Trials / Recruiting
RecruitingNCT07179575
Study of LW231 in Participants With Chronic Hepatitis B
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)
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 270 (estimated)
- Sponsor
- Shanghai Longwood Biopharmaceuticals Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LW231 | LW231 tablets |
| DRUG | LW231 placebo | LW231 placebo tablets |
Timeline
- Start date
- 2025-10-01
- Primary completion
- 2027-03-01
- Completion
- 2027-11-01
- First posted
- 2025-09-18
- Last updated
- 2025-10-02
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT07179575. Inclusion in this directory is not an endorsement.