A Phase I Clinical Study of AHB - 171 in Healthy Participants(HP) and Chronic Hepatitis B (CHB) Participants

Официальное название

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AHB - 171 Injection in Healthy Participants (HP) and Chronic Hepatitis B(CHB) Participants

Обзор

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.

Вмешательства

• Препарат AHB-171 Injection
  AHB-171 Injection is adminstrated via subcutaneous injection
• Препарат Placebo
  Placebo is admistrated via subcutaneous injection
• Препарат Nucleos(t)ide Analogue (NA)
  Oral administration

Первичные конечные точки

• Part A & Part B Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Срок оценки: PartA:Up to 16 weeks, PartB: Up to 48 weeks]
• Severity of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Срок оценки: PartA:Up to 16 weeks, PartB: Up to 48 weeks]
• Change from baseline in laboratory tests [Срок оценки: PartA:Up to 16 weeks, PartB: Up to 48 weeks]
• Change from baseline in physical examinations [Срок оценки: PartA:Up to 16 weeks, PartB: Up to 48 weeks]
• Change from baseline in vital signs [Срок оценки: PartA:Up to 16 weeks, PartB: Up to 48 weeks]
• Change from baseline in electrocardiograms (ECGs) [Срок оценки: PartA:Up to 16 weeks, PartB: Up to 48 weeks]
• Part A:Plasma Cmax of AHB-171 [Срок оценки: Up to Day 8]
• Part A:Plasma Tmax of AHB-171 [Срок оценки: Up to Day 8]
• Part A Plasma AUC of AHB-171 [Срок оценки: Up to Day 8]
• Part A Plasma t1/2 of AHB-171 [Срок оценки: Up to Day 8]

Вторичные конечные точки (12)

• Part A & Part B:Fraction excreted in urine in percentage for AHB-171 [Срок оценки: 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 [Срок оценки: Up to Day 3 in Part A; Up to Day 30 in Part B]
• Part A & Part B:Renal clearance for AHB-171 [Срок оценки: 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 [Срок оценки: Up to 16 weeks in Part A; Up to 48 weeks in Part B]
• Part B:Plasma Cmax of AHB-171 [Срок оценки: Up to Day 31]
• Part B:Plasma Tmax of AHB-171 [Срок оценки: Up to Day 31]
• Part B Plasma AUC of AHB-171 [Срок оценки: Up to Day 31]
• Part B Plasma t1/2 of AHB-171 [Срок оценки: Up to Day 31]
• Part B: Proportion of CHB who achieved hepatitis B surface antigen (HBsAg) clearance [Срок оценки: Up to 48 weeks]
• Part B: HBsAg Decline in CHB Participants at each assessment time point [Срок оценки: 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. [Срок оценки: Up to 48 weeks]
• Part B Proportion of participants achieve seroconversion to anti-HBs (HBsAb >10 IU/L) after HBsAg loss. [Срок оценки: Up to 48 weeks]

Критерии участия

Критерии включения

• Healthy Participants:
• Male or female participants, aged 18-55 years old (inclusive);
• Body mass index between 18.0 and 28.0 kg/m\^2 (inclusive);
• Laboratory safety tests during the screening period, 12-lead electrocardiogram (ECG), abdominal ultrasound, thyroid ultrasound, chest anteroposterior position, etc., are assessed by the investigatoras normal or abnormal without clinical significance;
• Female participants of childbearing potential must not be pregnant or lactating, must have a negative pregnancy test at screening, and must agree to use effective contraceptive methods and refrain from donating eggs from screening until 6 months after the last dose of the study drug.
• Male participants must agree to use highly effective contraceptive methods (to ensure effective contraception for their female partners of childbearing potential) and refrain from donating sperm from screening until 6 months after the last dose of the study drug. Liver and kidney function tests meet the requirements at the time of screening.
• CHB Participants:
• Male or female participants, aged 18-65 years old (inclusive);
• Body mass index between 18.0 and 32.0 kg/m\^2 (inclusive);
• Participants who take effective contraceptive measures as required;
• HBsAg > 100 IU/mL and ≤ 3000 IU/mL, and HBV DNA < 100 IU/mL at screening.
• Have received stable treatment with NA for at least 6 months and stable on the same NA for at least 3 months before screening.

Критерии исключения

• Healthy Participants:
• Currently participating in another study, or within 5 half-lives/3 months of the last dose of a previous investigational product.
• Presence diseases (cardiovascular, neurological, renal, immunological, metabolic, etc.) or malignant tumors.- Major surgery or severe trauma within the past 6 months.
• Acute infection (e.g., influenza, gastroenteritis) within 14 days; vaccination within 28 days prior to screening.
• Allergy to any investigational drug component.
• Heavy Smoking (> 5 cigarettes/day); history of drug/alcohol abuse; consumption of caffeine or alcohol within 48 hours before dosing.
• Blood donation/loss ≥400 mL or transfusion within 12 weeks, or plan to donate during study.
• Abdominal skin issues that may affect drug injection/observation.
• Positive for HBV, HCV, HIV, or syphilis.
• Clinically significant ECG abnormality or TdP risk factors.
• Any condition judged unsuitable by investigator.
• CHB Participants:
• Currently participating in another study, or within 5 half-lives/3 months of the last dose of a previous investigational product.
• Presence of ascites, gastrointestinal bleeding, hepatic encephalopathy, or varices.
• History or suspicion of hepatocellular carcinoma (HCC); AFP > 50 ng/mL.
• Diagnosed or Suspected cirrhosis within 12 months.
• History of transplantation, autoimmune diseases, or severe systemic diseases (besides chronic HBV).
• Use of ASO, siRNA (oligonucleotide therapies), or interferon within 12 months.
• Major injury/surgery within 6 months, planned surgery during study, or acute infection within 14 days.
• Allergy to any investigational drug component.
• Blood donation/loss ≥400 mL or transfusion within 12 weeks, or plan to donate during study.
• Abdominal skin issues that may affect drug injection/observation.
• Key laboratory result not suitable for clinical trial.
• HIV, HCV, or active syphilis infection; uncured hepatitis A, D, or E.
• Clinically significant ECG abnormality or TdP risk factors.
• Any condition judged unsuitable by investigator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• AusperBio Investigational Site — Ch’ang-ch’un
• AusperBio Investigational Site — Ханчжоу

Идентификаторы

NCT: NCT07511218 · AB-17-8002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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