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A clinical study evaluating the pharmacokinetic characteristics and safety of AHB-137 injection in participants with mild to moderate liver dysfunction and those with normal liver function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part1: Child-Pugh B group | Experimental |
| |
| Part2: Child-Pugh A group | Experimental |
| |
| Part1:Participants with normal liver function group | Experimental |
| |
| Part2:Participants with normal liver function group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AHB-137 injection | Drug | Single use subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Key PK parameters of AHB-137 injection after single subcutaneous administration: peak concentration (Cmax) | Up to day 29 | |
| Key PK parameters of AHB-137 injection after single subcutaneous administration: area under the drug time curve from 0 to infinity (AUC) | Up to day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameter: Area under the drug time curve from 0 to the last endpoint quantifiable concentration time point (AUCo- Last) | Up to day 29 | |
| PK parameter: Area under the drug time curve from 0 to 24 hours (AUCo-24) | Up to day 29 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lu | Contact | 0571-86959519 | clinicaltrial@ausperbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Jing Zhang | Huashan Hospital | Principal Investigator |
| Yuxian Huang | Huashan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital Fudan University | Shanghai | Shanghai Municipality | China |
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| PK parameter: Area under the drug time curve from 0 to 168 hours (AUCo-168) | Up to day 29 |
| PK parameter: D8 blood concentration (C168) | Up to day 29 |
| PK parameter: peak time (Tmax) | Up to day29 |
| Safety indicators | The proportion of participants who experienced all adverse events (TEAEs), serious adverse events (SAEs), and adverse events of particular concern (AESIs) during the treatment period after a single subcutaneous administration of AHB-137 injection; And laboratory tests, 12 lead ECG, and changes in vital signs compared to baseline. | Up to day 29 |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| D006509 | Hepatitis B |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
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