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Safety and Intrapulmonary Pharmacokinetics of Cefepime and Taniborbactam in Healthy Subjects

NCT04951505 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-06-08

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Subjects

Interventions

DRUG

cefepime-taniborbactam

IV infusion

Sponsors & Collaborators

  • Venatorx Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-29
Primary Completion
2021-09-27
Completion
2021-09-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04951505 on ClinicalTrials.gov