NCT04314206 is a Phase 1 clinical trial of VNRX-5024 in Healthy Subjects, sponsored by Basilea Pharmaceutica.

Who is sponsoring NCT04314206?

NCT04314206 is sponsored by Basilea Pharmaceutica.

What drugs are being tested in NCT04314206?

Interventions in NCT04314206: VNRX-5024, Placebo for VNRX-5024.

What condition does NCT04314206 study?

NCT04314206 studies Healthy Subjects.

Is NCT04314206 still recruiting?

NCT04314206 is currently completed. Last updated 3 December 2025.

Last reviewed 2025-12-03 · How we verify

NCT04314206

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

VNRX-5024 Safety and PK in Healthy Adult Volunteers

Completed Phase 1 Last updated 3 December 2025

What this trial tests

Phase 1 trial testing VNRX-5024 in Healthy Subjects in 36 participants. Completed in 31 December 2020.

Timeline

27 July 2020

Primary endpoint
31 December 2020

31 December 2020

Quick facts

Lead sponsor	Basilea Pharmaceutica
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	double
Primary purpose	basic science
Enrollment	36
Start date	27 July 2020
Primary completion	31 December 2020
Estimated completion	31 December 2020
Sites	1 location across Netherlands

Drugs / interventions tested

VNRX-5024 — full drug profile →
Placebo for VNRX-5024 — full drug profile →

Conditions studied

Healthy Subjects — all drugs for Healthy Subjects →

Sponsor

Basilea Pharmaceutica — full company profile →

Who can join

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

Sponsor's own description

This is a 2-part dose-ranging study to evaluate the safety and pharmacokinetics of escalating doses of VNRX-5024. Subjects will be enrolled in one of three dose cohorts. They will receive a single dose on Day 1 in Part 1 and will proceed into the multiple dose Part 2 of the study after safety assessments and PK samples are collected. In the multiple dose part of the study, subjects will receive multiple doses of VNRX-5024 for 10 days.

Publications & conference data

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

In vivo pharmacokinetics and pharmacodynamics of ceftibuten/ledaborbactam, a novel oral β-lactam/β-lactamase inhibitor combination.
Fratoni AJ, Avery LM, Nicolau DP, Asempa TE. · · 2022 · cited 7× · PMID 36272135 · DOI 10.1093/jac/dkac359
Pharmacokinetics and safety of single and repeat doses of ceftibuten in healthy participants: a phase 1 dose escalation study.
Dorr MB, de Oliveira CF, van de Wetering J, Lowe K, et al · · 2025 · cited 1× · PMID 40762485 · DOI 10.1128/aac.00087-25

Verify or expand the search:

Other recruiting trials for Healthy Subjects

Currently open trials in the same condition.

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NCT07331389 — A Drug-Drug Interaction Study of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin · 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 NCT04314206 (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/NCT04314206.

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