A Phase II Study of Subcutaneously Injected PD-L1 Antibody ASC22 in Chronic Hepatitis B Patients
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04465890 |
Recruitment Status :
Active, not recruiting
First Posted : July 10, 2020
Last Update Posted : April 3, 2024
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Hepatitis b | Drug: ASC22 Drug: sodium chloride | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 207 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Phase IIa Single Dose and Phase IIb Mutiple Dose Clinical Studies to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Subcutaneously Injected PD-L1 Antibody ASC22 in Patients With Chronic Hepatitis B |
Actual Study Start Date : | July 17, 2020 |
Estimated Primary Completion Date : | August 30, 2024 |
Estimated Study Completion Date : | August 30, 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: cohort1: Single dose ASC22 injection 0.3mg/kg
Single dose ASC22 Injection; Specification: 200mg/1ml/1bottle; Subcutaneous injection; once administration,0.3mg/kg dose of the drug once.
|
Drug: ASC22
200mg/1ml/1bottle |
Experimental: cohort2:Single dose ASC22 injection 1.0mg/kg
Single dose ASC22 Injection; Specification: 200mg/1ml/1bottle; Subcutaneous injection; once administration,1.0mg/kg dose of the drug once.
|
Drug: ASC22
200mg/1ml/1bottle |
Experimental: cohort3:Single dose ASC22 injection 2.5mg/kg
Single dose ASC22 Injection; Specification: 200mg/1ml/1bottle; Subcutaneous injection; once administration,2.5mg/kg dose of the drug once.
|
Drug: ASC22
200mg/1ml/1bottle |
Experimental: cohort4: Multiple dose ASC22 injection 1.0mg/kg
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
200mg/1ml/1bottle |
Experimental: cohort5: Multiple dose ASC22 injection 2.5mg/kg
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
200mg/1ml/1bottle |
Placebo Comparator: cohort4: Placebo sodium chloride injection A
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
90mg/10ml/1 bottle |
Placebo Comparator: cohort5: Placebo sodium chloride injection B
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
90mg/10ml/1 bottle |
Experimental: cohort6: Multiple dose ASC22 injection 1.0mg/kg
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
200mg/1ml/1bottle |
Placebo Comparator: cohort6: Placebo sodium chloride injection A
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
90mg/10ml/1 bottle |
- 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. [ Time Frame: 48 weeks ]Each multiple dose cohort will last 48 weeks (24-weeks treatment plus 24-weeks follow up).
- 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. [ Time Frame: 48 weeks ]Each multiple dose cohort will last 48 weeks (24-weeks treatment plus 24-weeks follow up).
- Evaluate the decline value of HBsAg level. [ Time Frame: 48 weeks ]Each multiple dose cohort will last 48 weeks (24-weeks treatment plus 24-weeks follow up).
- Evaluate the propotion's change of HBsAg < 0.05IU/ml in each cohort. [ Time Frame: 48 weeks ]Each multiple dose cohort will last 48 weeks (24-weeks treatment plus 24-weeks follow up).
- Evaluate the changes of cytokines (IL-2, IFN-γ) in each cohort. [ Time Frame: 48 weeks ]Each multiple dose cohort will last 48 weeks (24-weeks treatment plus 24-weeks follow up).
- Evaluate the changes of peripheral blood lymphocyte subsets in each cohort. [ Time Frame: 48 weeks ]Each multiple dose cohort will last 48 weeks (24-weeks treatment plus 24-weeks follow up).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 18-65 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.
Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04465890
China | |
Peking University First Hospital | |
Beijing, China |
Responsible Party: | Ascletis Pharmaceuticals Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT04465890 |
Other Study ID Numbers: |
ASC-ASC22-II-CTP-01 |
First Posted: | July 10, 2020 Key Record Dates |
Last Update Posted: | April 3, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Chronic Hepatitis b (CHB) PD-L1 Fc fusion protein injection |
Hepatitis A Hepatitis B Hepatitis B, Chronic Hepatitis Hepatitis, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Infections |
Enterovirus Infections Picornaviridae Infections RNA Virus Infections Blood-Borne Infections Communicable Diseases Hepadnaviridae Infections DNA Virus Infections Chronic Disease Disease Attributes Pathologic Processes |