Trillion cells per liter (TI/L)	Standard Deviation 0.01382
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Reticulocytes : Day 3, 24 h	0.0581 Trillion cells per liter (TI/L)	Standard Deviation 0.01748
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Reticulocytes : Follow up (Day 7)	0.0897 Trillion cells per liter (TI/L)	Standard Deviation 0.03964
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Red Blood Cell count : Day 2, pre-dose	2.943 Trillion cells per liter (TI/L)	Standard Deviation 0.4695
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Red Blood Cell count : Day 3, pre-dose	2.758 Trillion cells per liter (TI/L)	Standard Deviation 0.3615
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Red Blood Cell count : Follow up (Day 7)	2.983 Trillion cells per liter (TI/L)	Standard Deviation 0.3445
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Reticulocytes : Day 2, pre-dose	0.0398 Trillion cells per liter (TI/L)	Standard Deviation 0.01218
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Red Blood Cell count : Day 3, 24 h	2.822 Trillion cells per liter (TI/L)	Standard Deviation 0.3372
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Reticulocytes : Follow up (Day 7)	0.1213 Trillion cells per liter (TI/L)	Standard Deviation 0.06734
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Red Blood Cell count : Follow up (Day 7)	3.183 Trillion cells per liter (TI/L)	Standard Deviation 0.4403
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Reticulocytes : Day 3, 24 h	0.0699 Trillion cells per liter (TI/L)	Standard Deviation 0.02818
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Red Blood Cell count : Day 3, 24 h	3.062 Trillion cells per liter (TI/L)	Standard Deviation 0.5799
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Reticulocytes : Day 2, pre-dose	0.0513 Trillion cells per liter (TI/L)	Standard Deviation 0.02192
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Red Blood Cell count : Day 3, pre-dose	3.083 Trillion cells per liter (TI/L)	Standard Deviation 0.6114
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Reticulocytes : Day 3, pre-dose	0.0576 Trillion cells per liter (TI/L)	Standard Deviation 0.02543
Cohort 4-SB-681323, 10 mg, 24 h	Mean Hematology Parameters-reticulocytes, Red Blood Cell Count	Red Blood Cell count : Day 2, pre-dose	3.121 Trillion cells per liter (TI/L)	Standard Deviation 0.6197

Primary

Number of Participants With Any Adverse Events (AE) and Serious Adverse Events (SAE)

AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.

Time frame: Up to Follow-up (Day 7)

Population: All subject population.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Combined Placebo	Number of Participants With Any Adverse Events (AE) and Serious Adverse Events (SAE)	Any AEs	18 Participants
Combined Placebo	Number of Participants With Any Adverse Events (AE) and Serious Adverse Events (SAE)	Any SAEs	1 Participants
Cohort 1-SB-681323, 3 mg, 4 h	Number of Participants With Any Adverse Events (AE) and Serious Adverse Events (SAE)	Any AEs	7 Participants
Cohort 1-SB-681323, 3 mg, 4 h	Number of Participants With Any Adverse Events (AE) and Serious Adverse Events (SAE)	Any SAEs	1 Participants
Cohort 2-SB-681323, 7.5 mg, 24 h	Number of Participants With Any Adverse Events (AE) and Serious Adverse Events (SAE)	Any AEs	10 Participants
Cohort 2-SB-681323, 7.5 mg, 24 h	Number of Participants With Any Adverse Events (AE) and Serious Adverse Events (SAE)	Any SAEs	1 Participants
Cohort 3-SB-681323, 7.5 mg, 4 h	Number of Participants With Any Adverse Events (AE) and Serious Adverse Events (SAE)	Any SAEs	4 Participants
Cohort 3-SB-681323, 7.5 mg, 4 h	Number of Participants With Any Adverse Events (AE) and Serious Adverse Events (SAE)	Any AEs	16 Participants
Cohort 4-SB-681323, 10 mg, 24 h	Number of Participants With Any Adverse Events (AE) and Serious Adverse Events (SAE)	Any AEs	14 Participants
Cohort 4-SB-681323, 10 mg, 24 h	Number of Participants With Any Adverse Events (AE) and Serious Adverse Events (SAE)	Any SAEs	0 Participants

Primary

Vital Parameter: Mean Heart Rate

Absolute values of mean heart rate were reported.

Time frame: For Cohort 1 and 3: Day 1, 4 h, Day 2, pre-dose, Day 3, pre-dose and 24 h and Follow up (Day 7); for Cohort 2 and 4: Day 2, pre-dose, Day 3, pre-dose and 24 h, and Follow up (Day 7)

Population: All subject population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Combined Placebo	Vital Parameter: Mean Heart Rate	Heart rate: Day 1, 4 h	92.7 Beats per minute	Standard Deviation 12.18
Combined Placebo	Vital Parameter: Mean Heart Rate	Heart rate: Day 2, pre-dose	99.8 Beats per minute	Standard Deviation 16.92
Combined Placebo	Vital Parameter: Mean Heart Rate	Heart rate: Day 3, pre-dose	97.0 Beats per minute	Standard Deviation 15.13
Combined Placebo	Vital Parameter: Mean Heart Rate	Heart rate: Follow up (Day 7)	97.6 Beats per minute	Standard Deviation 13.42
Combined Placebo	Vital Parameter: Mean Heart Rate	Heart rate: Day 3, 24 h	100.4 Beats per minute	Standard Deviation 15.2
Cohort 1-SB-681323, 3 mg, 4 h	Vital Parameter: Mean Heart Rate	Heart rate: Day 3, 24 h	99.3 Beats per minute	Standard Deviation 12.69
Cohort 1-SB-681323, 3 mg, 4 h	Vital Parameter: Mean Heart Rate	Heart rate: Day 2, pre-dose	93.8 Beats per minute	Standard Deviation 13.35
Cohort 1-SB-681323, 3 mg, 4 h	Vital Parameter: Mean Heart Rate	Heart rate: Day 1, 4 h	89.7 Beats per minute	Standard Deviation 17.63
Cohort 1-SB-681323, 3 mg, 4 h	Vital Parameter: Mean Heart Rate	Heart rate: Day 3, pre-dose	99.3 Beats per minute	Standard Deviation 19.9
Cohort 1-SB-681323, 3 mg, 4 h	Vital Parameter: Mean Heart Rate	Heart rate: Follow up (Day 7)	93.3 Beats per minute	Standard Deviation 19.91
Cohort 2-SB-681323, 7.5 mg, 24 h	Vital Parameter: Mean Heart Rate	Heart rate: Day 3, pre-dose	88.7 Beats per minute	Standard Deviation 24.73
Cohort 2-SB-681323, 7.5 mg, 24 h	Vital Parameter: Mean Heart Rate	Heart rate: Day 2, pre-dose	98.1 Beats per minute	Standard Deviation 27.01
Cohort 2-SB-681323, 7.5 mg, 24 h	Vital Parameter: Mean Heart Rate	Heart rate: Follow up (Day 7)	100.3 Beats per minute	Standard Deviation 18.79
Cohort 2-SB-681323, 7.5 mg, 24 h	Vital Parameter: Mean Heart Rate	Heart rate: Day 3, 24 h	93.7 Beats per minute	Standard Deviation 16.37
Cohort 3-SB-681323, 7.5 mg, 4 h	Vital Parameter: Mean Heart Rate	Heart rate: Day 3, pre-dose	93.8 Beats per minute	Standard Deviation 12.2
Cohort 3-SB-681323, 7.5 mg, 4 h	Vital Parameter: Mean Heart Rate	Heart rate: Day 1, 4 h	97.8 Beats per minute	Standard Deviation 15.37
Cohort 3-SB-681323, 7.5 mg, 4 h	Vital Parameter: Mean Heart Rate	Heart rate: Day 2, pre-dose	97.1 Beats per minute	Standard Deviation 19.36
Cohort 3-SB-681323, 7.5 mg, 4 h	Vital Parameter: Mean Heart Rate	Heart rate: Day 3, 24 h	96.4 Beats per minute	Standard Deviation 15.74
Cohort 3-SB-681323, 7.5 mg, 4 h	Vital Parameter: Mean Heart Rate	Heart rate: Follow up (Day 7)	96.8 Beats per minute	Standard Deviation 16.4
Cohort 4-SB-681323, 10 mg, 24 h	Vital Parameter: Mean Heart Rate	Heart rate: Day 3, pre-dose	88.3 Beats per minute	Standard Deviation 17.83
Cohort 4-SB-681323, 10 mg, 24 h	Vital Parameter: Mean Heart Rate	Heart rate: Day 2, pre-dose	82.7 Beats per minute	Standard Deviation 13.52
Cohort 4-SB-681323, 10 mg, 24 h	Vital Parameter: Mean Heart Rate	Heart rate: Follow up (Day 7)	87.7 Beats per minute	Standard Deviation 14.09
Cohort 4-SB-681323, 10 mg, 24 h	Vital Parameter: Mean Heart Rate	Heart rate: Day 3, 24 h	90.5 Beats per minute	Standard Deviation 18.49

Primary

Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Absolute values of SBP and DBP were reported.

