Clinical trial NCT06311734: A Study of LW231 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Volunteers and Participants With Chronic Hepatitis B Virus Infection
Official title: A Single-center, Randomized, Double-blind,Placebo-controlled Study, to Evaluate Safety,Tolerability, Pharmacokinetics and Pharmacodynamics of LW231 in Healthy Volunteers and Patients With Chronic Hepatitis B Virus Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis B
Lead sponsor: Shanghai Longwood Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-03-15
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 4 days for SAD, up to 3 days after the last dose of study drug for MAD
Secondary outcomes:
measure: Maximum Plasma Concentration (Cmax) of LW231
timeFrame: Up to 4 days after the last dose of study drug
measure: Time to Cmax (Tmax) of LW231
timeFrame: Up to 4 days after the last dose of study drug
measure: Area Under the Curve From Time 0 to the Last Measurable Concentration (AUClast) of LW231
timeFrame: Up to 4 days after the last dose of study drug
measure: Area Under the Curve From Time 0 to 24 Hours (AUC0-24) of LW231
timeFrame: Up to 4 days after the last dose of study drug
measure: Half-life (t1/2) of LW231
timeFrame: Up to 4 days after the last dose of study drug
Other outcomes:
Locations:
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
Study officials:
References: