NCT06462326

A Study to Compare the Effect of Omadacycline Versus Moxifloxacin in Healthy Adult Volunteers

A Phase 1, Randomized, Double-Blind Study to Compare the Effect of Omadacycline PO Versus Moxifloxacin PO on the Gut Microbiota in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Zai Lab (Hong Kong), Ltd. · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This is a randomized (1:1), double-blind, double-dummy, phase I study to compare the effects of Omadacycline versus Moxifloxacin on gut microbiota and the resistomes in healthy adult volunteers.The study consists of 3 phases: Screening, double-blind treatment, and follow-up. Healthy volunteers aged 18-40 years, who meet entry criteria, are randomly assigned to a treatment group using an Interactive Voice Response System/Interactive Web Response System (IxRS) and receive the first dose of the study drug.

Detailed description

The study consists of 3 phases: Screening, double-blind treatment, and follow-up. Healthy volunteers aged 18-40 years, who meet entry criteria, are randomly assigned to a treatment group using an Interactive Voice Response System/Interactive Web Response System (IxRS) and receive the first dose of the study drug.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	Moxifloxacin Oral Tablet	400mg per tablet
DRUG	Omadacycline Oral Tablet	150 mg per tablet

Timeline

• Start date: 2024-04-16
• Primary completion: 2024-09-29
• Completion: 2024-09-29
• First posted: 2024-06-17
• Last updated: 2024-11-01

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study