A Study to Compare the Effect of Omadacycline Versus Moxifloxacin in Healthy Adult Volunteers
NCT Number: NCT06462326
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Volunteer
Interventions: DRUG: Moxifloxacin Oral Tablet|DRUG: Omadacycline Oral Tablet
Sponsor: Zai Lab (Hong Kong), Ltd.
Sex: ALL
Age: ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-04-16
Completion Date: 2024-07-30
Locations: The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China

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.

Primary Outcome Measures: Changes in the types of microbial resistomes., Metagenome will be extracted from fecal samples of ME population and subjected to second-generation high-throughput sequencing. Bioinformatics will be employed to study the changes in the types of resistance-related genes of microbiota during the drug administration process in the microbiologically evaluable population. This outcome is based on second-generation high-throughput sequencing. the outcome is to test the genes to confirm the changes in types of microbial resistors in different stages., 3months|Changes in the quantity of microbial resistomes., Metagenome will be extracted from fecal samples of ME population and subjected to second-generation high-throughput sequencing. Bioinformatics will be employed to study the changes in the quantity of resistance-related genes of microbiota during the drug administration process in the microbiologically evaluable population.This outcome is based on second-generation high-throughput sequencing. the outcome is to test the gene to confirm the changes in quantity of microbial resistors in different stages ., 3months|Changes in the abundance of microbial resistomes., Metagenome will be extracted from fecal samples of ME population and subjected to second-generation high-throughput sequencing. Bioinformatics will be employed to study the changes in the abundance of resistance-related genes of microbiota during the drug administration process in the microbiologically evaluable population.This outcome is based on second-generation high-throughput sequencing. the outcome is to test the genes to confirm the changes in abundance of microbial resistors in different stages., 3months
Secondary Outcome Measures: Changes in the microbial composition, Metagenome will be extracted from fecal samples of ME population and subjected to second-generation high-throughput sequencing. Principal component analysis will be employed to study the changes in the structure of microbiota during the drug administration process in the microbiologically evaluable population. This outcome is based on the result of principal component analysis to confirm the microbial composition in different stages based on different genes., 3months|Changes in the microbial functionality, Metagenome will be extracted from fecal samples of ME population and subjected to second-generation high-throughput sequencing. Principal coordinates analysis will be employed to study the changes in the structure of microbiota during the drug administration process in the microbiologically evaluable population. This outcome is based on result of principal coordinates analysis to confirm the microbial functionality in different stages based on different genes., 3months