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Clinical Trial Summary

This study will evaluate the safety, efficacy, and PK of low dose (750 mg) and high-dose (1250 mg) XG005 oral tablets compared with placebo in subjects undergoing bunionectomy. Subjects will be confined in the clinic from check-in through 72 hours post-surgery to monitor subject safety.


Clinical Trial Description

This is a multi-center, randomized, double-blind, parallel-group, placebo-controlled study. Eligible subjects will be randomized in a 1:1:1 ratio to receive either 750 mg XG005, 1250 mg XG005, or placebo, twice a day, post bunionectomy surgery in domiciled clinic. Subjects and all study staff performing study assessments will be blinded to treatment allocation. Subjects will be discharged at a reasonable hour of the day after the end of the 72-hour treatment period.There will be a Follow-up Visit on Day 15. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06017999
Study type Interventional
Source Xgene Pharmaceutical Group
Contact Joey Chang
Phone 312-468-5090
Email joey.chang@xgenepharm.com
Status Recruiting
Phase Phase 2/Phase 3
Start date August 8, 2023
Completion date August 30, 2024

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