A Study to Compare the Efficacy and Safety of 2 Dosing Re... | NCT01145560

Label	Type	Description	Intervention Names
1	Experimental	AZD9773 250/50 units/kg	Drug: AZD9773
2	Experimental	AZD9773 500/100 units/kg	Drug: AZD9773
3	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
AZD9773	Drug	A single loading dose following by up to 9 maintenance doses; doses to be given every 12 hours over a period of 5 days	1 2

Measure	Description	Time Frame
Ventilator-free Days (VFDs) Over 28 Days	Number of ventilator-free days (VFDs)	Over 28 days following first dose

Measure	Description	Time Frame
7-day Mortality	Number of patients who died over 7 days	Over 7 days following first dose
28-day Mortality	Number of patients who died over 28 days

Name	Affiliation	Role
Gordon Bernard, MD	Vanderbilt University	Principal Investigator
Warren Botnick, MD	Parexel	Study Director
Justin Lindemann, MD	AstraZeneca	Study Director
Wayne Dankner, MD	Parexel	Study Director
Jiri Juchelka, MD	Parexel	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Blacktown	New South Wales		Australia
Research Site

PubMed Identifier	Type	Citation	Retractions
23001587	Derived	Yates JW, Das S, Mainwaring G, Kemp J. Population pharmacokinetic/pharmacodynamic modelling of the anti-TNF-alpha polyclonal fragment antibody AZD9773 in patients with severe sepsis. J Pharmacokinet Pharmacodyn. 2012 Dec;39(6):591-9. doi: 10.1007/s10928-012-9270-4. Epub 2012 Sep 23.

Label	URL
CSR-D0620C00003.pdf	View source

ID	Title	Description
FG000	AZD9773 250/50 Units/kg	AZD9773 250/50 units/kg IV
FG001	AZD9773 500/100 Units/kg	AZD9773 500/100 units/kg IV

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Ventilator-free Days (VFDs) Over 28 Days

Number of ventilator-free days (VFDs)

Intention-to-treat analysis set

Median

Full Range

Days

Over 28 days following first dose

ID	Title	Description
OG000	AZD9773 250/50 Units/kg	AZD9773 250/50 units/kg IV
OG001	AZD9773 500/100 Units/kg	AZD9773 500/100 units/kg IV
OG002	Placebo	Saline

Units	Counts
Participants	OG000100 OG001100 OG002100

Title

Denominators

Categories

Title	Measurements
	OG00021.0(0 to 28) OG00117.5(0 to 28) OG00219.0(0 to 28)

Secondary

7-day Mortality

Number of patients who died over 7 days

Intention-to-treat analysis set

Number

Participants

Over 7 days following first dose

ID	Title	Description
OG000	AZD9773 250/50 Units/kg	AZD9773 250/50 units/kg IV
OG001	AZD9773 500/100 Units/kg	AZD9773 500/100 units/kg IV
OG002	Placebo	Saline

Units	Counts
Participants	OG000

Secondary

28-day Mortality

Number of patients who died over 28 days

Intention-to-treat analysis set

Number

Participants

Over 28 days following first dose

ID	Title	Description
OG000	AZD9773 250/50 Units/kg	AZD9773 250/50 units/kg IV
OG001	AZD9773 500/100 Units/kg	AZD9773 500/100 units/kg IV
OG002	Placebo	Saline

Units	Counts
Participants	OG000

Secondary

Safety and Tolerability

Number of patients with treatment-emergent adverse events

Safety Analysis Set

Number

Participants

All study visits (over 90 days following first dose)

ID	Title	Description
OG000	AZD9773 250/50 Units/kg	AZD9773 250/50 units/kg IV
OG001	AZD9773 500/100 Units/kg	AZD9773 500/100 units/kg IV
OG002	Placebo	Saline

