Healthy VolunteersPhase 1NCT01395108
Clinical Study on Oral Nemonoxacin Malate Capsules
A Phase 1 study testing Nemonoxacin in people with Healthy Volunteers, run by TaiGen Biotechnology Co., Ltd. at 1 site 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 Volunteers
- What is being tested?
- Nemonoxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- Jan 2008to Aug 2008
- 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 males and females, aged between 18 and 45 during screening
- Male volunteers who are capable of taking double-barrier contraception measures during the test (spermicide gel plus condom, for instance) until the end of the clinical study and do not cause their spouses to conceive within three months after the last administration of the medication; if the subjects are females, they shall not become pregnant during the test and within three months after the study
- No use of tobacco or nicotine product within 3 months prior to this study
- BMI 19-25
- Willing to abstain from coffee and any caffeine drink during the study
- Voluntarily sign the informed consent
Who cannot join
- History of diabetes, or cardiovascular, hepatic or renal disease
- Active digestive disease (e.g. diarrhea)
- Central nervous disease or psychiatric disorders
- Had surgery or trauma within 6 months prior to this study
- Alcohol or drug abuse
- HIV, HBV or HCV positive
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Antibiotics, Huashan Hospital, Fundan University
Shanghai, 200040
About this study
Official title: Phase I Clinical Study on Oral Nemonoxacin Malate Capsules
The purpose of this study is to evaluate the safety and tolerability of nemonoxacin in healthy Chinese volunteers.
Read the detailed description
Single dose study: evaluate safety and tolerability of oral nemonoxacin 125 mg, 250mg, 500mg, 750mg, and 1000mg.
Multiple dose study: evaluate PK profile of oral doses of 500mg or 750mg nemo after consecutive 10 days.
- Conditions
- Healthy Volunteers
- Being tested
- Nemonoxacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NemonoxacinDrug
Also called TG-873870
oral once daily
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Nemonoxacin |
| Nemonoxacin 125mg | Active comparator | Nemonoxacin 125mg Receives: Drug: Nemonoxacin |
| Nemonoxacin 250mg | Active comparator | Nemonoxacin 250mg Receives: Drug: Nemonoxacin |
| Nemonoxacin 500mg | Active comparator | Nemonoxacin 500mg Receives: Drug: Nemonoxacin |
| Nemonoxacin 750mg | Active comparator | Nemonoxacin 750mg Receives: Drug: Nemonoxacin |
| Nemonoxacin 1000mg | Active comparator | Nemonoxacin 1000mg Receives: Drug: Nemonoxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated single oral dose of nemonoxacin in healthy Chinese volunteers
Measured: 7 days
Pharmacokinetic profile of single oral dose of nemonoxacin in healthy Chinese volunteers
Measured: 7 days
Pharmacokinetic profile of repeated oral doses of nemonoxacin in healthy Chinese volunteers
Measured: 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2011 (estimated)
- Study startJan 2008
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- TaiGen Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Yingyuan Zhang, PhD, Principal investigator, Huashan Hospital, Fundan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01395108
- Sponsor's protocol ID
- TG-873870-C-1
- Status last verified
- Jul 2011
- First submitted
- 13 Jul 2011
- Last updated
- 15 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Guo B, Wu X, Zhang Y, Shi Y, Yu J, Cao G, Zhang J. Safety and clinical pharmacokinetics of nemonoxacin, a novel non-fluorinated quinolone, in healthy Chinese volunteers following single and multiple oral doses. Clin Drug Investig. 2012 Jul 1;32(7):475-86. doi: 10.2165/11632780-000000000-00000.
PubMed 22650326
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study on Oral Nemonoxacin Malate Capsules
- ClinicalTrials.gov ID
- NCT01395108
- Acronym / sponsor ID
- TG-873870-C-1
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- TaiGen Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 15 Jul 2011 (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 study: evaluate safety and tolerability of oral nemonoxacin 125 mg, 250mg, 500mg, 750mg, and 1000mg.
Multiple dose study: evaluate PK profile of oral doses of 500mg or 750mg nemo 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
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: NemonoxacinPlacebo |
| Nemonoxacin 125mg | Active comparator | Drug: NemonoxacinNemonoxacin 125mg |
| Nemonoxacin 250mg | Active comparator | Drug: NemonoxacinNemonoxacin 250mg |
| Nemonoxacin 500mg | Active comparator | Drug: NemonoxacinNemonoxacin 500mg |
| Nemonoxacin 750mg | Active comparator | Drug: NemonoxacinNemonoxacin 750mg |
| Nemonoxacin 1000mg | Active comparator | Drug: NemonoxacinNemonoxacin 1000mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy males and females, aged between 18 and 45 during screening
- Male volunteers who are capable of taking double-barrier contraception measures during the test (spermicide gel plus condom, for instance) until the end of the clinical study and do not cause their spouses to conceive within three months after the last administration of the medication; if the subjects are females, they shall not become pregnant during the test and within three months after the study
- No use of tobacco or nicotine product within 3 months prior to this study
- BMI 19-25
- Willing to abstain from coffee and any caffeine drink during the study
Key exclusion criteria (14 listed)
- History of diabetes, or cardiovascular, hepatic or renal disease
- Active digestive disease (e.g. diarrhea)
- Central nervous disease or psychiatric disorders
- Had surgery or trauma within 6 months prior to this study
- Alcohol or drug abuse
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 |
|---|---|---|
| NemonoxacinAlso: TG-873870oral once daily | Drug | Nemonoxacin 1000mg, Nemonoxacin 125mg, Nemonoxacin 250mg, Nemonoxacin 500mg, Nemonoxacin 750mg, Placebo |
Primary outcome
Maximum tolerated single oral dose of nemonoxacin in healthy Chinese volunteers
Time frame: 7 days
Pharmacokinetic profile of single oral dose of nemonoxacin in healthy Chinese volunteers
Time frame: 7 days
Pharmacokinetic profile of repeated oral doses of nemonoxacin in healthy Chinese volunteers
Time frame: 17 days
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 15 Jul 2011.
- Derived from this study: PubMed 22650326Guo B, Wu X, Zhang Y, Shi Y, Yu J, Cao G, Zhang J. Safety and clinical pharmacokinetics of nemonoxacin, a novel non-fluorinated quinolone, in healthy Chinese volunteers following single and multiple oral doses. Clin Drug Investig. 2012 Jul 1;32(7):475-86. doi: 10.2165/11632780-000000000-00000.
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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
1 site 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 in people with Healthy Volunteers, run by TaiGen Biotechnology Co., Ltd. at 1 site 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 15 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Maximum tolerated single oral dose of nemonoxacin in healthy Chinese volunteers (time frame: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01395108, which also lists 1 linked publication.
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 15 Jul 2011.