NCT03462173

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Sunshine Lake Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Chronic Hepatitis c

Interventions

Type	Name	Description
DRUG	yimitasvir	Capsule administered orally once daily
DRUG	placebo	Matching Placebo Capsule

Timeline

• Start date: 2014-12-03
• Primary completion: 2015-01-30
• Completion: 2016-01-22
• First posted: 2018-03-12
• Last updated: 2018-03-12

Locations

1 site across 1 country: China