None listed
Conditions
Interventions
Group 1:Eravacycline 0.5 mg/kg IV single dose
Group 2:Single dose: Eravacycline 1 mg/kg IV
Multiple dose: Eravacycline 1 mg/kg IV q12h, 10 days
Group 3:Eravacycline 2 mg/kg IV single dose
Sponsors
Huashan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Male or female subject between 18-50 years old. 2. Willing to sign the informed consent. 3. Healthy. 4. Agree to use reliable method o birth control. 5. BMI is between 18.5-26.0 kg/m2.
Exclusion criteria
Exclusion criteria: 1. Allergic to tetracyclines or contraindications; 2. Unable to tolerate blood sampling; 3. Subjects with clinically significant abnormalities in vital signs; 4. Clinically significant chest X-ray results abnormality; 5. Serious heart disease; 6. Creatinine clearance rate <= 90 mL / min; 7. History of critical illnesses, or gastrointestinal diseases, liver disease or kidney diseases; 8. Any diseases that may affect the assessment of the study drug; 9. Acute or chronic infection; 10. Clinically significant laboratory abnormalities; 11. One of the following results is positive: human immunodeficiency virus antibody (HIVAb), hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb) and syphilis serum immunological test (TPPA) is positive; 12. Alcohol screening test positive; 13. Urine drug screening test positive; 14. Nicotine screening test positive; 15. Women during pregnancy; 16. Male hemoglobin <= 128 g / L and hematocrit <= 37%, female hemoglobin <= 115 g / L and hematocrit <= 32%; 17. Those who have donated blood or lost more than 200 mL within 30 days before administration; 18. Any prescription drug used within 14 days prior to study drug administration; 19. Any over-the-counter (OTC) medication used within 7 days prior to study drug administration; 20. Participating in any other clinical study within 3 months; 21. Other investigators judge that it is not suitable for participating the study; 22. Those who are planning to become pregnant within 6 months of participating the study; 23. Site employees or relatives; 24. Disagree to stop smoking, drinking alcohol, tea, caffeine or fruit juice during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK assessment;Safety assessment; | — |
Countries
China
Contacts
Public ContactKevin Li
Outcome results
None listed