To Evaluate the Tolerability and Pharmacokinetics of LW231 Tablets in Single-center, Randomized, Double-blind, Placebo-controlled Multiple-dose, Single-dose, Multiple-dose Phase Ia Clinical Trials in Healthy Subjects .
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of LW231 tablets in healthy volunteers and in chronic hepatitis B (CHB) patients after single and multiple doses. In addition, the study will evaluate the initial antiviral efficacy of LW231 in CHB patients following a multiple dosing regimen.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
119
P.O.
P.O.
The First Hospital of Jilin University
Changchun, Jilin, China
Number of Participants With Adverse Events (AEs)
An adverse event (AE) was defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product (including investigational drug) during the course of a clinical investigation. An AE could therefore be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease that was temporally associated with the use of the investigational product, regardless of whether it was considered to be related to the investigational product or not.
Time frame: Up to 4 days for SAD, up to 3 days after the last dose of study drug for MAD
Maximum Plasma Concentration (Cmax) of LW231
Time frame: Up to 4 days after the last dose of study drug
Time to Cmax (Tmax) of LW231
Time frame: Up to 4 days after the last dose of study drug
Area Under the Curve From Time 0 to the Last Measurable Concentration (AUClast) of LW231
Time frame: Up to 4 days after the last dose of study drug
Area Under the Curve From Time 0 to 24 Hours (AUC0-24) of LW231
Time frame: Up to 4 days after the last dose of study drug
Half-life (t1/2) of LW231
Time frame: Up to 4 days after the last dose of study drug
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