A Phase II Study of Subcutaneously Injected PD-L1 Antibody ASC22 in Chronic Hepatitis B Patients

• Status: Active, not recruiting
• Trial end date: 2022-06-14
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to evaluate the safety and efficacy of ASC22 in the treatment of chronic hepatitis B after single and multiple drug administration.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ascletis Pharmaceuticals Co., Ltd.
• Collaborators: Beijing Clinical Service Center; Peking University First Hospital

Criteria

Inclusion Criteria:

1. 18-65 years old (including boundary value), gender unlimited；

2. Chronic hepatitis B patients with clear diagnosis of Hematology, etiology and clinical (for example: HBsAg positive for more than 6 months);

3. HBV-DNA turns negative after treatment with nucleoside (acid) drugs;

4. HBsAg≤ 10000 IU/ml;

5. HBeAg negative;

6. The fertile female subjects or the fertile male subjects agreed to take contraceptive measures from 7 days before the first administration until 24 weeks after the end of the administration cycle of ASC22. The serum pregnancy test of fertile female subjects must be negative within 7 days before the first administration.

Exclusion Criteria:

1. Patients with hepatitis a, hepatitis c (HCV RNA>15IU/L), hepatitis d or HIV infection; Patients with other active infections (e.g., respiratory tract infection, urinary tract infection and herpes simplex, cytomegalovirus, epstein-barr virus);

2. Fibrosis stage: Cirrhosis, portal hypertension, or advanced fibrosis (defined as Fibroscan≥9.5kPa or ARFI≥1.81m/sec or Fibrosis-4 (FIB-4)≥3.25 or METAVIR F≥3);

3. Liver cancer patients or blood AFP>1×ULN;

4. Patients who received interferon therapy within 6 months before the first administration;

5. Patients receiving immunosuppressive therapy within 3 months before the first administration (except interferon);

6. The investigator judges that the participants are not suitable for this study.