Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of AHB-171 in participants with chronic hepatitis B (CHB). Study advancement to subsequent parts/cohorts will require satisfactory interim reviews of available cumulative safety data by the Safety Review Committees (SRC), using the safety criteria and review procedures described in the protocol.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AHB-171 or Placebo in CHB (Part A: Single Ascending Dose [SAD]) | Experimental |
| |
| AHB-171 or Placebo in CHB (Part B: finite Multiple Dose [MD]) | Experimental |
| |
| AHB-171 and placebo in CHB (Part C: finite MD) | Experimental |
| |
| AHB-171 and placebo in CHB (Part D: finite MD) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AHB-171 | Drug | Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) [Safety and Tolerability] | Up to 72 weeks | |
| The plasma pharmacokinetic (PK) profile of AHB-171 and metabolites: the maximum observed plasma concentration (Cmax) of AHB-171. | Up to 72 weeks | |
| The plasma pharmacokinetic (PK) profile of AHB-171 and metabolites: the area under the concentration-time curve extrapolated to infinity (AUCinf ) of AHB-171 | Up to 72 weeks | |
| Incidence of clinically significant changes in Vital Signs [Safety and Tolerability] | Vital signs include body temperature, pulse rate, respiratory rate, and blood pressure | Up to 72 weeks |
| Incidence of clinically significant changes in cardiac parameters [Safety and Tolerability] | 12-lead electrocardiogram (ECG) abnormalities will be reported, with parameters evaluated including PR interval, QRS duration, QT/QTc interval. | Up to 72 weeks |
| Incidence of laboratory abnormalities [Safety and Tolerability] | Up to 72 weeks | |
| The plasma pharmacokinetic (PK) profile of AHB-171 and metabolites: area under the curve from the time of dosing to the last measurable concentration (AUClast) of AHB-171 | Up to 72 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute serum HBsAg (Hepatitis B surface antigen) and change from baseline across all evaluated timepoints in the study | Up to 72 weeks | |
| Absolute serum HBV (Hepatitis B virus) DNA and change from baseline across all evaluated timepoints in the study. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Debbie Liao | Contact | (650) 650-2877 | ausperbioclinicaltrials@ausperbio.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary Hospital | Hong Kong | Hong Kong | ||||
| New Zealand Clinical Research |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo matching [Investigational Product] | Drug | Injection |
|
| Nucleos(t)ide Analogue (NA) | Drug | Oral administration |
|
| Up to 72 weeks |
| Absolute serum HBeAb (Hepatitis B e Antibody) and change from baseline across all evaluated timepoints in the study. | Up to 72 weeks |
| Proportion of participants achieving pre-specified HBsAg reduction levels or absolute thresholds across all evaluated timepoints in the study. | Up to 72 weeks |
| Proportion of participants achieving HBsAg < or ≥ LOD (limit of detection) and/or HBV DNA < or ≥ LLOQ (lower limit of quantitation) across all evaluated timepoints in the study. | Up to 72 weeks |
| Proportion of participants achieving pre-specified HBV DNA levels or absolute thresholds across all evaluated timepoints in the study. | Up to 72 weeks |
| Time to achieving pre-specified HBsAg levels or absolute thresholds across all evaluated timepoints in the study | Up to 72 weeks |
| Change from baseline in alanine aminotransferase (ALT) levels | Up to 72 weeks |
| Proportion of participants with ALT normalization among those with elevated ALT at baseline across all evaluated timepoints in the study. | Up to 72 weeks |
| Proportion of participants achieving anti-HBs seroconversion across all evaluated timepoints in the study. | Up to 72 weeks |
| Proportion of participants experiencing virologic relapse. | Virologic relapse is defined as HBV DNA meeting a protocol-specified threshold value at 2 consecutive visits | Up to 72 weeks |
| Time to participants experiencing virologic relapse. | Virologic relapse is defined as HBV DNA meeting a protocol-specified threshold value at 2 consecutive visits | Up to 72 weeks |
| Proportion of participants with treatment emergent AEs (TEAEs), serious AEs (SAEs), or discontinuation due to AEs. | Up to 72 weeks |
| Proportion of participants with anti-drug antibodies (ADA) to AHB-171. | Up to 72 weeks |
| ADA titers in participants with ADA to AHB-171 across all evaluated timepoints in the study. | Up to 72 weeks |
| Plasma PK parameters AUC of AHB-171 and metabolites. | Up to 72 weeks |
| Plasma PK parameter Cmax of AHB-171 and metabolites. | Up to 72 weeks |
| Plasma PK parameter Time to Peak Concentration (tmax) of AHB-171 and metabolites. | Up to 72 weeks |
| Plasma PK parameter apparent clearance (CL [clearance]/F [Bioavailability]) of AHB-171 and metabolites. | Up to 72 weeks |
| Urine PK parameter cumulative amount excreted (Ae) of AHB-171 and metabolites. | Up to 72 weeks |
| Urine PK parameter renal clearance (CLr) of AHB-171 and metabolites. | Up to 72 weeks |
| Absolute serum HBV ribonucleic acid (RNA) and change from baseline across all evaluated timepoints in the study. | Up to 72 weeks |
| Absolute serum HBcrAg (Hepatitis B core-related antigen) and change from baseline across all evaluated timepoints in the study | Up to 72 weeks |
| Absolute serum HBeAg (Hepatitis B e antigen) and change from baseline across all evaluated timepoints in the study. | Up to 72 weeks |
| Proportion of participants with hs-HBsAg (high-sensitivity HBsAg) <LLOQ across all evaluated timepoints in the study. | Up to 72 weeks |
| Absolute serum HBsAb (Hepatitis B surface Antibody) and change from baseline across all evaluated timepoints in the study. | Time Frame: Up to 72 weeks |
| Time to first hs-HBsAg <LLOQ, assessed at scheduled visits | Up to 72 weeks |
| Grafton |
| Auckland |
| 1010 |
| New Zealand |
| 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 |