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

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

Detailed Description
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This was a Randomized，Double-blind, Placebo-controlled, Single Ascending Dose, Single-center Study to Assess the Safety, Tolerability and Pharmacokinetic of Yimitasvir in Healthy Adults Subjects A total of 56 healthy subjects were divided into 7 groups, with each group consisting of 8 subjects. Six of the subjects received the investigational drug, and two received placebo. All of the subjects received a single dose.

Official Title
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A Phase I, Randomized，Double-blind, Placebo-controlled, Single Ascending Dose, Single-center Study to Assess the Safety, Tolerability and Pharmacokinetic of Yimitasvir in Healthy Adults Subjects

Conditions
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Chronic Hepatitis c

Intervention / Treatment
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* Drug: yimitasvir
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

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: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 30 mg single dose<br>Healthy subjects, receiving a single dose of 30 mg yimitasvir(N=6) or placebo(N=2) | Drug: yimitasvir<br>* Capsule administered orally once daily<br>* Other names: DAG181;Drug: placebo<br>* Matching Placebo Capsule<br>* Other names: DAG181 placebo;|
| Experimental: 100 mg single dose<br>Healthy subjects, receiving a single dose of 100 mg yimitasvir (N=6) or placebo(N=2) | Drug: yimitasvir<br>* Capsule administered orally once daily<br>* Other names: DAG181;Drug: placebo<br>* Matching Placebo Capsule<br>* Other names: DAG181 placebo;|
| Experimental: 200 mg single dose<br>Healthy subjects, receiving a single dose of 200 mg yimitasvir (N=6) or placebo(N=2) | Drug: yimitasvir<br>* Capsule administered orally once daily<br>* Other names: DAG181;Drug: placebo<br>* Matching Placebo Capsule<br>* Other names: DAG181 placebo;|
| Experimental: 400 mg single dose<br>Healthy subjects, receiving a single dose of 400 mg yimitasvir (N=6) or placebo(N=2) | Drug: yimitasvir<br>* Capsule administered orally once daily<br>* Other names: DAG181;Drug: placebo<br>* Matching Placebo Capsule<br>* Other names: DAG181 placebo;|
| Experimental: 600 mg single dose<br>Healthy subjects, receiving a single dose of 600 mg yimitasvir (N=6) or placebo(N=2) | Drug: yimitasvir<br>* Capsule administered orally once daily<br>* Other names: DAG181;Drug: placebo<br>* Matching Placebo Capsule<br>* Other names: DAG181 placebo;|
| Experimental: 800 mg single dose<br>Healthy subjects, receiving a single dose of 800 mg yimitasvir (N=6) or placebo(N=2) | Drug: yimitasvir<br>* Capsule administered orally once daily<br>* Other names: DAG181;Drug: placebo<br>* Matching Placebo Capsule<br>* Other names: DAG181 placebo;|
| Experimental: 1000 mg single dose<br>Healthy subjects, receiving a single dose of 1000 mg yimitasvir (N=6) or placebo(N=2) | Drug: yimitasvir<br>* Capsule administered orally once daily<br>* Other names: DAG181;Drug: placebo<br>* Matching Placebo Capsule<br>* Other names: DAG181 placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | To assess the safety and tolerability after a single dose of DAG181 | Baseline to day 10 | 
| Cmax | Maximum observed plasma concentration of DAG181 | Prior to dosing (0 h) and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 h after dosing | 
| Tmax | Time of the maximum observed plasma concentration | Prior to dosing (0 h) and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 h after dosing | 
| AUC | Area under the plasma concentration-time curve (AUC) | Prior to dosing (0 h) and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 h after dosing | 
| T1/2 | Terminal elimination half-life | Prior to dosing (0 h) and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 h after dosing |