APG-1387 Study of Safety, Tolerability ,PK/PD in Patients With Chronic Hepatitis B

• Status: Completed
• Trial end date: 2021-10-15
• Target enrollment: 0
• Participant gender: All

Summary

This study is a Multiple Ascending Dose study to Explore the Tolerability, Safety and Pharmacokinetics/Pharmacodynamics of APG-1387 in Chronic Hepatitis B Patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ascentage Pharma Group Inc.
• Collaborator: HealthQuest Pharma Inc.

Criteria

Inclusion Criteria

1. Age ≥18 and ≤ 65 years old.

2. Confirmed diagnosis of chronic hepatitis B, HBsAg positive≥6 months.

3. HBV DNA≥2×103 IU/mL for HBeAg negative patients, HBV DNA≥1×104IU/mL for HBeAg positive patients in screening phase.

4. ALT≥ ULN and <10 ×ULN in screening phase (exclude non-HBV related ALT elevation such as drug or alcohol et al).

5. BMI 18~26.

6. Patients should not use antivirus treatment such as NAs and IFN within 6 months before screening.

7. Adequate hematologic function.

8. QTc interval ≤ 450 ms in males, and ≤ 470 ms in females.

9. Adequate renal and liver function.

10. Negative serum pregnancy test (for women of childbearing potential) documented within the 24-hour prior to the first dose of investigational product. Willing to use contraception by a method that is deemed effective by the investigator by Subject and their partners throughout the treatment period and for at least three months following the last dose of study drug.

11. Ability to understand and willing to sign a written informed consent form, the consent form must be signed by the patient prior to any study-specific procedures.

Exclusion Criteria

1. Clinical confirmed HCC or suspected HCC or AFP>50μg/L.

2. A history of decompensated liver function (such as Child-Pugh B or C or history of ascites, digestive tract bleeding, hepatic encephalopathy or spontaneous bacterial peritonitis et al.).

3. Advanced fibrosis/cirrhosis, defined as a fiber screening scan≥12.4kPa during screening phase or liver biopsy at any time found Metavir score F3, F4 fibrosis.

4. Patients with other liver diseases except hepatitis B, including chronic alcoholic hepatitis, drug-induced liver injury, autoimmune liver disease, hereditary liver disease and other causes of active hepatitis.

5. Patients with malignant tumours (excluding basal cell and in situ cervical cancer that have been cured without recurrence) or lymphatic proliferative diseases.

6. Have a clear history of neurological or psychiatric disorders, such as epilepsy, dementia, poor compliance.

7. Chronic kidney disease, renal insufficiency.

8. Poor control of other important primary diseases of the viscera, such as clear history of nervous system, cardiovascular system, urinary system, digestive system, respiratory system, Metabolism and skeletal muscle system (such as poor control diabetes, hypertension and etc.), which the investigator considers not suitable for the study.

9. Females who are pregnant or nursing.

10. History of alcoholism (average daily ethanol intake of 30 grams (male) or ≥ 20 grams (female) for 1 years), drug abuse history or drug abuse screening results positive.

11. Severe infection, trauma or a major surgical operation within 4 weeks prior to screening.

12. Use of immunomodulators (eg, corticosteroids) or biologics (eg, monoclonal antibody, IFN) within 3 months prior to screening, or will use immunomodulators (eg, corticosteroids) or biologics (eg, monoclonal antibody, IFN) during the study.

13. Treatment with an investigational agent or device within three months prior to screening.

14. Anti-HDV total antibody/IgM antibody positive, HCV antibody positive and HCV-RNA positive, anti-HIV antibody positive, or treponema pallidum antibody positive.

15. Known or suspected Wilson's Disease, or other disease that may affect copper accumulates or regulates.

16. Prior treatment with IAP inhibitors.

17. Any other condition or circumstance of that would, in the opinion of the investigator, make the patient unsuitable for participation in the study.