New antibiotic candidate enters first human safety trial
NCT ID NCT07500181
First seen Jun 25, 2026 · Last updated Sep 15, 2026 · Updated 3 times
Summary
This early-stage trial is testing a new experimental antibiotic, BAL2420, in 136 healthy adults. The goal is to check if it is safe and how the body processes it. Researchers will give single or multiple doses and watch for side effects. This is a first step toward possibly using it to treat severe bacterial infections.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BAL2420 (an experimental antibiotic)
- What this could lead to
- If successful, this could lead to a new treatment option for serious infections caused by Gram-negative bacteria.
- What could go wrong
- This is a very early Phase 1 safety study in healthy people, not patients. The drug may not work or may have side effects. Many early-stage drugs never reach the market.
Why investors are watching
Basilea is testing BAL2420, an antibacterial drug for severe Gram-negative infections, in a first-in-human Phase 1 trial with 136 healthy volunteers. For a small company, this readout matters because it is the first test of whether the drug is safe and tolerable in people, which determines whether the program can advance.
If it works: If the trial shows BAL2420 is safe and well tolerated, Basilea could move the drug into later-stage testing in infected patients. That would validate the drug's potential as a new treatment option for serious bacterial infections.
If it fails: Phase 1 trials often fail because the drug proves unsafe or has poor tolerability in humans. A negative result or delay would likely end the program and hurt Basilea, which depends on this asset's progress.
AI-written from the trial record. Speculative, and not investment advice.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 136 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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: * Body mass index: 18.0 to 30.0 kg/m2, inclusive, at screening * Total body weight: \> 50 kg at screening Exclusion Criteria: * Any uncontrolled or active major systemic disease, * Active infection * Acute illness within 5 days prior to the first study drug administration that, in the opinion of the Investigator, may impact safety assessments. * Clinically-significant physical examination, vital signs, laboratory safety tests, or ECG abnormalities * History of risk factors for QT prolongation or Torsades de Pointes * QTcF (Fridericia's corrected QT interval) \> 450 msec (males) and \> 470 msec (females) at screening. * Receipt of prescribed medication other than hormonal contraceptives within the 30 days prior to admission to the clinical site. * Receipt of over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (e.g., St. John's wort) within 14 days prior to admission to the clinical site. * History of relevant drug and/or food allergies, particularly to antibiotics. * History of tobacco use or e-cigarette within the past 6 months prior to the first study drug administration. * History of alcohol abuse or drug addiction (including soft drugs like cannabis products) within 12 months prior to screening. * Average intake of more than 24 units of alcohol per week: one unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits. * Positive screen for hepatitis B surface antigen, hepatitis B core antibodies, hepatitis C virus antibodies, human immunodeficiency virus 1 and 2 antibodies, or syphilis at screening. Note: Hepatitis B vaccination is allowed.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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ICON Early Clinical & Bioanalytical Solutions
RECRUITINGGroningen, 9728 NZ, Netherlands
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