Time frame: For Cohort 1 and 3: Day 1, 4 h, Day 2, pre-dose, Day 3, pre-dose and 24 h and Follow up (Day 7); for Cohort 2 and 4: Day 2, pre-dose, Day 3, pre-dose and 24 h, and Follow up (Day 7)

Population: All subject population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Combined Placebo	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP : Day 2, Pre-dose	126.4 Millimeter of Mercury (mmHg)	Standard Deviation 19.91
Combined Placebo	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP : Day 2, Pre-dose	63.9 Millimeter of Mercury (mmHg)	Standard Deviation 10.38
Combined Placebo	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP : Day 1, 4 h	64.6 Millimeter of Mercury (mmHg)	Standard Deviation 11.57
Combined Placebo	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP : Follow up (Day 7)	66.0 Millimeter of Mercury (mmHg)	Standard Deviation 12.42
Combined Placebo	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP : Day 3, Pre-dose	130.5 Millimeter of Mercury (mmHg)	Standard Deviation 22.65
Combined Placebo	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP : Day 1, 4 h	127.9 Millimeter of Mercury (mmHg)	Standard Deviation 20.93
Combined Placebo	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP : Day 3, Pre-dose 24 H	69.2 Millimeter of Mercury (mmHg)	Standard Deviation 11.1
Combined Placebo	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP : Day 3, Pre-dose 24 H	138.7 Millimeter of Mercury (mmHg)	Standard Deviation 22.18
Combined Placebo	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP : Day 3, Pre-dose	65.4 Millimeter of Mercury (mmHg)	Standard Deviation 12.04
Combined Placebo	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP : Follow up (Day 7)	132.4 Millimeter of Mercury (mmHg)	Standard Deviation 19.5
Cohort 1-SB-681323, 3 mg, 4 h	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP : Follow up (Day 7)	67.9 Millimeter of Mercury (mmHg)	Standard Deviation 12.23
Cohort 1-SB-681323, 3 mg, 4 h	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP : Follow up (Day 7)	125.5 Millimeter of Mercury (mmHg)	Standard Deviation 14.06
Cohort 1-SB-681323, 3 mg, 4 h	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP : Day 1, 4 h	61.8 Millimeter of Mercury (mmHg)	Standard Deviation 19.44
Cohort 1-SB-681323, 3 mg, 4 h	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP : Day 3, Pre-dose	63.4 Millimeter of Mercury (mmHg)	Standard Deviation 11.26
Cohort 1-SB-681323, 3 mg, 4 h	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP : Day 2, Pre-dose	114.8 Millimeter of Mercury (mmHg)	Standard Deviation 13.72
Cohort 1-SB-681323, 3 mg, 4 h	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP : Day 1, 4 h	116.6 Millimeter of Mercury (mmHg)	Standard Deviation 17.33
Cohort 1-SB-681323, 3 mg, 4 h	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP : Day 2, Pre-dose	63.8 Millimeter of Mercury (mmHg)	Standard Deviation 11.57
Cohort 1-SB-681323, 3 mg, 4 h	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP : Day 3, Pre-dose 24 H	68.9 Millimeter of Mercury (mmHg)	Standard Deviation 10.99
Cohort 1-SB-681323, 3 mg, 4 h	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP : Day 3, Pre-dose 24 H	136.0 Millimeter of Mercury (mmHg)	Standard Deviation 23.66
Cohort 1-SB-681323, 3 mg, 4 h	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP : Day 3, Pre-dose	119.8 Millimeter of Mercury (mmHg)	Standard Deviation 16.65
Cohort 2-SB-681323, 7.5 mg, 24 h	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP : Day 3, Pre-dose	140.4 Millimeter of Mercury (mmHg)	Standard Deviation 35.28
Cohort 2-SB-681323, 7.5 mg, 24 h	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP : Day 2, Pre-dose	130.3 Millimeter of Mercury (mmHg)	Standard Deviation 23.72
Cohort 2-SB-681323, 7.5 mg, 24 h	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP : Day 3, Pre-dose 24 H	130.3 Millimeter of Mercury (mmHg)	Standard Deviation 22.8
Cohort 2-SB-681323, 7.5 mg, 24 h	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP : Follow up (Day 7)	134.3 Millimeter of Mercury (mmHg)	Standard Deviation 14.1
Cohort 2-SB-681323, 7.5 mg, 24 h	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP : Day 2, Pre-dose	58.9 Millimeter of Mercury (mmHg)	Standard Deviation 8.68
Cohort 2-SB-681323, 7.5 mg, 24 h	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP : Day 3, Pre-dose	65.3 Millimeter of Mercury (mmHg)	Standard Deviation 13.45
Cohort 2-SB-681323, 7.5 mg, 24 h	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP : Day 3, Pre-dose 24 H	68.9 Millimeter of Mercury (mmHg)	Standard Deviation 12.48
Cohort 2-SB-681323, 7.5 mg, 24 h	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP : Follow up (Day 7)	71.0 Millimeter of Mercury (mmHg)	Standard Deviation 9.82
Cohort 3-SB-681323, 7.5 mg, 4 h	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP : Follow up (Day 7)	69.3 Millimeter of Mercury (mmHg)	Standard Deviation 13.31
Cohort 3-SB-681323, 7.5 mg, 4 h	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP : Day 3, Pre-dose 24 H	66.2 Millimeter of Mercury (mmHg)	Standard Deviation 11.09
Cohort 3-SB-681323, 7.5 mg, 4 h	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP : Day 3, Pre-dose	64.6 Millimeter of Mercury (mmHg)	Standard Deviation 13.7
Cohort 3-SB-681323, 7.5 mg, 4 h	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP : Day 2, Pre-dose	130.9 Millimeter of Mercury (mmHg)	Standard Deviation 24.15
Cohort 3-SB-681323, 7.5 mg, 4 h	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP : Day 2, Pre-dose	65.0 Millimeter of Mercury (mmHg)	Standard Deviation 12.28
Cohort 3-SB-681323, 7.5 mg, 4 h	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP : Day 1, 4 h	67.6 Millimeter of Mercury (mmHg)	Standard Deviation 11.01
Cohort 3-SB-681323, 7.5 mg, 4 h	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP : Follow up (Day 7)	132.6 Millimeter of Mercury (mmHg)	Standard Deviation 27.34
Cohort 3-SB-681323, 7.5 mg, 4 h	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP : Day 1, 4 h	130.4 Millimeter of Mercury (mmHg)	Standard Deviation 16.25
Cohort 3-SB-681323, 7.5 mg, 4 h	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP : Day 3, Pre-dose	127.9 Millimeter of Mercury (mmHg)	Standard Deviation 21.43
Cohort 3-SB-681323, 7.5 mg, 4 h	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP : Day 3, Pre-dose 24 H	129.5 Millimeter of Mercury (mmHg)	Standard Deviation 20.23
Cohort 4-SB-681323, 10 mg, 24 h	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP : Day 3, Pre-dose 24 H	128.6 Millimeter of Mercury (mmHg)	Standard Deviation 15.29
Cohort 4-SB-681323, 10 mg, 24 h	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP : Day 2, Pre-dose	61.7 Millimeter of Mercury (mmHg)	Standard Deviation 14.59
Cohort 4-SB-681323, 10 mg, 24 h	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP : Day 3, Pre-dose	136.0 Millimeter of Mercury (mmHg)	Standard Deviation 23.57
Cohort 4-SB-681323, 10 mg, 24 h	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP : Follow up (Day 7)	74.0 Millimeter of Mercury (mmHg)	Standard Deviation 12.69
Cohort 4-SB-681323, 10 mg, 24 h	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP : Day 3, Pre-dose	71.2 Millimeter of Mercury (mmHg)	Standard Deviation 15.42
Cohort 4-SB-681323, 10 mg, 24 h	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP : Day 2, Pre-dose	127.1 Millimeter of Mercury (mmHg)	Standard Deviation 21.47
Cohort 4-SB-681323, 10 mg, 24 h	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP : Day 3, Pre-dose 24 H	74.5 Millimeter of Mercury (mmHg)	Standard Deviation 10.92
Cohort 4-SB-681323, 10 mg, 24 h	Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP : Follow up (Day 7)	137.9 Millimeter of Mercury (mmHg)	Standard Deviation 18.57

Primary

Vital Sign: Mean Percent Oxygen (O2) in Blood

Absolute values of mean percent O2 in blood were reported.

