Clinical trial NCT01529957: A Study of Nemonoxacin Malate Sodium Chloride Injection Administered by Intravenous Infusion
Official title: A Phase I Clinical Study of Nemonoxacin Malate Sodium Chloride Injection Administered by Intravenous Infusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Volunteers
Lead sponsor: TaiGen Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-02-09
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Healthy male or female, aged 18 \~45
2. 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
3. Volunteers who have never used any tobacco or nicotine-containing product within three months before use of the investigational product
4. 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.
5. 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.
6. Volunteers who are able to sign the informed consent form (ICF) of their own accord.

Exclusion Criteria:

1. History of diabetes,or cardiovascular,hepatic or renal disease.
2. Had surgery or trauma within 6 months prior to this study
3. Alcohol or drug abuse
4. HIV, HBV or HCV positive
5. subject used any known hepatic enzyme inducer/hepatic enzyme inhibitor product within 30 days prior to the study
6. Used any prescribed drug (including traditional chinese medicine) within 14 days prior to the study
7. Donated 400ml of blood or plasma within 3 months prior to this study
8. Have an abnormal laboratory examination value that exceeds the normal range by 10%
9. Drug allergies
10. Have cardiac disorders or have a family history of cardiac disorders
11. Have abnormal 12-lead ECG during screening
12. Pregnant or lactating
13. Participated in any study within 3 months prior to this study
14. according to the investigator's judgment, affect the safety or efficacy evaluation.

Primary outcomes:
measure: Adverse event assessment in healthy Chinese volunteer
timeFrame: 46days
measure: Maximum tolerated single dose of nemonoxacin in healthy Chinese volunteers
timeFrame: 32days
Secondary outcomes:
measure: Pharmacokinetic profile of nemonoxacin in healthy Chinese volunteers
timeFrame: 4days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Zhen Hospital, Capital Medical University Beijing
city: Chengdu
country: China
facility: Kunming General Hospital of Chengdu Military Region
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
city: Chongqing
country: China
facility: Second Affiliated Hospital, Third Military Medical University
city: Chongqing
country: China
facility: Third Military Medical University First Affiliated Hospital
city: Chongqing
country: China
facility: Third Military Medical University, Third Affiliated Hospital
city: Dalian
country: China
facility: Second Affiliated Hospital of Dalian Medical University
city: Gansu
country: China
facility: Gansu Provincial People's Hospital
city: Guangzhou
country: China
facility: Guangzhou Red Cross Hospital
city: Guangzhou
country: China
facility: Second Affiliated Hospital of Sun Yat-sen
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
city: Hunan
country: China
facility: Third Xiangya Hospital, Central South University
city: Hunan
country: China
facility: Xiangya Hospital, Central South University
city: Jiangxi
country: China
facility: Jiangxi Provincial People's Hospital
city: Jiangxi
country: China
facility: Second Affiliated Hospital of Nanchang University
city: Liaoning
country: China
facility: Shengjing Hospital of China Medical University
city: Nanjing
country: China
facility: Huai'an First Hospital of Nanjing Medical University
city: Peking
country: China
facility: Peking University First Hospital
city: Peking
country: China
facility: Peking University People's Hospital
city: Qingdao
country: China
facility: Affiliated Hospital of Qingdao University Medical College
city: Shanghai
country: China
facility: Institute of Antibiotics, Huashan Hospital, Fundan University
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
city: Shanghai
country: China
facility: Shanghai Pudong New Area, Oriental Hospital
city: Shenyang
country: China
facility: People's Liberation Army General Hospital of Shenyang Military Region
city: Xi'an
country: China
facility: Second Affiliated Hospital of Xi'an Jiaotong University
city: Zhejiang
country: China
facility: First Affiliated Hospital,Zhejiang University School of Medicine
Study officials:
affiliation: Huashan Hospital, Fundan University
name: Yingyuan Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References: