NCT04482569

Study to Evaluate Safety, Tolerability, and Pharmacokinetics of XNW4107 Alone or in Combination With Imipenem/Cilastatin

A Phase 1, Randomized, Double Blind, Placebo Controlled Sequential Group Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of XNW4107 for Injection, and Multiple Doses of XNW4107 for Injection in Combination With Imipenem/Cilastatin for Injection in Healthy Adult Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Evopoint Biosciences Inc. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a 3-part, first-in-human study to evaluate the safety, tolerability and pharmacokinetics of escalating doses of XNW4107 given as intravenous (IV) infusion in healthy male subjects. In part 1, subjects will receive a single dose of XNW4107. In part 2, subjects will receive XNW4107 for 7 days. In Part 3, subjects will receive XNW4107 in combination with imipenem/cilastatin for 14 days.

Conditions

• Bacterial Infections

Interventions

Type	Name	Description
DRUG	XNW4107	Single or multiple dose ascending study for XNW4107 alone or multiple dose study of XNW4107 in combination with imipenem/cilastatin

Timeline

• Start date: 2020-07-10
• Primary completion: 2021-02-28
• Completion: 2021-09-30
• First posted: 2020-07-22
• Last updated: 2023-02-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study