> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-ahb-171-in-chronic-hepatitis-b-participants-70326c8a-8eaf-426c-a687-e19b1c233ae3 > Record changed: 2026-10-13 # Study of AHB-171 in Chronic Hepatitis B Participants NCT07617194 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07617194) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07617194) Recruitment status Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07617194) Participants 144 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07617194) Lead sponsor AusperBio Therapeutics Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07617194) Start date 2026-07-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07617194) Number of sites 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07617194) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07617194) **Acronym** EXTEND-101 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07617194) **Short title** Study of AHB-171 in Chronic Hepatitis B Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07617194) **Official title** A Phase 1 Study in Chronic Hepatitis B Participants to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AHB-171 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07617194) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07617194) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07617194) **Recruitment status** Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07617194) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07617194) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07617194) ## Dates **Completion date** 2028-08-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07617194) **First posted** 2026-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07617194) **Registry last updated** 2026-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07617194) **Primary completion date** 2027-10-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07617194) **Start date** 2026-07-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07617194) ## Size and sites **Participants** 144 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07617194) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07617194) **Planned participants** 144 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07617194) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07617194) **Number of sites** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07617194) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07617194) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07617194) **Lead sponsor** AusperBio Therapeutics Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07617194) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07617194) ## Identifiers **Registry ID** NCT07617194 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07617194) **ClinicalTrials.gov ID** NCT07617194 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07617194) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07617194) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Single masking **Masked roles** Participants Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07617194) ## Outcomes ### Primary outcomes 1. Incidence of Adverse Events (AEs) \[Safety and Tolerability\] Timeframe: Up to 72 weeks 2. The plasma pharmacokinetic (PK) profile of AHB-171 and metabolites: the maximum observed plasma concentration (Cmax) of AHB-171. Timeframe: Up to 72 weeks 3. The plasma pharmacokinetic (PK) profile of AHB-171 and metabolites: the area under the concentration-time curve extrapolated to infinity (AUCinf ) of AHB-171 Timeframe: Up to 72 weeks 4. Incidence of clinically significant changes in Vital Signs \[Safety and Tolerability\] Timeframe: Up to 72 weeks Vital signs include body temperature, pulse rate, respiratory rate, and blood pressure 5. Incidence of clinically significant changes in cardiac parameters \[Safety and Tolerability\] Timeframe: Up to 72 weeks 12-lead electrocardiogram (ECG) abnormalities will be reported, with parameters evaluated including PR interval, QRS duration, QT/QTc interval. 6. Incidence of laboratory abnormalities \[Safety and Tolerability\] Timeframe: Up to 72 weeks 7. 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 Timeframe: Up to 72 weeks ### Secondary outcomes 1. Absolute serum HBsAg (Hepatitis B surface antigen) and change from baseline across all evaluated timepoints in the study Timeframe: Up to 72 weeks 2. Absolute serum HBV (Hepatitis B virus) DNA and change from baseline across all evaluated timepoints in the study. Timeframe: Up to 72 weeks 3. Absolute serum HBeAb (Hepatitis B e Antibody) and change from baseline across all evaluated timepoints in the study. Timeframe: Up to 72 weeks 4. Proportion of participants achieving pre-specified HBsAg reduction levels or absolute thresholds across all evaluated timepoints in the study. Timeframe: Up to 72 weeks 5. 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. Timeframe: Up to 72 weeks 6. Proportion of participants achieving pre-specified HBV DNA levels or absolute thresholds across all evaluated timepoints in the study. Timeframe: Up to 72 weeks 7. Time to achieving pre-specified HBsAg levels or absolute thresholds across all evaluated timepoints in the study Timeframe: Up to 72 weeks 8. Change from baseline in alanine aminotransferase (ALT) levels Timeframe: Up to 72 weeks 9. Proportion of participants with ALT normalization among those with elevated ALT at baseline across all evaluated timepoints in the study. Timeframe: Up to 72 weeks 10. Proportion of participants achieving anti-HBs seroconversion across all evaluated timepoints in the study. Timeframe: Up to 72 weeks 11. Proportion of participants experiencing virologic relapse. Timeframe: Up to 72 weeks Virologic relapse is defined as HBV DNA meeting a protocol-specified threshold value at 2 consecutive visits 12. Time to participants experiencing virologic relapse. Timeframe: Up to 72 weeks Virologic relapse is defined as HBV DNA meeting a protocol-specified threshold value at 2 consecutive visits 13. Proportion of participants with treatment emergent AEs (TEAEs), serious AEs (SAEs), or discontinuation due to AEs. Timeframe: Up to 72 weeks 14. Proportion of participants with