Clinical trial NCT05542979: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic HBV Infection
Lead sponsor: Huahui Health
Sponsor class: INDUSTRY
First posted: 2022-09-16
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: From the first dose of study drug until Day 57
measure: Peak concentration (Cmax)
timeFrame: From predose to Day 113
measure: Area under the drug-time curve (AUC0-2W）
timeFrame: From predose to Day 113
measure: Area under the drug-time curve (AUClast)
timeFrame: From predose to Day 113
measure: Area under the drug-time curve (AUCinf)
timeFrame: From predose to Day 113
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital,Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital,Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Youan Hospital,Capital Medical University
state: Beijing
city: Fuzhou
country: China
facility: Mengchao Hepatobiliary Hospital Of Fujian Medical University
state: Fujian
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Zhengzhou
country: China
facility: The First Affiliated Hospital Of Zhengzhou University
state: Henan
city: Zhengzhou
country: China
facility: Henan Infectious Disease Hospital(The Sixth Peoples Hospital Of Zhengzhou)
state: Henan
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Yanji
country: China
facility: Yanbian University Hospital(Yanbian Hospital)
state: Jilin
city: Jinan
country: China
facility: Shandong Public Health Clinical Center
state: Shandong
city: Hangzhou
country: China
facility: The First Affiliated Hospital,Zhejiang University School Of Medicine
state: Zhejiang
Study officials:
References: