Back to resultsA Study to Evaluate the Safety, Tolerability of HH-003 Injection in Participants With Chronic Hepatitis B Virus Infection
Primary Purpose
Chronic HBV Infection
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
HH-003 injection
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic HBV Infection
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
Sites / Locations
- Beijing Ditan Hospital,Capital Medical University
- Beijing Friendship Hospital,Capital Medical University
- Beijing Youan Hospital,Capital Medical University
- Mengchao Hepatobiliary Hospital Of Fujian Medical University
- The First Hospital of Lanzhou University
- The First Affiliated Hospital Of Zhengzhou University
- Henan Infectious Disease Hospital(The Sixth Peoples Hospital Of Zhengzhou)
- The First Hospital of Jilin University
- Yanbian University Hospital(Yanbian Hospital)
- Shandong Public Health Clinical Center
- The First Affiliated Hospital,Zhejiang University School Of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
HH-003 Group
Placebo Group
Arm Description
Outcomes
Primary Outcome Measures
Incidence of Treatment-Emergent Adverse Events
Peak concentration (Cmax)
Area under the drug-time curve (AUC0-2W）
Area under the drug-time curve (AUClast)
Area under the drug-time curve (AUCinf)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05542979
Brief Title
A Study to Evaluate the Safety, Tolerability of HH-003 Injection in Participants With Chronic Hepatitis B Virus Infection
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
August 5, 2019 (Actual)
Primary Completion Date
March 15, 2022 (Actual)
Study Completion Date
March 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Huahui Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic HBV Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HH-003 Group
Arm Type
Experimental
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
HH-003 injection
Intervention Description
HH-003 injection is administrated via I.V. infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo is administrated via I.V. infusion
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events
Time Frame
From the first dose of study drug until Day 57
Title
Peak concentration (Cmax)
Time Frame
From predose to Day 113
Title
Area under the drug-time curve (AUC0-2W）
Time Frame
From predose to Day 113
Title
Area under the drug-time curve (AUClast)
Time Frame
From predose to Day 113
Title
Area under the drug-time curve (AUCinf)
Time Frame
From predose to Day 113
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Beijing Ditan Hospital,Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100015
Country
China
Facility Name
Beijing Friendship Hospital,Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Beijing Youan Hospital,Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100069
Country
China
Facility Name
Mengchao Hepatobiliary Hospital Of Fujian Medical University
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350025
Country
China
Facility Name
The First Hospital of Lanzhou University
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730000
Country
China
Facility Name
The First Affiliated Hospital Of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Facility Name
Henan Infectious Disease Hospital(The Sixth Peoples Hospital Of Zhengzhou)
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450006
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Yanbian University Hospital(Yanbian Hospital)
City
Yanji
State/Province
Jilin
ZIP/Postal Code
133000
Country
China
Facility Name
Shandong Public Health Clinical Center
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250102
Country
China
Facility Name
The First Affiliated Hospital,Zhejiang University School Of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Safety, Tolerability of HH-003 Injection in Participants With Chronic Hepatitis B Virus Infection
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