Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000995471
Ethics application status
Approved
Date submitted
25/07/2016
Date registered
28/07/2016
Date last updated
24/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
An interventional study to evaluate the Safety and Pharmacokinetics (PK, the measure of how the human body processes a substance) of ETX2514 when administered intravenously (IV, directly into the bloodstream through a vein in the arm) to healthy participants.
Scientific title
A Phase I, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous ETX2514 Administered in Healthy Subjects
Secondary ID [1] 289664 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acinetobacter baumannii infection 299465 0
Condition category
Condition code
Infection 299445 299445 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Part A- Single Ascending Dose (SAD)
Cohort 1- 0.25g IV ETX2514/ placebo infused over 3 hours to participants aged 18-55
Cohort 2- 0.5g IV ETX2514/ placebo infused over 3 hours to participants aged 18-55
Cohort 3- 1g IV ETX2514/ placebo infused over 3 hours to participants aged 18-55
Cohort 4- 1g IV ETX2514/ placebo infused over 2 hours to participants aged 18-55
Cohort 5- 2g IV ETX2514/ placebo infused over 3 hours to participants aged 18-55
Cohort 6- 4g IV ETX2514/ placebo infused over 3 hours to participants aged 18-55
Cohort 7- 8g IV ETX2514/ placebo infused over 3 hours to participants aged 18-55
Cohort 8- 1g IV ETX2514/ placebo infused over 3 hours in elderly subjects (aged 65 years or older)
Participants will be confined to the study unit from Day-1 until 48 hours post dose (Day 3), and will be confined to bed during the infusion.

Part B- Multiple Ascending Dose (MAD)
Cohort 9- 0.25g IV EXT2514/ placebo infused over 3 hours, every 6 hours (4 times a day) for 7 consecutive days and 1 dose on Day 8 to participants aged 18-55
Cohort 10- 0.5g IV EXT2514/ placebo infused over 3 hours, every 6 hours (4 times a day) for 7 consecutive days and 1 dose on Day 8 to participants aged 18-55
Cohort 11- 1g IV EXT2514/ placebo infused over 3 hours, every 6 hours (4 times a day) for 7 consecutive days and 1 dose on Day 8 to participants aged 18-55
Cohort 12- 2g IV EXT2514/ placebo infused over 3 hours, every 6 hours (4 times a day) for 7 consecutive days and 1 dose on Day 8 to participants aged 18-55
Participants will be confined to the study unit from Day-1 until 48 hours post Day 8 dose (Day 10), and will be confined to bed during each infusion.

Part C- single dose EXT2514 in combination with sulbactam and/or primaxin.
Cohort 13, Day 1- single dose of 1g* IV ETX2514/ placebo infused over 3 hours to participants aged 18-55
Cohort 13, Day 3- single dose of 1g IV sulbactam infused over 3 hours to participants aged 18-55
Cohort 13, Day 5- single dose of 1g* IV ETX2514/ placebo plus 1g sulbactam infused over 3 hours at the same time to participants aged 18-55
Cohort 14, Day 1- single dose of 1g* IV ETX2514/ placebo infused over 3 hours to participants aged 18-55
Cohort 14, Day 3- single dose of 0.5g IV primaxin infused over 30 minutes to participants aged 18-55
Cohort 14, Day 5- single dose of 1g* IV ETX2514/ placebo infused over 3 hours plus 0.5g IV primaxin infused over 30 minutes at the same time to participants aged 18-55
Cohort 14, Day 8- single dose of 1g* IV ETX2514/ placebo plus 1g sulbactam infused over 3 hours plus 0.5g IV primaxin infused over 30 minutes at the same time to participants aged 18-55
*The actual ETX2514 dose and infusion time studied in part C will be determined based on PK and safety data from Part A.
Participants will be confined to the study unit from Day-1 until 48 hours post Day 5 dose (Day 7), and will be confined to bed during each infusion.

Part D- multiple dose EXT2514 in combination with sulbactam and/or primaxin.
Cohort 15- 1g* IV ETX2514/ placebo plus 1g sulbactam infused over 3 hours plus 0.5g IV primaxin infused over 30 minutes at the same time, every 6 hours (4 times a day) for 10 consecutive days and 1 dose on Day 11 to participants aged 18-55
*The actual ETX2514 dose and infusion time studied in Part D will be determined based on PK and safety data from Part A.
Participants will be confined to the study unit from Day-1 until 48 hours post Day 8 dose (Day 10), and will be confined to bed during each infusion.

