Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06311734
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2024-03-08
Brief Title:
A Study of LW231 to Evaluate Safety Tolerability Pharmacokinetics and Pharmacodynamics in Healthy Volunteers and Participants With Chronic Hepatitis B Virus Infection
Sponsor:
Shanghai Longwood Biopharmaceuticals Co Ltd
Organization:
Shanghai Longwood Biopharmaceuticals Co Ltd
Study Overview
Official Title:
A Single-center Randomized Double-blindPlacebo-controlled Study to Evaluate SafetyTolerability Pharmacokinetics and Pharmacodynamics of LW231 in Healthy Volunteers and Patients With Chronic Hepatitis B Virus Infection
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None