Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03931876




Registration number
NCT03931876
Ethics application status
Date submitted
25/04/2019
Date registered
30/04/2019
Date last updated
1/05/2019

Titles & IDs
Public title
A Single Ascending Dose Study of AV-006 in Healthy Subjects
Scientific title
A Placebo Controlled, Double Blind, Single Ascending Dose Study of AV-006 in Healthy Subjects
Secondary ID [1] 0 0
Arixa-AV-006-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bacterial Infections 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebos
Treatment: Drugs - AV-006

Placebo Comparator: Placebo - placebo

Active Comparator: Active - AV-006


Treatment: Drugs: Placebos
Single ascending dose administration

Treatment: Drugs: AV-006
Single ascending dose administration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of treatment related adverse events, vital signs data, ECGs, clinical laboratory tests of AV-006 following oral administration
Timepoint [1] 0 0
7 days

Eligibility
Key inclusion criteria
1. Male or female subjects age 18-55 (inclusive).

2. Good general health, with no significant medical history. Subjects must have no
clinically significant abnormalities on physical examination at screening, and/or
before administration of study drug

3. Body weight = 50 kg at the screening visit

4. Body Mass Index (BMI) between 18 and 32 kg/m2 inclusive.

5. Has laboratory values (clinical chemistry and hematology) within the normal reference
range. Deviations from this range may be acceptable if they are considered not
clinically significant' (NCS) by the PI

6. Women of childbearing potential may be enrolled if one of the following criteria
applies:

1. Must be using two methods of contraception, consisting of (1) a highly-effective
method associated with a < 1% failure rate when used correctly and consistently
(e.g. hormonal contraception methods associated with suppression of ovulation or
an IUD) and (2) partner use of a condom. Contraception should have been used for
at least one month prior to study entry, the subject must have maintained a
normal menstrual pattern for the three months prior to study entry and have a
negative pregnancy test (urine) at the time of admission to the unit. Women must
be willing to continue this contraception for 45 days following administration of
study drug

2. Is abstinent from heterosexual intercourse where this is consistent with the
participant's usual and preferred lifestyle

3. Is monogamous with a vasectomized partner (>3 months prior)

4. Is postmenopausal (i.e., no cycle for at least the previous 12 months, is of
menopausal age (> 45 years) and has a negative pregnancy test (urine) both at
Screening and Day -1)

5. Is surgically sterilized (confirmed by medical record review)

6. Has had a total hysterectomy a minimum of 3 months prior to dosing on Day 1
(confirmed by medical record review)

7. Males who are sexually abstinent may be enrolled or, if sexually active, may be
enrolled if one of the following criteria applies:

1. Has had a vasectomy (>3 months prior to study entry, confirmed by medical record
review)

2. Using condoms and whose partner is using an acceptable form of contraception
(IUD, oral contraceptives, birth control patch or vaginal ring, injectable or
implanted contraceptives, or tubal ligation [surgical sterilization]) from Day -1
to 90 days after study drug administration

8. Understands the study procedures and agrees to participate in the study by giving
written informed consent

9. Is a non-smoker (i.e. fewer than 4 cigarettes in 12 weeks prior to screening) Able and
willing to attend the necessary visits to the study center
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Blood donation or recipient of blood transfusion in previous 30 days.

2. History of clinically significant endocrine, neurological, gastrointestinal,
cardiovascular, hematological, hepatic, immunological, renal, respiratory, or
genitourinary abnormalities or diseases.

3. History of neoplastic disease (except adequately-treated non-melanomatous skin
carcinoma)

4. Mentally or legally incapacitated, ie has significant emotional problems at the time
of Screening Visit or expected during the conduct of the study, or has a history of a
clinically significant psychiatric disorder within the last 5 years

5. Fever (body temperature >38?C) or symptomatic viral/bacterial infection or use of
antibiotics within 2 weeks prior to Screening

6. Resting blood pressure (BP) >140/90 mmHg or heart rate (HR) >100 beats per minute at
Screening or at Day -1 (vital signs to be taken with subject in semi- recumbent
position)

7. Clinically significant abnormality on ECG performed at the Screening Visit or prior to
administration of the initial dose of study drug. (Screening and predose ECG
conduction intervals (corrected for heart rate) must be within the normal range).

8. Clinically significant laboratory abnormalities. Impaired renal function (which should
be determined on the Screening day only) to be estimated using creatinine clearance
(CrCl) of <80 mL/minute based on the appropriate formula for calculation of CrCL
[calculation to be performed by laboratory responsible]

9. Positive test for hepatitis C antibody, hepatitis B surface antigen, or human
immunodeficiency virus (HIV) antibody at Screening

10. Participants with a positive toxicology screening panel (urine test including
qualitative identification of barbiturates, tetrahydrocannabinol, amphetamines,
benzodiazepines, opiates and cocaine)

11. Participants with a history of substance abuse or dependency or history of
recreational IV drug use (by self-declaration)

12. Alcohol consumption >14 alcohol units per week. (One unit of alcohol is 10 ml, in-
formation on calculation the content of drinks is provided at:
http://www.alcohol.gov.au/internet/alcohol/publishing.nsf/Content/standard)

13. Unable to refrain from or anticipates the use of any medications, including
prescription and non-prescription drugs and herbal remedies (such as St. John's Wort
[Hypericum perforatum]), beginning 14 days (or 5 half-lives, whichever is longer)
before administration of the initial dose of study drug and continuing throughout the
study until the final study visit. There may be certain medications that are permitted
at the discretion of the Investigator and Sponsor (including
paracetamol/acetaminophen, medications for the treatment of AEs following
administration of study drug

14. Subjects who are unlikely to comply with the study protocol or, in the opinion of the
investigator, would not be a suitable candidate for participation in the study.

15. Have participated in any other investigational drug trial within 30 days of dosing in
the present stud

16. Known intolerance of or sensitivity to avibactam

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)
Methods used to generate the sequence in which subjects will be randomised (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
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
24/06/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2019
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Arixa Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Characterization of the single dose pharmacokinetics of AV-006 in healthy male and female
subjects. Description of safety and tolerability of AV-006 in healthy subjects
Trial website
https://clinicaltrials.gov/ct2/show/NCT03931876
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jason Lickliter, PhD
Address 0 0
Nucleus Network
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Julie Pribyl, BA
Address 0 0
Country 0 0
Phone 0 0
9196960350
Fax 0 0
Email 0 0
jpribyl@pharmadirections.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03931876