A Randomized, Double-blind, Placebo-controlled Phase Ib Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple-dose HH-003 Injection in Treatment Naïve Participants With HBeAg-positive Chronic HBV Infection

Huahui Health11 sites in 1 country68 target enrollmentAugust 5, 2019

ConditionsChronic HBV Infection

InterventionsHH-003 injection Placebo

DrugsHH-003 injection Placebo

Overview

Phase: Phase 1
Intervention: HH-003 injection
Conditions: Chronic HBV Infection
Sponsor: Huahui Health
Enrollment: 68
Locations: 11
Primary Endpoint: Incidence of Treatment-Emergent Adverse Events
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 5, 2019

End Date

March 15, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Huahui Health

Responsible Party

Sponsor

Eligibility 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\<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