NCT07673068尚未招募1 期
Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of TVAX-028 Injection in Patients With Chronic Hepatitis B
Grand Theravac Life Sciences (Nanjing) Co., Ltd.0 个研究点目标入组 32 人开始时间: 2026年5月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Subjects voluntarily sign the informed consent, fully understand the study content, and are willing and able to comply with all trial procedures.
- •2. Male or female, aged 18 to 65 years.
- •3. Has a clinical diagnosis of chronic hepatitis B virus infection based on protocol-defined criteria.
- •4. Is receiving stable antiviral treatment with a single nucleos(t)ide analogue before enrollment. Has adequately suppressed HBV DNA and acceptable liver function based on protocol-defined criteria before the first administration of adjuvant or TVAX-
- •5. Has HBeAg-negative chronic hepatitis B virus infection based on protocol-defined criteria.
- •6. Has hepatitis B surface antigen (HBsAg) levels within the protocol-defined range before the first administration of adjuvant or TVAX-
- •7. Has no evidence of autoimmune liver disease based on protocol-defined testing and investigator assessment.
- •8. Participants of childbearing potential must agree to use effective contraception for the protocol-defined period.
排除标准
- •1. Has liver disease other than chronic hepatitis B virus infection that may interfere with study participation or interpretation of study results
- •2. Has evidence or suspected evidence of hepatocellular carcinoma, cirrhosis, clinically significant hepatic space-occupying lesions, or clinically significant liver fibrosis based on imaging, laboratory testing, or non-invasive liver assessment.
- •3. Has clinically significant abnormalities in laboratory tests, including but not limited to liver function, renal function, hematology, coagulation, or electrolyte parameters, based on protocol-defined criteria.
- •4. Has received interferon or pegylated interferon treatment within the protocol-defined period before the first administration of adjuvant or TVAX-028, or plans to receive such treatment during the study.
- •5. Has received immunosuppressive therapy within the protocol-defined period before the first administration of adjuvant or TVAX-
- •6. Has received corticosteroid therapy within the protocol-defined period before the first administration of adjuvant or TVAX-028, except for permitted topical or inhaled corticosteroids.
- •7. Has clinically significant cardiovascular, renal, pancreatic, or other systemic disease that may increase study risk or interfere with study assessments.
- •8. Has inadequately controlled diabetes mellitus or hypertension based on protocol-defined criteria.
- •9. Has evidence of clinically significant co-infection, including hepatitis C virus, hepatitis D virus, human immunodeficiency virus, or active syphilis infection.
- •10. Has a history of malignancy within the protocol-defined period before the first administration of adjuvant or TVAX-028, except for conditions permitted by the protocol.
- •11. Has previously received organ transplantation.
- •12. Has a history of severe drug and food allergy, or is known to be allergic to any component of the investigational product or related products.
- •13. Has a history of drug abuse or clinically significant alcohol abuse within the protocol-defined period before the first dose.
- •14. Has a history or current diagnosis of psychiatric disease, severe depression, or other condition that may affect compliance with study procedures.
- •15. Has a history of severe allergy, or is known or suspected to be allergic to any component of the investigational product, adjuvant, or related products.
- •16. Has participated in another clinical trial of an investigational drug, biologic, medical device, or vaccine within the protocol-defined period before the first administration of adjuvant or TVAX-
- •17. Is pregnant or breastfeeding.
- •18. Is considered by the investigator to be unsuitable for participation in this study for any other reason.
研究组 & 干预措施
TVAX-028 low-dose group
Experimental
Participants receive low-dose TVAX-028 with adjuvant
干预措施: TVAX-028 (Drug)
TVAX-028 medium-dose group
Experimental
Participants receive medium-dose TVAX-028 with adjuvant
干预措施: TVAX-028 (Drug)
Adjuvant Group
Other
Participants receive adjuvant alone
干预措施: Adjuvant (Other)
TVAX-028 high-dose group
Experimental
Participants receive high-dose TVAX-028 with adjuvant
干预措施: TVAX-028 (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: Through the end of the safety follow-up period, an average of 60 weeks
Adverse events will be assessed according to the protocol-defined safety assessment criteria.
Number of participants with dose-limiting toxicities
时间窗: Through the end of the safety follow-up period, an average of 60 weeks
Dose-limiting toxicities will be assessed according to protocol-defined criteria.
次要结局
未报告次要终点
研究者
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