Clinical Study on Oral Nemonoxacin Malate Capsules

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 study: evaluate safety and tolerability of oral nemonoxacin 125 mg, 250mg, 500mg, 750mg, and 1000mg. Multiple dose study: evaluate PK profile of oral doses of 500mg or 750mg nemo after consecutive 10 days.

Official Title
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Phase I Clinical Study on Oral Nemonoxacin Malate Capsules

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Nemonoxacin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males and females, aged between 18 and 45 during screening Male volunteers who are capable of taking double-barrier contraception measures during the test (spermicide gel plus condom, for instance) until the end of the clinical study and do not cause their spouses to conceive within three months after the last administration of the medication; if the subjects are females, they shall not become pregnant during the test and within three months after the study No use of tobacco or nicotine product within 3 months prior to this study BMI 19-25 Willing to abstain from coffee and any caffeine drink during the study Voluntarily sign the informed consent Exclusion Criteria: History of diabetes, or cardiovascular, hepatic or renal disease Active digestive disease (e.g. diarrhea) Central nervous disease or psychiatric disorders Had surgery or trauma within 6 months prior to this study Alcohol or drug abuse HIV, HBV or HCV positive 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

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 |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Drug: Nemonoxacin<br>* oral once daily<br>* Other names: TG-873870;|
| Active Comparator: Nemonoxacin 125mg<br>Nemonoxacin 125mg | Drug: Nemonoxacin<br>* oral once daily<br>* Other names: TG-873870;|
| Active Comparator: Nemonoxacin 250mg<br>Nemonoxacin 250mg | Drug: Nemonoxacin<br>* oral once daily<br>* Other names: TG-873870;|
| Active Comparator: Nemonoxacin 500mg<br>Nemonoxacin 500mg | Drug: Nemonoxacin<br>* oral once daily<br>* Other names: TG-873870;|
| Active Comparator: Nemonoxacin 750mg<br>Nemonoxacin 750mg | Drug: Nemonoxacin<br>* oral once daily<br>* Other names: TG-873870;|
| Active Comparator: Nemonoxacin 1000mg<br>Nemonoxacin 1000mg | Drug: Nemonoxacin<br>* oral once daily<br>* Other names: TG-873870;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated single oral dose of nemonoxacin in healthy Chinese volunteers |  | 7 days | 
| Pharmacokinetic profile of single oral dose of nemonoxacin in healthy Chinese volunteers |  | 7 days | 
| Pharmacokinetic profile of repeated oral doses of nemonoxacin in healthy Chinese volunteers |  | 17 days |