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

February 3, 2012
February 16, 2012
September 2008
March 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01529957 on ClinicalTrials.gov Archive Site
Pharmacokinetic profile of nemonoxacin in healthy Chinese volunteers [ Time Frame: 4days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Healthy
Drug: Nemonoxacin Malate Sodium Chloride
Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily
  • Active Comparator: Nemonoxacin Malate Sodium Chloride 25 mg
    Nemonoxacin Malate Sodium Chloride 25 mg
    Intervention: Drug: Nemonoxacin Malate Sodium Chloride
  • Active Comparator: Nemonoxacin Malate Sodium Chloride 50 mg
    Nemonoxacin Malate Sodium Chloride 50 mg
    Intervention: Drug: Nemonoxacin Malate Sodium Chloride
  • Active Comparator: Nemonoxacin Malate Sodium Chloride 125 mg
    Nemonoxacin Malate Sodium Chloride 125 mg
    Intervention: Drug: Nemonoxacin Malate Sodium Chloride
  • Placebo Comparator: placebol
    placebol
    Intervention: Drug: Nemonoxacin Malate Sodium Chloride
  • Active Comparator: Nemonoxacin Malate Sodium Chloride 250 mg
    Nemonoxacin Malate Sodium Chloride 250 mg
    Intervention: Drug: Nemonoxacin Malate Sodium Chloride
  • Active Comparator: Nemonoxacin Malate Sodium Chloride 500 mg
    Nemonoxacin Malate Sodium Chloride 500 mg
    Intervention: Drug: Nemonoxacin Malate Sodium Chloride
  • Active Comparator: Nemonoxacin Malate Sodium Chloride 650 mg
    Nemonoxacin Malate Sodium Chloride 650 mg
    Intervention: Drug: Nemonoxacin Malate Sodium Chloride
  • Active Comparator: Nemonoxacin Malate Sodium Chloride 750 mg
    Nemonoxacin Malate Sodium Chloride 750 mg
    Intervention: Drug: Nemonoxacin Malate Sodium Chloride
  • Active Comparator: Nemonoxacin Malate Sodium Chloride 1000 mg
    Nemonoxacin Malate Sodium Chloride 1000 mg
    Intervention: Drug: Nemonoxacin Malate Sodium Chloride
  • Active Comparator: Nemonoxacin Malate Sodium Chloride 1250 mg
    Nemonoxacin Malate Sodium Chloride 1250 mg
    Intervention: Drug: Nemonoxacin Malate Sodium Chloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
176
March 2011
March 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01529957
TG-873870-C-2
No
TaiGen Biotechnology Co., Ltd.
TaiGen Biotechnology Co., Ltd.
Not Provided
Principal Investigator: Yingyuan Zhang, PhD Huashan Hospital, Fundan University
TaiGen Biotechnology Co., Ltd.
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP