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Omadacycline

Phase 3

Undisclosed | Small molecule | Other |Zai Lab Limited|Trials Updated: Nov 1, 2024

Omadacycline development status

Highest phase Phase 3 (NCT06162286)
Phase scored for ZLABPhase 1
Registered trials 1 across 1 sponsor since Dec 2023

Omadacycline target and mechanism

ModalitySmall molecule

Also known as Omadacycline Oral Tablet

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Omadacycline clinical trials

Omadacycline · 1 trial · 1 indication

Phase 1 1
NCT06462326A Study to Compare the Effect of Omadacycline Versus Moxifloxacin in Healthy Adult VolunteersHealthy Volunteer
COMPLETED24 Analytics
PHASE1COMPLETED
A Study to Compare the Effect of Omadacycline Versus Moxifloxacin in Healthy Adult Volunteers
Healthy VolunteerUnlock trial analytics

Study Endpoints

Primary Endpoints

Changes in the types of microbial resistomes.
3months

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.

Changes in the quantity of microbial resistomes.
3months

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 .

Changes in the abundance of microbial resistomes.
3months

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.

Secondary Endpoints

Changes in the microbial composition
3months
Changes in the microbial functionality
3months
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeHEALTH_SERVICES_RESEARCH

Treatment Arms

ArmTypeDescription
MoxifloxacinACTIVE_COMPARATORMoxifloxacin PO (400 mg)q24h D1-D10
OmadacyclineEXPERIMENTALOmadacycline PO (450 mg) q24h D1-D2 PO (300 mg) q24h D3-D10

Interventions

NameTypeDescription
Moxifloxacin Oral TabletDRUG400mg per tablet
Omadacycline Oral TabletDRUG150 mg per tablet
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Eligibility Criteria

Age Range18 Years to 40 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Sign an Informed Consent Form (ICF) prior to the commencement of any study-related procedures. 2. Chinese healthy male and female subjects aged between 18 and 40 years (inclusive). 3. Body mass index (BMI) between 18.5 and 23.9 kg/m2 (inclusive). 4. Complete the stool sample ...

Countries:China
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Frequently asked questions about Omadacycline

What is omadacycline?

Omadacycline is a small molecule drug being developed by Zai Lab Limited under the ticker ZLAB. It is also known as omadacycline oral tablet. The compound is in Phase 1 clinical development, with one completed trial in healthy adult volunteers conducted in China.

Who is developing omadacycline?

Omadacycline is being developed by Zai Lab Limited, which trades under the ticker ZLAB. The company is responsible for the clinical program, including the completed Phase 1 trial in China.

What phase is omadacycline in?

Omadacycline is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is omadacycline in?

Omadacycline has been studied in one completed Phase 1 trial, NCT06462326, titled "A Study to Compare the Effect of Omadacycline Versus Moxifloxacin in Healthy Adult Volunteers." The trial enrolled 24 healthy volunteers in China and was randomized, double-blind, and active-controlled.

Is omadacycline the same as omadacycline oral tablet?

Yes, omadacycline oral tablet is an alternative name for omadacycline. Both refer to the same small molecule drug being developed by Zai Lab Limited under ticker ZLAB.