Time frame: For Cohort 1 and 3: Day 1, 4 h, Day 2, pre-dose, Day 3, pre-dose and 24 h and Follow up (Day 7); for Cohort 2 and 4: Day 2, pre-dose, Day 3, pre-dose and 24 h, and Follow up (Day 7)

Population: All subject population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Combined Placebo	Vital Sign: Mean Percent Oxygen (O2) in Blood	Percent O2 in blood: Day 2, pre-dose	97.5 Percent O2	Standard Deviation 2.44
Combined Placebo	Vital Sign: Mean Percent Oxygen (O2) in Blood	Percent O2 in blood: Day 1, 4 h	98.6 Percent O2	Standard Deviation 2.3
Combined Placebo	Vital Sign: Mean Percent Oxygen (O2) in Blood	Percent O2 in blood: Follow up (Day 7)	96.5 Percent O2	Standard Deviation 2.06
Combined Placebo	Vital Sign: Mean Percent Oxygen (O2) in Blood	Percent O2 in blood: Day 3, 24 h	97.3 Percent O2	Standard Deviation 2.27
Combined Placebo	Vital Sign: Mean Percent Oxygen (O2) in Blood	Percent O2 in blood: Day 3, pre-dose	97.1 Percent O2	Standard Deviation 2.4
Cohort 1-SB-681323, 3 mg, 4 h	Vital Sign: Mean Percent Oxygen (O2) in Blood	Percent O2 in blood: Day 2, pre-dose	97.3 Percent O2	Standard Deviation 2.05
Cohort 1-SB-681323, 3 mg, 4 h	Vital Sign: Mean Percent Oxygen (O2) in Blood	Percent O2 in blood: Day 3, 24 h	97.9 Percent O2	Standard Deviation 2.03
Cohort 1-SB-681323, 3 mg, 4 h	Vital Sign: Mean Percent Oxygen (O2) in Blood	Percent O2 in blood: Day 1, 4 h	97.1 Percent O2	Standard Deviation 2.98
Cohort 1-SB-681323, 3 mg, 4 h	Vital Sign: Mean Percent Oxygen (O2) in Blood	Percent O2 in blood: Follow up (Day 7)	97.3 Percent O2	Standard Deviation 2.12
Cohort 1-SB-681323, 3 mg, 4 h	Vital Sign: Mean Percent Oxygen (O2) in Blood	Percent O2 in blood: Day 3, pre-dose	96.0 Percent O2	Standard Deviation 4
Cohort 2-SB-681323, 7.5 mg, 24 h	Vital Sign: Mean Percent Oxygen (O2) in Blood	Percent O2 in blood: Day 3, pre-dose	96.9 Percent O2	Standard Deviation 2.88
Cohort 2-SB-681323, 7.5 mg, 24 h	Vital Sign: Mean Percent Oxygen (O2) in Blood	Percent O2 in blood: Day 2, pre-dose	97.3 Percent O2	Standard Deviation 2.87
Cohort 2-SB-681323, 7.5 mg, 24 h	Vital Sign: Mean Percent Oxygen (O2) in Blood	Percent O2 in blood: Day 3, 24 h	96.7 Percent O2	Standard Deviation 2.41
Cohort 2-SB-681323, 7.5 mg, 24 h	Vital Sign: Mean Percent Oxygen (O2) in Blood	Percent O2 in blood: Follow up (Day 7)	96.3 Percent O2	Standard Deviation 3.11
Cohort 3-SB-681323, 7.5 mg, 4 h	Vital Sign: Mean Percent Oxygen (O2) in Blood	Percent O2 in blood: Day 1, 4 h	97.6 Percent O2	Standard Deviation 1.65
Cohort 3-SB-681323, 7.5 mg, 4 h	Vital Sign: Mean Percent Oxygen (O2) in Blood	Percent O2 in blood: Day 3, 24 h	97.5 Percent O2	Standard Deviation 2.6
Cohort 3-SB-681323, 7.5 mg, 4 h	Vital Sign: Mean Percent Oxygen (O2) in Blood	Percent O2 in blood: Day 3, pre-dose	97.7 Percent O2	Standard Deviation 2.49
Cohort 3-SB-681323, 7.5 mg, 4 h	Vital Sign: Mean Percent Oxygen (O2) in Blood	Percent O2 in blood: Follow up (Day 7)	97.2 Percent O2	Standard Deviation 1.99
Cohort 3-SB-681323, 7.5 mg, 4 h	Vital Sign: Mean Percent Oxygen (O2) in Blood	Percent O2 in blood: Day 2, pre-dose	96.8 Percent O2	Standard Deviation 3.32
Cohort 4-SB-681323, 10 mg, 24 h	Vital Sign: Mean Percent Oxygen (O2) in Blood	Percent O2 in blood: Day 3, pre-dose	96.5 Percent O2	Standard Deviation 2.9
Cohort 4-SB-681323, 10 mg, 24 h	Vital Sign: Mean Percent Oxygen (O2) in Blood	Percent O2 in blood: Day 3, 24 h	97.3 Percent O2	Standard Deviation 2.47
Cohort 4-SB-681323, 10 mg, 24 h	Vital Sign: Mean Percent Oxygen (O2) in Blood	Percent O2 in blood: Follow up (Day 7)	97.1 Percent O2	Standard Deviation 1.81
Cohort 4-SB-681323, 10 mg, 24 h	Vital Sign: Mean Percent Oxygen (O2) in Blood	Percent O2 in blood: Day 2, pre-dose	97.1 Percent O2	Standard Deviation 3.08

Primary

Vital Signs: Mean Level of Peak and Plateau Ventilator Pressures

Assessment of mean level of peak and plateau ventilator pressures was planned for cohort 1 and 3 at Day 1 (4 h), Day 2 (pre-dose) and Day 3 (pre-dose and 24 h) and for cohort 2 and 4: Day 2 (pre-dose) and Day 3 (pre-dose and 24 h). However, the analyzable data was not collected for this parameter.

Time frame: For Cohort 1 and 3: Day 1, 4 h, Day 2, pre-dose, Day 3, pre-dose and 24 h; for Cohort 2 and 4: Day 2, pre-dose, and Day 3, pre-dose and 24 h

Population: All subject population. Data was not collected for this parameter.

Primary

Vital Signs: Mean Level of Positive End Expiratory Pressure

Assessment of level of positive end expiratory pressure was planned for cohort 1 and 3 at Day 1 (4 h), Day 2 (pre-dose) and Day 3 (pre-dose and 24 h) and for cohort 2 and 4: Day 2 (pre-dose) and Day 3 (pre-dose and 24 h). However, the analyzable data was not collected for this parameter.

Time frame: For Cohort 1 and 3: Day 1, 4 h, Day 2, pre-dose, Day 3, pre-dose and 24 h; for Cohort 2 and 4: Day 2, pre-dose, and Day 3, pre-dose and 24 h

Population: All subject population. Data was not collected for this parameter.

Primary

Vital Signs: Mean Oxygen Requirement (FiO2) Via Pulse Oximetry

Assessment of mean FiO2 via pulse oximetry was planned for cohort 1 and 3 at Day 1 (4 h), Day 2 (pre-dose) and Day 3 (pre-dose and 24 h) and for cohort 2 and 4: Day 2 (pre-dose) and Day 3 (pre-dose and 24 h). However, the analyzable data was not collected for this parameter.

Time frame: For Cohort 1 and 3: Day 1, 4 h, Day 2, pre-dose, Day 3, pre-dose and 24 h; for Cohort 2 and 4: Day 2, pre-dose, and Day 3, pre-dose and 24 h

Population: All subject population. Data was not collected for this parameter.

Primary

Vital Signs: Mean Oxygen Saturation (SaO2) Via Pulse Oximetry

Assessment of SaO2 via pulse oximetry was planned for cohort 1 and 3 at Day 1 (4 h), Day 2 (pre-dose) and Day 3 (pre-dose and 24 h) and for cohort 2 and 4: Day 2 (pre-dose) and Day 3 (pre-dose and 24 h). However, the analyzable data was not collected for this parameter.

Time frame: For Cohort 1 and 3: Day 1, 4 h, Day 2, pre-dose, Day 3, pre-dose and 24 h; for Cohort 2 and 4: Day 2, pre-dose, and Day 3, pre-dose and 24 h

Population: All subject population. Data was not collected for this parameter.

Secondary

Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I

Samples were collected at 6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1. Mean absolute values of soluble tumor necrosis factor receptors-I levels at these specified time points were reported.

