A Study of Nemonoxacin Malate Sodium Chloride Injection Administered by Intravenous Infusion

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and tolerability of nemonoxacin in healthy Chinese volunteers.

Detailed Description
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Single dose safety and tolerability study: evaluate safety and tolerability of intravenous infusion nemonoxacin 25mg, 50mg, 125mg, 250mg, 500mg, 750mg, 1000mg and 1250mg. Single dose pharmacokinetic (PK) study:evaluate PK profile of doses of 250mg, 500mg or 750mg intravenous infusion nemonoxacin . Multiple dose study: evaluate PK profile of doses of 500mg, 650mg or 750mg intravenous infusion nemonoxacin after consecutive 10 days.

Official Title
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A Phase I Clinical Study of Nemonoxacin Malate Sodium Chloride Injection Administered by Intravenous Infusion

Conditions
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Healthy

Intervention / Treatment
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* Drug: Nemonoxacin Malate Sodium Chloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male or female, aged 18  45 A male volunteer should be willing to use a double-barrier contraception until the study is completed, and should not make his partner pregnant during the study and within 3 months after completing the study Volunteers who have never used any tobacco or nicotine-containing product within three months before use of the investigational product Volunteers who are willing to abstain from caffeine- or xanthine- containing drinks or food within 24h before being enrolled in the study and throughout the study,such as coffee and tea,chocolate,alcohol, grapefruit juice,orange juice,etc. The body mass index (BMI) of the volunteer must be 19 24, and the weight of a male should be at least 50kg,and that of a female should be at least 45kg. Volunteers who are able to sign the informed consent form (ICF) of their own accord. Exclusion Criteria: History of diabetes,or cardiovascular,hepatic or renal disease. Had surgery or trauma within 6 months prior to this study Alcohol or drug abuse HIV, HBV or HCV positive subject used any known hepatic enzyme inducer/hepatic enzyme inhibitor product within 30 days prior to the study Used any prescribed drug (including traditional chinese medicine) within 14 days prior to the study Donated 400ml of blood or plasma within 3 months prior to this study Have an abnormal laboratory examination value that exceeds the normal range by 10% Drug allergies Have cardiac disorders or have a family history of cardiac disorders Have abnormal 12-lead ECG during screening Pregnant or lactating Participated in any study within 3 months prior to this study according to the investigator's judgment, affect the safety or efficacy evaluation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nemonoxacin Malate Sodium Chloride 25 mg<br>Nemonoxacin Malate Sodium Chloride 25 mg | Drug: Nemonoxacin Malate Sodium Chloride<br>* Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily<br>|
| Active Comparator: Nemonoxacin Malate Sodium Chloride 50 mg<br>Nemonoxacin Malate Sodium Chloride 50 mg | Drug: Nemonoxacin Malate Sodium Chloride<br>* Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily<br>|
| Active Comparator: Nemonoxacin Malate Sodium Chloride 125 mg<br>Nemonoxacin Malate Sodium Chloride 125 mg | Drug: Nemonoxacin Malate Sodium Chloride<br>* Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily<br>|
| Placebo Comparator: placebol<br>placebol | Drug: Nemonoxacin Malate Sodium Chloride<br>* Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily<br>|
| Active Comparator: Nemonoxacin Malate Sodium Chloride 250 mg<br>Nemonoxacin Malate Sodium Chloride 250 mg | Drug: Nemonoxacin Malate Sodium Chloride<br>* Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily<br>|
| Active Comparator: Nemonoxacin Malate Sodium Chloride 500 mg<br>Nemonoxacin Malate Sodium Chloride 500 mg | Drug: Nemonoxacin Malate Sodium Chloride<br>* Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily<br>|
| Active Comparator: Nemonoxacin Malate Sodium Chloride 650 mg<br>Nemonoxacin Malate Sodium Chloride 650 mg | Drug: Nemonoxacin Malate Sodium Chloride<br>* Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily<br>|
| Active Comparator: Nemonoxacin Malate Sodium Chloride 750 mg<br>Nemonoxacin Malate Sodium Chloride 750 mg | Drug: Nemonoxacin Malate Sodium Chloride<br>* Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily<br>|
| Active Comparator: Nemonoxacin Malate Sodium Chloride 1000 mg<br>Nemonoxacin Malate Sodium Chloride 1000 mg | Drug: Nemonoxacin Malate Sodium Chloride<br>* Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily<br>|
| Active Comparator: Nemonoxacin Malate Sodium Chloride 1250 mg<br>Nemonoxacin Malate Sodium Chloride 1250 mg | Drug: Nemonoxacin Malate Sodium Chloride<br>* Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event assessment in healthy Chinese volunteer |  | 46days | 
| Maximum tolerated single dose of nemonoxacin in healthy Chinese volunteers |  | 32days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic profile of nemonoxacin in healthy Chinese volunteers |  | 4days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Volunteers