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
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
The First Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
The First Affiliated Hospital, Zhejiang University School of Medicine
NOT_YET_RECRUITING
Hangzhou
Time Frame
Start Date: 2025-10
Estimated Completion Date: 2027-11
Participants
Target number of participants: 270
Treatments
Experimental: Part1: LW231 Dose 1
LW231 Dose Escalation Cohort 1, administered orally, QD
Experimental: Part1: LW231 Dose 2
LW231 Dose Escalation Cohort 2, administered orally, BID
Experimental: Part1: LW231 Dose 3
LW231 Dose Escalation Cohort 2, administered orally, QD
Experimental: Part2: LW231 treatment group 1
LW231 administered orally, BID + NUCs
Experimental: Part2: LW231 treatment group 2
LW231 administered orally, QD +NUCs
Placebo_comparator: Part2: LW231 placebo group
LW231 placebo + NUCs
Related Therapeutic Areas
Sponsors
Leads: Shanghai Longwood Biopharmaceuticals Co., Ltd.