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

Sponsor

Huahui Health (Industry)

Overall Status

Completed

CT.gov ID

NCT05542979

Collaborator

(none)

Enrollment

Locations

Arms

31.3

Actual Duration (Months)

6.2

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic HBV Infection	Drug: HH-003 injection Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Aug 5, 2019

Actual Primary Completion Date :

Mar 15, 2022

Actual Study Completion Date :

Mar 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HH-003 Group	Drug: HH-003 injection HH-003 injection is administrated via I.V. infusion
Placebo Comparator: Placebo Group	Drug: Placebo Placebo is administrated via I.V. infusion

Arm

Intervention/Treatment

Experimental: HH-003 Group

Drug: HH-003 injection

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

Placebo Comparator: Placebo Group

Drug: Placebo

Placebo is administrated via I.V. infusion

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Ditan Hospital,Capital Medical University	Beijing	Beijing	China	100015
2	Beijing Friendship Hospital,Capital Medical University	Beijing	Beijing	China	100050
3	Beijing Youan Hospital,Capital Medical University	Beijing	Beijing	China	100069
4	Mengchao Hepatobiliary Hospital Of Fujian Medical University	Fuzhou	Fujian	China	350025
5	The First Hospital of Lanzhou University	Lanzhou	Gansu	China	730000
6	The First Affiliated Hospital Of Zhengzhou University	Zhengzhou	Henan	China	450000
7	Henan Infectious Disease Hospital(The Sixth Peoples Hospital Of Zhengzhou)	Zhengzhou	Henan	China	450006
8	The First Hospital of Jilin University	Changchun	Jilin	China	130021
9	Yanbian University Hospital(Yanbian Hospital)	Yanji	Jilin	China	133000
10	Shandong Public Health Clinical Center	Jinan	Shandong	China	250102
11	The First Affiliated Hospital,Zhejiang University School Of Medicine	Hangzhou	Zhejiang	China	310003

Sponsors and Collaborators

Huahui Health

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Huahui Health

ClinicalTrials.gov Identifier:

NCT05542979

Other Study ID Numbers:

HH0031802

First Posted:

Sep 16, 2022

Last Update Posted:

Sep 16, 2022

Last Verified:

Sep 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infections

Communicable Diseases

Study Results

No Results Posted as of Sep 16, 2022