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

NCT06462326 | Completed Phase 1 FDA Drug

• 1 other identifier: ZL-2401-005
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Changes in the microbial composition

  3months

• Changes in the microbial functionality

  3months

Study Arms (2)

Moxifloxacin

ACTIVE COMPARATOR

Moxifloxacin PO (400 mg)q24h D1-D10

Drug: Moxifloxacin Oral Tablet

Omadacycline

EXPERIMENTAL

Omadacycline PO (450 mg) q24h D1-D2 PO (300 mg) q24h D3-D10

Drug: Omadacycline Oral Tablet

Interventions

Moxifloxacin Oral Tablet DRUG

400mg per tablet

Also known as: Avelox

Moxifloxacin

Omadacycline Oral Tablet DRUG

150 mg per tablet

Also known as: NUZYRA

Omadacycline

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Sign an Informed Consent Form (ICF) prior to the commencement of any study-related procedures.
• Chinese healthy male and female subjects aged between 18 and 40 years (inclusive).
• Body mass index (BMI) between 18.5 and 23.9 kg/m2 (inclusive).
• Complete the stool sample collections required during screening.

You may not qualify if:

• Subjects with clinically significant medical history of cardiovascular, hepatic, renal, gastrointestinal or psychiatric conditions, or any other condition as deemed by the investigators that may potentially jeopardize subject safety or impact study outcomes.
• Subjects who have undergone any major surgery within 4 weeks prior to the first dose of study drug administration.
• Subjects who have previously undergone gastrointestinal surgery that may affect the absorption of the study drug (eg. Intestinal resection surgery, fistula surgery).
• During screening, subjects with positive tests for hepatitis C antibodies, hepatitis B surface antigen, or hepatitis B virus (HBV) DNA or HBV RNA, or known positive tests for human immunodeficiency virus (HIV).
• Subjects with Fridericia-corrected QT interval (QTcF) \> 450 milliseconds (males) or \> 470 milliseconds (females); or known to have long QT syndrome; or using medications that may cause arrhythmia or prolong QT interval, and/or experiencing tachyarrhythmia.
• Subjects with a history of irritable bowel syndrome (with or without constipation) -

Sponsors & Collaborators

• Zai Lab (Hong Kong), Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, China

Location

MeSH Terms

Interventions

Moxifloxacin; omadacycline

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jian Liu

  Zhejiang University

  PRINCIPAL INVESTIGATOR

• Yonghong Xiao

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: June 17, 2024
• Study Start: April 16, 2024
• Primary Completion: September 29, 2024
• Study Completion: September 29, 2024
• Last Updated: November 1, 2024

Record last verified: 2024-10

Locations

CN (1)