Status:
RECRUITING
Study of LW231 in Participants With Chronic Hepatitis B
Lead Sponsor:
Shanghai Longwood Biopharmaceuticals Co., Ltd.
Conditions:
Chronic HBV Infection
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
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 participan...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT07179575
Start Date
October 1 2025
End Date
November 1 2027
Last Update
October 2 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
2
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China