Study of AHB-171 in Chronic Hepatitis B Participants (EXTEND-101)
2026年5月24日 更新者：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.
調査の概要
状態
まだ募集していません
条件
研究の種類
介入
入学 (推定)
144
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Debbie Liao
- 電話番号：(650) 650-2877
- メール：ausperbioclinicaltrials@ausperbio.com
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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).
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：AHB-171 or Placebo in CHB (Part A: Single Ascending Dose [SAD])
|
経口投与
Injection
Injection
|
|
実験的：AHB-171 or Placebo in CHB (Part B: finite Multiple Dose [MD])
|
経口投与
Injection
Injection
|
|
実験的：AHB-171 and placebo in CHB (Part C: finite MD)
|
Injection
Injection
|
|
実験的：AHB-171 and placebo in CHB (Part D: finite MD)
|
Injection
Injection
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of Adverse Events (AEs) [Safety and Tolerability]
時間枠：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.
時間枠：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
時間枠：Up to 72 weeks
|
Up to 72 weeks
|
|
|
Incidence of clinically significant changes in Vital Signs [Safety and Tolerability]
時間枠：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]
時間枠：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]
時間枠：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
時間枠：Up to 72 weeks
|
Up to 72 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Absolute serum HBsAg (Hepatitis B surface antigen) and change from baseline across all evaluated timepoints in the study
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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
時間枠：Up to 72 weeks
|
Up to 72 weeks
|
|
|
Change from baseline in alanine aminotransferase (ALT) levels
時間枠：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.
時間枠：Up to 72 weeks
|
Up to 72 weeks
|
|
|
Proportion of participants achieving anti-HBs seroconversion across all evaluated timepoints in the study.
時間枠：Up to 72 weeks
|
Up to 72 weeks
|
|
|
Proportion of participants experiencing virologic relapse.
時間枠：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.
時間枠：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.
時間枠：Up to 72 weeks
|
Up to 72 weeks
|
|
|
Proportion of participants with anti-drug antibodies (ADA) to AHB-171.
時間枠：Up to 72 weeks
|
Up to 72 weeks
|
|
|
ADA titers in participants with ADA to AHB-171 across all evaluated timepoints in the study.
時間枠：Up to 72 weeks
|
Up to 72 weeks
|
|
|
Plasma PK parameters AUC of AHB-171 and metabolites.
時間枠：Up to 72 weeks
|
Up to 72 weeks
|
|
|
Plasma PK parameter Cmax of AHB-171 and metabolites.
時間枠：Up to 72 weeks
|
Up to 72 weeks
|
|
|
Plasma PK parameter Time to Peak Concentration (tmax) of AHB-171 and metabolites.
時間枠：Up to 72 weeks
|
Up to 72 weeks
|
|
|
Plasma PK parameter apparent clearance (CL [clearance]/F [Bioavailability]) of AHB-171 and metabolites.
時間枠：Up to 72 weeks
|
Up to 72 weeks
|
|
|
Urine PK parameter cumulative amount excreted (Ae) of AHB-171 and metabolites.
時間枠：Up to 72 weeks
|
Up to 72 weeks
|
|
|
Urine PK parameter renal clearance (CLr) of AHB-171 and metabolites.
時間枠：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.
時間枠：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
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：Time Frame: Up to 72 weeks
|
Time Frame: Up to 72 weeks
|
|
|
Time to first hs-HBsAg <LLOQ, assessed at scheduled visits
時間枠：Up to 72 weeks
|
Up to 72 weeks
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月6日
一次修了 (推定)
2027年10月8日
研究の完了 (推定)
2028年8月14日
試験登録日
最初に提出
2026年5月7日
QC基準を満たした最初の提出物
2026年5月24日
最初の投稿 (実際)
2026年6月1日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月1日
QC基準を満たした最後の更新が送信されました
2026年5月24日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- AB-17-8001
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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