HealthyPhase 1NCT01529957
A Study of Nemonoxacin Malate Sodium Chloride Injection Administered by Intravenous Infusion
A Phase 1 study testing Nemonoxacin Malate Sodium Chloride in people with Healthy, run by TaiGen Biotechnology Co., Ltd. at 26 sites in China.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of nemonoxacin in healthy Chinese volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Nemonoxacin Malate Sodium Chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 26 sitesChina
- Study dates
- Sep 2008to Mar 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
China26 sites
Peking University First Hospital
Beijing
Peking University People's Hospital
Beijing
Zhen Hospital, Capital Medical University Beijing
Beijing
Kunming General Hospital of Chengdu Military Region
Chengdu
West China Hospital of Sichuan University
Chengdu
Second Affiliated Hospital, Third Military Medical University
Chongqing
Third Military Medical University First Affiliated Hospital
Chongqing
Third Military Medical University, Third Affiliated Hospital
Chongqing
Second Affiliated Hospital of Dalian Medical University
Dalian
Gansu Provincial People's Hospital
Gansu
Guangzhou Red Cross Hospital
Guangzhou
Second Affiliated Hospital of Sun Yat-sen
Guangzhou
Hangzhou First People's Hospital
Hangzhou
Third Xiangya Hospital, Central South University
Hunan
Xiangya Hospital, Central South University
Hunan
Jiangxi Provincial People's Hospital
Jiangxi
Second Affiliated Hospital of Nanchang University
Jiangxi
Shengjing Hospital of China Medical University
Liaoning
Huai'an First Hospital of Nanjing Medical University
Nanjing
Affiliated Hospital of Qingdao University Medical College
Qingdao
Institute of Antibiotics, Huashan Hospital, Fundan University
Shanghai
Shanghai Changzheng Hospital
Shanghai
Shanghai Pudong New Area, Oriental Hospital
Shanghai
People's Liberation Army General Hospital of Shenyang Military Region
Shenyang
Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an
First Affiliated Hospital,Zhejiang University School of Medicine
Zhejiang
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Nemonoxacin Malate Sodium Chloride
- Keywords
- Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nemonoxacin Malate Sodium ChlorideDrug
Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily
| Study group | Role | What they receive |
|---|---|---|
| Nemonoxacin Malate Sodium Chloride 25 mg | Active comparator | Nemonoxacin Malate Sodium Chloride 25 mg Receives: Drug: Nemonoxacin Malate Sodium Chloride |
| Nemonoxacin Malate Sodium Chloride 50 mg | Active comparator | Nemonoxacin Malate Sodium Chloride 50 mg Receives: Drug: Nemonoxacin Malate Sodium Chloride |
| Nemonoxacin Malate Sodium Chloride 125 mg | Active comparator | Nemonoxacin Malate Sodium Chloride 125 mg Receives: Drug: Nemonoxacin Malate Sodium Chloride |
| placebol | Placebo comparator | placebol Receives: Drug: Nemonoxacin Malate Sodium Chloride |
| Nemonoxacin Malate Sodium Chloride 250 mg | Active comparator | Nemonoxacin Malate Sodium Chloride 250 mg Receives: Drug: Nemonoxacin Malate Sodium Chloride |
| Nemonoxacin Malate Sodium Chloride 500 mg | Active comparator | Nemonoxacin Malate Sodium Chloride 500 mg Receives: Drug: Nemonoxacin Malate Sodium Chloride |
| Nemonoxacin Malate Sodium Chloride 650 mg | Active comparator | Nemonoxacin Malate Sodium Chloride 650 mg Receives: Drug: Nemonoxacin Malate Sodium Chloride |
| Nemonoxacin Malate Sodium Chloride 750 mg | Active comparator | Nemonoxacin Malate Sodium Chloride 750 mg Receives: Drug: Nemonoxacin Malate Sodium Chloride |
| Nemonoxacin Malate Sodium Chloride 1000 mg | Active comparator | Nemonoxacin Malate Sodium Chloride 1000 mg Receives: Drug: Nemonoxacin Malate Sodium Chloride |
| Nemonoxacin Malate Sodium Chloride 1250 mg | Active comparator | Nemonoxacin Malate Sodium Chloride 1250 mg Receives: Drug: Nemonoxacin Malate Sodium Chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event assessment in healthy Chinese volunteer
