HealthyPhase 1NCT07500181
A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BAL2420 in Healthy Adult Subjects
A Phase 1 study of Healthy, run by Basilea Pharmaceutica at 1 site in Netherlands.
Trial summary
BAL2420 (also known as BAL0302420) is being developed as an antibacterial agent for the treatment of severe infections caused by Gram-negative bacteria. In this study, the sponsor aims to investigate the safety, tolerability and pharmacokinetics (PK) of BAL2420 following administration of single ascending doses (Part… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 Mar 2026to Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Body mass index: 18.0 to 30.0 kg/m2, inclusive, at screening
- Total body weight: > 50 kg at screening
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
ICON Early Clinical & Bioanalytical Solutions
Groningen, 9728 NZ
About this study
Official title: A First-in-Human, Randomized, Dose-escalation, Double-blind, Placebo-controlled Study to Investigate Safety, Tolerability, and Pharmacokinetics of BAL2420 Administered to Healthy Adult Subjects
BAL2420 (also known as BAL0302420) is being developed as an antibacterial agent for the treatment of severe infections caused by Gram-negative bacteria. In this study, the sponsor aims to investigate the safety, tolerability and pharmacokinetics (PK) of BAL2420 following administration of single ascending doses (Part A) and multiple ascending doses (Parts B and C) in healthy adult volunteers. In all parts of the study, in each cohort, a different dose of study drug is to be investigated against a matched placebo in a randomized and double-blind manner.
- Conditions
- Healthy
- Being tested
- BAL2420 or placebo
- Keywords
- BAL2420, BAL0302420, Antibacterial agent, Pharmacokinetics, Healthy adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAL2420 or placeboDrug
Single ascending dose administration (SAD)
BAL2420 or placeboDrug
Multiple-ascending dose (MAD)
BAL2420 or placeboDrug
MAD
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | A single intravenous (IV) dose of BAL2420 or placebo will be administered to healthy subjects Receives: Drug: BAL2420 or placebo |
| Part B | Experimental | A daily IV dose of BAL2420 or placebo will be administered multiple times to healthy subjects Receives: Drug: BAL2420 or placebo |
| Part C | Experimental | A different IV dosing regimen of BAL2420 or placebo will be administered to healthy subjects Receives: Drug: BAL2420 or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants reporting adverse events (AEs) in Part A
Measured: From screening until Day 10
Number of participants with abnormal electrocardiograms QT Interval in Part A
Measured: From screening until Day 10
Number of participants reporting adverse events (AEs) in Part B and C
Measured: From screening until Day 14
Number of participants with abnormal ECG QT Interval in Part B and C
Measured: From screening until Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start4 Mar 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Basilea Pharmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- German Federal Ministry of Education and Research, Italian Ministry of Economy and Finance, Health Emergency Preparedness and Response Authority, Novo Nordisk Foundation, Wellcome Trust 224842/Z/21/Z, Wellcome Trust 325026/Z/25/Z
- Responsible party
- Sponsor
- Investigators
- Thomas Kaindl, MD, Study director, Basilea Pharmaceutica International Ltd, Allschwil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500181
- Sponsor's protocol ID
- BAL2420-CP-101
- Other IDs
- 75A50122C00028, 2025-523108-59-00, 2025
- Status last verified
- Sep 2026
- First submitted
- 18 Mar 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human, Randomized, Dose-escalation, Double-blind, Placebo-controlled Study to Investigate Safety, Tolerability, and Pharmacokinetics of BAL2420 Administered to Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT07500181
- Acronym / sponsor ID
- BAL2420-CP-101
- Conditions
- Healthy
- Keywords
- BAL2420, BAL0302420, Antibacterial agent, Pharmacokinetics, Healthy adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Basilea PharmaceuticaIndustry (pharma, biotech, devices)
- Collaborators
- German Federal Ministry of Education and Research, Italian Ministry of Economy and Finance, Health Emergency Preparedness and Response Authority, Novo Nordisk Foundation, Wellcome Trust 224842/Z/21/Z, Wellcome Trust 325026/Z/25/Z
- Study start
- 4 Mar 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
BAL2420 (also known as BAL0302420) is being developed as an antibacterial agent for the treatment of severe infections caused by Gram-negative bacteria. In this study, the sponsor aims to investigate the safety, tolerability and pharmacokinetics (PK) of BAL2420 following administration of single ascending doses (Part A) and multiple ascending doses (Parts B and C) in healthy adult volunteers. In all parts of the study, in each cohort, a different dose of study drug is to be investigated against a matched placebo in a randomized and double-blind manner.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: BAL2420 or placeboA single intravenous (IV) dose of BAL2420 or placebo will be administered to healthy subjects |
| Part B | Experimental | Drug: BAL2420 or placeboA daily IV dose of BAL2420 or placebo will be administered multiple times to healthy subjects |
| Part C | Experimental | Drug: BAL2420 or placeboA different IV dosing regimen of BAL2420 or placebo will be administered to healthy subjects |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index: 18.0 to 30.0 kg/m2, inclusive, at screening
- Total body weight: > 50 kg at screening
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAL2420 or placeboSingle ascending dose administration (SAD) | Drug | Part A |
| BAL2420 or placeboMultiple-ascending dose (MAD) | Drug | Part B |
| BAL2420 or placeboMAD | Drug | Part C |
Primary outcome
Number of participants reporting adverse events (AEs) in Part A
Time frame: From screening until Day 10
Number of participants with abnormal electrocardiograms QT Interval in Part A
Time frame: From screening until Day 10
Number of participants reporting adverse events (AEs) in Part B and C
Time frame: From screening until Day 14
Number of participants with abnormal ECG QT Interval in Part B and C
Time frame: From screening until Day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Kaindl, MD study director
Basilea Pharmaceutica International Ltd, Allschwil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Healthy, 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 2 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 14 Sep 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Kaindl, MD (+41615671505, thomas.kaindl@basilea.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants reporting adverse events (AEs) in Part A (time frame: From screening until Day 10). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2026.