The Safety, Tolerability and Pharmacokinetic Study of Chronic Hepatitis C Treatment Drug Yimitasvir in Healthy Adults Subjects.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
Capsule administered orally once daily
Matching Placebo Capsule
Peking University First Hospital
Beijing, Beijing Municipality, China
Adverse events
To assess the safety and tolerability after a single dose of DAG181
Time frame: Baseline to day 10
Cmax
Maximum observed plasma concentration of DAG181
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
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