Infections Caused by Anaerobic BacteriaPhase 1NCT07033182
Pharmacokinetics and Safety Study of Levornidazole Disodium Phosphate for Injection in Subjects With Renal Impairment and Normal Renal Impairment
A Phase 1 study testing Levornidazole Disodium Phosphate for Injection in people with Infections Caused by Anaerobic Bacteria and Renal Impairment, run by Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd at 1 site in China.
Trial summary
To evaluate the pharmacokinetics and safety of a single intravenous dose of levornidazole disodium phosphate for injection in subjects with moderate and severe renal impairment and healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Infections Caused by Anaerobic Bacteria, Renal Impairment
- What is being tested?
- Levornidazole Disodium Phosphate for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2023to 13 Jun 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -
- Inclusion criteria（Group A and B-Severe Renal Impairment Group and Moderate Renal Impairment Group）:
- Subjects who are able to understand and willing to complete the study in strict compliance with the clinical protocol and sign the informed consent form.
- Male or female subjects aged 18-75 years (inclusive).
- Weight ≥ 50.0 kg for males, or ≥ 45.0 kg for females, and body mass index (BMI) in the range of 19.0 ~ 30.0 kg/m2 (inclusive).
- Subjects with diagnosis of chronic kidney disease and/or absolute eGFR did not change significantly within 1 month before screening, absolute eGFR met the renal function classification criteria in the corresponding group at screening, severe renal insufficiency, absolute eGFR: 15 ~ 29 mL/min; moderate renal insufficiency, absolute eGFR: 30 ~ 59 mL/min.
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- Subjects of childbearing potential (including partners), voluntarily take appropriate contraceptive measures from 2 weeks before screening to 3 months after dosing.
- Subjects who are able to understand and willing to complete the study in strict compliance with the clinical protocol and sign the informed consent form.
- Male and female subjects aged 18 - 75 years (inclusive) were matched with subjects in groups A and B for age (mean ± 10 years) and gender (mean ± 1 case of gender in groups A and B).
- Weight ≥ 50.0 kg for males, or ≥ 45.0 kg for females, and body mass index (BMI) in the range of 19.0 ~ 30.0 kg/m2, matched with BMI of subjects in groups A and B(mean ± 15%).
- Normal renal function, 90 mL/min ≤ absolute eGFR < 130 mL/min.
- Screening physical examination, vital signs, 12-lead electrocardiogram, laboratory tests, imaging and abdominal ultrasonography results were normal or abnormal but the investigator judged no clinical significance.
- Subjects of childbearing potential (including partners), voluntarily take appropriate contraceptive measures from 2 weeks before screening to 3 months after dosing.
Who cannot join
- -
- Exclusion criteria(Group A and B-Severe Renal Impairment Group and Moderate Renal Impairment Group):
- Subjects who are known to be allergic to levornidazole phosphate disodium, levornidazole, ornidazole, other nitroimidazoles or their excipients, or have a history of drug or food allergy, or have a history of specific allergic diseases (such as asthma, urticaria, eczema, etc.).
- Subjects who have special dietary requirements,who cannot accept a unified diet.
- Subjects who have poor peripheral venous access or cannot tolerate venous puncture or have a history of needle and blood fainting.
- Subjects who have received renal transplantation and/or require renal dialysis during the study.
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- Subjects combined with cardiovascular, respiratory, digestive, endocrine, malignant tumor, hematopoietic, mental/nervous system serious diseases in addition to the disease causing renal dysfunction itself, which are considered not suitable for participation by the investigator.
- Subjects with other clinically significant abnormalities except for laboratory tests, physical examination, vital signs, 12-lead electrocardiogram, imaging tests, and abdominal ultrasonography that are judged to be caused by renal insufficiency and its associated diseases, such as ALT (alanine aminotransferase) and/or AST (aspartate aminotransferase) > 2 times the upper limit of normal and/or TBIL (total bilirubin) > 1.5 times the upper limit of normal; Hb (hemoglobin) < 80 g/L; QTc > 450 ms in men and QTc > 470 ms in women.
- Subjects with poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) or heart rate > 120 bmp.
- Patients with diabetic nephropathy HbAlc (glycosylated hemoglobin) > 8.5% or fasting blood glucose > 8.5 mmol/L, or stable treatment regimen for less than 1 month before screening.
- Subjects with clinically significant abnormalities in any of hepatitis B virus surface antigen, Treponema pallidum-specific antibody, human immunodeficiency virus antibody, hepatitis C virus antibody.
- Subjects with a history of drug abuse, drug use within 6 months before screening, or positive drug abuse screening.
- Subjects who frequently consume alcohol within 3 months prior to screening, i.e., consuming more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% spirits, or 150 mL of wine), or who cannot stop using any alcohol products during the study, or alcohol breath test result > 0.0 mg/100 mL.
- Subjects who have donated blood or experienced massive blood loss (> 400 mL) within 3 months prior to screening, received blood transfusions or used blood products, planned to donate blood during the trial period or within 1 month after the end of the trial.
