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NCT03931876

A Single Ascending Dose Study of AV-006 in Healthy Subjects

Status unknown Phase 1 Last updated 1 May 2019
What this trial tests

Phase 1 trial testing Placebos in Bacterial Infections in 40 participants. Status unknown.

Timeline
24 June 2019
Primary endpoint
1 September 2019
1 November 2019

Quick facts

Lead sponsorArixa Pharmaceuticals
PhasePhase 1
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designsequential
Maskingquadruple
Primary purposetreatment
Enrollment40
Start date24 June 2019
Primary completion1 September 2019
Estimated completion1 November 2019
Sites1 location across Australia

Drugs / interventions tested

Conditions studied

Sponsor

Arixa Pharmaceuticals — full company profile →

Who can join

Adults 18 to 55, any sex, with Bacterial Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. ESKAPE pathogens: antimicrobial resistance, epidemiology, clinical impact and therapeutics.
    Miller WR, Arias CA. · · 2024 · cited 481× · PMID 38831030 · DOI 10.1038/s41579-024-01054-w
  2. Antibiotics in the clinical pipeline in October 2019.
    Butler MS, Paterson DL. · · 2020 · cited 174× · PMID 32152527 · DOI 10.1038/s41429-020-0291-8
  3. Antibiotics in the clinical pipeline as of December 2022.
    Butler MS, Henderson IR, Capon RJ, Blaskovich MAT. · · 2023 · cited 147× · PMID 37291465 · DOI 10.1038/s41429-023-00629-8
  4. Strongly Bactericidal All-Oral β-Lactam Combinations for the Treatment of Mycobacterium abscessus Lung Disease.
    Negatu DA, Zimmerman MD, Dartois V, Dick T. · · 2022 · cited 26× · PMID 36047786 · DOI 10.1128/aac.00790-22
  5. Activity of Oral Tebipenem-Avibactam in a Mouse Model of Mycobacterium abscessus Lung Infection.
    Negatu DA, González Del Río R, Cacho-Izquierdo M, Barros-Aguirre D, et al · · 2023 · cited 15× · PMID 36688684 · DOI 10.1128/aac.01459-22
  6. Antibacterials with Novel Chemical Scaffolds in Clinical Development.
    Heimann D, Kohnhäuser D, Kohnhäuser AJ, Brönstrup M. · · 2025 · cited 10× · PMID 39847315 · DOI 10.1007/s40265-024-02137-x
  7. The <i>in vitro</i> effect of new combinations of carbapenem-β-lactamase inhibitors for <i>Mycobacterium abscessus</i>.
    Fröberg G, Ahmed A, Chryssanthou E, Davies Forsman L. · · 2023 · cited 8× · PMID 37671880 · DOI 10.1128/aac.00528-23
  8. Impact of acquired broad-spectrum β-lactamases on susceptibility to oral penems/carbapenems (tebipenem, sulopenem, and faropenem) alone or in combination with avibactam and taniborbactam β-lactamase inhibitors in <i>Escherichia coli</i>.
    Le Terrier C, Nordmann P, Bouvier M, Poirel L. · · 2023 · cited 6× · PMID 37668385 · DOI 10.1128/aac.00547-23

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