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

A Randomized, Double-blind, Placebo-controlled, Dose-escalating Phase I Trial With Single and Multiple Dosing to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of HECN30227 Injection in Healthy Volunteers and Subjects With Chronic Hepatitis B

To evaluate the safety, efficacy, pharmacokinetics and immunogenicity of single and multiple doses of HECN30227 Injection in healthy volunteers and patients with chronic hepatitis B

Inclusion Criteria:

1. Subjects must understand and comply with the study procedures, voluntarily participate, and sign the informed consent form.
2. Male subjects must weigh at least 50 kg; female subjects must weigh at least 45 kg.
3. 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.
4. 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.
5. 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.
6. HBV DNA < 90 IU/mL at screening.
7. HBsAg > 100 IU/mL at screening.
8. Serum ALT and AST ≤ 2 × ULN, and total serum bilirubin ≤ 2 × ULN at screening and baseline.

Exclusion Criteria:

1. Subjects who have undergone major surgery within 3 months prior to screening, or plan to undergo surgery during the study period.
2. 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).
3. 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.
4. 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.
5. 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.
6. Subjects who participated in another clinical trial within 3 months prior to screening.
7. 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.
8. Subjects who are breastfeeding or have a positive serum pregnancy test result.
9. Subjects with significant hepatic fibrosis or liver cirrhosis.
10. 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.
11. Subjects diagnosed with any malignant tumor within 5 years prior to screening , or those assessed to have potential malignant tumors at present.
12. Subjects with international normalized ratio (INR) >1.5, or platelet count <90×10⁹/L, or serum albumin <35 g/L at screening.
13. Subjects with alpha-fetoprotein (AFP) >50 ng/mL at screening.
14. Subjects with endogenous creatinine clearance (CLcr) <60 mL/min/1.73 m² at screening.
15. Subjects receiving, or who have received any interferon-containing regimen or immunosuppressive therapy within 1 year prior to screening.
16. Subjects whom the investigator considers unsuitable for participation in this trial for any other reasons.