ANZCTR - Registration

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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Acinetobacter baumannii infection

Condition category

Condition code

Infection

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]

Treatment: Drugs

Comparator / control treatment

Normal saline placebo control

Control group

Placebo

Outcomes

Primary outcome [1]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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

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]

Nucleus Network - Melbourne

Recruitment postcode(s) [1]

3004 - Melbourne

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Entasis Therapeutics, Inc.

Country [1]

United States of America

Primary sponsor type

Commercial sector/Industry

Name

INCResearch Australia Pty Ltd

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Hospital Ethics Committee

Ethics committee address [1]

The Alfred Hospital
55 Commercial Road
Melbourne VIC 3004

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/08/2016

Approval date [1]

20/09/2016

Ethics approval number [1]

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

Public notes

Contacts

Principal investigator

Name

Dr Jason Lickliter

Address

Nucleus Network
Level 5, Burnet Tower, AMREP Precinct
Commercial Road
Melbourne VIC 3004

Country

Australia

Phone

+61 390768609

Email

[email protected]

Contact person for public queries

Name

Sally Johnsson

Address

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

Australia

Phone

+61 284379283

Email

[email protected]

Contact person for scientific queries

Name

David Fuller

Address

INCResearch Australia Pty Ltd
Suite 1, Level 2, 924 Pacific Highway
Gordon NSW 2072

Country

Australia

Phone

+61 450965709

Email

[email protected]

Trial Review

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