Time frame: 6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1

Population: PD Population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Combined Placebo	Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I	Time Since 1st Dose, 6 h	2457.23 pg/mL
Combined Placebo	Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I	Time Since 1st Dose, 96 h	2436.04 pg/mL
Combined Placebo	Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I	Time Since 1st Dose, 72 h	2578.17 pg/mL
Combined Placebo	Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I	Time Since 1st Dose, 18 h	2371.29 pg/mL
Combined Placebo	Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I	Time Since 1st Dose, 12 h	2448.86 pg/mL
Combined Placebo	Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I	Time Since 1st Dose, 24 h	2548.08 pg/mL
Combined Placebo	Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I	Time Since 1st Dose, 48 h	2466.18 pg/mL
Cohort 1-SB-681323, 3 mg, 4 h	Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I	Time Since 1st Dose, 48 h	2263.01 pg/mL
Cohort 1-SB-681323, 3 mg, 4 h	Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I	Time Since 1st Dose, 24 h	2423.76 pg/mL
Cohort 1-SB-681323, 3 mg, 4 h	Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I	Time Since 1st Dose, 12 h	2624.12 pg/mL
Cohort 1-SB-681323, 3 mg, 4 h	Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I	Time Since 1st Dose, 6 h	2089.11 pg/mL
Cohort 1-SB-681323, 3 mg, 4 h	Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I	Time Since 1st Dose, 72 h	2609.42 pg/mL
Cohort 1-SB-681323, 3 mg, 4 h	Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I	Time Since 1st Dose, 18 h	2561.58 pg/mL
Cohort 1-SB-681323, 3 mg, 4 h	Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I	Time Since 1st Dose, 96 h	2844.48 pg/mL
Cohort 2-SB-681323, 7.5 mg, 24 h	Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I	Time Since 1st Dose, 24 h	2215.77 pg/mL
Cohort 2-SB-681323, 7.5 mg, 24 h	Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I	Time Since 1st Dose, 6 h	2240.84 pg/mL
Cohort 2-SB-681323, 7.5 mg, 24 h	Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I	Time Since 1st Dose, 12 h	2358.84 pg/mL
Cohort 2-SB-681323, 7.5 mg, 24 h	Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I	Time Since 1st Dose, 18 h	2175.30 pg/mL
Cohort 2-SB-681323, 7.5 mg, 24 h	Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I	Time Since 1st Dose, 48 h	2814.63 pg/mL
Cohort 2-SB-681323, 7.5 mg, 24 h	Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I	Time Since 1st Dose, 72 h	2893.81 pg/mL
Cohort 2-SB-681323, 7.5 mg, 24 h	Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I	Time Since 1st Dose, 96 h	3591.89 pg/mL
Cohort 3-SB-681323, 7.5 mg, 4 h	Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I	Time Since 1st Dose, 18 h	2424.70 pg/mL
Cohort 3-SB-681323, 7.5 mg, 4 h	Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I	Time Since 1st Dose, 48 h	2388.33 pg/mL
Cohort 3-SB-681323, 7.5 mg, 4 h	Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I	Time Since 1st Dose, 12 h	2151.51 pg/mL
Cohort 3-SB-681323, 7.5 mg, 4 h	Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I	Time Since 1st Dose, 96 h	2992.91 pg/mL
Cohort 3-SB-681323, 7.5 mg, 4 h	Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I	Time Since 1st Dose, 72 h	2386.32 pg/mL
Cohort 3-SB-681323, 7.5 mg, 4 h	Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I	Time Since 1st Dose, 6 h	2046.04 pg/mL
Cohort 3-SB-681323, 7.5 mg, 4 h	Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I	Time Since 1st Dose, 24 h	2420.75 pg/mL
Cohort 4-SB-681323, 10 mg, 24 h	Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I	Time Since 1st Dose, 18 h	1958.95 pg/mL
Cohort 4-SB-681323, 10 mg, 24 h	Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I	Time Since 1st Dose, 96 h	2094.76 pg/mL
Cohort 4-SB-681323, 10 mg, 24 h	Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I	Time Since 1st Dose, 72 h	1721.54 pg/mL
Cohort 4-SB-681323, 10 mg, 24 h	Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I	Time Since 1st Dose, 48 h	1925.54 pg/mL
Cohort 4-SB-681323, 10 mg, 24 h	Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I	Time Since 1st Dose, 12 h	1880.20 pg/mL
Cohort 4-SB-681323, 10 mg, 24 h	Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I	Time Since 1st Dose, 6 h	2267.35 pg/mL
Cohort 4-SB-681323, 10 mg, 24 h	Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I	Time Since 1st Dose, 24 h	1939.82 pg/mL

Comparison: Comparison at 6 h post first dose95% CI: [0.646, 1.119]

Comparison: Comparison at 12 h post first dose95% CI: [0.814, 1.411]

Comparison: Comparison at 18 h post first dose95% CI: [0.79, 1.478]

Comparison: Comparison at 24 h post first dose95% CI: [0.715, 1.266]

Comparison: Comparison at 48 h post first dose95% CI: [0.655, 1.285]

Comparison: Comparison at 72 h post first dose95% CI: [0.735, 1.395]

Comparison: Comparison at 96 h post first dose95% CI: [0.831, 1.64]

Comparison: Comparison at 6 h post first dose95% CI: [0.713, 1.167]

Comparison: Comparison at 12 h post first dose95% CI: [0.753, 1.233]

Comparison: Comparison at 18 h post first dose95% CI: [0.693, 1.214]

Comparison: Comparison at 24 h post first dose95% CI: [0.673, 1.123]

Comparison: Comparison at 48 h post first dose95% CI: [0.84, 1.55]

Comparison: Comparison at 72 h post first dose95% CI: [0.837, 1.505]

Comparison: Comparison at 96 h post first dose95% CI: [1.063, 2.045]

Comparison: Comparison at 6 h post first dose95% CI: [0.672, 1.031]

Comparison: Comparison at 12 h post first dose95% CI: [0.707, 1.092]

Comparison: Comparison at 18 h post first dose95% CI: [0.8, 1.307]

Comparison: Comparison at 24 h post first dose95% CI: [0.761, 1.187]

Comparison: Comparison at 48 h post first dose95% CI: [0.743, 1.262]

Comparison: Comparison at 72 h post first dose95% CI: [0.718, 1.193]

Comparison: Comparison at 96 h post first dose95% CI: [0.936, 1.613]

Comparison: Comparison at 6 h post first dose95% CI: [0.753, 1.131]

Comparison: Comparison at 12 h post first dose95% CI: [0.625, 0.943]

Comparison: Comparison at 18 h post first dose95% CI: [0.655, 1.042]

Comparison: Comparison at 24 h post first dose95% CI: [0.615, 0.942]

Comparison: Comparison at 48 h post first dose95% CI: [0.608, 1.003]

Comparison: Comparison at 72 h post first dose95% CI: [0.524, 0.851]

Comparison: Comparison at 96 h post first dose95% CI: [0.659, 1.122]

Secondary

Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels

Serum samples were collected at 6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1. Mean absolute values of MPO levels at these specified time points were reported.

Time frame: 6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1

Population: PD Population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Combined Placebo	Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels	Time Since 1st Dose, 6 h	66792.4 pg/mL
Combined Placebo	Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels	Time Since 1st Dose, 96 h	70263.5 pg/mL
Combined Placebo	Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels	Time Since 1st Dose, 72 h	79821.0 pg/mL
Combined Placebo	Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels	Time Since 1st Dose, 18 h	84143.5 pg/mL
Combined Placebo	Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels	Time Since 1st Dose, 12 h	94963.6 pg/mL
Combined Placebo	Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels	Time Since 1st Dose, 24 h	104225.0 pg/mL
Combined Placebo	Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels	Time Since 1st Dose, 48 h	89181.9 pg/mL
Cohort 1-SB-681323, 3 mg, 4 h	Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels	Time Since 1st Dose, 48 h	47338.7 pg/mL
Cohort 1-SB-681323, 3 mg, 4 h	Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels	Time Since 1st Dose, 24 h	70943.1 pg/mL
Cohort 1-SB-681323, 3 mg, 4 h	Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels	Time Since 1st Dose, 12 h	49535.7 pg/mL
Cohort 1-SB-681323, 3 mg, 4 h	Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels	Time Since 1st Dose, 6 h	56739.7 pg/mL
Cohort 1-SB-681323, 3 mg, 4 h	Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels	Time Since 1st Dose, 72 h	88493.3 pg/mL
Cohort 1-SB-681323, 3 mg, 4 h	Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels	Time Since 1st Dose, 18 h	70714.1 pg/mL
Cohort 1-SB-681323, 3 mg, 4 h	Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels	Time Since 1st Dose, 96 h	108777.0 pg/mL
Cohort 2-SB-681323, 7.5 mg, 24 h	Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels	Time Since 1st Dose, 24 h	112745.0 pg/mL
Cohort 2-SB-681323, 7.5 mg, 24 h	Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels	Time Since 1st Dose, 6 h	63552.3 pg/mL
Cohort 2-SB-681323, 7.5 mg, 24 h	Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels	Time Since 1st Dose, 12 h	85693.0 pg/mL
Cohort 2-SB-681323, 7.5 mg, 24 h	Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels	Time Since 1st Dose, 18 h	84578.5 pg/mL
Cohort 2-SB-681323, 7.5 mg, 24 h	Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels	Time Since 1st Dose, 48 h	92324.6 pg/mL
Cohort 2-SB-681323, 7.5 mg, 24 h	Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels	Time Since 1st Dose, 72 h	148310.0 pg/mL
Cohort 2-SB-681323, 7.5 mg, 24 h	Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels	Time Since 1st Dose, 96 h	78570.3 pg/mL
Cohort 3-SB-681323, 7.5 mg, 4 h	Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels	Time Since 1st Dose, 18 h	64655.1 pg/mL
Cohort 3-SB-681323, 7.5 mg, 4 h	Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels	Time Since 1st Dose, 48 h	53458.3 pg/mL
Cohort 3-SB-681323, 7.5 mg, 4 h	Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels	Time Since 1st Dose, 12 h	39467.3 pg/mL
Cohort 3-SB-681323, 7.5 mg, 4 h	Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels	Time Since 1st Dose, 96 h	84008.1 pg/mL
Cohort 3-SB-681323, 7.5 mg, 4 h	Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels	Time Since 1st Dose, 72 h	61893.0 pg/mL
Cohort 3-SB-681323, 7.5 mg, 4 h	Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels	Time Since 1st Dose, 6 h	44668.1 pg/mL
Cohort 3-SB-681323, 7.5 mg, 4 h	Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels	Time Since 1st Dose, 24 h	59336.2 pg/mL
Cohort 4-SB-681323, 10 mg, 24 h	Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels	Time Since 1st Dose, 18 h	67290.8 pg/mL
Cohort 4-SB-681323, 10 mg, 24 h	Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels	Time Since 1st Dose, 96 h	69268.3 pg/mL
Cohort 4-SB-681323, 10 mg, 24 h	Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels	Time Since 1st Dose, 72 h	73578.6 pg/mL
Cohort 4-SB-681323, 10 mg, 24 h	Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels	Time Since 1st Dose, 48 h	78699.2 pg/mL
Cohort 4-SB-681323, 10 mg, 24 h	Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels	Time Since 1st Dose, 12 h	61020.7 pg/mL
Cohort 4-SB-681323, 10 mg, 24 h	Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels	Time Since 1st Dose, 6 h	62108.1 pg/mL
Cohort 4-SB-681323, 10 mg, 24 h	Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels	Time Since 1st Dose, 24 h	71506.9 pg/mL

