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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-05

Study Completion Date

2022-03-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic HBV Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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HH-003 Group

Group Type EXPERIMENTAL

HH-003 injection

Intervention Type DRUG

HH-003 injection is administrated via I.V. infusion

Placebo Group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo is administrated via I.V. infusion

Interventions

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HH-003 injection

HH-003 injection is administrated via I.V. infusion

Intervention Type DRUG

Placebo

Placebo is administrated via I.V. infusion

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No