About this trial
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.
Eligibility criteria
Qualifiers
Male or female participants, aged 18-55 years old (inclusive);
Body mass index between 18.0 and 28.0 kg/m² (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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- AHB-171 Injection
- Placebo
- Nucleos(t)ide Analogue (NA)