Overview

A Study to Evaluate the Safety, Tolerability of HH-003 Injection in Participants With Chronic Hepatitis B Virus Infection

Status:
Completed
Trial end date:
2022-03-15
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Huahui Health
Criteria
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
- 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