Study of AHB-171 in Chronic Hepatitis B Participants (EXTEND-101)
2026년 5월 24일 업데이트: AusperBio Therapeutics Inc.
A Phase 1 Study in Chronic Hepatitis B Participants to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AHB-171
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.
연구 개요
상태
아직 모집하지 않음
정황
연구 유형
중재적
등록 (추정된)
144
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Debbie Liao
- 전화번호: (650) 650-2877
- 이메일: ausperbioclinicaltrials@ausperbio.com
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Male or female participants, aged 18-65 years old (inclusive)
- Body Mass Index between 19 to 35 kg/m2 (inclusive)
- Body weight > 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).
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: AHB-171 or Placebo in CHB (Part A: Single Ascending Dose [SAD])
|
경구 투여
Injection
Injection
|
|
실험적: AHB-171 or Placebo in CHB (Part B: finite Multiple Dose [MD])
|
경구 투여
Injection
Injection
|
|
실험적: AHB-171 and placebo in CHB (Part C: finite MD)
|
Injection
Injection
|
|
실험적: AHB-171 and placebo in CHB (Part D: finite MD)
|
Injection
Injection
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence of Adverse Events (AEs) [Safety and Tolerability]
기간: Up to 72 weeks
|
Up to 72 weeks
|
|
|
The plasma pharmacokinetic (PK) profile of AHB-171 and metabolites: the maximum observed plasma concentration (Cmax) of AHB-171.
기간: Up to 72 weeks
|
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
기간: Up to 72 weeks
|
Up to 72 weeks
|
|
|
Incidence of clinically significant changes in Vital Signs [Safety and Tolerability]
기간: Up to 72 weeks
|
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]
기간: Up to 72 weeks
|
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]
기간: Up to 72 weeks
|
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
기간: Up to 72 weeks
|
Up to 72 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Absolute serum HBsAg (Hepatitis B surface antigen) and change from baseline across all evaluated timepoints in the study
기간: Up to 72 weeks
|
Up to 72 weeks
|
|
|
Absolute serum HBV (Hepatitis B virus) DNA and change from baseline across all evaluated timepoints in the study.
기간: Up to 72 weeks
|
Up to 72 weeks
|
|
|
Absolute serum HBeAb (Hepatitis B e Antibody) and change from baseline across all evaluated timepoints in the study.
기간: Up to 72 weeks
|
Up to 72 weeks
|
|
|
Proportion of participants achieving pre-specified HBsAg reduction levels or absolute thresholds across all evaluated timepoints in the study.
기간: Up to 72 weeks
|
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.
기간: Up to 72 weeks
|
Up to 72 weeks
|
|
|
Proportion of participants achieving pre-specified HBV DNA levels or absolute thresholds across all evaluated timepoints in the study.
기간: Up to 72 weeks
|
Up to 72 weeks
|
|
|
Time to achieving pre-specified HBsAg levels or absolute thresholds across all evaluated timepoints in the study
기간: Up to 72 weeks
|
Up to 72 weeks
|
|
|
Change from baseline in alanine aminotransferase (ALT) levels
기간: Up to 72 weeks
|
Up to 72 weeks
|
|
|
Proportion of participants with ALT normalization among those with elevated ALT at baseline across all evaluated timepoints in the study.
기간: Up to 72 weeks
|
Up to 72 weeks
|
|
|
Proportion of participants achieving anti-HBs seroconversion across all evaluated timepoints in the study.
기간: Up to 72 weeks
|
Up to 72 weeks
|
|
|
Proportion of participants experiencing virologic relapse.
기간: Up to 72 weeks
|
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.
기간: Up to 72 weeks
|
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.
기간: Up to 72 weeks
|
Up to 72 weeks
|
|
|
Proportion of participants with anti-drug antibodies (ADA) to AHB-171.
기간: Up to 72 weeks
|
Up to 72 weeks
|
|
|
ADA titers in participants with ADA to AHB-171 across all evaluated timepoints in the study.
기간: Up to 72 weeks
|
Up to 72 weeks
|
|
|
Plasma PK parameters AUC of AHB-171 and metabolites.
기간: Up to 72 weeks
|
Up to 72 weeks
|
|
|
Plasma PK parameter Cmax of AHB-171 and metabolites.
기간: Up to 72 weeks
|
Up to 72 weeks
|
|
|
Plasma PK parameter Time to Peak Concentration (tmax) of AHB-171 and metabolites.
기간: Up to 72 weeks
|
Up to 72 weeks
|
|
|
Plasma PK parameter apparent clearance (CL [clearance]/F [Bioavailability]) of AHB-171 and metabolites.
기간: Up to 72 weeks
|
Up to 72 weeks
|
|
|
Urine PK parameter cumulative amount excreted (Ae) of AHB-171 and metabolites.
기간: Up to 72 weeks
|
Up to 72 weeks
|
|
|
Urine PK parameter renal clearance (CLr) of AHB-171 and metabolites.
기간: Up to 72 weeks
|
Up to 72 weeks
|
|
|
Absolute serum HBV ribonucleic acid (RNA) and change from baseline across all evaluated timepoints in the study.
기간: Up to 72 weeks
|
Up to 72 weeks
|
|
|
Absolute serum HBcrAg (Hepatitis B core-related antigen) and change from baseline across all evaluated timepoints in the study
기간: Up to 72 weeks
|
Up to 72 weeks
|
|
|
Absolute serum HBeAg (Hepatitis B e antigen) and change from baseline across all evaluated timepoints in the study.
기간: Up to 72 weeks
|
Up to 72 weeks
|
|
|
Proportion of participants with hs-HBsAg (high-sensitivity HBsAg) <LLOQ across all evaluated timepoints in the study.
기간: Up to 72 weeks
|
Up to 72 weeks
|
|
|
Absolute serum HBsAb (Hepatitis B surface Antibody) and change from baseline across all evaluated timepoints in the study.
기간: Time Frame: Up to 72 weeks
|
Time Frame: Up to 72 weeks
|
|
|
Time to first hs-HBsAg <LLOQ, assessed at scheduled visits
기간: Up to 72 weeks
|
Up to 72 weeks
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 7월 6일
기본 완료 (추정된)
2027년 10월 8일
연구 완료 (추정된)
2028년 8월 14일
연구 등록 날짜
최초 제출
2026년 5월 7일
QC 기준을 충족하는 최초 제출
2026년 5월 24일
처음 게시됨 (실제)
2026년 6월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 1일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 24일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- AB-17-8001
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .