Ignite Creation Date:
2024-07-17 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06462326
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-04-29
Brief Title:
A Study to Compare the Effect of Omadacycline Versus Moxifloxacin in Healthy Adult Volunteers
Sponsor:
Zai Lab Hong Kong Ltd
Organization:
Zai Lab Hong Kong Ltd
Study Overview
Official Title:
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:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized 11 double-blind double-dummy phase I study to compare the effects of Omadacycline versus Moxifloxacin on gut microbiota and the resistomes in healthy adult volunteersThe 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 SystemInteractive 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 SystemInteractive Web Response System IxRS and receive the first dose of the study drug
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None