NCT04243863 is a Phase 1 clinical trial of VNRX-7145 in Healthy Volunteers, sponsored by Basilea Pharmaceutica.

Who is sponsoring NCT04243863?

NCT04243863 is sponsored by Basilea Pharmaceutica.

What drugs are being tested in NCT04243863?

Interventions in NCT04243863: VNRX-7145, Placebo.

What condition does NCT04243863 study?

NCT04243863 studies Healthy Volunteers.

Is NCT04243863 still recruiting?

NCT04243863 is currently completed. Last updated 3 December 2025.

Last reviewed 2025-12-03 · How we verify

NCT04243863

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

VNRX-7145 SAD/MAD Safety and PK in Healthy Adult Volunteers

Completed Phase 1 Last updated 3 December 2025

What this trial tests

Phase 1 trial testing VNRX-7145 in Healthy Volunteers in 83 participants. Completed in 5 April 2021.

Timeline

20 January 2020

Primary endpoint
5 April 2021

5 April 2021

Quick facts

Lead sponsor	Basilea Pharmaceutica
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	double
Primary purpose	basic science
Enrollment	83
Start date	20 January 2020
Primary completion	5 April 2021
Estimated completion	5 April 2021
Sites	1 location across United States

Drugs / interventions tested

VNRX-7145 — full drug profile →
Placebo

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Basilea Pharmaceutica — full company profile →

Who can join

Adults 18 to 45, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a 2-part, first-in-human dose-ranging study to evaluate the safety and pharmacokinetics of escalating doses of VNRX-7145. In part 1, subjects will receive a single dose of VNRX-7145; in part 2 subjects will receive multiple doses of VNRX-7145 for 10 days.

Publications & conference data

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

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
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
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
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
Discovery of VNRX-7145 (VNRX-5236 Etzadroxil): An Orally Bioavailable β-Lactamase Inhibitor for Enterobacterales Expressing Ambler Class A, C, and D Enzymes.
Trout RE, Zulli A, Mesaros E, Jackson RW, et al · · 2021 · cited 32× · PMID 34191513 · DOI 10.1021/acs.jmedchem.1c00437
Oral Antibiotics in Clinical Development for Community-Acquired Urinary Tract Infections.
Veeraraghavan B, Bakthavatchalam YD, Sahni RD. · · 2021 · cited 26× · PMID 34357517 · DOI 10.1007/s40121-021-00509-4
Ceftibuten-Ledaborbactam Activity against Multidrug-Resistant and Extended-Spectrum-β-Lactamase-Positive Clinical Isolates of Enterobacterales from a 2018-2020 Global Surveillance Collection.
Karlowsky JA, Wise MG, Hackel MA, Pevear DC, et al · · 2022 · cited 15× · PMID 36286518 · DOI 10.1128/aac.00934-22
In Vitro Activity of Ceftibuten/VNRX-5236 against Urinary Tract Infection Isolates of Antimicrobial-Resistant Enterobacterales.
Karlowsky JA, Hackel MA, Sahm DF. · · 2022 · cited 12× · PMID 34662183 · DOI 10.1128/aac.01304-21

Verify or expand the search:

Other trials of VNRX-7145

Trials testing the same drug.

NCT05488678 — Ceftibuten/VNRX-7145 in Participants With Varying Degrees of Renal Function · Phase 1 · completed
NCT05527834 — Food Effect on Ceftibuten/VNRX-7145 in Healthy Participants · Phase 1 · completed
NCT04877379 — VNRX-7145 Drug-Drug Interaction in Healthy Adult Volunteers · Phase 1 · completed

Other recruiting trials for Healthy Volunteers

Currently open trials in the same condition.

NCT07504003 — Influence of Training Session Duration on Improvements in Physiological Resilience to Exercise · NA · recruiting
NCT07446400 — A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuva · Phase 1 · recruiting
NCT07495813 — A Study to See How RO7763505 Works and How Safe it is When Given to Healthy People and People With Stable Heart Disease · Phase 1 · recruiting
NCT07499050 — A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity · Phase 1 · recruiting
NCT07342114 — A Dose-Escalation Study of RO7875913 in Healthy Participants · Phase 1 · recruiting

Other Basilea Pharmaceutica trials

Trials by the same sponsor.

NCT06961708 — A Study of Fosmanogepix in Healthy Adult Chinese Subjects · Phase 1 · completed
NCT06808646 — A Study to Assess the Effect of Ceftobiprole on the PK of Pitavastatin and on Plasma Levels of Coproporphyrin · Phase 1 · completed
NCT06733675 — Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination · Phase 1 · recruiting
NCT05421858 — A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invas · Phase 3 · recruiting
NCT06665555 — Plasma and Intrapulmonary Pharmacokinetics of Ceftibuten and Ledaborbactam in Healthy Male and Female Participants 18 to · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04243863 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Basilea Pharmaceutica
Last refreshed: 3 December 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04243863.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing