Healthy VolunteerPhase 1NCT06462326
A Study to Compare the Effect of Omadacycline Versus Moxifloxacin in Healthy Adult Volunteers
A Phase 1 study testing Moxifloxacin Oral Tablet and Omadacycline Oral Tablet in people with Healthy Volunteer, run by Zai Lab (Hong Kong), Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Moxifloxacin Oral Tablet and Omadacycline Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 16 Apr 2024to 29 Sep 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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) -
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou
About this study
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
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.
Read the 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 System/Interactive Web Response System (IxRS) and receive the first dose of the study drug.
- Conditions
- Healthy Volunteer
- Being tested
- Moxifloxacin Oral Tablet, Omadacycline Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxifloxacin Oral TabletDrug
Also called Avelox
400mg per tablet
Omadacycline Oral TabletDrug
Also called NUZYRA
150 mg per tablet
| Study group | Role | What they receive |
|---|---|---|
| Moxifloxacin | Active comparator | Moxifloxacin PO (400 mg)q24h D1-D10 Receives: Drug: Moxifloxacin Oral Tablet |
| Omadacycline | Experimental | Omadacycline PO (450 mg) q24h D1-D2 PO (300 mg) q24h D3-D10 Receives: Drug: Omadacycline Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 .
Measured: 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.
Measured: 3months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start16 Apr 2024
- Primary completion29 Sep 2024
- Study completion29 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zai Lab (Hong Kong), Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jian Liu, Principal investigator, Zhejiang UniversityYonghong Xiao, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462326
- Sponsor's protocol ID
- ZL-2401-005
- Status last verified
- Oct 2024
- First submitted
- 29 Apr 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06462326
- Acronym / sponsor ID
- ZL-2401-005
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Zai Lab (Hong Kong), Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 29 Sep 2024 (actual)
- Study completion
- 29 Sep 2024 (actual)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 System/Interactive Web Response System (IxRS) and receive the first dose of the study drug.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moxifloxacin | Active comparator | Drug: Moxifloxacin Oral TabletMoxifloxacin PO (400 mg)q24h D1-D10 |
| Omadacycline | Experimental | Drug: Omadacycline Oral TabletOmadacycline PO (450 mg) q24h D1-D2 PO (300 mg) q24h D3-D10 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moxifloxacin Oral TabletAlso: Avelox400mg per tablet | Drug | Moxifloxacin |
| Omadacycline Oral TabletAlso: NUZYRA150 mg per tablet | Drug | Omadacycline |
Primary outcome
Changes in the types of microbial resistomes.
Time frame: 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.
Time frame: 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.
Time frame: 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.
2 secondary outcomes
Changes in the microbial composition
Time frame: 3months
Changes in the microbial functionality
Time frame: 3months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian Liu principal investigator
Zhejiang University
Yonghong Xiao principal investigator
Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Moxifloxacin Oral Tablet and Omadacycline Oral Tablet in people with Healthy Volunteer, run by Zai Lab (Hong Kong), Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the types of microbial resistomes. (time frame: 3months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2024.