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute Myocardial Infarction	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0010 affected97 at risk EG0021 affected99 at risk
Arrhythmia	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected97 at risk EG0020 affected99 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0010 affected97 at risk EG0022 affected99 at risk
Cardiac Arrest	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected97 at risk EG0021 affected99 at risk
Cardiac Failure Acute	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected97 at risk EG0020 affected99 at risk
Cardiogenic Shock	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected97 at risk EG0020 affected99 at risk
Sick Sinus Syndrome	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected97 at risk EG0020 affected99 at risk
Inappropriate Antidiuretic Hormone Secretion	Endocrine disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected97 at risk EG0020 affected99 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0010 affected97 at risk EG0021 affected99 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected97 at risk EG0020 affected99 at risk
Gastrointestinal Fistula	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected97 at risk EG0020 affected99 at risk
Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected100 at risk EG0012 affected97 at risk EG0021 affected99 at risk
Gastrointestinal Necrosis	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected100 at risk EG0011 affected97 at risk EG0020 affected99 at risk
Intestinal Infarction	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected97 at risk EG0020 affected99 at risk
Intestinal Ischaemia	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected97 at risk EG0022 affected99 at risk
Intestinal Perforation	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0010 affected97 at risk EG0021 affected99 at risk
Pancreatic Fistula	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected97 at risk EG0020 affected99 at risk
Vomiting	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected97 at risk EG0020 affected99 at risk
Multi-Organ Failure	General disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0013 affected97 at risk EG0023 affected99 at risk
Pyrexia	General disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0010 affected97 at risk EG0021 affected99 at risk
Biliary Tract Disorder	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0010 affected97 at risk EG0021 affected99 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0010 affected97 at risk EG0021 affected99 at risk
Cytolytic Hepatitis	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected97 at risk EG0020 affected99 at risk
Hepatic Failure	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected97 at risk EG0020 affected99 at risk
Hepatic Function Abnormal	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected97 at risk EG0020 affected99 at risk
Hepatic Lesion	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected97 at risk EG0020 affected99 at risk
Drug Hypersensitivity	Immune system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected97 at risk EG0020 affected99 at risk
Abdominal Wall Abscess	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0010 affected97 at risk EG0021 affected99 at risk
Aspergillosis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0010 affected97 at risk EG0021 affected99 at risk
Device Related Sepsis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected97 at risk EG0021 affected99 at risk
Empyema	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected97 at risk EG0020 affected99 at risk
Encephalitis Herpes	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected97 at risk EG0020 affected99 at risk
Endocarditis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected97 at risk EG0020 affected99 at risk
Fungal Oesophagitis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected97 at risk EG0020 affected99 at risk
Infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected97 at risk EG0020 affected99 at risk
Infectious Peritonitis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected97 at risk EG0021 affected99 at risk
Meningitis Staphylococcal	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected97 at risk EG0020 affected99 at risk
Pneumonia	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0012 affected97 at risk EG0025 affected99 at risk
Sepsis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 affected100 at risk EG0011 affected97 at risk EG0021 affected99 at risk
Septic Shock	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 affected100 at risk EG0012 affected97 at risk EG0021 affected99 at risk
Systemic Candida	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected97 at risk EG0020 affected99 at risk
Tracheobronchitis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected97 at risk EG0020 affected99 at risk
Splenic Rupture	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0010 affected97 at risk EG0021 affected99 at risk
Subdural Haematoma	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0010 affected97 at risk EG0021 affected99 at risk
Bile Duct Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected97 at risk EG0020 affected99 at risk
Colon Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0010 affected97 at risk EG0021 affected99 at risk
Oesophageal Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0010 affected97 at risk EG0021 affected99 at risk
Rectal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected97 at risk EG0020 affected99 at risk
Autonomic Nervous System Imbalance	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected97 at risk EG0020 affected99 at risk
Cerebral Infarction	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected97 at risk EG0020 affected99 at risk
Convulsion	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected97 at risk EG0020 affected99 at risk
Critical Illness Polyneuropathy	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0010 affected97 at risk EG0021 affected99 at risk
Guillain-Barre Syndrome	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected97 at risk EG0020 affected99 at risk
Hepatic Encephalopathy	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected97 at risk EG0020 affected99 at risk
Ischaemic Stroke	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0010 affected97 at risk EG0021 affected99 at risk
Polyneuropathy	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected97 at risk EG0020 affected99 at risk