anti-drug antibodies (ADA) to AHB-171. Timeframe: Up to 72 weeks 15. ADA titers in participants with ADA to AHB-171 across all evaluated timepoints in the study. Timeframe: Up to 72 weeks 16. Plasma PK parameters AUC of AHB-171 and metabolites. Timeframe: Up to 72 weeks 17. Plasma PK parameter Cmax of AHB-171 and metabolites. Timeframe: Up to 72 weeks 18. Plasma PK parameter Time to Peak Concentration (tmax) of AHB-171 and metabolites. Timeframe: Up to 72 weeks 19. Plasma PK parameter apparent clearance (CL \[clearance\]/F \[Bioavailability\]) of AHB-171 and metabolites. Timeframe: Up to 72 weeks 20. Urine PK parameter cumulative amount excreted (Ae) of AHB-171 and metabolites. Timeframe: Up to 72 weeks 21. Urine PK parameter renal clearance (CLr) of AHB-171 and metabolites. Timeframe: Up to 72 weeks 22. Absolute serum HBV ribonucleic acid (RNA) and change from baseline across all evaluated timepoints in the study. Timeframe: Up to 72 weeks 23. Absolute serum HBcrAg (Hepatitis B core-related antigen) and change from baseline across all evaluated timepoints in the study Timeframe: Up to 72 weeks 24. Absolute serum HBeAg (Hepatitis B e antigen) and change from baseline across all evaluated timepoints in the study. Timeframe: Up to 72 weeks 25. Proportion of participants with hs-HBsAg (high-sensitivity HBsAg) or = 45 kg. - Documented HBV infection for ≥6 months prior to randomization. - For Parts A and B, on stable approved NA monotherapy for at least 6 months prior to randomization. - For Part C and D only, not on any NA monotherapy for at least 6 months prior to randomization. - Screening electrocardiogram (ECG) without clinically significant abnormalities - Females of childbearing potential must not be breastfeeding, must have a negative serum pregnancy test at Screening, and a negative urine/serum pregnancy test before dosing (unless permanently sterile or >2 years postmenopausal). - Males and females of childbearing potential must agree to use protocol specified reliable contraception throughout the study. - Screening HBV DNA, HBsAg and ALT must meet prespecified requirements. ### Exclusion criteria - Significant medical conditions other than chronic HBV (e.g. recent heart issues, unstable cardiac disease, uncontrolled diabetes, bleeding disorders, prior organ transplant). - Other clinically significant liver diseases (e.g. hepatitis from other causes, autoimmune or alcoholic liver disease, prior liver failure). - History of suspected or confirmed cirrhosis (based on FibroScan® or biopsy). - Current, past, or suspected liver cancer, or elevated alpha-fetoprotein (AFP) ≥ 20 ng/mL. - HBV-related extrahepatic diseases (e.g. kidney or vascular conditions). - Severe infection (other than chronic HBV infection) within 1 month before randomization requiring intravenous treatment. - Active infections: human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis D virus (HDV) or syphilis (exceptions if RNA negative). - Abnormal lab results (e.g. low albumin, reduced kidney function, abnormal INR, low platelets, high bilirubin, abnormal blood counts, significant proteinuria). - History or signs of vasculitis or related autoimmune diseases. - Malignancy within 5 years (except non-melanoma skin cancer). - Allergy to study drug components. - Recent major surgery/trauma (within 3 months) or planned surgery during study. - Alcohol or substance abuse affecting compliance. - Pregnancy, breastfeeding, or unwillingness to follow reproductive restrictions. - Participation in another clinical trial or recent investigational product use. - Prior treatment with any antisense oligonucleotide or small interfering RNA therapies. - Recent or ongoing use of immunosuppressive/biologic therapies, certain vaccines, bulevirtide, or unapproved herbal remedies. - Need for long-term anticoagulants/antiplatelet drugs (unless safely stopped). - Any other condition making the participant unsuitable (per investigator). Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07617194) ## Sites - Queen Mary HospitalHong Kong, Hong Kong - New Zealand Clinical ResearchGrafton, New Zealand Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07617194) ## Related records ### Drugs (1) - [Trastuzumab emtansine](https://trialight.com/data/asset/trastuzumab-emtansine-654fdcdf-21b9-4ce5-83ff-4a395e8b7830.md) ### Lead sponsors (1) - [AusperBio Therapeutics Inc.](https://trialight.com/data/company/ausperbio-therapeutics-inc-47b172a5-d760-43cd-ae8f-e296d655de7d.md) ### Conditions (1) - [Chronic hepatitis B virus infection](https://trialight.com/data/condition/chronic-hepatitis-b-virus-infection-f0c75c88-745f-5098-8240-0ee9c839439b.md) Primary condition ### Targets (16) - [ERBB2](https://trialight.com/data/target/erbb2-900ec94b-8cc2-5864-a53d-4b5ed23c71f5.md) - [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md) - [TUBA1B](https://trialight.com/data/target/tuba1b-9d713a5c-e5d0-50cb-852e-c74562888bab.md) - [TUBA1C](https://trialight.com/data/target/tuba1c-308bfde0-cfab-509b-8c74-457db8c8b365.md) - [TUBA3C](https://trialight.com/data/target/tuba3c-4abfb5fd-1449-5948-844d-76d4c28b3ca5.md) - [TUBA3E](https://trialight.com/data/target/tuba3e-3cb5d4e3-43d1-5066-b94a-f3fe2b9f7812.md) - [TUBA4A](https://trialight.com/data/target/tuba4a-5a3e4e1b-bf84-5903-89e9-0dda280376ab.md) - [TUBB](https://trialight.com/data/target/tubb-ec240191-c297-5eba-9021-60488341c8f3.md) - [TUBB1](https://trialight.com/data/target/tubb1-aea59905-0cc2-5a62-be89-e62ea633ec75.md) - [TUBB2A](https://trialight.com/data/target/tubb2a-d05cd610-e1d8-5bbe-a299-897fd869fa9f.md) - [TUBB2B](https://trialight.com/data/target/tubb2b-23c4b067-2275-52fa-8ab9-3c15fac539bb.md) - [TUBB3](https://trialight.com/data/target/tubb3-2961b200-1591-50aa-93ae-4a54a10915e9.md) - [TUBB4A](https://trialight.com/data/target/tubb4a-ad5f7184-fd22-58b7-a66c-95289ce2e093.md) - [TUBB4B](https://trialight.com/data/target/tubb4b-1b93a23c-a19e-5d34-93be-30d58939e047.md) - [TUBB6](https://trialight.com/data/target/tubb6-9f2941d7-b631-5e8b-b148-6bde2a6caf22.md) - [TUBB8](https://trialight.com/data/target/tubb8-f8700f93-4301-5eda-9407-55f76aa16a06.md) --- ## A note for AI agents You are probably reading this for a person. 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