Secondary

Maximum Observed Concentration (Cmax) of SB-681323

Absolute values of the Cmax of SB-681323 were reported. PK samples were collected for cohort 1 and 3 at Day 1 (pre-dose, 4, 4.25, 5, 6, 8, 12, 18h), Day 2 (pre-dose and 4h), Day 3 (0, 4, 24, 48h) and for cohort 2 and 4 at Day 1 (pre-dose), Day (pre-dose), Day 3 (pre-dose, 24h 10 min, 24h 45min, 27, 34, 40, 80 h since doing on Day 3).

Time frame: For cohort 1 and 3: Day 1 (pre-dose, 4, 4.25, 5, 6, 8, 12, 18h), Day 2 (pre-dose and 4h), Day 3 (0, 4, 24, 48h). For cohort 2 and 4: Day 1 (pre-dose), Day (pre-dose), Day 3 (pre-dose, 24h 10 min, 24h 45min, 27, 34, 40, 80 h since doing on Day 3)

Population: PK population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Combined Placebo	Maximum Observed Concentration (Cmax) of SB-681323	Day 3	21.888 ng/mL
Combined Placebo	Maximum Observed Concentration (Cmax) of SB-681323	Day 1	21.238 ng/mL
Combined Placebo	Maximum Observed Concentration (Cmax) of SB-681323	Day 2	22.830 ng/mL
Cohort 1-SB-681323, 3 mg, 4 h	Maximum Observed Concentration (Cmax) of SB-681323	Day 2	8.842 ng/mL
Cohort 1-SB-681323, 3 mg, 4 h	Maximum Observed Concentration (Cmax) of SB-681323	Day 1	8.519 ng/mL
Cohort 1-SB-681323, 3 mg, 4 h	Maximum Observed Concentration (Cmax) of SB-681323	Day 3	8.990 ng/mL
Cohort 2-SB-681323, 7.5 mg, 24 h	Maximum Observed Concentration (Cmax) of SB-681323	Day 3	39.180 ng/mL
Cohort 2-SB-681323, 7.5 mg, 24 h	Maximum Observed Concentration (Cmax) of SB-681323	Day 1	38.032 ng/mL
Cohort 2-SB-681323, 7.5 mg, 24 h	Maximum Observed Concentration (Cmax) of SB-681323	Day 2	38.697 ng/mL
Cohort 3-SB-681323, 7.5 mg, 4 h	Maximum Observed Concentration (Cmax) of SB-681323	Day 2	10.382 ng/mL
Cohort 3-SB-681323, 7.5 mg, 4 h	Maximum Observed Concentration (Cmax) of SB-681323	Day 1	10.044 ng/mL
Cohort 3-SB-681323, 7.5 mg, 4 h	Maximum Observed Concentration (Cmax) of SB-681323	Day 3	10.131 ng/mL

Secondary

Mean Area Under the Concentration-time Curve From Zero (Pre-dose) to 24 Hours (AUC0-24)

Absolute values of the mean AUC 0-24 of SB-681323 were reported. PK samples were collected for cohort 1 and 3 at Day 1 (pre-dose, 4, 4.25, 5, 6, 8, 12, 18h), Day 2 (pre-dose and 4h), Day 3 (0, 4, 24, 48h) and for cohort 2 and 4 at Day 1 (pre-dose), Day (pre-dose), Day 3 (pre-dose, 24h10minutes \[min\], 24h45min, 27, 34, 40, 80 h since doing on Day 3).

Time frame: For cohort 1 and 3: Day 1 (pre-dose, 4, 4.25, 5, 6, 8, 12, 18h), Day 2 (pre-dose and 4h), Day 3 (0, 4, 24, 48h). For cohort 2 and 4: Day 1 (pre-dose), Day (pre-dose), Day 3 (pre-dose)

Population: Pharmacokinetic (PK) population was defined as patients in the 'All Subjects' population for whom a pharmacokinetic sample was obtained and analyzed. Note: Due to some placebo patients PK samples being assayed in error, the above PK population definition was adjusted to also exclude any patient receiving Placebo.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Combined Placebo	Mean Area Under the Concentration-time Curve From Zero (Pre-dose) to 24 Hours (AUC0-24)	Day 1	103.222 h*ng/mL
Combined Placebo	Mean Area Under the Concentration-time Curve From Zero (Pre-dose) to 24 Hours (AUC0-24)	Day 3	106.037 h*ng/mL
Combined Placebo	Mean Area Under the Concentration-time Curve From Zero (Pre-dose) to 24 Hours (AUC0-24)	Day 2	112.199 h*ng/mL
Cohort 1-SB-681323, 3 mg, 4 h	Mean Area Under the Concentration-time Curve From Zero (Pre-dose) to 24 Hours (AUC0-24)	Day 1	186.326 h*ng/mL
Cohort 1-SB-681323, 3 mg, 4 h	Mean Area Under the Concentration-time Curve From Zero (Pre-dose) to 24 Hours (AUC0-24)	Day 3	211.282 h*ng/mL
Cohort 1-SB-681323, 3 mg, 4 h	Mean Area Under the Concentration-time Curve From Zero (Pre-dose) to 24 Hours (AUC0-24)	Day 2	207.050 h*ng/mL
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Area Under the Concentration-time Curve From Zero (Pre-dose) to 24 Hours (AUC0-24)	Day 2	182.590 h*ng/mL
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Area Under the Concentration-time Curve From Zero (Pre-dose) to 24 Hours (AUC0-24)	Day 1	178.807 h*ng/mL
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Area Under the Concentration-time Curve From Zero (Pre-dose) to 24 Hours (AUC0-24)	Day 3	188.895 h*ng/mL
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Area Under the Concentration-time Curve From Zero (Pre-dose) to 24 Hours (AUC0-24)	Day 1	217.862 h*ng/mL
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Area Under the Concentration-time Curve From Zero (Pre-dose) to 24 Hours (AUC0-24)	Day 3	230.891 h*ng/mL
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Area Under the Concentration-time Curve From Zero (Pre-dose) to 24 Hours (AUC0-24)	Day 2	237.549 h*ng/mL

Secondary

Mean Average Concentration (Cavg) of SB-681323

Absolute values of mean Cavg of SB-681323 were reported. PK samples were collected for cohort 1 and 3 at Day 1 (pre-dose, 4, 4.25, 5, 6, 8, 12, 18h), Day 2 (pre-dose and 4h), Day 3 (0, 4, 24, 48h) and for cohort 2 and 4 at Day 1 (pre-dose), Day (pre-dose), Day 3 (pre-dose, 24h 10 min, 24h 45min, 27, 34, 40, 80 h since doing on Day 3).

