community-acquired bacterial pneumonia
Conditions
Interventions
Series 1:Lefamulin Injection to Lefamulin Tablets
Series 2:Lefamulin Tablets to Lefamulin Injection
Sponsors
Huashan Hospital Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Subjects who fully understand the purpose, nature, methods and possible adverse events (AEs) of the clinical trial, and are willing to participate in this study as a subject and sign the Informed Consent Form (ICF); 2. Healthy Chinese adults of either sex who are aged 18-45 years (including the critical value); 3. Subjects whose body mass index is 19 - 24 kg/m2 (including the critical value), with bodyweight of no less than 50 kg (for males) and 45 kg (for females); 4. Subjects who have no pregnancy plan and are willing to adopt effective contraceptive measures voluntarily, and have no plan of sperm donation and egg donation during the trial till 3 months after last dose of the investigational drug (see concrete contraceptive measures in Appendix 1). 5. Subjects who are able to abide by the diet provided by the study site, and complete the test procedures as per protocol; 6. Subjects who have normal or clinically insignificant abnormal vital signs, physical examination, laboratory tests, coagulation function test, chest X-ray and 12-lead electrocardiogram (12-lead ECG).
Exclusion criteria
Exclusion criteria: 1. Subjects who have positive human immunodeficiency virus antibody (HIV-Ab), syphilis antibody (TP-Ab), hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab); 2. Subjects who have abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; heart rate 100 bpm; ear temperature 37.5 degree C); 3. Subjects who have liver dysfunction (alanine aminotransferase (ALT), aspartate aminotransferase (AST) or total bilirubin [TBIL] exceeds the upper limit of normal (ULN)), or renal dysfunction (serum creatinine exceeds its ULN). If ALT, AST or TBIL is 1 ~ 1.2 x ULN and judged clinically insignificant by the investigator, subjects can still be enrolled; 4. 12-lead ECG: QTcF > 430 ms (for males) or > 450 ms (females); 5. Subjects who have blood potassium or magnesium of < lower limit of normal (according to the normal range determined using testing instruments at the study site); 6. Subjects who have a definite history of allergies to pleuromytilins, Lefamulin and its excipients; 7. Subjects who have a previous history of drug abuse or are detected positive in drug abuse screening at the screening period; 8. Subjects who have symptoms or a history of any serious systemic disease, including but not limited to systemic diseases involving cardiovascular system, liver, kidney, gastrointestinal tract, respiratory system, nervous system, blood, metabolic system or other factors that the investigator judge may affect drug absorption, distribution, metabolism and excretion; 9. Subjects who have a medical or family history of prolonged QT syndrome, or have a medical history of arrhythmia, syncope or epilepsy (excluding juvenile febrile convulsion), myocardial hypertrophy or other organic heart disease, complete left bundle branch block or atrioventricular block; 10. Subjects who have experienced nausea, vomiting or diarrhea caused by any cause within 14 days prior to screening; 11. Female subjects who are detected positive in the pregnancy test at the screening period or baseline, or are during lactation; 12. Subjects who are smokers (smoking an average of 5 or more cigarettes a day or the same amount of tobacco in the past six months), are on habitual use of nicotine-containing products, or are detected to be positive in the urine nicotine screening results at the screening period or baseline; 13. Subjects who have drunk more than 14 units of alcohol per week (1 unit alcohol = 360 mL beer, 45 mL spirits (alcohol content: 40%), or 150 mL wine), have taken alcoholic products 48 h prior to administration, or are detected positive in the alcohol breath test at the screening period or baseline; 14. Subjects who have taken any drugs that induce or inhibit CYP3A metabolic enzymes within 14 days prior to the initiation of investigational drug (see common CYP3A inhibitors and inducers in Appendix 5); 15. Subjects who have been inoculated with vaccines (e.g. influenza vaccine, varicella vaccine, etc.) or other biological agents within 28 days prior to the initiation of investigational drug; 16. Subjects who have taken any prescription drug, over-the-counter drug or Chinese herbal medicine (including vitamins, calcium supplements, etc.) within 14 days prior to the initiation of investigational drug; 17. Subjects who have taken grapefruit or grapefruit-containing beverages within 7 days prior to the initiation of investigational drug; 18. Subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics, PK; | — |
Countries
China
Contacts
Public ContactJing Zhang, Jufang Wu
Huashan Hospital
Outcome results
None listed