A Study of Nemonoxacin Malate Sodium Chloride Injection Administered by Intravenous Infusion
- Registration Number
- NCT01529957
- Lead Sponsor
- TaiGen Biotechnology Co., Ltd.
- Brief Summary
The purpose of this study is to evaluate the safety and tolerability of nemonoxacin in healthy Chinese volunteers.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 176
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nemonoxacin Malate Sodium Chloride 50 mg Nemonoxacin Malate Sodium Chloride Nemonoxacin Malate Sodium Chloride 50 mg Nemonoxacin Malate Sodium Chloride 125 mg Nemonoxacin Malate Sodium Chloride Nemonoxacin Malate Sodium Chloride 125 mg Nemonoxacin Malate Sodium Chloride 750 mg Nemonoxacin Malate Sodium Chloride Nemonoxacin Malate Sodium Chloride 750 mg Nemonoxacin Malate Sodium Chloride 25 mg Nemonoxacin Malate Sodium Chloride Nemonoxacin Malate Sodium Chloride 25 mg placebol Nemonoxacin Malate Sodium Chloride placebol Nemonoxacin Malate Sodium Chloride 250 mg Nemonoxacin Malate Sodium Chloride Nemonoxacin Malate Sodium Chloride 250 mg Nemonoxacin Malate Sodium Chloride 500 mg Nemonoxacin Malate Sodium Chloride Nemonoxacin Malate Sodium Chloride 500 mg Nemonoxacin Malate Sodium Chloride 650 mg Nemonoxacin Malate Sodium Chloride Nemonoxacin Malate Sodium Chloride 650 mg Nemonoxacin Malate Sodium Chloride 1000 mg Nemonoxacin Malate Sodium Chloride Nemonoxacin Malate Sodium Chloride 1000 mg Nemonoxacin Malate Sodium Chloride 1250 mg Nemonoxacin Malate Sodium Chloride Nemonoxacin Malate Sodium Chloride 1250 mg
- Primary Outcome Measures
Name Time Method Adverse event assessment in healthy Chinese volunteer 46days Maximum tolerated single dose of nemonoxacin in healthy Chinese volunteers 32days
- Secondary Outcome Measures
Name Time Method Pharmacokinetic profile of nemonoxacin in healthy Chinese volunteers 4days
Trial Locations
- Locations (26)
Guangzhou Red Cross Hospital
π¨π³Guangzhou, China
Third Military Medical University, Third Affiliated Hospital
π¨π³Chongqing, China
Zhen Hospital, Capital Medical University Beijing
π¨π³Beijing, China
Second Affiliated Hospital of Nanchang University
π¨π³Jiangxi, China
Shanghai Changzheng Hospital
π¨π³Shanghai, China
Shanghai Pudong New Area, Oriental Hospital
π¨π³Shanghai, China
Kunming General Hospital of Chengdu Military Region
π¨π³Chengdu, China
West China Hospital of Sichuan University
π¨π³Chengdu, China
Second Affiliated Hospital, Third Military Medical University
π¨π³Chongqing, China
Third Military Medical University First Affiliated Hospital
π¨π³Chongqing, China
Second Affiliated Hospital of Dalian Medical University
π¨π³Dalian, China
Gansu Provincial People's Hospital
π¨π³Gansu, China
Second Affiliated Hospital of Sun Yat-sen
π¨π³Guangzhou, China
Hangzhou First People's Hospital
π¨π³Hangzhou, China
Xiangya Hospital, Central South University
π¨π³Hunan, China
Jiangxi Provincial People's Hospital
π¨π³Jiangxi, China
Shengjing Hospital of China Medical University
π¨π³Liaoning, China
Peking University First Hospital
π¨π³Peking, China
Peking University People's Hospital
π¨π³Peking, China
Affiliated Hospital of Qingdao University Medical College
π¨π³Qingdao, China
Second Affiliated Hospital of Xi'an Jiaotong University
π¨π³Xi'an, China
Third Xiangya Hospital, Central South University
π¨π³Hunan, China
Institute of Antibiotics, Huashan Hospital, Fundan University
π¨π³Shanghai, China
First Affiliated Hospital,Zhejiang University School of Medicine
π¨π³Zhejiang, China
People's Liberation Army General Hospital of Shenyang Military Region
π¨π³Shenyang, China
Huai'an First Hospital of Nanjing Medical University
π¨π³Nanjing, China