A Clinical Trial of Hepalatide for Injection in Patients With Chronic Hepatitis D

Inclusion Criteria:

1. Male or female subjects aged 18-65 years (both inclusive);

2. Subjects with positive HBsAg and/or HBV DNA for at least 6 months ("CHB");

3. Subjects with positive serum anti-HDV antibody before or at screening or withpositive HDV RNA for at least 6 months before screening ("CHD");

4. Subjects with positive and quantifiable HDV RNA before enrollment;

5. 1 × ULN < ALT < 10 × ULN;

6. Subjects who should be treated with nucleoside/nucleotide reverse transcriptaseinhibitors at enrollment or after enrollment according to the guidelines forthe treatment of hepatitis D (compensated cirrhosis with detectable HBV DNA, orHBV DNA > 2000 IU/mL in patients without cirrhosis) and consent to the use ofentecavir for the treatment of chronic hepatitis B;

7. Subjects who do not plan a pregnancy within 3 years (women who are not pregnantor lactating, and males who agree to take effective contraceptive measuresthroughout the treatment period and for 3 months after the last dose);

8. Subjects exhibiting good compliance to the study protocol;

9. Subjects who understand the ICF and agree to sign it.

Exclusion Criteria:

1. Subjects suffering from severe decompensated liver fibrosis or decompensatedliver cirrhosis with a Child-Pugh score > 7;

2. Decompensated liver disease: Direct bilirubin > 1.2 x ULN or prothrombin time > 1.2 x ULN or serum albumin < 35 g/L;

3. Abnormal hematology findings: White blood cell count (WBC) < 3 × 109/L,neutrophil count < 1.5 × 109/L or platelet count < 60 × 109/L;

4. Creatinine clearance < 60 mL/min;

5. Subjects who have any of the following conditions:

6. History of current or past decompensated liver diseases (includingcoagulopathy, hepatic encephalopathy, and variceal bleeding);

7. Comorbidity of underlying diseases such as severe infection, heart failure andchronic obstructive pulmonary disease, and other severe diseases;

8. Diabetes mellitus and hypertension not effectively controlled (systolic bloodpressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg);

9. Current or previous uncontrolled epilepsy or psychiatric disorders;

10. History of solid organ transplantation;

11. Evidence of active or suspected malignancies or history of malignancies, oruntreated premalignant lesions within the past 5 years (except for successfullytreated cervical carcinoma in situ at least 1 year before screening, andsuccessfully treated basal cell carcinoma and squamous cell carcinoma [≤ 3cases of resected skin cancer within 5 years before screening ]), or history ofliver cancer;

12. History of alcohol abuse or drug addiction at present or within 6 months priorto participation in this study; 6. Subjects co-infected with hepatitis A, C, orE virus or with uncontrolled HIV co-infection (those with positive HCV antibodybut negative HCV RNA at screening are eligible for enrollment. HIV-infectedpatients may be enrolled if cluster of differentiation 4 (CD4) cell count is > 500/mL and HIV RNA is below the limit of detection for at least 12 months);

7. Presence of one or more other known primary or secondary liver diseases, suchas alcoholism, autoimmune hepatitis, malignancies involving the liver,hemochromatosis, other congenital or metabolic diseases affecting the liver,congestive heart failure, or other serious cardiopulmonary diseases, excludinghepatitis B;

8. Subjects with one or more autoimmune diseases, immune-related extrahepaticmanifestations (such as vasculitis, purpura, arteritis nodosa, peripheralneuropathy, and glomerulonephritis), or a history of requiring regular use ofsystemic corticosteroids (inhaled corticosteroids are allowed) or otherimmunosuppressive agents;

9. Subjects who have used interferon within 6 months before screening;

10. Subjects who have used L47 or Bulevirtide within 3 months;

11. Allergy to entecavir;

12. Pregnant or breastfeeding women;

13. Subjects who participated in other drug clinical trials within 30 days beforerandomization;

14. Subjects who are receiving prohibited treatment at screening that cannot bediscontinued;

15. Subjects who cannot comply with the study protocol and complete all proceduresas scheduled, or have significant abnormalities in other laboratory orauxiliary examinations, which render them ineligible for this trial.