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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Nemonoxacin Malate Sodium Chloride

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.

• Study Type: Interventional
• Enrollment (Actual): 176
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Zhen Hospital, Capital Medical University Beijing
  • Chengdu, China
    • West China Hospital of Sichuan University
  • Chengdu, China
    • Kunming General Hospital of Chengdu Military Region
  • Chongqing, 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
  • Dalian, China
    • Second Affiliated Hospital of Dalian Medical University
  • Gansu, China
    • Gansu Provincial People's Hospital
  • Guangzhou, China
    • Guangzhou red cross hospital
  • Guangzhou, China
    • Second Affiliated Hospital of Sun Yat-sen
  • Hangzhou, China
    • Hangzhou First People's Hospital
  • Hunan, China
    • Third Xiangya Hospital, Central South University
  • Hunan, China
    • Xiangya Hospital, Central South University
  • Jiangxi, China
    • Jiangxi Provincial People's Hospital
  • Jiangxi, China
    • Second Affiliated Hospital of Nanchang University
  • Liaoning, China
    • Shengjing Hospital of China Medical University
  • Nanjing, China
    • Huai'an First Hospital of Nanjing Medical University
  • Peking, China
    • Peking University People's Hospital
  • Peking, China
    • Peking University First Hospital
  • Qingdao, China
    • Affiliated Hospital of Qingdao University Medical College
  • Shanghai, China
    • Shanghai Changzheng Hospital
  • Shanghai, China
    • Institute of Antibiotics, Huashan Hospital, Fundan University
  • Shanghai, China
    • Shanghai Pudong New Area, Oriental Hospital
  • Shenyang, China
    • People's Liberation Army General Hospital of Shenyang Military Region
  • Xi'an, China
    • Second Affiliated Hospital of Xi'an JiaoTong University
  • Zhejiang, China
    • First Affiliated Hospital,Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: QUADRUPLE

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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	Drug: Nemonoxacin Malate Sodium Chloride; Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily
ACTIVE_COMPARATOR: Nemonoxacin Malate Sodium Chloride 125 mg	Drug: Nemonoxacin Malate Sodium Chloride; Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily
PLACEBO_COMPARATOR: placebol	Drug: Nemonoxacin Malate Sodium Chloride; Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily
ACTIVE_COMPARATOR: 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	Drug: Nemonoxacin Malate Sodium Chloride; Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily
ACTIVE_COMPARATOR: 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	Drug: Nemonoxacin Malate Sodium Chloride; Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily
ACTIVE_COMPARATOR: 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	Drug: Nemonoxacin Malate Sodium Chloride; Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse event assessment in healthy Chinese volunteer	46days
Maximum tolerated single dose of nemonoxacin in healthy Chinese volunteers	32days

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic profile of nemonoxacin in healthy Chinese volunteers	4days

Collaborators and Investigators

• Sponsor: TaiGen Biotechnology Co., Ltd.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (ACTUAL): March 1, 2011
• Study Completion (ACTUAL): March 1, 2011

Study Registration Dates

• First Submitted: February 3, 2012
• First Submitted That Met QC Criteria: February 8, 2012
• First Posted (ESTIMATE): February 9, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): February 20, 2012
• Last Update Submitted That Met QC Criteria: February 16, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Volunteers
• Other Study ID Numbers: TG-873870-C-2