Healthy
Conditions
Keywords
Volunteers
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.
Interventions
DRUGNemonoxacin Malate Sodium Chloride
Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily
Sponsors
TaiGen Biotechnology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event assessment in healthy Chinese volunteer | 46days |
| Maximum tolerated single dose of nemonoxacin in healthy Chinese volunteers | 32days |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic profile of nemonoxacin in healthy Chinese volunteers | 4days |
Countries
China
Outcome results
None listed