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

Chronic HBV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05542979
• Other study ID #: HH0031802
• Status: Completed
• Phase: Phase 1
• Start date: August 5, 2019
• Est. completion date: March 15, 2022

Study information

• Verified date: September 2022
• Source: Huahui Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: March 15, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic HBV Infection
• Communicable Diseases
• Infections

Intervention

Drug:
• HH-003 injection
HH-003 injection is administrated via I.V. infusion
• Placebo
Placebo is administrated via I.V. infusion

Locations

Country	Name	City	State
China	Beijing Ditan Hospital,Capital Medical University	Beijing	Beijing
China	Beijing Friendship Hospital,Capital Medical University	Beijing	Beijing
China	Beijing Youan Hospital,Capital Medical University	Beijing	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	Mengchao Hepatobiliary Hospital Of Fujian Medical University	Fuzhou	Fujian
China	The First Affiliated Hospital,Zhejiang University School Of Medicine	Hangzhou	Zhejiang
China	Shandong Public Health Clinical Center	Jinan	Shandong
China	The First Hospital of Lanzhou University	Lanzhou	Gansu
China	Yanbian University Hospital(Yanbian Hospital)	Yanji	Jilin
China	Henan Infectious Disease Hospital(The Sixth Peoples Hospital Of Zhengzhou)	Zhengzhou	Henan
China	The First Affiliated Hospital Of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Huahui Health

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events		From the first dose of study drug until Day 57
Primary	Peak concentration (Cmax)		From predose to Day 113
Primary	Area under the drug-time curve (AUC0-2W)		From predose to Day 113
Primary	Area under the drug-time curve (AUClast)		From predose to Day 113
Primary	Area under the drug-time curve (AUCinf)		From predose to Day 113