NCT07179575 Study of LW231 in Participants With Chronic Hepatitis B
| NCT ID | NCT07179575 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Shanghai Longwood Biopharmaceuticals Co., Ltd. |
| Condition | Chronic HBV Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 270 participants |
| Start Date | 2025-10 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 270 participants in total. It began in 2025-10 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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: * 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
Frequently Asked Questions
Who can join the NCT07179575 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Chronic HBV Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07179575 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07179575 currently recruiting?
Yes, NCT07179575 is actively recruiting participants. Visit ClinicalTrials.gov or contact Shanghai Longwood Biopharmaceuticals Co., Ltd. to inquire about joining.
Where is the NCT07179575 trial being conducted?
This trial is being conducted at Hangzhou, China, Hangzhou, China.
Who is sponsoring the NCT07179575 clinical trial?
NCT07179575 is sponsored by Shanghai Longwood Biopharmaceuticals Co., Ltd.. The trial plans to enroll 270 participants.