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Healthy SubjectsPhase 1NCT04314206

VNRX-5024 Safety and PK in Healthy Adult Volunteers

A Phase 1 study testing VNRX-5024 in people with Healthy Subjects, run by Basilea Pharmaceutica at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Subjects
What is being tested?
VNRX-5024
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
1 siteNetherlands
Study dates
27 Jul 2020to 31 Dec 2020
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

  • Healthy adults 18-55 years
  • Males or non-pregnant, non-lactating females
  • Body mass index (BMI): ≥18.5 kg/m2 and ≤32.0 kg/m2
  • Normal blood pressure
  • Normal lab tests

Who cannot join

  • Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder
  • History of drug allergy or hypersensitivity to penicillin, cephalosporin, or beta-lactam antibacterial drug
  • Use of antacid medications
  • Abnormal ECG or history of clinically significant abnormal rhythm disorder
  • Positive alcohol, drug, or tobacco use/test

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • PRA Health Sciences - Early Development Services

    Groningen

Other trials in Netherlands

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Sequential Group, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Single and Repeat Doses of VNRX-5024 Administered Orally for 10 Days in Healthy Adult Volunteers

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.

Being tested
VNRX-5024, Placebo for VNRX-5024

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VNRX-5024Drug

    Part 1: one dose

    Part 2:

    Cohort 1: 10 doses (once a day for 10 days) Cohort 2: 19 doses (once every 12 hours [q12h] dosing for 9 days with a single morning dose on Day 10) Cohort 3: 28 doses (once every 8 hours [q8h] dosing for 9 days with a single morning dose on Day 10)

  • Placebo for VNRX-5024Drug

    Part 1: one dose

    Part 2:

    Cohort 1: 10 doses (once a day for 10 days) Cohort 2: 19 doses (once every 12 hours [q12h] dosing for 9 days with a single morning dose on Day 10) Cohort 3: 28 doses (once every 8 hours [q8h] dosing for 9 days with a single morning dose on Day 10)

Study groups in NCT04314206
Study groupRoleWhat they receive
VNRX-5024ExperimentalCapsule formulation
Receives: Drug: VNRX-5024
PlaceboPlacebo comparatorPlacebo for VNRX-5024
Receives: Drug: Placebo for VNRX-5024

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of subjects with adverse events

    Measured: Day 19

Secondary outcomes (8)

  1. Part 1: AUC0-tau

    Measured: Days 1-2

  2. Part 2: AUC0-tau

    Measured: Days 3-12

  3. Part 1: Cmax

    Measured: Days 1-2

  4. Part 2: Cmax

    Measured: Days 3-12

  5. Part 1: tmax

    Measured: Days 1-2

  6. Part 2: tmax

    Measured: Days 3-12

  7. Part 1: CLr

    Measured: Days 1-2

  8. Part 2: CLr

    Measured: Days 3-12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2020
  2. Study start27 Jul 2020
  3. Primary completion31 Dec 2020
  4. Study completion31 Dec 2020

Resources

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
Basic science
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04314206
Sponsor's protocol ID
VNRX-5024-101
Other IDs
272201600029C-P00007-9999-2, 17-0004
Status last verified
Nov 2025
First submitted
16 Mar 2020
Last updated
3 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Darpo B, Xue H, Hamed KA, Litherland K, Engelhardt M, Lowe K, McGovern PC. No clinically relevant QTc prolongation with ceftibuten or ledaborbactam etzadroxil: concentration-QTc analyses from two phase I studies. J Antimicrob Chemother. 2026 Oct 6;81(11):dkag365. doi: 10.1093/jac/dkag365.

    PubMed 42920101

  • Dorr MB, de Oliveira CF, van de Wetering J, Lowe K, Sabato P, Winchell G, Chen H, McGovern PC. Pharmacokinetics and safety of single and repeat doses of ceftibuten in healthy participants: a phase 1 dose escalation study. Antimicrob Agents Chemother. 2025 Sep 3;69(9):e0008725. doi: 10.1128/aac.00087-25. Epub 2025 Aug 5.

    PubMed 40762485

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VNRX-5024 in people with Healthy Subjects, run by Basilea Pharmaceutica at 1 site in Netherlands.

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 5 inclusion and 5 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: finished, as of the sponsor's last update on 3 Dec 2025. 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 Netherlands. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of subjects with adverse events (time frame: Day 19). 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 NCT04314206, which also lists 2 linked publications.

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 3 Dec 2025.

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