Study of LW231 in Participants With Chronic Hepatitis B
Recruiting
Phase 1
Phase 2
Interventional Study
Chronic HBV Infection
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 60
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 270 (estimated)
- Sponsor
- Shanghai Longwood Biopharmaceuticals Co., Ltd. · Industry
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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.
Trial Locations
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Eligibility Criteria
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 e…
Contacts
No contact information available.