A Phase I Clinical Trial to Evaluate HECN30227 Injection in Healthy Subjects and Subjects With Chronic Hepatitis B

Inclusion criteria

• Subjects must understand and comply with the study procedures, voluntarily participate, and sign the informed consent form.
• Male subjects must weigh at least 50 kg; female subjects must weigh at least 45 kg.
• Vital signs, physical examination, laboratory tests, electrocardiography (ECG), chest X-ray, and abdominal ultrasound (liver, gallbladder, spleen, pancreas, and both kidneys) are normal, or abnormalities are judged by the investigator to be clinically insignificant.
• Female subjects of childbearing potential or male subjects must agree to use effective contraception from the time of signing the informed consent form until 6 months after the last dose of study drug.
• Subjects must have received stable treatment with nucleos(t)ide analogues (NAs) (e.g., entecavir, tenofovir disoproxil fumarate, or tenofovir alafenamide) for at least 6 months prior to screening.
• HBV DNA < 90 IU/mL at screening.
• HBsAg > 100 IU/mL at screening.
• Serum ALT and AST ≤ 2 × ULN, and total serum bilirubin ≤ 2 × ULN at screening and baseline.

Exclusion criteria

• Subjects who have undergone major surgery within 3 months prior to screening, or plan to undergo surgery during the study period.
• Subjects with a history of allergy to the study drug or any of its components, or with allergic diathesis (allergic to two or more types of drugs or foods).
• Subjects with a history of alcohol abuse within 1 year prior to screening , or those with a positive blood alcohol test result prior to dosing.
• Subjects with a history of drug abuse or use of illicit drugs within 1 year prior to screening, or those with a positive urine drug screening result prior to dosing.
• Subjects who donated blood ≥200 mL, or donated any blood component, or suffered a total blood loss ≥200 mL for any reason within 3 months prior to screening; or those with a history of blood transfusion or blood product administration.
• Subjects who participated in another clinical trial within 3 months prior to screening.
• Subjects who develop an acute illness (e.g., acute respiratory disease) or receive concomitant medication from the time of signing the informed consent form to prior to the first dose.
• Subjects who are breastfeeding or have a positive serum pregnancy test result.
• Subjects with significant hepatic fibrosis or liver cirrhosis.
• Subjects with a history of hepatic decompensation manifestations or disease at screening or in the past, including but not limited to ruptured esophageal and gastric variceal bleeding, ascites, hepatic encephalopathy, etc.
• Subjects diagnosed with any malignant tumor within 5 years prior to screening , or those assessed to have potential malignant tumors at present.
• Subjects with international normalized ratio (INR) >1.5, or platelet count <90×10⁹/L, or serum albumin <35 g/L at screening.
• Subjects with alpha-fetoprotein (AFP) >50 ng/mL at screening.
• Subjects with endogenous creatinine clearance (CLcr) <60 mL/min/1.73 m² at screening.
• Subjects receiving, or who have received any interferon-containing regimen or immunosuppressive therapy within 1 year prior to screening.
• Subjects whom the investigator considers unsuitable for participation in this trial for any other reasons.