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The purpose of this study is to evaluate the safety and tolerability of nemonoxacin in healthy Chinese volunteers.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nemonoxacin Malate Sodium Chloride 25 mg | Active Comparator | Nemonoxacin Malate Sodium Chloride 25 mg |
|
| Nemonoxacin Malate Sodium Chloride 50 mg | Active Comparator | Nemonoxacin Malate Sodium Chloride 50 mg |
|
| Nemonoxacin Malate Sodium Chloride 125 mg | Active Comparator | Nemonoxacin Malate Sodium Chloride 125 mg |
|
| placebol | Placebo Comparator | placebol |
|
| Nemonoxacin Malate Sodium Chloride 250 mg | Active Comparator | Nemonoxacin Malate Sodium Chloride 250 mg |
|
| Nemonoxacin Malate Sodium Chloride 500 mg | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nemonoxacin Malate Sodium Chloride | Drug | Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event assessment in healthy Chinese volunteer | 46days | |
| Maximum tolerated single dose of nemonoxacin in healthy Chinese volunteers | 32days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile of nemonoxacin in healthy Chinese volunteers | 4days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yingyuan Zhang, PhD | Huashan Hospital, Fundan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | China | ||||
| Peking University People's Hospital |
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Nemonoxacin Malate Sodium Chloride 500 mg
|
| Nemonoxacin Malate Sodium Chloride 650 mg | Active Comparator | Nemonoxacin Malate Sodium Chloride 650 mg |
|
| Nemonoxacin Malate Sodium Chloride 750 mg | Active Comparator | Nemonoxacin Malate Sodium Chloride 750 mg |
|
| Nemonoxacin Malate Sodium Chloride 1000 mg | Active Comparator | Nemonoxacin Malate Sodium Chloride 1000 mg |
|
| Nemonoxacin Malate Sodium Chloride 1250 mg | Active Comparator | Nemonoxacin Malate Sodium Chloride 1250 mg |
|
| Beijing |
| China |
| Zhen Hospital, Capital Medical University Beijing | Beijing | China |
| Kunming General Hospital of Chengdu Military Region | Chengdu | China |
| West China Hospital of Sichuan University | Chengdu | China |
| Second Affiliated Hospital, Third Military Medical University | Chongqing | China |
| Third Military Medical University First Affiliated Hospital | Chongqing | China |
| Third Military Medical University, Third Affiliated Hospital | Chongqing | China |
| Second Affiliated Hospital of Dalian Medical University | Dalian | China |
| Gansu Provincial People's Hospital | Gansu | China |
| Guangzhou Red Cross Hospital | Guangzhou | China |
| Second Affiliated Hospital of Sun Yat-sen | Guangzhou | China |
| Hangzhou First People's Hospital | Hangzhou | China |
| Third Xiangya Hospital, Central South University | Hunan | China |
| Xiangya Hospital, Central South University | Hunan | China |
| Jiangxi Provincial People's Hospital | Jiangxi | China |
| Second Affiliated Hospital of Nanchang University | Jiangxi | China |
| Shengjing Hospital of China Medical University | Liaoning | China |
| Huai'an First Hospital of Nanjing Medical University | Nanjing | China |
| Affiliated Hospital of Qingdao University Medical College | Qingdao | China |
| Institute of Antibiotics, Huashan Hospital, Fundan University | Shanghai | China |
| Shanghai Changzheng Hospital | Shanghai | China |
| Shanghai Pudong New Area, Oriental Hospital | Shanghai | China |
| People's Liberation Army General Hospital of Shenyang Military Region | Shenyang | China |
| Second Affiliated Hospital of Xi'an Jiaotong University | Xi'an | China |
| First Affiliated Hospital,Zhejiang University School of Medicine | Zhejiang | China |