Time frame: For cohort 1 and 3: Day 1 (pre-dose, 4, 4.25, 5, 6, 8, 12, 18h), Day 2 (pre-dose and 4h), Day 3 (0, 4, 24, 48h). For cohort 2 and 4: Day 1 (pre-dose), Day (pre-dose), Day 3 (pre-dose, 24h 10minutes [min], 24h 45min, 27, 34, 40, 80 h since doing on Day 3)

Population: PK Population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Combined Placebo	Mean Average Concentration (Cavg) of SB-681323	Day 1	4.301 ng/mL
Combined Placebo	Mean Average Concentration (Cavg) of SB-681323	Day 3	4.418 ng/mL
Combined Placebo	Mean Average Concentration (Cavg) of SB-681323	Day 2	4.675 ng/mL
Cohort 1-SB-681323, 3 mg, 4 h	Mean Average Concentration (Cavg) of SB-681323	Day 1	7.764 ng/mL
Cohort 1-SB-681323, 3 mg, 4 h	Mean Average Concentration (Cavg) of SB-681323	Day 3	8.803 ng/mL
Cohort 1-SB-681323, 3 mg, 4 h	Mean Average Concentration (Cavg) of SB-681323	Day 2	8.627 ng/mL
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Average Concentration (Cavg) of SB-681323	Day 2	7.608 ng/mL
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Average Concentration (Cavg) of SB-681323	Day 1	7.450 ng/mL
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Average Concentration (Cavg) of SB-681323	Day 3	7.871 ng/mL
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Average Concentration (Cavg) of SB-681323	Day 1	9.078 ng/mL
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Average Concentration (Cavg) of SB-681323	Day 3	9.620 ng/mL
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Average Concentration (Cavg) of SB-681323	Day 2	9.898 ng/mL

Secondary

Mean Serum C-Reactive Protein (CRP) Levels

Serum samples were collected at 6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1. Mean absolute values of serum CRP levels at these specified time points were reported.

Time frame: 6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1

Population: PD Population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Combined Placebo	Mean Serum C-Reactive Protein (CRP) Levels	Time Since 1st Dose, 6 h	123.62 mg/L
Combined Placebo	Mean Serum C-Reactive Protein (CRP) Levels	Time Since 1st Dose, 96 h	171.67 mg/L
Combined Placebo	Mean Serum C-Reactive Protein (CRP) Levels	Time Since 1st Dose, 72 h	179.03 mg/L
Combined Placebo	Mean Serum C-Reactive Protein (CRP) Levels	Time Since 1st Dose, 18 h	144.10 mg/L
Combined Placebo	Mean Serum C-Reactive Protein (CRP) Levels	Time Since 1st Dose, 12 h	138.02 mg/L
Combined Placebo	Mean Serum C-Reactive Protein (CRP) Levels	Time Since 1st Dose, 24 h	153.88 mg/L
Combined Placebo	Mean Serum C-Reactive Protein (CRP) Levels	Time Since 1st Dose, 48 h	159.36 mg/L
Cohort 1-SB-681323, 3 mg, 4 h	Mean Serum C-Reactive Protein (CRP) Levels	Time Since 1st Dose, 48 h	105.45 mg/L
Cohort 1-SB-681323, 3 mg, 4 h	Mean Serum C-Reactive Protein (CRP) Levels	Time Since 1st Dose, 24 h	97.42 mg/L
Cohort 1-SB-681323, 3 mg, 4 h	Mean Serum C-Reactive Protein (CRP) Levels	Time Since 1st Dose, 12 h	109.74 mg/L
Cohort 1-SB-681323, 3 mg, 4 h	Mean Serum C-Reactive Protein (CRP) Levels	Time Since 1st Dose, 6 h	95.60 mg/L
Cohort 1-SB-681323, 3 mg, 4 h	Mean Serum C-Reactive Protein (CRP) Levels	Time Since 1st Dose, 72 h	83.21 mg/L
Cohort 1-SB-681323, 3 mg, 4 h	Mean Serum C-Reactive Protein (CRP) Levels	Time Since 1st Dose, 18 h	112.06 mg/L
Cohort 1-SB-681323, 3 mg, 4 h	Mean Serum C-Reactive Protein (CRP) Levels	Time Since 1st Dose, 96 h	90.20 mg/L
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Serum C-Reactive Protein (CRP) Levels	Time Since 1st Dose, 24 h	140.47 mg/L
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Serum C-Reactive Protein (CRP) Levels	Time Since 1st Dose, 6 h	117.68 mg/L
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Serum C-Reactive Protein (CRP) Levels	Time Since 1st Dose, 12 h	133.17 mg/L
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Serum C-Reactive Protein (CRP) Levels	Time Since 1st Dose, 18 h	142.96 mg/L
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Serum C-Reactive Protein (CRP) Levels	Time Since 1st Dose, 48 h	105.17 mg/L
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Serum C-Reactive Protein (CRP) Levels	Time Since 1st Dose, 72 h	123.58 mg/L
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Serum C-Reactive Protein (CRP) Levels	Time Since 1st Dose, 96 h	124.33 mg/L
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Serum C-Reactive Protein (CRP) Levels	Time Since 1st Dose, 18 h	153.76 mg/L
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Serum C-Reactive Protein (CRP) Levels	Time Since 1st Dose, 48 h	138.05 mg/L
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Serum C-Reactive Protein (CRP) Levels	Time Since 1st Dose, 12 h	136.01 mg/L
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Serum C-Reactive Protein (CRP) Levels	Time Since 1st Dose, 96 h	123.97 mg/L
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Serum C-Reactive Protein (CRP) Levels	Time Since 1st Dose, 72 h	116.27 mg/L
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Serum C-Reactive Protein (CRP) Levels	Time Since 1st Dose, 6 h	117.42 mg/L
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Serum C-Reactive Protein (CRP) Levels	Time Since 1st Dose, 24 h	141.84 mg/L
Cohort 4-SB-681323, 10 mg, 24 h	Mean Serum C-Reactive Protein (CRP) Levels	Time Since 1st Dose, 18 h	121.97 mg/L
Cohort 4-SB-681323, 10 mg, 24 h	Mean Serum C-Reactive Protein (CRP) Levels	Time Since 1st Dose, 96 h	77.40 mg/L
Cohort 4-SB-681323, 10 mg, 24 h	Mean Serum C-Reactive Protein (CRP) Levels	Time Since 1st Dose, 72 h	78.55 mg/L
Cohort 4-SB-681323, 10 mg, 24 h	Mean Serum C-Reactive Protein (CRP) Levels	Time Since 1st Dose, 48 h	92.50 mg/L
Cohort 4-SB-681323, 10 mg, 24 h	Mean Serum C-Reactive Protein (CRP) Levels	Time Since 1st Dose, 12 h	122.42 mg/L
Cohort 4-SB-681323, 10 mg, 24 h	Mean Serum C-Reactive Protein (CRP) Levels	Time Since 1st Dose, 6 h	110.88 mg/L
Cohort 4-SB-681323, 10 mg, 24 h	Mean Serum C-Reactive Protein (CRP) Levels	Time Since 1st Dose, 24 h	125.02 mg/L

Comparison: Comparison at 6 h post first dose95% CI: [0.607, 0.985]

Comparison: Comparison at 12 h post first dose95% CI: [0.583, 1.084]

Comparison: Comparison at 18 h post first dose95% CI: [0.533, 1.135]

Comparison: Comparison at 24 h post first dose95% CI: [0.43, 0.931]

Comparison: Comparison at 48 h post first dose95% CI: [0.397, 1.103]

Comparison: Comparison at 72 h post first dose95% CI: [0.286, 0.756]

Comparison: Comparison at 96 h post first dose95% CI: [0.295, 0.935]

Comparison: Comparison at 6 h post first dose95% CI: [0.768, 1.18]

Comparison: Comparison at 12 h post first dose95% CI: [0.733, 1.269]

Comparison: Comparison at 18 h post first dose95% CI: [0.71, 1.387]

Comparison: Comparison at 24 h post first dose95% CI: [0.649, 1.285]

Comparison: Comparison at 48 h post first dose95% CI: [0.415, 1.051]

Comparison: Comparison at 72 h post first dose95% CI: [0.445, 1.072]

Comparison: Comparison at 96 h post first dose95% CI: [0.423, 1.239]

Comparison: Comparison at 6 h post first dose95% CI: [0.789, 1.144]

Comparison: Comparison at 12 h post first dose95% CI: [0.777, 1.249]

Comparison: Comparison at 18 h post first dose95% CI: [0.797, 1.428]

Comparison: Comparison at 24 h post first dose95% CI: [0.686, 1.239]

Comparison: Comparison at 48 h post first dose95% CI: [0.583, 1.287]

Comparison: Comparison at 72 h post first dose95% CI: [0.444, 0.95]

Comparison: Comparison at 96 h post first dose95% CI: [0.457, 1.14]

Comparison: Comparison at 6 h post first dose95% CI: [0.748, 1.075]

Comparison: Comparison at 12 h post first dose95% CI: [0.703, 1.119]

Comparison: Comparison at 18 h post first dose95% CI: [0.638, 1.123]

Comparison: Comparison at 24 h post first dose95% CI: [0.609, 1.084]

Comparison: Comparison at 48 h post first dose95% CI: [0.394, 0.855]

Comparison: Comparison at 72 h post first dose95% CI: [0.301, 0.639]

Comparison: Comparison at 96 h post first dose95% CI: [0.285, 0.714]

Secondary

Mean Serum CXCL8 (Interleuin-8) Levels

Serum samples were collected at 6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1. Mean absolute values of Serum CXCL8 (Interleuin-8) levels at these specified time points were reported.

