Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Omadacycline · 1 trial · 1 indication
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.
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 .
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.
| Arm | Type | Description |
|---|---|---|
| Moxifloxacin | ACTIVE_COMPARATOR | Moxifloxacin PO (400 mg)q24h D1-D10 |
| Omadacycline | EXPERIMENTAL | Omadacycline PO (450 mg) q24h D1-D2 PO (300 mg) q24h D3-D10 |
| Name | Type | Description |
|---|---|---|
| Moxifloxacin Oral Tablet | DRUG | 400mg per tablet |
| Omadacycline Oral Tablet | DRUG | 150 mg per tablet |
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 ...
Omadacycline is a small molecule being studied in healthy adult volunteers. It is currently in Phase 1 clinical development, with a completed trial comparing it to moxifloxacin. The drug is being developed by Zai Lab Limited and is intended for use in healthy volunteer studies.
Omadacycline is a small molecule, but its specific molecular target has not been disclosed in the available information. The drug is being studied in a Phase 1 clinical trial to compare its effects with moxifloxacin in healthy adult volunteers.
Omadacycline is being developed by Zai Lab Limited, a biopharmaceutical company listed on the stock exchange under the ticker ZLAB. The company is conducting clinical trials for this drug, with one Phase 1 study completed in China.
Omadacycline is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. A Phase 1 trial has been completed, and the drug is being studied in healthy adult volunteers.
Omadacycline has one completed Phase 1 clinical trial with the identifier NCT06462326. This study compared omadacycline versus moxifloxacin in healthy adult volunteers in China, enrolling 24 participants. The trial was randomized, double-blind, and active-controlled.
No, Omadacycline is not the same as moxifloxacin. They are different drugs being compared in a clinical trial. The Phase 1 study NCT06462326 evaluated the effect of omadacycline versus moxifloxacin in healthy adult volunteers to assess their comparative effects.