A Study of LW231 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Volunteers and Participants With Chronic Hepatitis B Virus Infection

Shanghai Longwood Biopharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis B

Treatments: Drug: LW231 tablets; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06311734

LW231-I-01

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 119 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

---

119 participants in 3 patient groups

Part A: SAD in healthy participants

Experimental group

Description:

Part A: Single ascending doses of up to 800 mg LW231 tablets in healthy participants.

Treatment:

Drug: Placebo

Drug: LW231 tablets

Part b: MAD in healthy participants

Experimental group

Description:

Part B: Multiple ascending doses of up to 400 mg LW231 tablets in healthy participants. Dosages will be determined from data collected from Part A.

Treatment:

Drug: Placebo

Drug: LW231 tablets

Part c: MAD in CHB participants (optional)

Experimental group

Description:

Part C: Multiple ascending doses of up to 400 mg LW231 tablets in CHB participants. Dosages will be determined from data collected from Part A and Part B.

Treatment:

Drug: Placebo

Drug: LW231 tablets