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This is a Phase Ib/II, multicenter, randomized, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of LW231 in participants with chronic hepatitis B virus (HBV) infection. The trial will include multiple-dose regimens of LW231 and assess LW231 in combination with NUCs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part1: LW231 Dose 1 | Experimental | LW231 Dose Escalation Cohort 1, administered orally, QD |
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| Part1: LW231 Dose 2 | Experimental | LW231 Dose Escalation Cohort 2, administered orally, BID |
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| Part1: LW231 Dose 3 | Experimental | LW231 Dose Escalation Cohort 2, administered orally, QD |
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| Part2: LW231 treatment group 1 | Experimental | LW231 administered orally, BID + NUCs |
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| Part2: LW231 treatment group 2 | Experimental | LW231 administered orally, QD +NUCs |
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| Part2: LW231 placebo group | Placebo Comparator | LW231 placebo + NUCs |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LW231 | Drug | LW231 tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HBV DNA Viral Load Assay | 4 weeks |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | China |
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|
| LW231 placebo | Drug | LW231 placebo tablets |
|
| up to 28 weeks |
| Change from baseline in HBsAg | Up to 28 weeks |
| Maximum Plasma Concentration (Cmax) of LW231 | Up to 28 Weeks |
| Area Under the Curve From Time 0 to the Last Measurable Concentration (AUClast) of LW231 | Up to 28 weeks |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Not yet recruiting | Hangzhou | China |