A Study of Nemonoxacin Malate Sodium Chloride Injection Administered by Intravenous Infusion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TaiGen Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01529957
First received: February 3, 2012
Last updated: February 16, 2012
Last verified: February 2012
  Purpose

The purpose of this study is to evaluate the safety and tolerability of nemonoxacin in healthy Chinese volunteers.


Condition Intervention Phase
Healthy
Drug: Nemonoxacin Malate Sodium Chloride
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I Clinical Study of Nemonoxacin Malate Sodium Chloride Injection Administered by Intravenous Infusion

Resource links provided by NLM:


Further study details as provided by TaiGen Biotechnology Co., Ltd.:

Primary Outcome Measures:
  • Adverse event assessment in healthy Chinese volunteer [ Time Frame: 46days ] [ Designated as safety issue: Yes ]
  • Maximum tolerated single dose of nemonoxacin in healthy Chinese volunteers [ Time Frame: 32days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetic profile of nemonoxacin in healthy Chinese volunteers [ Time Frame: 4days ] [ Designated as safety issue: Yes ]

Enrollment: 176
Study Start Date: September 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nemonoxacin Malate Sodium Chloride 25 mg
Nemonoxacin Malate Sodium Chloride 25 mg
Drug: Nemonoxacin Malate Sodium Chloride
Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily
Active Comparator: Nemonoxacin Malate Sodium Chloride 50 mg
Nemonoxacin Malate Sodium Chloride 50 mg
Drug: Nemonoxacin Malate Sodium Chloride
Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily
Active Comparator: Nemonoxacin Malate Sodium Chloride 125 mg
Nemonoxacin Malate Sodium Chloride 125 mg
Drug: Nemonoxacin Malate Sodium Chloride
Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily
Placebo Comparator: placebol
placebol
Drug: Nemonoxacin Malate Sodium Chloride
Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily
Active Comparator: Nemonoxacin Malate Sodium Chloride 250 mg
Nemonoxacin Malate Sodium Chloride 250 mg
Drug: Nemonoxacin Malate Sodium Chloride
Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily
Active Comparator: Nemonoxacin Malate Sodium Chloride 500 mg
Nemonoxacin Malate Sodium Chloride 500 mg
Drug: Nemonoxacin Malate Sodium Chloride
Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily
Active Comparator: Nemonoxacin Malate Sodium Chloride 650 mg
Nemonoxacin Malate Sodium Chloride 650 mg
Drug: Nemonoxacin Malate Sodium Chloride
Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily
Active Comparator: Nemonoxacin Malate Sodium Chloride 750 mg
Nemonoxacin Malate Sodium Chloride 750 mg
Drug: Nemonoxacin Malate Sodium Chloride
Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily
Active Comparator: Nemonoxacin Malate Sodium Chloride 1000 mg
Nemonoxacin Malate Sodium Chloride 1000 mg
Drug: Nemonoxacin Malate Sodium Chloride
Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily
Active Comparator: Nemonoxacin Malate Sodium Chloride 1250 mg
Nemonoxacin Malate Sodium Chloride 1250 mg
Drug: Nemonoxacin Malate Sodium Chloride
Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01529957

Locations
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
Third Military Medical University, Third Affiliated Hospital
Chongqing, China
Second Affiliated Hospital, Third Military Medical University
Chongqing, China
Third Military Medical University First 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
Xiangya Hospital, Central South University
Hunan, China
Third 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
Peking University People's Hospital
Peking, China
Peking University First Hospital
Peking, China
Affiliated Hospital of Qingdao University Medical College
Qingdao, China
Shanghai Changzheng Hospital
Shanghai, China
Institute of Antibiotics, Huashan Hospital, Fundan University
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
Sponsors and Collaborators
TaiGen Biotechnology Co., Ltd.
Investigators
Principal Investigator: Yingyuan Zhang, PhD Huashan Hospital, Fundan University
  More Information

No publications provided

Responsible Party: TaiGen Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT01529957     History of Changes
Other Study ID Numbers: TG-873870-C-2
Study First Received: February 3, 2012
Last Updated: February 16, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by TaiGen Biotechnology Co., Ltd.:
Volunteers

ClinicalTrials.gov processed this record on July 24, 2014