Measured: 46days
Maximum tolerated single dose of nemonoxacin in healthy Chinese volunteers
Measured: 32days
Secondary outcomes (1)
Pharmacokinetic profile of nemonoxacin in healthy Chinese volunteers
Measured: 4days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2012 (estimated)
- Study startSep 2008
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- TaiGen Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yingyuan Zhang, PhD, Principal investigator, Huashan Hospital, Fundan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01529957
- Sponsor's protocol ID
- TG-873870-C-2
- Status last verified
- Feb 2012
- First submitted
- 3 Feb 2012
- Last updated
- 20 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study of Nemonoxacin Malate Sodium Chloride Injection Administered by Intravenous Infusion
- ClinicalTrials.gov ID
- NCT01529957
- Acronym / sponsor ID
- TG-873870-C-2
- Conditions
- Healthy
- Keywords
- Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- TaiGen Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 9 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Nemonoxacin Malate Sodium Chloride 25 mg | Active comparator | Drug: Nemonoxacin Malate Sodium ChlorideNemonoxacin Malate Sodium Chloride 25 mg |
| Nemonoxacin Malate Sodium Chloride 50 mg | Active comparator | Drug: Nemonoxacin Malate Sodium ChlorideNemonoxacin Malate Sodium Chloride 50 mg |
| Nemonoxacin Malate Sodium Chloride 125 mg | Active comparator | Drug: Nemonoxacin Malate Sodium ChlorideNemonoxacin Malate Sodium Chloride 125 mg |
| placebol | Placebo comparator | Drug: Nemonoxacin Malate Sodium Chlorideplacebol |
| Nemonoxacin Malate Sodium Chloride 250 mg | Active comparator | Drug: Nemonoxacin Malate Sodium ChlorideNemonoxacin Malate Sodium Chloride 250 mg |
| Nemonoxacin Malate Sodium Chloride 500 mg | Active comparator | Drug: Nemonoxacin Malate Sodium ChlorideNemonoxacin Malate Sodium Chloride 500 mg |
| Nemonoxacin Malate Sodium Chloride 650 mg | Active comparator | Drug: Nemonoxacin Malate Sodium ChlorideNemonoxacin Malate Sodium Chloride 650 mg |
| Nemonoxacin Malate Sodium Chloride 750 mg | Active comparator | Drug: Nemonoxacin Malate Sodium ChlorideNemonoxacin Malate Sodium Chloride 750 mg |
| Nemonoxacin Malate Sodium Chloride 1000 mg | Active comparator | Drug: Nemonoxacin Malate Sodium ChlorideNemonoxacin Malate Sodium Chloride 1000 mg |
| Nemonoxacin Malate Sodium Chloride 1250 mg | Active comparator | Drug: Nemonoxacin Malate Sodium ChlorideNemonoxacin Malate Sodium Chloride 1250 mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nemonoxacin Malate Sodium ChlorideNemonoxacin Malate Sodium Chloride,intravenous injection,once daily | Drug | Nemonoxacin Malate Sodium Chloride 1000 mg, Nemonoxacin Malate Sodium Chloride 125 mg, Nemonoxacin Malate Sodium Chloride 1250 mg, Nemonoxacin Malate Sodium Chloride 25 mg, Nemonoxacin Malate Sodium Chloride 250 mg, Nemonoxacin Malate Sodium Chloride 50 mg, Nemonoxacin Malate Sodium Chloride 500 mg, Nemonoxacin Malate Sodium Chloride 650 mg, Nemonoxacin Malate Sodium Chloride 750 mg, placebol |
Primary outcome
Adverse event assessment in healthy Chinese volunteer
Time frame: 46days
Maximum tolerated single dose of nemonoxacin in healthy Chinese volunteers
Time frame: 32days
1 secondary outcome
Pharmacokinetic profile of nemonoxacin in healthy Chinese volunteers
Time frame: 4days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yingyuan Zhang, PhD principal investigator
Huashan Hospital, Fundan University
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nemonoxacin Malate Sodium Chloride in people with Healthy, run by TaiGen Biotechnology Co., Ltd. at 26 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event assessment in healthy Chinese volunteer (time frame: 46days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2012.