A Study to Evaluate the Pharmacokinetics and Safety of ASC16 Tablets in Healthy Volunteers in China

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the pharmacokinetics and safety of ASC16 after 3-single dose(50mg、100mg、200mg) or fixed continuous dose(200mg) in healthy volunteers.

Official Title
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A Randomized, Open, Three-dose (100 mg, 200 mg and 300 mg) Duplicate Bifunctional Crossover and Fixed 200mg Continuous Dose Study to Evaluate the Pharmacokinetics and Safety of ASC16 Tablets in Healthy Volunteers

Conditions
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Chronic Hepatitis c

Intervention / Treatment
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* Drug: Ravidasvir 50mg
* Drug: Ravidasvir 200mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18-45 years old; Male body weight not less than 50kg; Female body weight not less than 45kg; BMI in the range of 19 24kg/m2 Healthy men or women based on history, physical examination, laboratory examination and ECG. no plan of pregnancy in at least six months, and willing to take effective measures to prevent contraception from the first time when the drug is administered till the last time the drug is administered within 30 days. Female has negative pregnancy tests at the screening stage. Voluntary to sign the informed consent. Exclusion Criteria: Have medical history, or has disease, such as cardiovascular system, respiratory system, endocrine and metabolic system, urinary system, digestive system, blood system, nerve system disease or psychiatric disease and acute or chronic infectious diseases and malignant tumors. Has a history of drug or food allergy. Positive hepatitis A antibody，positive hepatitis B surface antigen， positive hepatitis C antibody，syphilis antibody or HIV antibody at screening. Laboratory tests out of normal range and judged by the investigators as clinically significant. Had gastrointestinal surgery, vagotomy, intestinal resection or any possible interference with gastrointestinal peristalsis, pH or absorbed by surgery. Pregnant, lactating women and people who unwilling to take effective measures to prevent contraception. People who consumed pomelo, apple or orange and foods or drinks containing their extracted ingredients within 3 days of taking the drug. Any prescription or over-the-counter medications, herbs, and vitamins are required to be taken prior to or within the first month of taking the drug. Selected within the first 6 months of smoking, alcohol, drug abuse or history of drug abuse. Selected within the first 3 months had blood loss or blood donation of 200ml. Participate in other clinical trials within the first 3 months of the study and received other study drug treatment. In addition to the above, the investigators judged not suitable for participating in this clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GROUP 1<br>1st day: 2 tablets of Ravidasvir 50mg administered orally once daily; 2nd day: 1 tablet of Ravidasvir 200mg administered orally once daily; 3rd day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily ; 19th to 25th day： Ravidasvir 200mg administered orally once daily. | Drug: Ravidasvir 50mg<br>* 50mg, Tablet<br>* Other names: ASC16;Drug: Ravidasvir 200mg<br>* 200mg, Tablet<br>* Other names: ASC16;|
| Experimental: GROUP 2<br>1st day: Ravidasvir 200mg administered orally once daily; 2nd day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily ; 3rd day: 2 tablets of Ravidasvir 50mg administered orally once daily; 19th to 25th day：Ravidasvir 200mg administered orally once daily. | Drug: Ravidasvir 50mg<br>* 50mg, Tablet<br>* Other names: ASC16;Drug: Ravidasvir 200mg<br>* 200mg, Tablet<br>* Other names: ASC16;|
| Experimental: GROUP 3<br>1st day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily; 2nd day: 2 tablets of Ravidasvir 50mg administered orally once daily; 3rd day: Ravidasvir 200mg administered orally once daily; 19th to 25th day：Ravidasvir 200mg administered orally once daily. | Drug: Ravidasvir 50mg<br>* 50mg, Tablet<br>* Other names: ASC16;Drug: Ravidasvir 200mg<br>* 200mg, Tablet<br>* Other names: ASC16;|
| Experimental: GROUP 4<br>1st day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily; 2nd day: Ravidasvir 200mg administered orally once daily; 3rd day: 2 tablets of Ravidasvir 50mg administered orally once daily; 19th to 25th day：Ravidasvir 200mg administered orally once daily. | Drug: Ravidasvir 50mg<br>* 50mg, Tablet<br>* Other names: ASC16;Drug: Ravidasvir 200mg<br>* 200mg, Tablet<br>* Other names: ASC16;|
| Experimental: GROUP 5<br>1st day: Ravidasvir 200mg administered orally once daily; 2nd day: 2 tablets of Ravidasvir 50mg administered orally once daily; 3rd day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily; 19th to 25th day：Ravidasvir 200mg administered orally once daily. | Drug: Ravidasvir 50mg<br>* 50mg, Tablet<br>* Other names: ASC16;Drug: Ravidasvir 200mg<br>* 200mg, Tablet<br>* Other names: ASC16;|
| Experimental: GROUP 6<br>1st day: 2 tablets of Ravidasvir 50mg administered orally once daily; 2nd day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily; 3rd day: Ravidasvir 200mg administered orally once daily; 19th to 25th day：Ravidasvir 200mg administered orally once daily. | Drug: Ravidasvir 50mg<br>* 50mg, Tablet<br>* Other names: ASC16;Drug: Ravidasvir 200mg<br>* 200mg, Tablet<br>* Other names: ASC16;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak plasma concentration (Cmax) | Pharmacokinetics (blood draws, pre- and post-dose) | 27 days | 
| Area under the plasma concentration versus time curve (AUC) | Pharmacokinetics (blood draws, pre- and post-dose) | 27 days |