A triple lumen catheter will be used allowing the concurrent infusion of up to three drugs through a single line.
Intervention code [1] 295290 0
Treatment: Drugs
Comparator / control treatment
Normal saline placebo control
Control group
Placebo

Outcomes
Primary outcome [1] 298927 0
To determine the safety and tolerability of intravenous ETX2514 when administered as a single ascending dose (SAD) and as a multiple ascending dose (MAD) to healthy subjects.
This will be assessed by looking at the incidence, severity, causality, and seriousness of adverse events; changes in clinical laboratory evaluations; changes in vital signs parameters, physical examinations, and ECGs; and the incidence of infusion site reactions.
Timepoint [1] 298927 0
Adverse event information will be recorded from the time of admission to the study unit until 14 days after the last dose of study drug.
Clinical laboratory evaluations will be conducted at screening and Day -1 (baseline evaluations) for Parts A and B. They will also be collected at the following timepoints:
Part A- Days 3, 5, 7, and 15 (Follow-up).
Part B- Pre-dose on Days 3, 5, and 7, and Days 10 and 22 (Follow-up).

Physical examinations will be performed at Screening and Day -1 (baseline) and at the Follow-up visit.

ECGs will be performed at Screening and Day -1 (baseline evaluations) for parts A and B, They will also be performed at the following timepoints:
Part A - 150 minutes after the start of the infusion on Day 1; Day 3 (48 hours post start of infusion), and at the follow-up visit.
Part B- 150 minutes after the start of the infusion on Days 1, 3, 5, and 7; Day 10 (48 hours post start of Day 8infusion), and at the follow-up visit.

Vital signs will be measured at Screening and Day -1 (baseline evaluations) for Parts A and B. They will also be performed at the following timepoints:
Part A- pre-dose, and 1, 3, 6, 12, 24, and 48 hours from the start of the infusion; and Days 5, 7, and 15 (follow-up).
Part B- 30 minutes prior to each infusion, and 3, 6, and 12 hours from the start of the first infusion on Days 1-8; and Days 9 (24 hours post the start of Day 8 infusion), 10 (48 hours post the start of Day 8 infusion), and 22 (follow-up).
Primary outcome [2] 298930 0
To determine the safety and tolerability of intravenous ETX2514 when administered as a single dose in combination with sulbactam and/or primaxin to healthy subjects.
This will be assessed by looking at the incidence, severity, causality, and seriousness of adverse events; changes in clinical laboratory evaluations; changes in vital signs parameters, physical examinations, and ECGs; and the incidence of infusion site reactions.
Timepoint [2] 298930 0
Adverse event information will be recorded from the time of admission to the study unit until 14 days after the last dose of study drug.

Clinical laboratory evaluations will be conducted at screening and Day -1 (baseline evaluations), an at the following timepoints:
Part C, Cohort 13- Pre-dose on Days 3 and 5; and Days 7 and 19 (Follow-up).
Part C, Cohort 14- Pre-dose on Days 3 and 5; and Days 7, 10, and 22 (Follow-up).

Physical examinations will be performed at Screening and Day -1 (baseline) and at the Follow-up visit.

ECGs will be performed at Screening and Day -1 (baseline evaluations) and at the following timepoints:
Part C, Cohort 13- 150 minutes post start of infusion on Days 1, 3 and 5; and Days 7 (48 hours post start of Day 5 infusion) and 19 (Follow-up).
Part C, Cohort 14- 150 minutes post start of infusion on Days 1, 3, 5 and 8; and Days 10 (48 hours post start of Day 8 infusion) and 22 (Follow-up).

