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The goal of this clinical trial is to evaluate the safety, tolerability, immunogenicity and Pharmacokinetics (PK) characteristics of AHB-171 Injection in healthy participants (Part A) and participants with chronic hepatitis B (CHB, Part B), and assess its preliminary efficacy in CHB participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AHB-171 and placebo in CHB (Part B: MAD) | Experimental | Drug: AHB-171 Injection Drug: Placebo Drug: Nucleos(t)ide Analogue (NA) Background treatment |
|
| AHB-171 and placebo in HP(Part A: SAD) | Experimental | Drug: AHB-171Injection Drug: Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AHB-171 Injection | Drug | AHB-171 Injection is adminstrated via subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A & Part B Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | PartA:Up to 16 weeks, PartB: Up to 48 weeks | |
| Severity of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | PartA:Up to 16 weeks, PartB: Up to 48 weeks | |
| Proportion of participants with clinically significant abnormalities in laboratory tests, electrocardiograms (ECGs), physical examinations, and vital signs | PartA:Up to 16 weeks, PartB: Up to 48 weeks | |
| Change from baseline in laboratory tests, electrocardiograms (ECGs), physical examinations, and vital signs | PartA:Up to 16 weeks, PartB: Up to 48 weeks | |
| Part A:Plasma Cmax of AHB-171 | Up to Day 8 | |
| Part A:Plasma Tmax of AHB-171 | Up to Day 8 | |
| Part A Plasma AUC of AHB-171 | Up to Day 8 | |
| Part A Plasma t1/2 of AHB-171 | Up to Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Part A & Part B:Fraction excreted in urine in percentage for AHB-171 | Up to Day 3 in Part A; Up to Day 30 in Part B | |
| Part A & Part B:Amount excreted in urine for AHB-171 | Up to Day 3 in Part A; Up to Day 30 in Part B |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bella Lu | Contact | 0571-86959519 | clinicaltrial@ausperbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AusperBio Investigational Site | Recruiting | Ch’ang-ch’un | Jilin | China |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| Placebo | Drug | Placebo is admistrated via subcutaneous injection |
|
| Nucleos(t)ide Analogue (NA) | Drug | Oral administration |
|
| Part A & Part B:Renal clearance for AHB-171 | Up to Day 3 in Part A; Up to Day 30 in Part B |
| Part A & Part B: Immunogenicity: The number of participants develop anti-drug antibodies (ADA) against AHB-171 and the ADA antibody titer | Up to 16 weeks in Part A; Up to 48 weeks in Part B |
| Part B:Plasma Cmax of AHB-171 | Up to Day 31 |
| Part B:Plasma Tmax of AHB-171 | Up to Day 31 |
| Part B Plasma AUC of AHB-171 | Up to Day 31 |
| Part B Plasma t1/2 of AHB-171 | Up to Day 31 |
| Part B: Proportion of CHB who achieved hepatitis B surface antigen (HBsAg) clearance | Up to 48 weeks |
| Part B: HBsAg Decline in CHB Participants at each assessment time point | Up to 48 weeks |
| Part B:Proportion of participants with HBsAg < 1 IU/mL, < 10 IU/mL, and < 100 IU/mL at each assessment time point. | Up to 48 weeks |
| Part B Proportion of participants achieve seroconversion to anti-HBs (HBsAb >10 IU/L) after HBsAg loss. | Up to 48 weeks |
| Part B Proportion of participants with HBV DNA < LLOQ (10 IU/mL) | Up to 48 weeks |
| Part B Proportion of participants with HBsAg < LOD and HBV DNA < LLOQ at each assessment time point | Up to 48 weeks |
| Part B Serum levels of HBsAg, HBV DNA, HBV RNA, HBcrAg, HBsAb , HBeAb , HBeAg | Up to 48 weeks |
| Part B The level of ALT. | Up to 48 weeks |
| PartB: Proportion of participants achieving ALT normalization and time to ALT normalization among those with baseline ALT > ULN. | Up to 48 weeks |
| Part B Correlation between pharmacokinetic and pharmacodynamic parameters of AHB-171 | Up to 48 weeks |
| 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 |