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

Phase 1

Completed

• Conditions: Chronic HBV Infection
• Interventions: Drug: HH-003 injection; Drug: Placebo

• Registration Number: NCT05542979
• Lead Sponsor: Huahui Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-05
• Primary Completion: 2022-03-15
• Study Completion: 2022-03-15
• Status Verified: 2022-09
• Study First Submitted: 2022-09-11
• Study First Submitted QC: 2022-09-14
• Last Update Submitted: 2022-09-14
• Study First Posted: 2022-09-16
• Last Update Posted: 2022-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HH-003 Group	HH-003 injection	-
Placebo Group	Placebo	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (11)

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

Mengchao Hepatobiliary Hospital Of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China

The First Hospital of Lanzhou University; 🇨🇳 Lanzhou, Gansu, China

The First Affiliated Hospital Of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Henan Infectious Disease Hospital(The Sixth Peoples Hospital Of Zhengzhou); 🇨🇳 Zhengzhou, Henan, China

The First Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China

Yanbian University Hospital(Yanbian Hospital); 🇨🇳 Yanji, Jilin, China

Shandong Public Health Clinical Center; 🇨🇳 Jinan, Shandong, China

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