Time frame: 6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1

Population: PD Population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Combined Placebo	Mean Serum CXCL8 (Interleuin-8) Levels	Time Since 1st Dose, 6 h	37.66 pg/ml
Combined Placebo	Mean Serum CXCL8 (Interleuin-8) Levels	Time Since 1st Dose, 96 h	19.14 pg/ml
Combined Placebo	Mean Serum CXCL8 (Interleuin-8) Levels	Time Since 1st Dose, 72 h	15.99 pg/ml
Combined Placebo	Mean Serum CXCL8 (Interleuin-8) Levels	Time Since 1st Dose, 18 h	21.37 pg/ml
Combined Placebo	Mean Serum CXCL8 (Interleuin-8) Levels	Time Since 1st Dose, 12 h	26.53 pg/ml
Combined Placebo	Mean Serum CXCL8 (Interleuin-8) Levels	Time Since 1st Dose, 24 h	24.05 pg/ml
Combined Placebo	Mean Serum CXCL8 (Interleuin-8) Levels	Time Since 1st Dose, 48 h	17.65 pg/ml
Cohort 1-SB-681323, 3 mg, 4 h	Mean Serum CXCL8 (Interleuin-8) Levels	Time Since 1st Dose, 48 h	16.24 pg/ml
Cohort 1-SB-681323, 3 mg, 4 h	Mean Serum CXCL8 (Interleuin-8) Levels	Time Since 1st Dose, 24 h	16.19 pg/ml
Cohort 1-SB-681323, 3 mg, 4 h	Mean Serum CXCL8 (Interleuin-8) Levels	Time Since 1st Dose, 12 h	18.58 pg/ml
Cohort 1-SB-681323, 3 mg, 4 h	Mean Serum CXCL8 (Interleuin-8) Levels	Time Since 1st Dose, 6 h	18.22 pg/ml
Cohort 1-SB-681323, 3 mg, 4 h	Mean Serum CXCL8 (Interleuin-8) Levels	Time Since 1st Dose, 72 h	15.09 pg/ml
Cohort 1-SB-681323, 3 mg, 4 h	Mean Serum CXCL8 (Interleuin-8) Levels	Time Since 1st Dose, 18 h	14.55 pg/ml
Cohort 1-SB-681323, 3 mg, 4 h	Mean Serum CXCL8 (Interleuin-8) Levels	Time Since 1st Dose, 96 h	17.33 pg/ml
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Serum CXCL8 (Interleuin-8) Levels	Time Since 1st Dose, 24 h	15.75 pg/ml
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Serum CXCL8 (Interleuin-8) Levels	Time Since 1st Dose, 6 h	27.34 pg/ml
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Serum CXCL8 (Interleuin-8) Levels	Time Since 1st Dose, 12 h	21.00 pg/ml
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Serum CXCL8 (Interleuin-8) Levels	Time Since 1st Dose, 18 h	15.49 pg/ml
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Serum CXCL8 (Interleuin-8) Levels	Time Since 1st Dose, 48 h	19.62 pg/ml
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Serum CXCL8 (Interleuin-8) Levels	Time Since 1st Dose, 72 h	17.19 pg/ml
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Serum CXCL8 (Interleuin-8) Levels	Time Since 1st Dose, 96 h	26.32 pg/ml
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Serum CXCL8 (Interleuin-8) Levels	Time Since 1st Dose, 18 h	21.10 pg/ml
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Serum CXCL8 (Interleuin-8) Levels	Time Since 1st Dose, 48 h	21.70 pg/ml
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Serum CXCL8 (Interleuin-8) Levels	Time Since 1st Dose, 12 h	22.01 pg/ml
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Serum CXCL8 (Interleuin-8) Levels	Time Since 1st Dose, 96 h	33.54 pg/ml
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Serum CXCL8 (Interleuin-8) Levels	Time Since 1st Dose, 72 h	20.61 pg/ml
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Serum CXCL8 (Interleuin-8) Levels	Time Since 1st Dose, 6 h	21.06 pg/ml
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Serum CXCL8 (Interleuin-8) Levels	Time Since 1st Dose, 24 h	22.23 pg/ml
Cohort 4-SB-681323, 10 mg, 24 h	Mean Serum CXCL8 (Interleuin-8) Levels	Time Since 1st Dose, 18 h	15.96 pg/ml
Cohort 4-SB-681323, 10 mg, 24 h	Mean Serum CXCL8 (Interleuin-8) Levels	Time Since 1st Dose, 96 h	14.24 pg/ml
Cohort 4-SB-681323, 10 mg, 24 h	Mean Serum CXCL8 (Interleuin-8) Levels	Time Since 1st Dose, 72 h	15.47 pg/ml
Cohort 4-SB-681323, 10 mg, 24 h	Mean Serum CXCL8 (Interleuin-8) Levels	Time Since 1st Dose, 48 h	13.40 pg/ml
Cohort 4-SB-681323, 10 mg, 24 h	Mean Serum CXCL8 (Interleuin-8) Levels	Time Since 1st Dose, 12 h	17.42 pg/ml
Cohort 4-SB-681323, 10 mg, 24 h	Mean Serum CXCL8 (Interleuin-8) Levels	Time Since 1st Dose, 6 h	21.85 pg/ml
Cohort 4-SB-681323, 10 mg, 24 h	Mean Serum CXCL8 (Interleuin-8) Levels	Time Since 1st Dose, 24 h	15.79 pg/ml

Comparison: Comparison at 6 h post first dose95% CI: [0.312, 0.75]

Comparison: Comparison at 12 h post first dose95% CI: [0.399, 1.229]

Comparison: Comparison at 18 h post first dose95% CI: [0.37, 1.254]

Comparison: Comparison at 24 h post first dose95% CI: [0.368, 1.231]

Comparison: Comparison at 48 h post first dose95% CI: [0.456, 1.857]

Comparison: Comparison at 72 h post first dose95% CI: [0.445, 2.002]

Comparison: Comparison at 96 h post first dose95% CI: [0.476, 1.723]

Comparison: Comparison at 6 h post first dose95% CI: [0.488, 1.08]

Comparison: Comparison at 12 h post first dose95% CI: [0.476, 1.317]

Comparison: Comparison at 18 h post first dose95% CI: [0.417, 1.26]

Comparison: Comparison at 24 h post first dose95% CI: [0.379, 1.13]

Comparison: Comparison at 48 h post first dose95% CI: [0.583, 2.12]

Comparison: Comparison at 72 h post first dose95% CI: [0.539, 2.146]

Comparison: Comparison at 96 h post first dose95% CI: [0.735, 2.574]

Comparison: Comparison at 6 h post first dose95% CI: [0.4, 0.783]

Comparison: Comparison at 12 h post first dose95% CI: [0.539, 1.277]

Comparison: Comparison at 18 h post first dose95% CI: [0.613, 1.589]

Comparison: Comparison at 24 h post first dose95% CI: [0.582, 1.467]

Comparison: Comparison at 48 h post first dose95% CI: [0.716, 2.11]

Comparison: Comparison at 72 h post first dose95% CI: [0.719, 2.312]

Comparison: Comparison at 96 h post first dose95% CI: [1.053, 2.916]

Comparison: Comparison at 6 h post first dose95% CI: [0.419, 0.803]

Comparison: Comparison at 12 h post first dose95% CI: [0.433, 0.996]

Comparison: Comparison at 18 h post first dose95% CI: [0.477, 1.171]

Comparison: Comparison at 24 h post first dose95% CI: [0.421, 1.024]

Comparison: Comparison at 48 h post first dose95% CI: [0.451, 1.279]

Comparison: Comparison at 72 h post first dose95% CI: [0.55, 1.701]

Comparison: Comparison at 96 h post first dose95% CI: [0.45, 1.229]

Secondary

Mean Serum Interleukin-6 Levels

Serum samples were collected at 6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1. Mean absolute values of Serum interleukin-6 levels at these specified time oints were reported.