Vital signs will be measured at Screening and Day -1 (baseline evaluations) and at the following timepoints:
Part C, Cohort 13- 30 minutes prior to each infusion, and 3, 6, and 12 hours from the start of the infusion on Days 1, 3, and 5; and Days 2 (24 hours post start of Day 1 infusion), 4 (24 hours post start of Day 3 infusion), 6 (24 hours post start of Day 5 infusion) and 19 (follow-up).
Part C, Cohort 14- 30 minutes prior to each infusion, and 3, 6, and 12 hours from the start of the infusion on Days 1, 3, 5, and 8; and Days 2 (24 hours post start of Day 3 infusion), 6 (24 hours post start of Day 5 infusion), 7 (48 hours post start of Day 5 infusion), 9 (24 hours post start of Day 8 infusion), 10 (48 hours post start of Day 8 infusion), and 22 (follow-up).
Primary outcome [3] 298931 0
To determine the PK profile of single and multiple intravenous doses of ETX2514 in healthy subjects.
Blood (plasma) and urine samples will be collected and the following PK parameters will be assessed:
Peak plasma concentration (Cmax)
Plasma concentration at time t (Ct)
Time to peak plasma concentration (Tmax)
Area under the concentration-time curve from time 0 to 24 hours (AUC0-24)
Area under the concentration-time curve from time 0 to the last time point evaluated (AUC0-t)
Area under the concentration-time curve from time 0 and extrapolated to infinity (AUC0-8)
Elimination rate constant (Kel)
Elimination half-life (t1/2)
Clearance (CL) of ETX2514
Volume of distribution (VzVdss)
Cumulative excretion of unchanged drug in urine (Ae)
Timepoint [3] 298931 0
Blood samples for ETX2514 PK will be collected at the following timepoints:
Part A, Cohorts 1-3 and 5-8: 30 minutes prior to infusion, and 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, and 48 hours following the start of the infusion.
Part A, Cohort 4: 30 minutes prior to infusion, and 1, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours following the start of the infusion.

Part B, Day 1: 30 minutes prior to first infusion, and 1, 2, 3, 3.5, 4, 5, 6 (immediately prior to infusion of next dose), 8, and 12 (immediately prior to infusion of next dose) hours following the start of the first infusion.
Part B, Days 2 and 4: 30 minutes prior to second infusion given on the Day.
Part B, Day 8: 30 minutes prior to final infusion on Day 8, and 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, and 48 hours following the start of the final infusion.

Urine for ETX2514 PK will be collected over the following intervals:
Part A: from 12 hours prior to infusion to time of infusion start; 0 - 6 hours from time of infusion start; 6 - 12 hours from time of infusion start; 12 - 24 hours from time of infusion start; and 24 - 48 hours from time of infusion start.

Part B: from 12 hours prior to Day 1 first infusion to time of Day 1 first infusion start; 0 - 6 hours from time of Day 1 first infusion start; 6 - 12 hours from time of Day 1 first infusion start; 12 - 24 hours from time of Day 1 first infusion start; and 24 - 48 hours from time of Day 1 first infusion start; and
from 12 hours prior to Day 8 final infusion to time of Day 8 final infusion start; 0 - 6 hours from time of Day 8 final infusion start; 6 - 12 hours from time of Day 8 final infusion start; 12 - 24 hours from time of Day 8 final infusion start; and 24 - 48 hours from time of Day 8 final infusion start.
Secondary outcome [1] 325668 0
To determine the safety and tolerability of intravenous ETX2514 when administered as a single dose to healthy elderly subjects.
This will be assessed by looking at the incidence, severity, causality, and seriousness of adverse events; changes in clinical laboratory evaluations; changes in vital signs parameters, physical examinations, and ECGs; and the incidence of infusion site reactions.
Timepoint [1] 325668 0
Adverse event information will be recorded from the time of admission to the study unit until 14 days after the last dose of study drug.

Clinical laboratory evaluations will be conducted at screening and Day -1 (baseline evaluations), and at the following timepoints: Days 3, 5, 7, and 15 (Follow-up).

Physical examinations will be performed at Screening and Day -1 (baseline) and at the Follow-up visit.

ECGs will be performed at Screening and Day -1 (baseline evaluations) and at the following timepoints: 150 minutes after the start of the infusion on Day 1, Day 3 (48 hours post start of infusion); and at the follow-up visit.

