This is an open-label phase IIa study of HH-003 to evaluate its antiviral activity and safety in subjects with chronic hepatitis B and hepatitis D co-infection. HH-003 is a human monoclonal antibody targeting the pre-S1 domain of the HBV large envelope protein. It blocks engagement of preS1 with sodium taurocholate co-transporting polypeptide (NTCP), the cellular receptor for HBV/HDV.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
HH-003 20mg/kg Q2W intravenously for 24 weeks
HH-003 3mg/kg Q2W intravenously for 24 weeks
First Hospital of Jilin University
Changchun, Jilin, China
Percentage of Participants with HBV DNA Negativation or Decrease by ≥1 log10 from Baseline at Week 24
Time frame: Week 24
Percentage of Participants with HDV RNA Negativation or Decrease by ≥1 log10 from Baseline at Week 24
Time frame: Week 24
Change from Baseline in Serum HBsAg Levels at Week 24
Time frame: from baseline to Week 24
Percentage of participants with ALT normalization at week 24
Time frame: Week 24
Changes from Baseline in Serum HBsAg Levels during the Study Period
Time frame: from baseline to Week 48
Changes from Baseline in Serum HBV RNA Levels during the Study Period
Time frame: from baseline to Week 48
Changes from Baseline in Serum HBV DNA Levels during the Study Period
Time frame: from baseline to Week 48
Changes from Baseline in Serum HDV RNA Levels during the Study Period
Time frame: from baseline to Week 48
Changes from Baseline in Serum HBeAg Levels in HBeAg-positive Subjects at Screening
Time frame: from baseline to Week 48
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