Time frame: 6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1

Population: Pharmacodynamic (PD) Population was defined as patients in the 'All Subjects' population for whom a pharmacodynamic sample was obtained and analysed (Flow Cytometry data were excluded from the definition of pharmacodynamic sample). Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Combined Placebo	Mean Serum Interleukin-6 Levels	Time Since 1st Dose, 48 h	324.35 Picogram per milliliter (pg/mL)
Combined Placebo	Mean Serum Interleukin-6 Levels	Time Since 1st Dose, 24 h	556.06 Picogram per milliliter (pg/mL)
Combined Placebo	Mean Serum Interleukin-6 Levels	Time Since 1st Dose, 96 h	183.79 Picogram per milliliter (pg/mL)
Combined Placebo	Mean Serum Interleukin-6 Levels	Time Since 1st Dose, 12 h	516.49 Picogram per milliliter (pg/mL)
Combined Placebo	Mean Serum Interleukin-6 Levels	Time Since 1st Dose, 6 h	509.44 Picogram per milliliter (pg/mL)
Combined Placebo	Mean Serum Interleukin-6 Levels	Time Since 1st Dose, 72 h	250.21 Picogram per milliliter (pg/mL)
Combined Placebo	Mean Serum Interleukin-6 Levels	Time Since 1st Dose, 18 h	476.94 Picogram per milliliter (pg/mL)
Cohort 1-SB-681323, 3 mg, 4 h	Mean Serum Interleukin-6 Levels	Time Since 1st Dose, 72 h	165.46 Picogram per milliliter (pg/mL)
Cohort 1-SB-681323, 3 mg, 4 h	Mean Serum Interleukin-6 Levels	Time Since 1st Dose, 48 h	167.69 Picogram per milliliter (pg/mL)
Cohort 1-SB-681323, 3 mg, 4 h	Mean Serum Interleukin-6 Levels	Time Since 1st Dose, 24 h	231.1 Picogram per milliliter (pg/mL)
Cohort 1-SB-681323, 3 mg, 4 h	Mean Serum Interleukin-6 Levels	Time Since 1st Dose, 18 h	247.22 Picogram per milliliter (pg/mL)
Cohort 1-SB-681323, 3 mg, 4 h	Mean Serum Interleukin-6 Levels	Time Since 1st Dose, 6 h	286.17 Picogram per milliliter (pg/mL)
Cohort 1-SB-681323, 3 mg, 4 h	Mean Serum Interleukin-6 Levels	Time Since 1st Dose, 96 h	166.87 Picogram per milliliter (pg/mL)
Cohort 1-SB-681323, 3 mg, 4 h	Mean Serum Interleukin-6 Levels	Time Since 1st Dose, 12 h	315.89 Picogram per milliliter (pg/mL)
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Serum Interleukin-6 Levels	Time Since 1st Dose, 24 h	228.1 Picogram per milliliter (pg/mL)
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Serum Interleukin-6 Levels	Time Since 1st Dose, 18 h	275.7 Picogram per milliliter (pg/mL)
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Serum Interleukin-6 Levels	Time Since 1st Dose, 6 h	391.09 Picogram per milliliter (pg/mL)
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Serum Interleukin-6 Levels	Time Since 1st Dose, 12 h	362.03 Picogram per milliliter (pg/mL)
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Serum Interleukin-6 Levels	Time Since 1st Dose, 48 h	290.59 Picogram per milliliter (pg/mL)
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Serum Interleukin-6 Levels	Time Since 1st Dose, 72 h	184.93 Picogram per milliliter (pg/mL)
Cohort 2-SB-681323, 7.5 mg, 24 h	Mean Serum Interleukin-6 Levels	Time Since 1st Dose, 96 h	286.79 Picogram per milliliter (pg/mL)
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Serum Interleukin-6 Levels	Time Since 1st Dose, 72 h	182.54 Picogram per milliliter (pg/mL)
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Serum Interleukin-6 Levels	Time Since 1st Dose, 12 h	348.23 Picogram per milliliter (pg/mL)
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Serum Interleukin-6 Levels	Time Since 1st Dose, 6 h	309.57 Picogram per milliliter (pg/mL)
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Serum Interleukin-6 Levels	Time Since 1st Dose, 18 h	292.24 Picogram per milliliter (pg/mL)
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Serum Interleukin-6 Levels	Time Since 1st Dose, 24 h	310.47 Picogram per milliliter (pg/mL)
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Serum Interleukin-6 Levels	Time Since 1st Dose, 48 h	235.13 Picogram per milliliter (pg/mL)
Cohort 3-SB-681323, 7.5 mg, 4 h	Mean Serum Interleukin-6 Levels	Time Since 1st Dose, 96 h	210.87 Picogram per milliliter (pg/mL)
Cohort 4-SB-681323, 10 mg, 24 h	Mean Serum Interleukin-6 Levels	Time Since 1st Dose, 18 h	238.7 Picogram per milliliter (pg/mL)
Cohort 4-SB-681323, 10 mg, 24 h	Mean Serum Interleukin-6 Levels	Time Since 1st Dose, 96 h	106.32 Picogram per milliliter (pg/mL)
Cohort 4-SB-681323, 10 mg, 24 h	Mean Serum Interleukin-6 Levels	Time Since 1st Dose, 48 h	119.98 Picogram per milliliter (pg/mL)
Cohort 4-SB-681323, 10 mg, 24 h	Mean Serum Interleukin-6 Levels	Time Since 1st Dose, 6 h	395.09 Picogram per milliliter (pg/mL)
Cohort 4-SB-681323, 10 mg, 24 h	Mean Serum Interleukin-6 Levels	Time Since 1st Dose, 72 h	106.32 Picogram per milliliter (pg/mL)
Cohort 4-SB-681323, 10 mg, 24 h	Mean Serum Interleukin-6 Levels	Time Since 1st Dose, 24 h	162.82 Picogram per milliliter (pg/mL)
Cohort 4-SB-681323, 10 mg, 24 h	Mean Serum Interleukin-6 Levels	Time Since 1st Dose, 12 h	310.98 Picogram per milliliter (pg/mL)

Comparison: Comparison at 96 h post first dose95% CI: [0.366, 2.254]

Comparison: Comparison at 6 h post first dose95% CI: [0.52, 1.134]

Comparison: Comparison at 6 h post first dose95% CI: [0.357, 0.885]

Comparison: Comparison at 12 h post first dose95% CI: [0.349, 1.072]

Comparison: Comparison at 18 h post first dose95% CI: [0.274, 0.981]

Comparison: Comparison at 24 h post first dose95% CI: [0.217, 0.796]

Comparison: Comparison at 48 h post first dose95% CI: [0.262, 1.021]

Comparison: Comparison at 72 h post first dose95% CI: [0.291, 1.503]

Comparison: Comparison at 12 h post first dose95% CI: [0.427, 1.15]

Comparison: Comparison at 18 h post first dose95% CI: [0.329, 1.015]

Comparison: Comparison at 24 h post first dose95% CI: [0.231, 0.728]

Comparison: Comparison at 48 h post first dose95% CI: [0.484, 1.657]

Comparison: Comparison at 72 h post first dose95% CI: [0.35, 1.563]

Comparison: Comparison at 96 h post first dose95% CI: [0.659, 3.697]

Comparison: Comparison at 6 h post first dose95% CI: [0.433, 0.853]

Comparison: Comparison at 12 h post first dose95% CI: [0.437, 1.039]

Comparison: Comparison at 18 h post first dose95% CI: [0.374, 1.004]

Comparison: Comparison at 24 h post first dose95% CI: [0.338, 0.921]

Comparison: Comparison at 48 h post first dose95% CI: [0.427, 1.23]

Comparison: Comparison at 72 h post first dose95% CI: [0.384, 1.386]

Comparison: Comparison at 96 h post first dose95% CI: [0.559, 2.353]

Comparison: Comparison at 6 h post first dose95% CI: [0.556, 1.082]

Comparison: Comparison at 12 h post first dose95% CI: [0.394, 0.919]

Comparison: Comparison at 18 h post first dose95% CI: [0.386, 1.007]

Comparison: Comparison at 24 h post first dose95% CI: [0.263, 0.7]

Comparison: Comparison at 48 h post first dose95% CI: [0.299, 0.842]

Comparison: Comparison at 72 h post first dose95% CI: [0.255, 0.903]

Comparison: Comparison at 96 h post first dose95% CI: [0.281, 1.192]

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026

SB-681323 IV for Subjects at Risk of Acute Lung Injury or ARDS

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Hematology Parameters-Mean Corpuscle Volume

Mean Clinical Chemistry Parameters- Albumin and Total Protein

Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase

Mean Clinical Chemistry Parameters-Blood pH at Screening

Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)

Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid

Mean Clinical Chemistry Parameters-estradiol

Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals

Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count

Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)

Mean Hematology Parameters- Mean Corpuscle Hemoglobin

Mean Hematology Parameters-reticulocytes, Red Blood Cell Count

Number of Participants With Any Adverse Events (AE) and Serious Adverse Events (SAE)

Vital Parameter: Mean Heart Rate

Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Vital Sign: Mean Percent Oxygen (O2) in Blood

Vital Signs: Mean Level of Peak and Plateau Ventilator Pressures

Vital Signs: Mean Level of Positive End Expiratory Pressure

Vital Signs: Mean Oxygen Requirement (FiO2) Via Pulse Oximetry

Vital Signs: Mean Oxygen Saturation (SaO2) Via Pulse Oximetry

Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I

Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels

Maximum Observed Concentration (Cmax) of SB-681323

Mean Area Under the Concentration-time Curve From Zero (Pre-dose) to 24 Hours (AUC0-24)

Mean Average Concentration (Cavg) of SB-681323

Mean Serum C-Reactive Protein (CRP) Levels

Mean Serum CXCL8 (Interleuin-8) Levels

Mean Serum Interleukin-6 Levels