NCT04802863

Intrapulmonary Pharmacokinetics of XNW4107, Imipenem and Cilastatin in Healthy Subjects

A Phase 1, Open-label Study to Evaluate the Safety and Intrapulmonary Pharmacokinetics of XNW4107, Imipenem and Cilastatin in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Evopoint Biosciences Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, open-label, single-center study of XNW4107 and imipenem/cilastatin administered intravenously.

Conditions

• Bacterial Infections

Interventions

Type	Name	Description
DRUG	XNW4107, Imipenem/Cilastatin	Five doses of 250 mg XNW4107 in combination with 500 mg imipenem/500 mg cilastatin

Timeline

• Start date: 2021-03-25
• Primary completion: 2021-05-15
• Completion: 2021-09-30
• First posted: 2021-03-17
• Last updated: 2023-02-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study