Study of LW231 in Participants With Chronic Hepatitis B
Recruiting · NCT07179575 · Interventional (participants receive a specific treatment) · Lead sponsor: Shanghai Longwood Biopharmaceuticals Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
LW231LW231 placebo
What this trial is about
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.
Who can take part
Age range
18 Years to 60 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
2 locations listed.
- The First Affiliated Hospital, Zhejiang University School of Medicine - Hangzhou, China
- The First Affiliated Hospital, Zhejiang University School of Medicine - Hangzhou, Zhejiang, China