Healthy VolunteerPhase 1NCT06733675
Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination
A Phase 1 study testing Ledaborbactam etzadroxil, Ceftibuten and Ceftibuten-ledaborbactam etzadroxil in people with Healthy Volunteer and Pharmacokinetics, run by Basilea Pharmaceutica at 1 site in United States.
Trial summary
This is a Phase 1, open-label, three-part, study in approximately 96 healthy adult participants between 18 and 55 years of age (both inclusive) (16 participants in Part 1, 20 participants in Part 2 and , and approximately 60 participants in Part 3). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer, Pharmacokinetics, Safety
- What is being tested?
- Ledaborbactam etzadroxil, Ceftibuten and Ceftibuten-ledaborbactam etzadroxil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2025to 30 Dec 2026
- 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
- Healthy adult male or female, between 18 and 55 years of age
- Body mass index ≥ 18 and ≤ 32 kg/m2
- Laboratory values meeting defined laboratory ranges
- Males or non-pregnant, non-lactating females
Who cannot join
- History of any hypersensitivity reaction following administration of a cephalosporin, penicillin, or other β-lactam antibacterial drug
- Any acute illness or surgery within the past 3 months determined by the investigator to be clinically relevant
- Positive alcohol, drug or tobacco use/test
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
ICON, Clinical Research Phase I Unit
Lenexa, Kansas, 66219
Daniel Dickerson, MD. PhD, FAAFP, 913-205-4397, Daniel.Dickerson@iconplc.com
Daniel Dickerson, MD, PhD, FAAFP
About this study
Official title: A Phase 1, Open-label Study to Evaluate the Safety and to Characterize the Pharmacokinetics of a Fixed-Dose Combination Formulation of Ceftibuten-Ledaborbactam Etzadroxil
This is a Phase 1, open-label, three-part, study in approximately 96 healthy adult participants between 18 and 55 years of age (both inclusive) (16 participants in Part 1, 20 participants in Part 2 and , and approximately 60 participants in Part 3). The study will be conducted at one clinical site in the United States. Participants in Part 1 and Part 2 may be conducted in parallel. The duration of an individual participation will be approximately 46 days for Part 1 , 43 days for Part 2 and 83 days for Part 3. All participants in Parts I und 2 will be screened within 28 days prior to dosing. All participants in Part 3 will be screened within 33 days prior to dosing. They will be admitted to the clinical research unit (CRU) the day prior to dosing and will remain in the CRU until the end of the PK sample collection period. All participants will return to the clinic for follow-up assessments 7 days ± 1 day after the last dose of study intervention. Participants in Part 3 will also return to the clinic for follow-up assessments 28 days ± 2 days and 42 days ± 2 days after the last dose of study intervention.
- Conditions
- Healthy Volunteer, Pharmacokinetics, Safety, Drug-Drug Interaction (DDI), FDC
- Being tested
- Ledaborbactam etzadroxil, Ceftibuten, Ceftibuten-ledaborbactam etzadroxil, Esomeprazole, amoxicillin-clavulanate
- Keywords
- Healthy Volunteers, Ceftibuten, Ledaborbactam etzadroxil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ledaborbactam etzadroxilDrug
capsules
CeftibutenDrug
capsules
Ceftibuten-ledaborbactam etzadroxilDrug
Fixed Dose Combination (FDC)
EsomeprazoleDrug
40 mg capsule
amoxicillin-clavulanateDrug
500 mg-125 mg oral doses
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Part 1 will enroll at least 16 participants who will receive a single oral dose of ceftibuten and ledaborbactam etzadroxil following a 10-hour fast on 3 occasions in a fixed sequence: (a) Ceftibuten and ledaborbactam etzadroxil as separate capsules; (b) Ceftibuten-ledaborbactam etzadroxil as fixed-dose combination (FDC) capsules; (c) Ceftibuten-ledaborbactam etzadroxil as FDC capsules after 5 days of esomeprazole orally once daily Receives: Drug: Ledaborbactam etzadroxil; Drug: Ceftibuten; Drug: Ceftibuten-ledaborbactam etzadroxil; Drug: Esomeprazole |
| Part 2 Group 1 | Experimental | Part 2 Group 1 will enroll 10 participants. Each will receive oral doses of Ceftibuten-ledaborbactam etzadroxil FDC capsules for 7 days (Fasted Group) Receives: Drug: Ceftibuten-ledaborbactam etzadroxil |
| Part 2 Group 2 | Experimental | Part 2 Group 2 will enroll 10 participants. Each will receive oral doses of Ceftibuten-ledaborbactam etzadroxil FDC capsules for 7 days (Fed Group) Receives: Drug: Ceftibuten-ledaborbactam etzadroxil |
| Part 3 (Groups 1, 2, 4, 5, 6) | Experimental | Part 3 will enroll up to 50 participants. Each will receive oral doses of ceftibuten and/or ledaborbactam etzadroxil capsules (combined as FDC when administered together) in fed conditions Receives: Drug: Ledaborbactam etzadroxil; Drug: Ceftibuten |
| Part 3 Group 3 | Active comparator | Part 3 Group 3 will enroll up to 10 participants. Each will receive oral doses of amoxicillin-clavulanate Receives: Drug: amoxicillin-clavulanate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 Plasma PK AUC0-∞ (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil)
Area under the concentration time curve from time zero to infinity (AUC0-∞)
Measured: 0 - 48 hours on days 1, 4 and 11
Part 1 Plasma PK Cmax (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil)
Maximum observed concentration (Cmax)
Measured: 0 - 48 hours on days 1, 4 and 11
Proportion of participants of Part 2 experiencing Treatment-emergent adverse events (TEAEs), Serious TEAEs, or TEAEs leading to discontinuation.
