Clinical Study on Oral Nemonoxacin Malate Capsules

TaiGen Biotechnology

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Nemonoxacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01395108

TG-873870-C-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 76 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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
• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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76 participants in 6 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Nemonoxacin

Nemonoxacin 125mg

Active Comparator group

Description:

Nemonoxacin 125mg

Treatment:

Drug: Nemonoxacin

Nemonoxacin 250mg

Active Comparator group

Description:

Nemonoxacin 250mg

Treatment:

Drug: Nemonoxacin

Nemonoxacin 500mg

Active Comparator group

Description:

Nemonoxacin 500mg

Treatment:

Drug: Nemonoxacin

Nemonoxacin 750mg

Active Comparator group

Description:

Nemonoxacin 750mg

Treatment:

Drug: Nemonoxacin

Nemonoxacin 1000mg

Active Comparator group

Description:

Nemonoxacin 1000mg

Treatment:

Drug: Nemonoxacin