Chronic HBV InfectionPhase 1/2NCT07179575
Study of LW231 in Participants With Chronic Hepatitis B
A Phase 1/2 study testing LW231 in people with Chronic HBV Infection, run by Shanghai Longwood Biopharmaceuticals Co., Ltd. at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic HBV Infection
- What is being tested?
- LW231
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 2 sitesChina
- Study dates
- 11 Nov 2025to Nov 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
Yunqing Qiu, +86 13588189339, qiuyq@zju.edu.cn
- Not yet recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
About this study
Official title: Phase Ib/II Study of LW231 in Patients With Chronic Hepatitis B: Evaluation of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy With Multiple-Dose, Dose-Escalation, and Combination With Nucleos(t)Ide Analogs (NUC)
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.
- Conditions
- Chronic HBV Infection
- Being tested
- LW231, LW231 placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LW231Drug
LW231 tablets
LW231 placeboDrug
LW231 placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Part1: LW231 Dose 1 | Experimental | LW231 Dose Escalation Cohort 1, administered orally, QD Receives: Drug: LW231; Drug: LW231 placebo |
| Part1: LW231 Dose 2 | Experimental | LW231 Dose Escalation Cohort 2, administered orally, BID Receives: Drug: LW231; Drug: LW231 placebo |
| Part1: LW231 Dose 3 | Experimental | LW231 Dose Escalation Cohort 2, administered orally, QD Receives: Drug: LW231; Drug: LW231 placebo |
| Part2: LW231 treatment group 1 | Experimental | LW231 administered orally, BID + NUCs Receives: Drug: LW231 |
| Part2: LW231 treatment group 2 | Experimental | LW231 administered orally, QD +NUCs Receives: Drug: LW231 |
| Part2: LW231 placebo group | Placebo comparator | LW231 placebo + NUCs Receives: Drug: LW231 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in HBV DNA Viral Load Assay
Measured: 4 weeks
Secondary outcomes (4)
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.
Measured: up to 28 weeks
Change from baseline in HBsAg
Measured: Up to 28 weeks
Maximum Plasma Concentration (Cmax) of LW231
Measured: Up to 28 Weeks
Area Under the Curve From Time 0 to the Last Measurable Concentration (AUClast) of LW231
Measured: Up to 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start11 Nov 2025
- Primary completionMar 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic HBV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Longwood Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07179575
- Sponsor's protocol ID
- LW231-Ib/II-01
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib/II Study of LW231 in Patients With Chronic Hepatitis B: Evaluation of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy With Multiple-Dose, Dose-Escalation, and Combination With Nucleos(t)Ide Analogs (NUC)
- ClinicalTrials.gov ID
- NCT07179575
- Acronym / sponsor ID
- LW231-Ib/II-01
- Conditions
- Chronic HBV Infection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Shanghai Longwood Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part1: LW231 Dose 1 | Experimental | Drug: LW231, Drug: LW231 placeboLW231 Dose Escalation Cohort 1, administered orally, QD |
| Part1: LW231 Dose 2 | Experimental | Drug: LW231, Drug: LW231 placeboLW231 Dose Escalation Cohort 2, administered orally, BID |
| Part1: LW231 Dose 3 | Experimental | Drug: LW231, Drug: LW231 placeboLW231 Dose Escalation Cohort 2, administered orally, QD |
| Part2: LW231 treatment group 1 | Experimental | Drug: LW231LW231 administered orally, BID + NUCs |
| Part2: LW231 treatment group 2 | Experimental | Drug: LW231LW231 administered orally, QD +NUCs |
| Part2: LW231 placebo group | Placebo comparator | Drug: LW231 placeboLW231 placebo + NUCs |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LW231LW231 tablets | Drug | Part1: LW231 Dose 1, Part1: LW231 Dose 2, Part1: LW231 Dose 3, Part2: LW231 treatment group 1, Part2: LW231 treatment group 2 |
| LW231 placeboLW231 placebo tablets | Drug | Part1: LW231 Dose 1, Part1: LW231 Dose 2, Part1: LW231 Dose 3, Part2: LW231 placebo group |
Primary outcome
Change from baseline in HBV DNA Viral Load Assay
Time frame: 4 weeks
4 secondary outcomes
Number of Participants With Adverse Events (AEs)
Time frame: up to 28 weeks
Change from baseline in HBsAg
Time frame: Up to 28 weeks
Maximum Plasma Concentration (Cmax) of LW231
Time frame: Up to 28 Weeks
Area Under the Curve From Time 0 to the Last Measurable Concentration (AUClast) of LW231
Time frame: Up to 28 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LW231 in people with Chronic HBV Infection, run by Shanghai Longwood Biopharmaceuticals Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in HBV DNA Viral Load Assay (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.