Chronic Hepatitis B
Conditions
Brief summary
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 .
Detailed description
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.
Interventions
DRUGLW231 tablets
P.O.
DRUGPlacebo
P.O.
Sponsors
Shanghai Longwood Biopharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1.18-55 years old male or female. 2.Body Mass Index (BMI) between 18 to 28 kg/m2 (inclusive) and body weight equal to or over 45 kg for females and 50kg for males. 3.Healthy status will be defined as the absence of evidence of any active or chronic disease following a detailed medical and surgical history, concomitant drug use (including hormonal supplements), a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology, and urinalysis.
Exclusion criteria
1. Any clinically significant abnormalities in laboratory test results at screening. In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility. 2. Participants who have donated over 450 mL of blood or blood products or had significant blood loss within three months prior to screening. 3. Heavy smokers (those who smoke greater than or equal to 5 or more cigarettes a day within three months prior to screening).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | Up to 4 days for SAD, up to 3 days after the last dose of study drug for MAD | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Maximum Plasma Concentration (Cmax) of LW231 | Up to 4 days after the last dose of study drug |
| Time to Cmax (Tmax) of LW231 | 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 | 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 | Up to 4 days after the last dose of study drug |
| Half-life (t1/2) of LW231 | Up to 4 days after the last dose of study drug |
Countries
China
Outcome results
None listed