The Safety, Tolerability and Pharmacokinetic Study of Yimitasvir in Healthy Adults Subjects

• Status: Completed
• Trial end date: 2016-01-22
• Target enrollment: 0
• Participant gender: All

Summary

The Safety, Tolerability and Pharmacokinetic Study of Chronic Hepatitis C Treatment Drug Yimitasvir in Healthy Adults Subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sunshine Lake Pharma Co., Ltd.
• Treatments: Yimitasvir

Criteria

Inclusion Criteria:

• Male or female, overall healthy subjects;

• Between 18 and 45 years of age, inclusive, similar ages;

• Body weight should be≥50 kg; Body Mass Index (BMI) is between 19 and 25 kg/m2, inclusive, similar body weights;

• Able to comprehend and sign the ICF voluntarily prior to initiate the study;

• Able to communicate well with the investigator and complete the study according to the protocol.

Exclusion Criteria:

• Pregnant or nursing female, or plan for pregnancy within 6 months;

• Female with positive urine pregnancy test results;

• Positive test results for HBsAg, anti-HCV Ab, anti-HIV Ab or syphilis;

• Have taken any drug inhibiting gastric acid secretion within 1 month prior to study drug administration, such as: H2 receptor antagonists (eg: Cimetidine, Ranitidine, Famotidine, Nizatidine and Roxatidine); Proton pump inhibitors (eg: Omeprazole, Lansoprazole, Rabeprazole, Pantoprazole and Esomeprazole); cholinoceptor blocking drugs (eg: Atropine and Pirenzepine);

• History of immune system disease (such as thymus disease);

• Have undergone major surgery within 6 months before enrollment;

• History of tumor;

• Drink frequently within 6 months prior to study drug administration, namely alcohol consumption are more than 20 grams per day;

• Smokers, who smoke more than 1 cigarettes/day within 3 months before the study;

• Participated in any clinical trial within 3 months prior to the study;

• Cannot be tolerant to oral drugs.