A Study of Nemonoxacin Malate Sodium Chloride Injection Administered by Intravenous Infusion
This study has been completed.
Sponsor:
TaiGen Biotechnology Co., Ltd.
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
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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:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
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 May 16, 2013