AHB-171 Injection: AHB-171 Injection is adminstrated via subcutaneous injection
Placebo: Placebo is admistrated via subcutaneous injection
Nucleos(t)ide Analogue (NA): Oral administration
Study summary
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
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Part A & Part B Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — PartA:Up to 16 weeks, PartB: Up to 48 weeks
Severity of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — PartA:Up to 16 weeks, PartB: Up to 48 weeks
Change from baseline in laboratory tests — PartA:Up to 16 weeks, PartB: Up to 48 weeks
Change from baseline in physical examinations — PartA:Up to 16 weeks, PartB: Up to 48 weeks
Change from baseline in vital signs — PartA:Up to 16 weeks, PartB: Up to 48 weeks
Change from baseline in electrocardiograms (ECGs) — PartA:Up to 16 weeks, PartB: Up to 48 weeks
Part A:Plasma Cmax of AHB-171 — Up to Day 8
Part A:Plasma Tmax of AHB-171 — Up to Day 8
Part A Plasma AUC of AHB-171 — Up to Day 8
Part A Plasma t1/2 of AHB-171 — Up to Day 8
Proportion of participants with clinically significant abnormalities in laboratory tests — PartA:Up to 16 weeks, PartB: Up to 48 weeks
Proportion of participants with clinically significant abnormalities in electrocardiograms (ECGs) — PartA:Up to 16 weeks, PartB: Up to 48 weeks
Proportion of participants with physical examinations — PartA:Up to 16 weeks, PartB: Up to 48 weeks
Proportion of participants with other vital signs — PartA:Up to 16 weeks, PartB: Up to 48 weeks
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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