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This is a multicenter, open-label, non-randomized, Phase 1 clinical study with single-dose and multiple-dose dose-escalation cohorts. The study is designed to evaluate the safety, tolerability, and pharmacokinetic characteristics of TVAX-028 in patients with chronic hepatitis B virus infection
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adjuvant Group | Other | Participants receive adjuvant alone |
|
| TVAX-028 low-dose group | Experimental | Participants receive low-dose TVAX-028 with adjuvant |
|
| TVAX-028 medium-dose group | Experimental | Participants receive medium-dose TVAX-028 with adjuvant |
|
| TVAX-028 high-dose group | Experimental | Participants receive high-dose TVAX-028 with adjuvant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TVAX-028 | Drug | TVAX-028 will be administered with adjuvant at low, medium, or high dose levels in the investigational dose groups. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Adverse events will be assessed according to the protocol-defined safety assessment criteria. | Through the end of the safety follow-up period, an average of 60 weeks |
| Number of participants with dose-limiting toxicities | Dose-limiting toxicities will be assessed according to protocol-defined criteria. | Through the end of the safety follow-up period, an average of 60 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lina Chen | Contact | 086+19921306230 | chenlina@theravac.cn |
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| ID | Term |
|---|---|
| D000277 | Adjuvants, Pharmaceutic |
| ID | Term |
|---|---|
| D010592 | Pharmaceutic Aids |
| D004364 | Pharmaceutical Preparations |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
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| Adjuvant | Other | Adjuvant will be administered alone in the adjuvant group |
|