NCT02955459

VNRX-5133-101/102: A Randomized, Double Blind, Placebo-Controlled, Sequential Group, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Doses of VNRX-5133 in Healthy Adult Volunteers

Completed Phase 1 Last updated 20 July 2017

What this trial tests

Phase 1 trial testing VNRX-5133 in Bacterial Infections in 84 participants. Completed in 1 June 2017.

Timeline

1 November 2016

Primary endpoint
1 June 2017

1 June 2017

Quick facts

Lead sponsor	Venatorx Pharmaceuticals, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	basic science
Enrollment	84
Start date	1 November 2016
Primary completion	1 June 2017
Estimated completion	1 June 2017
Sites	1 location across United States

Drugs / interventions tested

• VNRX-5133 — full drug profile →
• Placebo

Conditions studied

• Bacterial Infections — all drugs for Bacterial Infections →

Sponsor

Venatorx Pharmaceuticals, Inc. — full company profile →

Who can join

Adults 18 to 45, any sex, with Bacterial Infections. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of subjects with adverse events; assessed by patient reporting, physical exams, collection of vital signs, ECGs and absolute values and changes over time of hematology, chemistry and urinalysis.
  Time frame: Part 1: 8 days. Part 2: 17 days

Sponsor's own description

This is a 2-part, first-in-human dose-ranging study to evaluate the safety, tolerability and pharmacokinetics of escalating doses of VNRX-5133 administered via intravenous (IV) infusion in healthy subjects. In part 1, subjects will receive a single dose of VNRX-5133; in part 2 subjects will receive VNRX-5133 for 7 days.

Publications & conference data

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

1. NDM Metallo-β-Lactamases and Their Bacterial Producers in Health Care Settings.
   Wu W, Feng Y, Tang G, Qiao F, et al · · 2019 · cited 498× · PMID 30700432 · DOI 10.1128/cmr.00115-18
2. Metallo-β-Lactamases: Structure, Function, Epidemiology, Treatment Options, and the Development Pipeline.
   Boyd SE, Livermore DM, Hooper DC, Hope WW. · · 2020 · cited 206× · PMID 32690645 · DOI 10.1128/aac.00397-20
3. Antibiotic resistance breakers: current approaches and future directions.
   Laws M, Shaaban A, Rahman KM. · · 2019 · cited 193× · PMID 31150547 · DOI 10.1093/femsre/fuz014
4. New Carbapenemase Inhibitors: Clearing the Way for the β-Lactams.
   Vázquez-Ucha JC, Arca-Suárez J, Bou G, Beceiro A. · · 2020 · cited 87× · PMID 33291334 · DOI 10.3390/ijms21239308
5. β-Lactam Antibiotics and β-Lactamase Enzymes Inhibitors, Part 2: Our Limited Resources.
   Alfei S, Schito AM. · · 2022 · cited 42× · PMID 35455473 · DOI 10.3390/ph15040476
6. Safety and Pharmacokinetics in Human Volunteers of Taniborbactam (VNRX-5133), a Novel Intravenous β-Lactamase Inhibitor.
   Dowell JA, Dickerson D, Henkel T. · · 2021 · cited 32× · PMID 34370573 · DOI 10.1128/aac.01053-21