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This study is divided into two parts. Phase Ib is a randomized, double-blind, placebo-controlled trial, designed to evaluate the safety, tolerability, pharmacokinetic characteristics, preliminary efficacy, and immunogenicity of TQA3038 injection in patients with chronic hepatitis B. It is expected to include 72 subjects. Phase IIa adopted an open-label, randomized, parallel-controlled design, with a total of 90 subjects included, mainly evaluating the changes in serum HBsAg compared to baseline at the end of the 48th week.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQA3038 injection/placebo | Experimental | 100/0mg~400/0mg, subcutaneous injection, 2 weeks~8 weeks as a cycle, a total of 2 doses. Nucleotide drugs: Oral, once a day, orally administered with food, for 16 weeks. |
|
| Nucleotide drugs Control group | Active Comparator | Nucleotide drugs: Oral, once a day, orally administered with food, for 48weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQA3038 injection/placebo | Drug | TQA3038 is a Anti-Hepatitis B virus (HBV) drugs. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | The incidence of adverse events (AEs) during treatment. | Baseline up to 16 weeks |
| Serious adverse events (SAEs) | The incidence of serious adverse events (SAEs) during treatment. | Baseline up to 16 weeks |
| Hepatitis B virus surface antigen (HbsAg) | Changes of serum HbsAg compared with baseline at the 48th week of treatment in each group. | Baseline up to 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Maximum Plasma Concentration (Tmax) | Time to reach Cmax of TQA3038 and its metabolite in plasma. | Predose on the 1st dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose and Predose on the 2nd dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose |
| Maximum Plasma Concentration (Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qin Ning, Doctor | Contact | 13971521450 | qning@vip.sina.com | |
| Junqi Niu, Doctor | Contact | 13756661205 | junqiniu@aliyun.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical College | Bengbu | Anhui | 233000 | China |
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| Nucleotide drugs Control group | Drug | Nucleotide drugs are nucleoside reverse transcriptase inhibitors. |
|
Maximum concentration of TQA3038 and its metabolite in plasma. |
| Predose on the 1st dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose and Predose on the 2nd dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose |
| Area Under the Plasma Concentration Versus Time Curve (AUC) | Area under the curve of TQA3038 and its metabolite from time 0 to last measurable time. | Predose on the 1st dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose and Predose on the 2nd dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose |
| Volume of distribution (Vd/F) | Volume of distribution (Vd/F) of TQA3038 in Plasma. | Predose on the 1st dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose and Predose on the 2nd dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose |
| Apparent Plasma Clearance (CL/F) | Apparent Plasma Clearance (CL/F) of TQA3038 in Plasma. | Predose on the 1st dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose and Predose on the 2nd dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose |
| Apparent Terminal Elimination Half-life (t1/2) | Apparent Elimination Half-life (T1/2) of TQA3038 in Plasma | Predose on the 1st dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose and Predose on the 2nd dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose |
| The incidence and titer of anti drug antibodies (ADA) | The incidence and titer of anti drug antibodies (ADA) in serum. | Day1 before administration, Week 8, Week 16, and during withdrawal |
| Incidence of Neutralization antibody (Nab) | Incidence of Neutralization antibody (Nab) in serum. | Day1 before administration, Week 8, Week 16, and during withdrawal |
| Hepatitis B surface antigen (HBsAg) | Changes in Hepatitis B surface antigen (HbsAg) levels from baseline during the study period. | Baseline up to 48 weeks |
| Hepatitis B E antigen (HBeAg) | Changes in HbeAg levels from baseline during the study period. | Baseline up to 48 weeks |
| Mengchao Hepatobiliary Hospital of Fujian Medical University | Fuzhou | Fujian | 350025 | China |
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| Gansu province people hospital | Lanzhou | Gansu | 730030 | China |
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| The Third Affiliated Hospital of Sun Yat sen University | Guangzhou | Guangdong | 510630 | China |
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| The First Affiliated Hospital of GUANGXI Medical University | Nanning | Guangxi | 530021 | China |
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| Guizhou Provincial People's Hospital | Guiyang | Guizhou | 550002 | China |
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| The Fourth Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | 150000 | China |
|
| Shiyan City Taihe Hospital | Shiyan | Hubei | 442000 | China |
|
| Tongji Hospital of Tongji medical college of HUST | Wuhan | Hubei | 430030 | China |
|
| Xiangya Third Hospital of Central of Central Suoth University | Changsha | Hunan | 410000 | China |
|
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330000 | China |
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| The first hospital of Jilin University | Changchun | Jilin | 130061 | China |
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| Hepatobiliary Hospital of Jilin | Changchun | Jilin | 130062 | China |
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| The sixth people's hospital at of Shenyang | Shenyang | Liaoning | 110006 | China |
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| Shengjing Hospital Affiliated to China Medical University | Shenyang | Liaoning | 110136 | China |
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| Shandong Public Health Clinical Center | Jinan | Shandong | 250102 | China |
|
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610041 | China |
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| The First Affiliated Hospital of Xinjiang Medical University | Ürümqi | Xinjiang | 830054 | China |
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| The Southwest Hospital of AMU | Chongqing | 400038 | China |
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| The Second Affilated Hospital of Chongqing medical university | Chongqing | 400080 | China |
|
| Shanghai Tongren Hospital | Shanghai | 200000 | China |
|
| People's Hospital of Tianjin (City) | Tianjin | 300000 | China |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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