A Study of Nemonoxacin Malate Sodium Chloride Injection Administered by Intravenous Infusion
A Phase I Clinical Study of Nemonoxacin Malate Sodium Chloride Injection Administered by Intravenous Infusion
1 other identifier
interventional
176
1 country
26
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of nemonoxacin in healthy Chinese volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Sep 2008
Longer than P75 for phase_1 healthy
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 3, 2012
CompletedFirst Posted
Study publicly available on registry
February 9, 2012
CompletedFebruary 20, 2012
February 1, 2012
2.5 years
February 3, 2012
February 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Adverse event assessment in healthy Chinese volunteer
46days
Maximum tolerated single dose of nemonoxacin in healthy Chinese volunteers
32days
Secondary Outcomes (1)
Pharmacokinetic profile of nemonoxacin in healthy Chinese volunteers
4days
Study Arms (10)
Nemonoxacin Malate Sodium Chloride 25 mg
ACTIVE COMPARATORNemonoxacin Malate Sodium Chloride 25 mg
Nemonoxacin Malate Sodium Chloride 50 mg
ACTIVE COMPARATORNemonoxacin Malate Sodium Chloride 50 mg
Nemonoxacin Malate Sodium Chloride 125 mg
ACTIVE COMPARATORNemonoxacin Malate Sodium Chloride 125 mg
placebol
PLACEBO COMPARATORplacebol
Nemonoxacin Malate Sodium Chloride 250 mg
ACTIVE COMPARATORNemonoxacin Malate Sodium Chloride 250 mg
Nemonoxacin Malate Sodium Chloride 500 mg
ACTIVE COMPARATORNemonoxacin Malate Sodium Chloride 500 mg
Nemonoxacin Malate Sodium Chloride 650 mg
ACTIVE COMPARATORNemonoxacin Malate Sodium Chloride 650 mg
Nemonoxacin Malate Sodium Chloride 750 mg
ACTIVE COMPARATORNemonoxacin Malate Sodium Chloride 750 mg
Nemonoxacin Malate Sodium Chloride 1000 mg
ACTIVE COMPARATORNemonoxacin Malate Sodium Chloride 1000 mg
Nemonoxacin Malate Sodium Chloride 1250 mg
ACTIVE COMPARATORNemonoxacin Malate Sodium Chloride 1250 mg
Interventions
Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Peking University First Hospital
Beijing, China
Peking University People's Hospital
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
Study Officials
- PRINCIPAL INVESTIGATOR
Yingyuan Zhang, PhD
Huashan Hospital, Fundan University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2012
First Posted
February 9, 2012
Study Start
September 1, 2008
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
February 20, 2012
Record last verified: 2012-02