RECRUITINGPhase 1 / Phase 2INTERVENTIONAL
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)
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
LW231
LW231 tablets
DRUG
LW231 placebo
LW231 placebo tablets
Locations (2)
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China