Chronic HBV Infection
Conditions
Brief summary
This is a multicenter, randomized, double-blind, placebo-controlled, multiple-ascending dose phase Ib study of HH-003 injection, which is a monoclonal antibody targeting Hepatitis B virus. This study aims to evaluate the safety, tolerability and pharmacokinetics of HH-003 injection in treatment-naive participants chronically infected with hepatitis B virus.
Interventions
DRUGHH-003 injection
HH-003 injection is administrated via I.V. infusion
DRUGPlacebo
Placebo is administrated via I.V. infusion
Sponsors
Huahui Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* 18 to 45 years old * Body weight ≥ 45 kg for men and ≥ 40 kg for women, and 18 kg/m\^2≤BMI≤28 kg/m\^2 * Positive serum HBsAg or HBV DNA for at least 6 months,or previous liver biopsy results confirm the Hepatitis B * HBeAg positive, and 2000 IU/mL\<HBsAg\<100,000 IU/mL * Have not received interferon treatment before, and have not received nucleotide/nucleoside analogue treatment within 6 months prior to Screening
Exclusion criteria
* Positive test for hepatitis C antibody (HCV-Ab), treponema pallidum antibody (TP-Ab), or anti-HIV antibody (HIV-Ab) * Hemoglobin \<100 g/L, platelets \<100,000/mm\^3 (100×10\^9/L), absolute neutrophils count \<1,500/mm\^3 (1.5×10\^9/L) * Serum albumin \<35 g/L, international normalized ratio (INR)\>1.5; serum creatinine \>115 μmol/L, Glomerular Filtration Rate (GFR) \<70 mL/min/1.73m\^2(calculated by Modification of Diet in Renal Disease (MDRD) formula); uric acid\>540 μmol/L; triglyceride\>3.5mmol/L * Participants with a history of alcoholic liver disease, moderate or higher nonalcoholic fatty liver disease, autoimmune liver disease, Gilbert syndrome or other hereditary liver disease, drug-induced liver disease and other chronic liver diseases * Participants with a history of progressive liver fibrosis (eg: liver cirrhosis diagnosed by liver histopathological examination, or esophagogastric varices diagnosed by endoscopy) * Participants with confirmed or suspected decompensated HBV cirrhosis with complications of ascites, hepatic encephalopathy, gastroesophageal variceal bleeding, and Child-Pugh score of B\ C, or with primary liver cancer * Alpha Fetoprotein (AFP) \>50 ng/ml at screening or the suspected malignant liver mass indicated by imaging * Any previous or current malignant neoplasms * Breast-feeding or pregnant females * Participants who are not suitable to participate in this trial per the Investigator's judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Treatment-Emergent Adverse Events | From the first dose of study drug until Day 57 |
| Peak concentration (Cmax) | From predose to Day 113 |
| Area under the drug-time curve (AUC0-2W） | From predose to Day 113 |
| Area under the drug-time curve (AUClast) | From predose to Day 113 |
| Area under the drug-time curve (AUCinf) | From predose to Day 113 |
Countries
China
Outcome results
None listed