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

NCT04465890 | Completed Phase 2

• 1 other identifier: ASC-ASC22-II-CTP-01
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Hepatitis b

Keywords

Chronic Hepatitis b (CHB); PD-L1; Fc fusion protein injection

Outcome Measures

Primary Outcomes (2)

• Evaluate the decreased HBsAg levels at 12 or 24 weeks of treatment or at 4, 12, or 24 weeks of follow-up visits compared with baseline.

  Each multiple dose cohort will last 48 weeks (24-weeks treatment plus 24-weeks follow up).

  48 weeks

• Evaluate the number of patients with ≥0.5log reduction in HBsAg log10IU/ mL at 12 or 24 weeks of treatment, or at 4, 12, or 24 weeks of follow-up visits compared with baseline.

  Each multiple dose cohort will last 48 weeks (24-weeks treatment plus 24-weeks follow up).

  48 weeks

Secondary Outcomes (4)

• Evaluate the decline value of HBsAg level.

  48 weeks

• Evaluate the propotion's change of HBsAg < 0.05IU/ml in each cohort.

  48 weeks

• Evaluate the changes of cytokines (IL-2, IFN-γ) in each cohort.

  48 weeks

• Evaluate the changes of peripheral blood lymphocyte subsets in each cohort.

  48 weeks

Study Arms (9)

cohort1: Single dose ASC22 injection 0.3mg/kg

EXPERIMENTAL

Single dose ASC22 Injection; Specification: 200mg/1ml/1bottle; Subcutaneous injection; once administration,0.3mg/kg dose of the drug once.

Drug: ASC22

cohort2:Single dose ASC22 injection 1.0mg/kg

EXPERIMENTAL

Single dose ASC22 Injection; Specification: 200mg/1ml/1bottle; Subcutaneous injection; once administration,1.0mg/kg dose of the drug once.

Drug: ASC22

cohort3:Single dose ASC22 injection 2.5mg/kg

EXPERIMENTAL

Single dose ASC22 Injection; Specification: 200mg/1ml/1bottle; Subcutaneous injection; once administration,2.5mg/kg dose of the drug once.

Drug: ASC22

cohort4: Multiple dose ASC22 injection 1.0mg/kg

EXPERIMENTAL

Multiple dose ASC22 injection; Specification: 200mg/1ml/1bottle; Subcutaneously administered once every 2 weeks , 4 received 1.0mg/kg, up to 24 weeks

Drug: ASC22

cohort5: Multiple dose ASC22 injection 2.5mg/kg

EXPERIMENTAL

Multiple dose ASC22 injection; Specification: 200mg/1ml/1bottle; Subcutaneously administered once every 2 weeks , 4 received 2.5mg/kg, up to 24 weeks

Drug: ASC22

cohort4: Placebo sodium chloride injection A

PLACEBO COMPARATOR

Placebo saline injection; Specification: 90mg/10ml/1 bottle; Subcutaneously administered every 2 weeks (Q2W, known as one drug administration cycle), duration: once every 2 weeks (Q2W), up to 12 weeks. Based on the weight of the patients, an equal dose of placebo was administered according to the incoming dose group (1.0mg/kg).

Drug: sodium chloride

cohort5: Placebo sodium chloride injection B

PLACEBO COMPARATOR

Placebo saline injection; Specification: 90mg/10ml/1 bottle; Subcutaneously administered every 2 weeks (Q2W, known as one drug administration cycle), duration: once every 2 weeks (Q2W), up to 12 weeks. Based on the weight of the patients, an equal dose of placebo was administered according to the incoming dose group (2.5mg/kg).

Drug: sodium chloride

cohort6: Multiple dose ASC22 injection 1.0mg/kg

EXPERIMENTAL

Multiple dose ASC22 injection; Specification: 200mg/1ml/1bottle; Subcutaneously administered once every 2 weeks , 4 received 1.0mg/kg, up to 24 weeks

Drug: ASC22

cohort6: Placebo sodium chloride injection A

PLACEBO COMPARATOR

Placebo saline injection; Specification: 90mg/10ml/1 bottle; Subcutaneously administered every 2 weeks (Q2W, known as one drug administration cycle), duration: once every 2 weeks (Q2W), up to 12 weeks. Based on the weight of the patients, an equal dose of placebo was administered according to the incoming dose group (1.0mg/kg).

Drug: sodium chloride

Interventions

ASC22 DRUG

200mg/1ml/1bottle

cohort1: Single dose ASC22 injection 0.3mg/kg; cohort2:Single dose ASC22 injection 1.0mg/kg; cohort3:Single dose ASC22 injection 2.5mg/kg; cohort4: Multiple dose ASC22 injection 1.0mg/kg; cohort5: Multiple dose ASC22 injection 2.5mg/kg; cohort6: Multiple dose ASC22 injection 1.0mg/kg

sodium chloride DRUG

90mg/10ml/1 bottle

cohort4: Placebo sodium chloride injection A; cohort5: Placebo sodium chloride injection B; cohort6: Placebo sodium chloride injection A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old (including boundary value), gender unlimited；
• Chronic hepatitis B patients with clear diagnosis of Hematology, etiology and clinical (for example: HBsAg positive for more than 6 months);
• HBV-DNA turns negative after treatment with nucleoside (acid) drugs;
• cohort1-5:HBsAg≤ 10000 IU/mL; cohort6: HBsAg≤ 100 IU/mL;
• HBeAg negative;
• 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.

You may not qualify if:

• 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);
• 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);
• Liver cancer patients or blood AFP\>1×ULN;
• cohort1-5：Patients who received interferon therapy within 6 months before the first administration; cohort6: Patients who received interferon therapy before the first administration;
• Patients receiving immunosuppressive therapy within 3 months before the first administration (except interferon);
• The investigator judges that the participants are not suitable for this study.

Sponsors & Collaborators

• Ascletis Pharmaceuticals Co., Ltd.: lead
• Peking University First Hospital: collaborator
• Beijing Clinical Service Center: collaborator

Study Sites (1)

Peking University First Hospital

Beijing, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: July 10, 2020
• Study Start: July 17, 2020
• Primary Completion: August 9, 2024
• Study Completion: August 9, 2024
• Last Updated: December 2, 2024

Record last verified: 2024-09

Locations

CN (1)