Abnormal Behaviour	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected97 at risk EG0020 affected99 at risk
Renal Failure	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0010 affected97 at risk EG0021 affected99 at risk
Renal Failure Acute	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected97 at risk EG0020 affected99 at risk
Acute Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected97 at risk EG0020 affected99 at risk
Acute Respiratory Distress Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected97 at risk EG0020 affected99 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected97 at risk EG0020 affected99 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected97 at risk EG0020 affected99 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected97 at risk EG0020 affected99 at risk
Pneumonia Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0010 affected97 at risk EG0023 affected99 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0012 affected97 at risk EG0021 affected99 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0010 affected97 at risk EG0021 affected99 at risk
Respiratory Distress	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0010 affected97 at risk EG0021 affected99 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected100 at risk EG0010 affected97 at risk EG0021 affected99 at risk
Respiratory Gas Exchange Disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected97 at risk EG0020 affected99 at risk
Rash Vesicular	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected97 at risk EG0020 affected99 at risk
Air Embolism	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected97 at risk EG0020 affected99 at risk
Extremity Necrosis	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected97 at risk EG0021 affected99 at risk
Ischaemia	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected100 at risk EG0010 affected97 at risk EG0021 affected99 at risk
Shock	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected100 at risk EG0011 affected97 at risk EG0020 affected99 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG00020 affected100 at risk EG00118 affected97 at risk EG00222 affected99 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0005 affected100 at risk EG0014 affected97 at risk EG0024 affected99 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG00011 affected100 at risk EG00114 affected97 at risk EG0028 affected99 at risk
Constipation	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0007 affected100 at risk EG00111 affected97 at risk EG0029 affected99 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00012 affected100 at risk EG0019 affected97 at risk EG00214 affected99 at risk
Nausea	Gastrointestinal disorders	MedDRA 14	Systematic Assessment	EG0005 affected100 at risk EG0012 affected97 at risk EG0027 affected99 at risk
Vomiting	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0005 affected100 at risk EG0012 affected97 at risk EG0025 affected99 at risk
Generalised Oedema	General disorders	MedDRA 14.1	Systematic Assessment	EG0006 affected100 at risk EG0012 affected97 at risk EG0024 affected99 at risk
Oedema	General disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected100 at risk EG0012 affected97 at risk EG0025 affected99 at risk
Oedema Peripheral	General disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected100 at risk EG0013 affected97 at risk EG0025 affected99 at risk
Pyrexia	General disorders	MedDRA 14.1	Systematic Assessment	EG0006 affected100 at risk EG0015 affected97 at risk EG0025 affected99 at risk
Pneumonia	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0005 affected100 at risk EG0014 affected97 at risk EG0027 affected99 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 affected100 at risk EG0016 affected97 at risk EG0027 affected99 at risk
Fluid Overload	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected100 at risk EG0015 affected97 at risk EG0023 affected99 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected100 at risk EG0011 affected97 at risk EG0025 affected99 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0006 affected100 at risk EG0013 affected97 at risk EG0025 affected99 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0006 affected100 at risk EG0013 affected97 at risk EG0024 affected99 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected100 at risk EG0011 affected97 at risk EG0025 affected99 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0005 affected100 at risk EG0015 affected97 at risk EG0022 affected99 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00010 affected100 at risk EG0019 affected97 at risk EG0025 affected99 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0005 affected100 at risk EG0012 affected97 at risk EG0026 affected99 at risk
Agitation	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0006 affected100 at risk EG0017 affected97 at risk EG0028 affected99 at risk
Anxiety	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0006 affected100 at risk EG0011 affected97 at risk EG0027 affected99 at risk
Confusional State	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0007 affected100 at risk EG0014 affected97 at risk EG0025 affected99 at risk
Insomnia	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0005 affected100 at risk EG0013 affected97 at risk EG00211 affected99 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0006 affected100 at risk EG0017 affected97 at risk EG0024 affected99 at risk
Decubitus Ulcer	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected100 at risk EG0015 affected97 at risk EG0026 affected99 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0005 affected100 at risk EG0013 affected97 at risk EG0024 affected99 at risk
Hypertension	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0005 affected100 at risk EG0015 affected97 at risk EG0027 affected99 at risk
Hypotension	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected100 at risk EG0015 affected97 at risk EG0025 affected99 at risk

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D012769	Shock

ID	Title	Description
BG000	AZD9773 250/50 Units/kg	AZD9773 250/50 units/kg IV
BG001	AZD9773 500/100 Units/kg	AZD9773 500/100 units/kg IV
BG002	Placebo	Saline
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	AZD9773 250/50 Units/kg	AZD9773 250/50 units/kg IV	28	100	74	100
EG001	AZD9773 500/100 Units/kg	AZD9773 500/100 units/kg IV	27	97	71	97
EG002	Placebo	Saline	31	99	68	99