chronic hepatitis C
Conditions
Interventions
1:Yimitasvir 100mg
2:Yimitasvir 200mg
3:Yimitasvir 400mg
1:placebo 100mg
2:placebo 200mg
3:placebo 400mg
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female healthy subjects; 2. Between 18 and 45 years of age, inclusive, similar ages; 3. Body weight should be=50 kg; Body Mass Index (BMI) is between 19 and 25 kg/m2, inclusive, similar body weight.
Exclusion criteria
Exclusion criteria: 1. Gender and Fertility 1) During the entire trial period up to 6 months after the end of the study , women of child-bearing potential and their spouses are unwilling or unable to take the following contraceptive measures: Condoms, IUDs; 2) Males who are sexually active and whose spouses are women of child-bearing potential without effective birth control measures; 3) Subjects who have taken oral contraceptive within 1 month before administration of investigational drug; 4) Subjects who have taken long-term estrogen or progesterone injections or implant tablets within 6 months before administration of investigation drug; 5) Women of child-bearing potential who don't take appropriate contraception measures within 2 weeks prior to administration of investigation drugs; 6) Women who are on gestation period, lactation or planning to get pregnant in 6 months after the last administration of investigational drug; 7) Women who have the positive result of urine pregnancy test. 2. Physical and laboratory examination: 1) Baseline values of any safety assessment index before the trial were considered of clinically significant abnormalities by the investigator; 2) Subjects with positive HBsAg test; 3) Subjects with positive anti-HCV Ab test; 4) Subjects with positive anti-HIV Ab or syphilis test; 5) Systolic blood pressure >140 mm Hg or 90 mm Hg; 6) ECG findings during the screening period and before the first day of the investigational drug administration show any of the following abnormalities: QTc>430 ms for males and QTc >450 ms for females on screening or baseline ; IIo atrioventricular or IIIo atrioventricular block; heart rate 100 beats/min; PR interval >200 ms or 120 ms; pathological Q waves (according to Q Wave >40 ms defined); ventricular evoked syndrome. 3. Forbidden treatment and/or drugs 1) Have taken any drug inhibiting gastric acid secretion within 1 month prior to administration of investigational drug; 2) Have taken any gastric antacids within 1 month prior to administration of investigational drug; 3) Have taken any drugs that can inhibit or induce hepatic metabolism within 1 month before administration of investigation drug; 4) Have taken any drugs (including prescription and non-prescription medicines, Chinese herbal medicines) within 2 weeks before the study. 4. Disease and Surgery History 1) History of organic heart disease, cardiac failure, myocardial infarction, stenocardia, inexplicable arrhythmia, torsades points, ventricular tachycardia, long QT syndrome or symptomatic long QT and corresponding family history (genetic evidence or sudden death of close relatives in youth due to heart disease); 2) History of immune system disease (such as thymus disease); 3) Undergone major surgery within 6 months before enrolling; 4) History of severe digestive diseases (such as gallbladder disease with significant clinical significance, pancreatitis symptoms or pancreatitis, known or suspected jaundice, hepatocellular adenoma, hepatic cavernous hemangioma, and other severe liver lesions); 5) Have gastrointestinal tract and kidney disease that could interfere with the absorption or excretion of the study drug (whether cured or not) within 6 months before the study; 6) Any history of severe circulatory system, respiratory system, urinary system, and nervous system disease; 7) Have blood disease such as coagulation disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety;pharmacokinetics; | — |
Countries
China
Contacts
Public ContactRowling Luo
Sunshine Lake Pharma co., ltd.
Outcome results
None listed