- Subjects who have consumed excessive tea, coffee and/or caffeine-containing beverages (more than 8 cups, 1 cup ≈ 250 mL) daily during the 3 months before screening.
- Subjects smoke an average of 5 or more cigarettes per day within 3 months prior to screening, or those who cannot stop using any tobacco products during the study.
- Subjects who have participated in any clinical trial within 3 months prior to screening, or plan to participate in other clinical trials during the study.
- Subjects who have received any surgery or severe trauma that may affect the safety of the trial or the process of drug in vivo within 30 days before screening, or plan to undergo surgery during the study.
- Subjects who have received vaccination within 30 days prior to screening, or plan to receive vaccination during the study.
- Subjects who have used any drugs that inhibit or induce hepatic metabolism of drugs within 30 days before administration.
- Subjects who have used any prescription drugs, over-the-counter drugs, vitamin products, health products or Chinese herbal medicines other than those for the treatment of renal insufficiency and or its concomitant chronic diseases within 14 days before administration.
- Subjects who started taking new drugs, dosage forms or adjusted current doses for the treatment of chronic kidney disease and its combined chronic diseases within 14 days before administration.
- Subjects who have consumed grapefruit, pomelo, pitaya, mango and other fruits or related products affecting metabolic enzymes within 7 days before administration.
- Subjects who have consumed xanthine-rich, caffeine-containing or alcohol-containing beverages or foods (such as animal viscera, coffee, strong tea, chocolate, cola, etc.) within 48 hours before administration.
- Lactating women, or women who test positive for pregnancy.
- Subjects with acute illness from screening to prior to administration.
- Those who, in the opinion of the investigator, are not suitable for inclusion.
- Subjects who are known to be allergic to levornidazole phosphate disodium, levornidazole, ornidazole, other nitroimidazoles or their excipients, or have a history of drug or food allergy, or have a history of specific allergic diseases (such as asthma, urticaria, eczema, etc.).
- Subjects who have special dietary requirements,who cannot accept a unified diet.
- Subjects who have poor peripheral venous access or cannot tolerate venous puncture or have a history of needle and blood fainting.
- Subjects who have a history of serious diseases and chronic diseases such as respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, mental system.
- Those who are positive in any index screening of hepatitis B virus surface antigen, Treponema pallidum-specific antibody, human immunodeficiency virus antibody,or hepatitis C virus antibody；
- Subjects with a history of drug abuse, drug use within 6 months before screening, or positive drug abuse screening;
- Subjects who frequently consume alcohol within 3 months prior to screening, i.e., consuming more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% spirits, alcohol or 150 mL of wine), or who cannot stop using any alcohol products during the study, or whose alcohol breath test result > 0.0 mg/100 mL;
- Subjects who have donated blood or experienced massive blood loss (> 400 mL) within 3 months prior to screening, received blood transfusions or used blood products, planned to donate blood during the trial period or within 1 month after the end of the trial;
- Subjects who have consumed excessive tea, coffee and/or caffeine-containing beverages (more than 8 cups, 1 cup ≈ 250 mL) daily during the 3 months before screening;
- Subjects smoke an average of 5 or more cigarettes per day within 3 months prior to screening, or those who cannot stop using any tobacco products during the study.
- Subjects who have participated in any clinical trial within 3 months prior to screening, or plan to participate in other clinical trials during the study.
- Subjects who have received any surgery or severe trauma that may affect the safety of the trial or the process of drug in vivo within 30 days before screening, or plan to undergo surgery during the study.
- Subjects who have received vaccination within 30 days prior to screening, or plan to receive vaccination during the study.
- Subjects who have used any drugs that inhibit or induce hepatic metabolism of drugs within 30 days before administration.
- Subjects who have taken any prescription drugs, over-the-counter drugs, health products, vitamins, and Chinese herbal medicines within 14 days before administration.
- Subjects who have consumed grapefruit, pomelo, pitaya, mango and other fruits or related products affecting metabolic enzymes within 7 days before administration.
- Subjects who have consumed xanthine-rich, caffeine-containing or alcohol-containing beverages or foods (such as animal viscera, coffee, strong tea, chocolate, cola, etc.) within 48 hours before administration.
- Lactating women, or women who test positive for pregnancy.
- Subjects with acute illness from screening to prior to administration.
- Those who, in the opinion of the investigator, are not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Parallel, Single-Dose Study to Assess the Pharmacokinetics and Safety of Levornidazole Disodium Phosphate for Injection in Subjects With Varying Degrees of Renal Impairment
To evaluate the pharmacokinetics and safety of a single intravenous dose of levornidazole disodium phosphate for injection in subjects with moderate and severe renal impairment and healthy subjects.
