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

NCT06311734 | Completed Phase 1

• 1 other identifier: LW231-I-01
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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 .

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (3)

Part A: SAD in healthy participants

EXPERIMENTAL

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

Drug: LW231 tablets; Drug: Placebo

Part b: MAD in healthy participants

EXPERIMENTAL

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; Drug: Placebo

Part c: MAD in CHB participants (optional)

EXPERIMENTAL

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; Drug: Placebo

Interventions

LW231 tablets DRUG

P.O.

Also known as: LW231

Part A: SAD in healthy participants; Part b: MAD in healthy participants; Part c: MAD in CHB participants (optional)

Placebo DRUG

P.O.

Part A: SAD in healthy participants; Part b: MAD in healthy participants; Part c: MAD in CHB participants (optional)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• Participants who have donated over 450 mL of blood or blood products or had significant blood loss within three months prior to screening.
• Heavy smokers (those who smoke greater than or equal to 5 or more cigarettes a day within three months prior to screening).

Sponsors & Collaborators

• Shanghai Longwood Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 15, 2024
• Study Start: June 21, 2022
• Primary Completion: January 1, 2024
• Study Completion: March 18, 2024
• Last Updated: October 15, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)