Image

Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination

Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination

Recruiting
18-55 years
All
Phase 1

Powered by AI

Overview

This is a Phase 1, open-label, two-part, study in approximately 46 healthy adult participants between 18 and 55 years of age (both inclusive) (at least 16 participants in Part 1 and up to 30 participants in Part 2). 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 and 43 days for Part 2. All participants will be screened within 28 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.

Eligibility

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study details
    Healthy Volunteer
    Pharmacokinetics
    Safety
    Drug-Drug Interaction (DDI)
    FDC

NCT06733675

Basilea Pharmaceutica

31 January 2026

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.