- Being tested
- Levornidazole Disodium Phosphate for Injection
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levornidazole Disodium Phosphate for InjectionDrug
Single dose, IV
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group A | Experimental | Severe renal impairment Receives: Drug: Levornidazole Disodium Phosphate for Injection |
| Experimental Group B | Experimental | Moderate renal impairment Receives: Drug: Levornidazole Disodium Phosphate for Injection |
| Experimental Group C | Experimental | Normal renal function Receives: Drug: Levornidazole Disodium Phosphate for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC0-t) of levornidazole
Measured: From Day 1 to Day 5
Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of levornidazole
Measured: From Day 1 to Day 5
Maximum Observed Plasma Concentration (Cmax) of levornidazole
Measured: From Day 1 to Day 5
Clearance (CL) of levornidazole
Measured: From Day 1 to Day 5
The Volume of Distribution (Vd) of levornidazole
Measured: From Day 1 to Day 5
Time of Maximum Observed Plasma Concentration (Tmax) of levornidazole
Measured: From Day 1 to Day 5
Apparent Terminal Elimination Half-life (t1/2) of levornidazole
Measured: From Day 1 to Day 5
Mean Residence Time (MRT0-t) of levornidazole
Measured: From Day 1 to Day 5
Renal Excretion (Ae) of levornidazole
Measured: From Day 1 to Day 5
renal clearance (CLR) of levornidazole
Measured: From Day 1 to Day 5
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: From Day 1 to Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start30 Oct 2023
- Primary completion7 Apr 2024
- Study completion13 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections Caused by Anaerobic BacteriaStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033182
- Sponsor's protocol ID
- YZJ-ZAXZ-403
- Status last verified
- Jun 2025
- First submitted
- 13 Jun 2025
- Last updated
- 29 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Parallel, Single-Dose Study to Assess the Pharmacokinetics and Safety of Levornidazole Disodium Phosphate for Injection in Subjects With Varying Degrees of Renal Impairment
- ClinicalTrials.gov ID
- NCT07033182
- Acronym / sponsor ID
- YZJ-ZAXZ-403
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. LtdIndustry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Zhengzhou University
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 7 Apr 2024 (actual)
- Study completion
- 13 Jun 2024 (actual)
- First posted
- 24 Jun 2025 (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.
To evaluate the pharmacokinetics and safety of a single intravenous dose of levornidazole disodium phosphate for injection in subjects with moderate and severe renal impairment and healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Group A | Experimental | Drug: Levornidazole Disodium Phosphate for InjectionSevere renal impairment |
| Experimental Group B | Experimental | Drug: Levornidazole Disodium Phosphate for InjectionModerate renal impairment |
| Experimental Group C | Experimental | Drug: Levornidazole Disodium Phosphate for InjectionNormal renal function |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- -
- Inclusion criteria（Group A and B-Severe Renal Impairment Group and Moderate Renal Impairment Group）:
- Subjects who are able to understand and willing to complete the study in strict compliance with the clinical protocol and sign the informed consent form.
- Male or female subjects aged 18-75 years (inclusive).
- Weight ≥ 50.0 kg for males, or ≥ 45.0 kg for females, and body mass index (BMI) in the range of 19.0 ~ 30.0 kg/m2 (inclusive).
Key exclusion criteria (47 listed)
- -
- Exclusion criteria(Group A and B-Severe Renal Impairment Group and Moderate Renal Impairment Group):
- Subjects who are known to be allergic to levornidazole phosphate disodium, levornidazole, ornidazole, other nitroimidazoles or their excipients, or have a history of drug or food allergy, or have a history of specific allergic diseases (such as asthma, urticaria, eczema, etc.).
- Subjects who have special dietary requirements,who cannot accept a unified diet.
- Subjects who have poor peripheral venous access or cannot tolerate venous puncture or have a history of needle and blood fainting.
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 |
|---|---|---|
| Levornidazole Disodium Phosphate for InjectionSingle dose, IV | Drug | Experimental Group A, Experimental Group B, Experimental Group C |
Primary outcome
Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC0-t) of levornidazole
Time frame: From Day 1 to Day 5
Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of levornidazole
Time frame: From Day 1 to Day 5
Maximum Observed Plasma Concentration (Cmax) of levornidazole
Time frame: From Day 1 to Day 5
Clearance (CL) of levornidazole
Time frame: From Day 1 to Day 5
The Volume of Distribution (Vd) of levornidazole
Time frame: From Day 1 to Day 5
Time of Maximum Observed Plasma Concentration (Tmax) of levornidazole
Time frame: From Day 1 to Day 5
Apparent Terminal Elimination Half-life (t1/2) of levornidazole
Time frame: From Day 1 to Day 5
Mean Residence Time (MRT0-t) of levornidazole
Time frame: From Day 1 to Day 5
Renal Excretion (Ae) of levornidazole
Time frame: From Day 1 to Day 5
renal clearance (CLR) of levornidazole
Time frame: From Day 1 to Day 5
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Day 1 to Day 9
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 29 Jun 2026.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Levornidazole Disodium Phosphate for Injection in people with Infections Caused by Anaerobic Bacteria and Renal Impairment, run by Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. 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 13 inclusion and 47 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 29 Jun 2026. 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?
Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC0-t) of levornidazole (time frame: From Day 1 to Day 5). The study lists 11 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 29 Jun 2026.