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

NCT05542979 | Completed Phase 1

• 1 other identifier: HH0031802
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 11

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.

Conditions

Chronic HBV Infection

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

HH-003 Group

EXPERIMENTAL

Drug: HH-003 injection

Placebo Group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HH-003 injection DRUG

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

HH-003 Group

Placebo DRUG

Placebo is administrated via I.V. infusion

Placebo Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Huahui Health: lead

Study Sites (11)

Beijing Ditan Hospital,Capital Medical University

Beijing, Beijing Municipality, 100015, China

Location

Beijing Friendship Hospital,Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Beijing Youan Hospital,Capital Medical University

Beijing, Beijing Municipality, 100069, China

Location

Mengchao Hepatobiliary Hospital Of Fujian Medical University

Fuzhou, Fujian, 350025, China

Location

The First Hospital of Lanzhou University

Lanzhou, Gansu, 730000, China

Location

The First Affiliated Hospital Of Zhengzhou University

Zhengzhou, Henan, 450000, China

Location

Henan Infectious Disease Hospital(The Sixth Peoples Hospital Of Zhengzhou)

Zhengzhou, Henan, 450006, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Yanbian University Hospital(Yanbian Hospital)

Yanji, Jilin, 133000, China

Location

Shandong Public Health Clinical Center

Jinan, Shandong, 250102, China

Location

The First Affiliated Hospital,Zhejiang University School Of Medicine

Hangzhou, Zhejiang, 310003, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2022
• First Posted: September 16, 2022
• Study Start: August 5, 2019
• Primary Completion: March 15, 2022
• Study Completion: March 15, 2022
• Last Updated: September 16, 2022

Record last verified: 2022-09

Locations

CN (11)