Ceftibuten-ledaborbactam Etzadroxil for Healthy Subjects

Overseen By Venatorx Clinical Science

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Venatorx Pharmaceuticals, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Fernando de Oliveira, MD, PhD, MS

Principal Investigator

Venatorx Pharmaceuticals

Eligibility Criteria

This trial is for healthy adults aged 18-55 with a BMI between 18 and 32 kg/m2. Participants must have lab values within specific ranges and cannot be pregnant or breastfeeding. The study excludes anyone not meeting these health criteria.

Inclusion Criteria

I am a male or a female not pregnant or breastfeeding.

I am a healthy adult aged between 18 and 55.

Body mass index ≥ 18 and ≤ 32 kg/m2

Exclusion Criteria

Positive alcohol, drug or tobacco use/test

History of any hypersensitivity reaction following administration of a cephalosporin, penicillin, or other β-lactam antibacterial drug

I haven't had any significant illness or surgery in the last 3 months.

Treatment Details

Interventions

• Ceftibuten-ledaborbactam Etzadroxil (Combination Therapy)

Trial Overview The study tests a fixed-dose combination of Ceftibuten-ledaborbactam etzadroxil, comparing it to Ledaborbactam etzadroxil, Ceftibuten, and Esomeprazole alone. It's designed to assess safety and how the body processes these drugs in two parts over roughly six weeks.

Participant Groups

Group I: Part 2 Group 3 Experimental Treatment 1 Intervention

Part 2 Group 3 will possibly enroll 10 participants. Following availability of PK and safety data from Groups 1 and 2, a determination will be made regarding whether or not Group 3 is needed and the dosing conditions that apply

Group II: Part 2 Group 2 Experimental Treatment 1 Intervention

Part 2 Group 2 will enroll 10 participants. Each will receive oral doses of Ceftibuten-ledaborbactam etzadroxil as fixed-dose capsules for 7 days (Fed Group)

Group III: Part 2 Group 1 Experimental Treatment 1 Intervention

Part 2 Group 1 will enroll 10 participants. Each will receive oral doses of Ceftibuten-ledaborbactam etzadroxil as fixed-dose capsules for 7 days (Fasted Group)

Group IV: Part 1 Experimental Treatment 4 Interventions

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 capsules; (c) Ceftibuten-ledaborbactam etzadroxil as fixed-dose combination capsules after 5 days of esomeprazole orally once daily

Who Is Running the Clinical Trial?

Venatorx Pharmaceuticals, Inc.

Lead Sponsor

Trials

15

Recruited

1,200+

Biomedical Advanced Research and Development Authority

Collaborator

Trials

108

Recruited

574,000+