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

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

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 .

Study Overview

• Status: Completed
• Conditions: Chronic Hepatitis B
• Intervention / Treatment: Drug: LW231 tablets; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China
      • The First Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: SAD in healthy participants; Part A: Single ascending doses of up to 800 mg LW231 tablets in healthy participants.	Drug: LW231 tablets; P.O.; Other Names: LW231; Drug: Placebo; P.O.
Experimental: Part b: MAD in healthy participants; 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.	Drug: LW231 tablets; P.O.; Other Names: LW231; Drug: Placebo; P.O.
Experimental: Part c: MAD in CHB participants (optional); 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.	Drug: LW231 tablets; P.O.; Other Names: LW231; Drug: Placebo; P.O.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 4 days for SAD, up to 3 days after the last dose of study drug for MAD

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Shanghai Longwood Biopharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2022
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): March 18, 2024

Study Registration Dates

• First Submitted: March 8, 2024
• First Submitted That Met QC Criteria: March 8, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 11, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Infections; Blood-Borne Infections; Communicable Diseases; Disease Attributes; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Chronic Disease; Hepatitis B; Hepatitis; Hepatitis A; Virus Diseases; Hepatitis B, Chronic; Hepatitis, Chronic; Herpesviridae Infections
• Other Study ID Numbers: LW231-I-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No