Status:
COMPLETED
The Safety, Tolerability and Pharmacokinetic Study of Yimitasvir in Healthy Adults Subjects
Lead Sponsor:
Sunshine Lake Pharma Co., Ltd.
Conditions:
Chronic Hepatitis c
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The Safety, Tolerability and Pharmacokinetic Study of Chronic Hepatitis C Treatment Drug Yimitasvir in Healthy Adults Subjects.
Detailed Description
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 to...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 3 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 22 2016
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03462173
Start Date
December 3 2014
End Date
January 22 2016
Last Update
March 12 2018
Active Locations (1)
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1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034