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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Nemonoxacin Malate Sodium Chloride

• Registration Number: NCT01529957
• Lead Sponsor: TaiGen Biotechnology Co., Ltd.

Brief Summary

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

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 Timeline

• Study Start: 2008-09
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2012-02
• Study First Submitted: 2012-02-03
• Study First Submitted QC: 2012-02-08
• Study First Posted: 2012-02-09
• Last Update Submitted: 2012-02-16
• Last Update Posted: 2012-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nemonoxacin Malate Sodium Chloride 50 mg	Nemonoxacin Malate Sodium Chloride	Nemonoxacin Malate Sodium Chloride 50 mg
Nemonoxacin Malate Sodium Chloride 125 mg	Nemonoxacin Malate Sodium Chloride	Nemonoxacin Malate Sodium Chloride 125 mg
Nemonoxacin Malate Sodium Chloride 750 mg	Nemonoxacin Malate Sodium Chloride	Nemonoxacin Malate Sodium Chloride 750 mg
Nemonoxacin Malate Sodium Chloride 25 mg	Nemonoxacin Malate Sodium Chloride	Nemonoxacin Malate Sodium Chloride 25 mg
placebol	Nemonoxacin Malate Sodium Chloride	placebol
Nemonoxacin Malate Sodium Chloride 250 mg	Nemonoxacin Malate Sodium Chloride	Nemonoxacin Malate Sodium Chloride 250 mg
Nemonoxacin Malate Sodium Chloride 500 mg	Nemonoxacin Malate Sodium Chloride	Nemonoxacin Malate Sodium Chloride 500 mg
Nemonoxacin Malate Sodium Chloride 650 mg	Nemonoxacin Malate Sodium Chloride	Nemonoxacin Malate Sodium Chloride 650 mg
Nemonoxacin Malate Sodium Chloride 1000 mg	Nemonoxacin Malate Sodium Chloride	Nemonoxacin Malate Sodium Chloride 1000 mg
Nemonoxacin Malate Sodium Chloride 1250 mg	Nemonoxacin Malate Sodium Chloride	Nemonoxacin Malate Sodium Chloride 1250 mg

Primary Outcome Measures

Name	Time	Method
Adverse event assessment in healthy Chinese volunteer	46days
Maximum tolerated single dose of nemonoxacin in healthy Chinese volunteers	32days

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic profile of nemonoxacin in healthy Chinese volunteers	4days

Trial Locations

Locations (26)

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

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