Bacterial InfectionsPhase 1NCT03931876
A Single Ascending Dose Study of AV-006 in Healthy Subjects
A Phase 1 study testing AV-006 in people with Bacterial Infections, run by Arixa Pharmaceuticals at 1 site in Australia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- AV-006
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- 24 Jun 2019to 1 Nov 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female subjects age 18-55 (inclusive).
- 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
- Body weight ≥ 50 kg at the screening visit
- Body Mass Index (BMI) between 18 and 32 kg/m2 inclusive.
- 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
- Women of childbearing potential may be enrolled if one of the following criteria applies:
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- 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
- Is abstinent from heterosexual intercourse where this is consistent with the participant's usual and preferred lifestyle
- Is monogamous with a vasectomized partner (>3 months prior)
- 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)
- Is surgically sterilized (confirmed by medical record review)
- Has had a total hysterectomy a minimum of 3 months prior to dosing on Day 1 (confirmed by medical record review)
- Males who are sexually abstinent may be enrolled or, if sexually active, may be enrolled if one of the following criteria applies:
- Has had a vasectomy (>3 months prior to study entry, confirmed by medical record review)
- 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
- Understands the study procedures and agrees to participate in the study by giving written informed consent
- 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
Who cannot join
- Blood donation or recipient of blood transfusion in previous 30 days.
- History of clinically significant endocrine, neurological, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases.
- History of neoplastic disease (except adequately-treated non-melanomatous skin carcinoma)
- 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
- Fever (body temperature >38◦C) or symptomatic viral/bacterial infection or use of antibiotics within 2 weeks prior to Screening
- 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)
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- 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).
- 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]
- Positive test for hepatitis C antibody, hepatitis B surface antigen, or human immunodeficiency virus (HIV) antibody at Screening
- Participants with a positive toxicology screening panel (urine test including qualitative identification of barbiturates, tetrahydrocannabinol, amphetamines, benzodiazepines, opiates and cocaine)
- Participants with a history of substance abuse or dependency or history of recreational IV drug use (by self-declaration)
- 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)
- 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
- 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.
- Have participated in any other investigational drug trial within 30 days of dosing in the present stud
- Known intolerance of or sensitivity to avibactam
Trial locations and contacts
1 site in 1 country.
Australia1 site
Nucleus Network
Melbourne, Victoria, 3004
Biljana Georgievska, 61 3 85939817, b.georgievska@nucleusnetwork.com.au
About this study
Official title: A Placebo Controlled, Double Blind, Single Ascending Dose Study of AV-006 in Healthy Subjects
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
Read the detailed description
The present study is a first in human study of an avibactam prodrug to be administered orally. Avibactam is the β-lactamase inhibitor (BLI) component of the intravenous antibiotic AVYCAZQR (ceftazidime avibactam), approved in the US in 2015 to treat resistant Gram-negative infections. Avibactam is a non-β-lactam BLI without intrinsic antibacterial activity. Avibactam binds covalently with bacterial β-lactamases thereby preventing hydrolysis and inactivation of the partner β-lactam antibiotic.
Arixa and others have shown that that avibactam (the product of AV-006) restores the susceptibility of many oral β-lactam antibiotics against broad panels of clinical Enterobacteriaceae isolates that produce β-lactamases.
- Conditions
- Bacterial Infections
- Being tested
- Placebos, AV-006
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlacebosDrug
Single ascending dose administration
AV-006Drug
Single ascending dose administration
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | placebo Receives: Drug: Placebos |
| Active | Active comparator | AV-006 Receives: Drug: AV-006 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment related adverse events, vital signs data, ECGs, clinical laboratory tests of AV-006 following oral administration
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start24 Jun 2019 (estimated)
- Primary completion1 Sep 2019 (estimated)
- Study completion1 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arixa Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Lickliter, PhD, Principal investigator, Nucleus Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931876
- Sponsor's protocol ID
- Arixa-AV-006-01
- Status last verified
- Apr 2019
- First submitted
- 25 Apr 2019
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sahasrabudhe SA, Shoji S, Jakate AS, Abraham BK, Toussi SS, Maligalig BJ, Darekar AS, Tripathy S, Kantaridis C, Mfopou JK, Selivanova O, Bergman A, Alami NN, Singh RSP. Dose Selection for Ceftibuten Combined with Avibactam Tomilopil, a Potential Oral Alternative to Carbapenems for Patients with Complicated Urinary Tract Infections. J Clin Pharmacol. 2026 Sep;66(9):e70263. doi: 10.1002/jcph.70263.
PubMed 42678337
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo Controlled, Double Blind, Single Ascending Dose Study of AV-006 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03931876
- Acronym / sponsor ID
- Arixa-AV-006-01
- Conditions
- Bacterial Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Arixa PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2019 (estimated)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 1 Nov 2019 (estimated)
- First posted
- 30 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The present study is a first in human study of an avibactam prodrug to be administered orally. Avibactam is the β-lactamase inhibitor (BLI) component of the intravenous antibiotic AVYCAZQR (ceftazidime avibactam), approved in the US in 2015 to treat resistant Gram-negative infections. Avibactam is a non-β-lactam BLI without intrinsic antibacterial activity. Avibactam binds covalently with bacterial β-lactamases thereby preventing hydrolysis and inactivation of the partner β-lactam antibiotic.
Arixa and others have shown that that avibactam (the product of AV-006) restores the susceptibility of many oral β-lactam antibiotics against broad panels of clinical Enterobacteriaceae isolates that produce β-lactamases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebosplacebo |
| Active | Active comparator | Drug: AV-006AV-006 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Male or female subjects age 18-55 (inclusive).
- 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
- Body weight ≥ 50 kg at the screening visit
- Body Mass Index (BMI) between 18 and 32 kg/m2 inclusive.
- 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
Key exclusion criteria (16 listed)
- Blood donation or recipient of blood transfusion in previous 30 days.
- History of clinically significant endocrine, neurological, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases.
- History of neoplastic disease (except adequately-treated non-melanomatous skin carcinoma)
- 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
- Fever (body temperature >38◦C) or symptomatic viral/bacterial infection or use of antibiotics within 2 weeks prior to Screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlacebosSingle ascending dose administration | Drug | Placebo |
| AV-006Single ascending dose administration | Drug | Active |
Primary outcome
Incidence of treatment related adverse events, vital signs data, ECGs, clinical laboratory tests of AV-006 following oral administration
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
- Derived from this study: PubMed 42678337Sahasrabudhe SA, Shoji S, Jakate AS, Abraham BK, Toussi SS, Maligalig BJ, Darekar AS, Tripathy S, Kantaridis C, Mfopou JK, Selivanova O, Bergman A, Alami NN, Singh RSP. Dose Selection for Ceftibuten Combined with Avibactam Tomilopil, a Potential Oral Alternative to Carbapenems for Patients with Complicated Urinary Tract Infections. J Clin Pharmacol. 2026 Sep;66(9):e70263. doi: 10.1002/jcph.70263.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Lickliter, PhD principal investigator
Nucleus Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AV-006 in people with Bacterial Infections, run by Arixa Pharmaceuticals at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie Pribyl, BA (9196960350, jpribyl@pharmadirections.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment related adverse events, vital signs data, ECGs, clinical laboratory tests of AV-006 following oral administration (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03931876, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2019; AzTrials last refreshed its copy on 6 Nov 2026.