Vital signs will be measured at Screening and Day -1 (baseline evaluations), and at the following timepoints: pre-dose, and 1, 3, 6, 12, 24, and 48 hours from the start of the infusion; and Days 5, 7, and 15 (follow-up).
Secondary outcome [2] 325669 0
To determine the PK profile of a single dose of ETX2514 in healthy elderly subjects.
Blood (plasma) and urine samples will be collected and the following PK parameters will be assessed:
Peak plasma concentration (Cmax)
Plasma concentration at time t (Ct)
Time to peak plasma concentration (Tmax)
Area under the concentration-time curve from time 0 to 24 hours (AUC0-24)
Area under the concentration-time curve from time 0 to the last time point evaluated (AUC0-t)
Area under the concentration-time curve from time 0 and extrapolated to infinity (AUC0-8)
Elimination rate constant (Kel)
Elimination half-life (t1/2)
Clearance (CL) of ETX2514
Volume of distribution (VzVdss)
Cumulative excretion of unchanged drug in urine (Ae)
Timepoint [2] 325669 0
Blood samples for ETX2514 PK will be collected at the following timepoints:
30 minutes prior to infusion, and 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, and 48 hours following the start of the infusion.

Urine for ETX2514 PK will be collected over the following intervals:
from 12 hours prior to infusion to time of infusion start; 0 - 6 hours from time of infusion start; 6 - 12 hours from time of infusion start; 12 - 24 hours from time of infusion start; and 24 - 48 hours from time of infusion start.
Secondary outcome [3] 325670 0
To determine the safety and tolerability of intravenous ETX2514 when administered in multiple doses in combination with sulbactam and/ or primaxin to healthy subjects.
This will be assessed by looking at the incidence, severity, causality, and seriousness of adverse events; changes in clinical laboratory evaluations; changes in vital signs parameters, physical examinations, and ECGs; and the incidence of infusion site reactions.
Timepoint [3] 325670 0
Adverse event information will be recorded from the time of admission to the study unit until 14 days after the last dose of study drug.

Clinical laboratory evaluations will be conducted at screening and Day -1 (baseline evaluations), an at the following timepoints: Pre-dose on Days 3, 5, and 7, and Days 11, 13 and 25 (Follow-up).

Physical examinations will be performed at Screening and Day -1 (baseline) and at the Follow-up visit.

ECGs will be performed at Screening and Day -1 (baseline evaluations) and at the following timepoints: 150 minutes after the start of the first infusion on Days 1, 3, 5, 7, 9 and 11; Day 13 (48 hours post start of Day 11 infusion) and at the follow-up visit.

Vital signs will be measured at Screening and Day -1 (baseline evaluations) and at the following timepoints: 30 minutes prior to each infusion, and 3, 6, and 12 hours from the start of the first infusion on Days 1-11; and Days 12, 13, and 25 (follow-up).
Secondary outcome [4] 325671 0
To determine the PK profile of intravenous doses of ETX2514 and co-administered agents when administered in combination with sulbactam and/ or primaxin in healthy subjects.
Blood (plasma) and urine samples will be collected and the following PK parameters will be assessed:
Peak plasma concentration (Cmax)
Plasma concentration at time t (Ct)
Time to peak plasma concentration (Tmax)
Area under the concentration-time curve from time 0 to 24 hours (AUC0-24)
Area under the concentration-time curve from time 0 to the last time point evaluated (AUC0-t)
Area under the concentration-time curve from time 0 and extrapolated to infinity (AUC0-8)
Elimination rate constant (Kel)
Elimination half-life (t1/2)
Clearance (CL) of ETX2514
Volume of distribution (VzVdss)
Cumulative excretion of unchanged drug in urine (Ae)
Timepoint [4] 325671 0
Blood samples for ETX2514 PK will be collected at the following timepoints:
Cohort 13, Day 1: 30 minutes prior to infusion, and 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 24, and 36 hours following the start of Day 1 infusion.
Cohort 13, Day 3: immediately prior to infusion (48 hours post start of Day 1 infusion), and 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 24, and 36 hours following the start of Day 3 infusion.
Cohort 13, Day 5: immediately prior to infusion (48 hours post start of Day 3 infusion), and 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, and 48 hours following the start of Day 5 infusion.

Cohort 14, Day 1: 30 minutes prior to infusion, and 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 24, and 36 hours following the start of Day 1 infusion.
Cohort 14, Day 3: immediately prior to infusion (48 hours post start of Day 1 infusion), and 1, 2, 3, 4, 5, 6, 8, 12, 24, and 36 hours following the start of Day 3 infusion.
Cohort 14, Day 5: immediately prior to infusion (48 hours post start of Day 3 infusion), and 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, and 48 hours following the start of Day 5 infusion.
Cohort 14, Day 8: 30 minutes prior to infusion, and 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, and 48 hours following the start of Day 8 infusion.

