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Healthy volunteers help test new antibiotic Combo's safety

NCT ID NCT04877379

Knowledge-focused Sponsor: Basilea Pharmaceutica Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how safe two experimental antibiotics (VNRX-7145 and ceftibuten) are when given alone or together. It involved 53 healthy adults aged 18 to 55. The goal was to measure how the drugs move through the body and check for side effects, not to treat any illness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

53 people

The number who actually took part.

Started

Jun 2021

Finished

Nov 2021

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Healthy adults 18-55 years 2. Males or non-pregnant, non-lactating females 3. Body mass index (BMI): ≥18.5 kg/m2 and ≤32.0 kg/m2 4. Normal blood pressure 5. Normal lab tests Exclusion Criteria: 1. History or presence of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorders 2. History of drug allergy or hypersensitivity to penicillin, cephalosporin, or beta-lactam antibacterial drug 3. Use of antacid medications 4. Abnormal ECG or history of clinically significant abnormal rhythm disorder 5. Positive alcohol, drug, or tobacco use/test

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy subjects

Contacts and locations

Locations

  • PRA Health Sciences - Early Development Services

    Groningen, Netherlands

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