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RecruitingNCT07179575Updated Aug 26, 2026

Study of LW231 in Participants With Chronic Hepatitis B

A Phase 1/2 interventional study of LW231 and LW231 placebo in Chronic HBV Infection, sponsored by Shanghai Longwood Biopharmaceuticals Co., Ltd.. Recruiting at 2 sites in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by Shanghai Longwood Biopharmaceuticals Co., Ltd. · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2025; still recruiting 10 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
270
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Chronic HBV Infection
03

In context

Lead sponsor

Shanghai Longwood Biopharmaceuticals Co., Ltd. is the lead sponsor of 7 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Part 1: treatment-naïve and currently not treated subjects: LLOQ\<HBV DNA≤20000 IU/ml; 100 IU/mL\<HBsAg\<10000 IU/ml
  • Part 2: HBV DNA\<LLOQ or \< 20 IU/mL at screening; 100 IU/mL\<HBsAg\<3000 IU/mL

Exclusion criteria

Exclusion Criteria:

  • Co-infection with hepatitis A, C, D, E or HIV or any evidence of clinically significant liver disease of non-HBV etiology.
  • History or current evidence of cirrhosis.
  • ALT or AST>3×ULN; TBil>1.3×ULN or DBil>1.3×ULN; INR>1.3×ULN
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
270 participants (estimated)

Study arms

  • Experimental
    Part1: LW231 Dose 1

    LW231 Dose Escalation Cohort 1, administered orally, QD

    Drug: LW231 · Drug: LW231 placebo

  • Experimental
    Part1: LW231 Dose 2

    LW231 Dose Escalation Cohort 2, administered orally, BID

    Drug: LW231 · Drug: LW231 placebo

  • Experimental
    Part1: LW231 Dose 3

    LW231 Dose Escalation Cohort 2, administered orally, QD

    Drug: LW231 · Drug: LW231 placebo

  • Experimental
    Part2: LW231 treatment group 1

    LW231 administered orally, BID + NUCs

    Drug: LW231

  • Experimental
    Part2: LW231 treatment group 2

    LW231 administered orally, QD +NUCs

    Drug: LW231

  • Placebo comparator
    Part2: LW231 placebo group

    LW231 placebo + NUCs

    Drug: LW231 placebo

Interventions

  • DrugLW231

    LW231 tablets

  • DrugLW231 placebo

    LW231 placebo tablets

06

What researchers measure

Primary outcomes

  1. Change from baseline in HBV DNA Viral Load Assay

    Time frame: 4 weeks

Secondary 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.

    Time frame: up to 28 weeks

  2. Change from baseline in HBsAg

    Time frame: Up to 28 weeks

  3. Maximum Plasma Concentration (Cmax) of LW231

    Time frame: Up to 28 Weeks

  4. Area Under the Curve From Time 0 to the Last Measurable Concentration (AUClast) of LW231

    Time frame: Up to 28 weeks

07

Study locations

1 of 2 sites recruiting
  • The First Affiliated Hospital, Zhejiang University School of Medicine
    Hangzhou, Zhejiang, China
    Recruiting
  • The First Affiliated Hospital, Zhejiang University School of Medicine
    Hangzhou, China
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07179575
Lead sponsor
Shanghai Longwood Biopharmaceuticals Co., Ltd.
Responsible party
Sponsor
First posted
Sep 18, 2025
Start date
Nov 11, 2025
Primary completion
Mar 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
Aug 26, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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