NCT04801043

To Evaluate the Pharmacokinetics of XNW4107 in Healthy Adult Young Females and in Healthy Adult Elderly Males and Females.

A Phase 1, Single-Dose, Randomized, Double Blind, Placebo-Controlled Study to Evaluate Pharmacokinetics, Safety and Tolerability of XNW4107 for Injection in Healthy Adult Young Females and in Healthy Adult Elderly Males and Females.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Evopoint Biosciences Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, randomized, double-blind, placebo-controlled study to assess the PK, safety and tolerability of XNW4107, imipenem and cilastatin administered by 60-min (± 3 min) IV infusion in healthy adult young females and in healthy adult elderly males and females.

Conditions

• Bacterial Infections

Interventions

Type	Name	Description
DRUG	XNW4107	XNW4107 250mg IV over 60 minutes as a single dose
DRUG	Imipenem/Cilastatin	500mg/500mg IV over 60 minutes as a single dose
DRUG	placebo	Matching placebo to XNW4107 containing the same inactive ingredients IV over 60 minutes as a single dose Matching placebo to Imipenem/Cilastatin 0.9% sodium chloride IV over 60 minutes as a single dose

Timeline

• Start date: 2021-03-02
• Primary completion: 2021-10-30
• Completion: 2022-01-31
• First posted: 2021-03-16
• Last updated: 2023-02-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study