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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HH-003 Group | Experimental |
| |
| Placebo Group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HH-003 injection | Drug | HH-003 injection is administrated via I.V. infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Ditan Hospital,Capital Medical University | Beijing | Beijing Municipality | 100015 | China | ||
| Beijing Friendship Hospital,Capital Medical University |
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| Placebo |
| Drug |
Placebo is administrated via I.V. infusion |
|
| Beijing |
| Beijing Municipality |
| 100050 |
| China |
| Beijing Youan Hospital,Capital Medical University | Beijing | Beijing Municipality | 100069 | China |
| Mengchao Hepatobiliary Hospital Of Fujian Medical University | Fuzhou | Fujian | 350025 | China |
| The First Hospital of Lanzhou University | Lanzhou | Gansu | 730000 | China |
| The First Affiliated Hospital Of Zhengzhou University | Zhengzhou | Henan | 450000 | China |
| Henan Infectious Disease Hospital(The Sixth Peoples Hospital Of Zhengzhou) | Zhengzhou | Henan | 450006 | China |
| The First Hospital of Jilin University | Changchun | Jilin | 130021 | China |
| Yanbian University Hospital(Yanbian Hospital) | Yanji | Jilin | 133000 | China |
| Shandong Public Health Clinical Center | Jinan | Shandong | 250102 | China |
| The First Affiliated Hospital,Zhejiang University School Of Medicine | Hangzhou | Zhejiang | 310003 | China |