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NCT Number: NCT04951505

Safety and Intrapulmonary Pharmacokinetics of Cefepime and Taniborbactam in Healthy Subjects

This is a single-center, open-label study to assess the safety and intrapulmonary pharmacokinetics of cefepime and taniborbactam in healthy adult male and female subjects. Thirty subjects will receive a total of 6 doses of cefepime-taniborbactam (2 g cefepime/0.5g taniborbactam) administered intravenously every 8 hours. Following the sixth dose of cefepime-taniborbactam, subjects will be assigned to one of six bronchoscopy sampling times.

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Key information

Conditions

Healthy Subjects

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pulmonary Associates PA

Phoenix, Arizona, 85032, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adults 18-55 years
  • Males or non-pregnant, non-lactating females
  • Body mass index (BMI): ≥18 kg/m2 and ≤32.0 kg/m2, weight >50.0 kg.
  • Must have negative alcohol, drug, or tobacco use/test and no use of alcohol, caffeine during the study

Exclusion criteria

  • History or presence of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorders
  • History of drug allergy or hypersensitivity to penicillin, cephalosporin, or beta-lactam antibacterial drug
  • Recent history of known or suspected Clostridioides difficile infection
  • Abnormal ECG or history of clinically significant abnormal rhythm disorder
  • Abnormal lab tests

Treatment and study plan

cefepime-taniborbactam

Drug

IV infusion

Primary outcomes

  1. ELF Cmax

    Time frame: 0-8 hours after 6th dose

    Maximum concentrations of cefepime and taniborbactam, determined directly from individual concentration-time data, in epithelial lining fluid (ELF)

Secondary outcomes

  1. Number of subjects with adverse events

    Time frame: Day 1 - Day 8

Sponsors and collaborators

Lead sponsor

Venatorx Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Phase 1 Study to Evaluate the Safety and Intrapulmonary Pharmacokinetics of Cefepime and Taniborbactam in Healthy Subjects

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 6, 2021
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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