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

Chronic Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06311734
• Other study ID #: LW231-I-01
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: November 1, 2021
• Est. completion date: May 1, 2024

Study information

• Verified date: September 2023
• Source: Shanghai Longwood Biopharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: May 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic
• Herpesviridae Infections
• Virus Diseases

Intervention

Drug:
• LW231 tablets
P.O.
• Placebo
P.O.

Locations

Country	Name	City	State
China	The First Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Longwood Biopharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maximum Plasma Concentration (Cmax) of LW231		Up to 4 days after the last dose of study drug
Secondary	Time to Cmax (Tmax) of LW231		Up to 4 days after the last dose of study drug
Secondary	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
Secondary	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
Secondary	Half-life (t1/2) of LW231		Up to 4 days after the last dose of study drug