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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
68
HH-003 injection is administrated via I.V. infusion
Placebo is administrated via I.V. infusion
Beijing Ditan Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Beijing Friendship Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Beijing Youan Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Incidence of Treatment-Emergent Adverse Events
Time frame: From the first dose of study drug until Day 57
Peak concentration (Cmax)
Time frame: From predose to Day 113
Area under the drug-time curve (AUC0-2W)
Time frame: From predose to Day 113
Area under the drug-time curve (AUClast)
Time frame: From predose to Day 113
Area under the drug-time curve (AUCinf)
Time frame: From predose to Day 113
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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
...and 1 more locations