Urine for ETX2514 PK will be collected over the following intervals:
Cohort 13: from 12 hours prior to Day 1 infusion to time of Day 1 infusion start; 0 - 6 hours from time of Day 1 infusion start; 6 - 12 hours from time of Day 1 infusion start; 12 - 24 hours from time of Day 1 infusion start; and 24 - 48 hours from time of Day 1 infusion start;
and
from 12 hours prior to Day 5 infusion to time of Day 5 infusion start; 0 - 6 hours from time of Day 5 infusion start; 6 - 12 hours from time of Day 5 infusion start; 12 - 24 hours from time of Day 5 infusion start; and 24 - 48 hours from time of Day 5 infusion start.

Cohort 14: from 12 hours prior to Day 1 infusion to time of Day 1 infusion start; 0 - 6 hours from time of Day 1 infusion start; 6 - 12 hours from time of Day 1 infusion start; 12 - 24 hours from time of Day 1 infusion start; and 24 - 48 hours from time of Day 1 infusion start;
and
from 12 hours prior to Day 8 infusion to time of Day 8 infusion start; 0 - 6 hours from time of Day 8 infusion start; 6 - 12 hours from time of Day 8 infusion start; 12 - 24 hours from time of Day 8 infusion start; and 24 - 48 hours from time of Day 8 infusion start.
Secondary outcome [5] 325672 0
To determine the PK profile of multiple doses of intravenous ETX2514 and co-administered agents when administered in combination with sulbactam and/ or primaxin in healthy subjects.
Blood (plasma) and urine samples will be collected and the following PK parameters will be assessed:
Peak plasma concentration (Cmax)
Plasma concentration at time t (Ct)
Time to peak plasma concentration (Tmax)
Area under the concentration-time curve from time 0 to 24 hours (AUC0-24)
Area under the concentration-time curve from time 0 to the last time point evaluated (AUC0-t)
Area under the concentration-time curve from time 0 and extrapolated to infinity (AUC0-8)
Elimination rate constant (Kel)
Elimination half-life (t1/2)
Clearance (CL) of ETX2514
Volume of distribution (VzVdss)
Cumulative excretion of unchanged drug in urine (Ae)
Timepoint [5] 325672 0
Blood samples for ETX2514 PK will be collected at the following timepoints:
Day 1: 30 minutes prior to infusion, and 0.5, 1, 2, 3, 3.5, 4, 5, 6 (immediately prior to start of next infusion), 8, and 12 (immediately prior to start of next infusion) hours following the start of the first infusion.
Days 2 and 4: 30 minutes prior to second infusion of that Day.
Day 11: 30 minutes prior to first infusion, and 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, and 48 hours following the start of the first infusion.

Urine for ETX2514 PK will be collected over the following intervals:
from 12 hours prior to Day 1 first infusion to time of Day 1 first infusion start; 0 - 6 hours from time of Day 1 first infusion start; 6 - 12 hours from time of Day 1 first infusion start; 12 - 24 hours from time of Day 1 first infusion start; and 24 - 48 hours from time of Day 1 first infusion start; and
from 12 hours prior to Day 11 infusion to time of Day 8 first infusion start; 0 - 6 hours from time of Day 11 infusion start; 6 - 12 hours from time of Day 11 infusion start; 12 - 24 hours from time of Day 11 infusion start; and 24 - 48 hours from time of Day 11 infusion start.

Eligibility
Key inclusion criteria
1. Aged 18 to 55 years (inclusive). In addition, 8 subjects greater than or equal to 65 years of age will be enrolled.
2. Be in general good health without clinically significant medical history.
3. Provide voluntary written informed consent prior to any study procedures and are willing and able to comply with the prescribed treatment protocol and evaluations.
4. Body mass index (BMI) greater than or equal to 18.0 kg/m^2 and less than or equal to 32.0 kg/m^2.
5. Clinical laboratory values within the normal limits as defined by the clinical laboratory, unless the Principal Investigator decides that out-of-range values are not clinically significant.
6. Negative screen for drugs of abuse, alcohol, hepatitis B surface antigen (HBS Ag), hepatitis C virus antibody (HCV Ab) and Human Immunodeficiency Virus (HIV) at screening; and drugs of abuse, alcohol pre dose on Day -1.
7. Female subjects must be of non-childbearing potential, or using a medically acceptable contraceptive regimen and must have a negative pregnancy test at Screening (serum) and on Day -1 (urine) prior to study drug dosing. Male subjects must be surgically sterile, or using a medically acceptable contraceptive regimen.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of any moderate or severe hypersensitivity or allergic reaction to any beta-lactam antimicrobial (e.g., penicillin, cephalosporin, sulbactam or carbapenem).
2. Use of prescription or over the counter medications within 7 days of Investigational Product administration, with the exception of contraceptive medications, paracetamol, oral non-steroidal anti-inflammatory agents, topical over the counter preparations and routine vitamins (if they do not exceed an intake of 20 to 600 times the recommended daily dose), unless agreed as non-clinically relevant by the Principal Investigator and Sponsor.
3. Participation in an investigational drug or device study within 30 days before study drug dosing, i.e., there was at least 30 days in between the last dose on a prior study and dose administration on this study.
4. Current smoker, or difficulty abstaining from smoking for the duration of study confinement.
5. History of major organ dysfunction.
6. Infection or any serious underlying medical condition that would impair the subject from receiving study drug.
7. History of excessive alcohol intake (more than four standard drinks daily, on average) or use of recreational drugs within the last 3 months.
8. Standard donation of blood within 30 days of the study.
9. Concomitant disease or condition, including laboratory abnormality, which could interfere with the conduct of the study, or which would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.
10. Anticipated need for surgery or hospitalization during the study
11. Unwillingness or inability to comply with the study protocol for any other reason.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involves contacting the holder of the allocation schedule who is the off-site pharmacist with no contact with participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Other
Other design features
Participants will be assigned to different dosages and treatments depending on which study part and cohort they are enrolled into.
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/10/2016
Actual
3/10/2016
Date of last participant enrolment
Anticipated
9/03/2017
Actual
4/05/2017
Date of last data collection
Anticipated
Actual
29/05/2017
Sample size
Target
124
Accrual to date
Final
124
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6162 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 13599 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 294052 0
Commercial sector/Industry
Name [1] 294052 0
Entasis Therapeutics, Inc.
Country [1] 294052 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
INCResearch Australia Pty Ltd
Address
159 Port Road
Hindmarsh SA 5007
Country
Australia
Secondary sponsor category [1] 292877 0
None
Name [1] 292877 0
Address [1] 292877 0
Country [1] 292877 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295467 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 295467 0
The Alfred Hospital
55 Commercial Road
Melbourne VIC 3004
Ethics committee country [1] 295467 0
Australia
Date submitted for ethics approval [1] 295467 0
25/08/2016
Approval date [1] 295467 0
20/09/2016
Ethics approval number [1] 295467 0
396/16

Summary
Brief summary
This research project is being conducted to look at the safety, tolerability and pharmacokinetics (PK, how the human body processes a substance) of a ETX2514 when given to healthy volunteers intravenously as a single dose, and when given as multiple intravenous doses for up to 8 consecutive days.
As it is anticipated that ETX2514 could be used as a treatment for Acinetobacter baumannii (a type of bacteria) infections, this project will also look at whether ETX2514 will interact with the current treatments for these infections when they are administered at the same time.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67386 0
Dr Jason Lickliter
Address 67386 0
Nucleus Network
Level 5, Burnet Tower, AMREP Precinct
Commercial Road
Melbourne VIC 3004
Country 67386 0
Australia
Phone 67386 0
+61 390768609
Fax 67386 0
Email 67386 0
[email protected]
Contact person for public queries
Name 67387 0
Ms Sally Johnsson
Address 67387 0
INCResearch Australia Pty Ltd
159 Port Road Hindmarsh SA 5007 (head office)
Suite 1, Level 2, 924 Pacific Highway, Gordon NSW 2072 (actual office location of personnel)
Country 67387 0
Australia
Phone 67387 0
+61 284379283
Fax 67387 0
Email 67387 0
[email protected]
Contact person for scientific queries
Name 67388 0
Dr David Fuller
Address 67388 0
INCResearch Australia Pty Ltd
Suite 1, Level 2, 924 Pacific Highway
Gordon NSW 2072
Country 67388 0
Australia
Phone 67388 0
+61 450965709
Fax 67388 0
Email 67388 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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