💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
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