Study of LW231 in Participants With Chronic Hepatitis B
NCT ID: NCT07179575
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
270 participants
INTERVENTIONAL
2025-10-31
2027-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Part1: LW231 Dose 1
LW231 Dose Escalation Cohort 1, administered orally, QD
LW231
LW231 tablets
LW231 placebo
LW231 placebo tablets
Part1: LW231 Dose 2
LW231 Dose Escalation Cohort 2, administered orally, BID
LW231
LW231 tablets
LW231 placebo
LW231 placebo tablets
Part1: LW231 Dose 3
LW231 Dose Escalation Cohort 2, administered orally, QD
LW231
LW231 tablets
LW231 placebo
LW231 placebo tablets
Part2: LW231 treatment group 1
LW231 administered orally, BID + NUCs
LW231
LW231 tablets
Part2: LW231 treatment group 2
LW231 administered orally, QD +NUCs
LW231
LW231 tablets
Part2: LW231 placebo group
LW231 placebo + NUCs
LW231 placebo
LW231 placebo tablets
Interventions
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LW231
LW231 tablets
LW231 placebo
LW231 placebo tablets
Eligibility Criteria
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Inclusion Criteria
* Part 2: HBV DNA\<LLOQ or \< 20 IU/mL at screening; 100 IU/mL\<HBsAg\<3000 IU/mL
Exclusion Criteria
* History or current evidence of cirrhosis.
* ALT or AST\>3×ULN; TBil\>1.3×ULN or DBil\>1.3×ULN; INR\>1.3×ULN
18 Years
60 Years
ALL
No
Sponsors
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Shanghai Longwood Biopharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, , China
Countries
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Facility Contacts
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Other Identifiers
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LW231-Ib/II-01
Identifier Type: -
Identifier Source: org_study_id
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