Participants experiencing Treatment-emergent adverse events (TEAEs), Serious TEAEs, or TEAEs leading to discontinuation.
Measured: Day 1 thru Day 18 (+/-1)
Proportion of participants of Part 3 experiencing Treatment-emergent adverse events (TEAEs), Serious TEAEs, or TEAEs leading to discontinuation.
Participants experiencing Treatment-emergent adverse events (TEAEs), Serious TEAEs, or TEAEs leading to discontinuation.
Measured: Day 1 thru Day 49 (± 2 days)
Secondary outcomes (5)
Proportion of participants of Part 1 experiencing Treatment-emergent adverse events (TEAEs), Serious TEAEs, or TEAEs leading to discontinuation.
Participants experiencing Treatment-emergent adverse events (TEAEs), Serious TEAEs, or TEAEs leading to discontinuation.
Measured: Day 1 thru Day 18 (+/-1)
Part 2 Plasma PK AUC0-12h (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil)
Area under the concentration time curve from time zero to 12h (AUC0-12h)
Measured: Day 1 and Day 7
Part 2 Plasma PK Cmax (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil)
Maximum observed concentration (Cmax)
Measured: Day 1 and Day 7
Part 3 Plasma PK AUC0-Tau (ceftibuten and/or ledaborbactam)
Area under the concentration time curve from time zero to Tau (AUC0-Tau)
Measured: At Day 1 and Day 7
Part 3 Plasma PK Cmax (ceftibuten and/or ledaborbactam)
Maximum observed concentration (Cmax)
Measured: At Day 1 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start7 Jan 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Basilea Pharmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
- Investigators
- Kamal Hamed, MD, Study director, Basilea Pharmaceutica International Ltd, Allschwil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733675
- Sponsor's protocol ID
- VNRX-7145-106
- Status last verified
- Jul 2026
- First submitted
- 10 Dec 2024
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study to Evaluate the Safety and to Characterize the Pharmacokinetics of a Fixed-Dose Combination Formulation of Ceftibuten-Ledaborbactam Etzadroxil
- ClinicalTrials.gov ID
- NCT06733675
- Acronym / sponsor ID
- VNRX-7145-106
- Conditions
- Healthy Volunteer, Pharmacokinetics, Safety, Drug-Drug Interaction (DDI), FDC
- Keywords
- Healthy Volunteers, Ceftibuten, Ledaborbactam etzadroxil
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Basilea PharmaceuticaIndustry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 13 Dec 2024 (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.
This is a Phase 1, open-label, three-part, study in approximately 96 healthy adult participants between 18 and 55 years of age (both inclusive) (16 participants in Part 1, 20 participants in Part 2 and , and approximately 60 participants in Part 3). The study will be conducted at one clinical site in the United States. Participants in Part 1 and Part 2 may be conducted in parallel. The duration of an individual participation will be approximately 46 days for Part 1 , 43 days for Part 2 and 83 days for Part 3. All participants in Parts I und 2 will be screened within 28 days prior to dosing. All participants in Part 3 will be screened within 33 days prior to dosing. They will be admitted to the clinical research unit (CRU) the day prior to dosing and will remain in the CRU until the end of the PK sample collection period. All participants will return to the clinic for follow-up assessments 7 days ± 1 day after the last dose of study intervention. Participants in Part 3 will also return to the clinic for follow-up assessments 28 days ± 2 days and 42 days ± 2 days after the last dose of study intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: Ledaborbactam etzadroxil, Drug: Ceftibuten, Drug: Ceftibuten-ledaborbactam etzadroxil, Drug: EsomeprazolePart 1 will enroll at least 16 participants who will receive a single oral dose of ceftibuten and ledaborbactam etzadroxil following a 10-hour fast on 3 occasions in a fixed sequence: (a) Ceftibuten and ledaborbactam etzadroxil as separate capsules; (b) Ceftibuten-ledaborbactam etzadroxil as fixed-dose combination (FDC) capsules; (c) Ceftibuten-ledaborbactam etzadroxil as FDC capsules after 5 days of esomeprazole orally once daily |
| Part 2 Group 1 | Experimental | Drug: Ceftibuten-ledaborbactam etzadroxilPart 2 Group 1 will enroll 10 participants. Each will receive oral doses of Ceftibuten-ledaborbactam etzadroxil FDC capsules for 7 days (Fasted Group) |
| Part 2 Group 2 | Experimental | Drug: Ceftibuten-ledaborbactam etzadroxilPart 2 Group 2 will enroll 10 participants. Each will receive oral doses of Ceftibuten-ledaborbactam etzadroxil FDC capsules for 7 days (Fed Group) |
| Part 3 (Groups 1, 2, 4, 5, 6) | Experimental | Drug: Ledaborbactam etzadroxil, Drug: CeftibutenPart 3 will enroll up to 50 participants. Each will receive oral doses of ceftibuten and/or ledaborbactam etzadroxil capsules (combined as FDC when administered together) in fed conditions |
| Part 3 Group 3 | Active comparator | Drug: amoxicillin-clavulanatePart 3 Group 3 will enroll up to 10 participants. Each will receive oral doses of amoxicillin-clavulanate |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adult male or female, between 18 and 55 years of age
- Body mass index ≥ 18 and ≤ 32 kg/m2
- Laboratory values meeting defined laboratory ranges
- Males or non-pregnant, non-lactating females
Key exclusion criteria (3 listed)
- History of any hypersensitivity reaction following administration of a cephalosporin, penicillin, or other β-lactam antibacterial drug
- Any acute illness or surgery within the past 3 months determined by the investigator to be clinically relevant
- Positive alcohol, drug or tobacco use/test
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 |
|---|---|---|
| Ledaborbactam etzadroxilcapsules | Drug | Part 1, Part 3 (Groups 1, 2, 4, 5, 6) |
| Ceftibutencapsules | Drug | Part 1, Part 3 (Groups 1, 2, 4, 5, 6) |
| Ceftibuten-ledaborbactam etzadroxilFixed Dose Combination (FDC) | Drug | Part 1, Part 2 Group 1, Part 2 Group 2 |
| Esomeprazole40 mg capsule | Drug | Part 1 |
| amoxicillin-clavulanate500 mg-125 mg oral doses | Drug | Part 3 Group 3 |
Primary outcome
Part 1 Plasma PK AUC0-∞ (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil)
Time frame: 0 - 48 hours on days 1, 4 and 11
Area under the concentration time curve from time zero to infinity (AUC0-∞)
Part 1 Plasma PK Cmax (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil)
Time frame: 0 - 48 hours on days 1, 4 and 11
Maximum observed concentration (Cmax)
Proportion of participants of Part 2 experiencing Treatment-emergent adverse events (TEAEs), Serious TEAEs, or TEAEs leading to discontinuation.
Time frame: Day 1 thru Day 18 (+/-1)
Participants experiencing Treatment-emergent adverse events (TEAEs), Serious TEAEs, or TEAEs leading to discontinuation.
Proportion of participants of Part 3 experiencing Treatment-emergent adverse events (TEAEs), Serious TEAEs, or TEAEs leading to discontinuation.
Time frame: Day 1 thru Day 49 (± 2 days)
Participants experiencing Treatment-emergent adverse events (TEAEs), Serious TEAEs, or TEAEs leading to discontinuation.
5 secondary outcomes
Proportion of participants of Part 1 experiencing Treatment-emergent adverse events (TEAEs), Serious TEAEs, or TEAEs leading to discontinuation.
Time frame: Day 1 thru Day 18 (+/-1)
Part 2 Plasma PK AUC0-12h (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil)
Time frame: Day 1 and Day 7
Part 2 Plasma PK Cmax (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil)
Time frame: Day 1 and Day 7
Part 3 Plasma PK AUC0-Tau (ceftibuten and/or ledaborbactam)
Time frame: At Day 1 and Day 7
Part 3 Plasma PK Cmax (ceftibuten and/or ledaborbactam)
Time frame: At Day 1 and Day 7
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 9 Jul 2026.
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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.
Kamal Hamed, 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 testing Ledaborbactam etzadroxil, Ceftibuten and Ceftibuten-ledaborbactam etzadroxil in people with Healthy Volunteer and Pharmacokinetics, run by Basilea Pharmaceutica at 1 site in United States.
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 4 inclusion and 3 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 9 Jul 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 United States. 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 Karine Litherland, PhD (+41616061111, Karine.Litherland@basilea.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1 Plasma PK AUC0-∞ (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil) (time frame: 0 - 48 hours on days 1, 4 and 11). 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 9 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.