ACTRN12623000105640招募中1 期
A Phase 1/2a, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of BJT-778 in Healthy Volunteers and in Subjects with Chronic Hepatitis B Infection, Including Subjects with Chronic Hepatitis D Infection - Part 3 conducted in individuals with chronic hepatitis B and D co-infection.
Bluejay Therapeutics Inc.0 个研究点目标入组 32 人开始时间: 2023年1月30日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •Able and willing to provide written informed consent (signed and dated) and any authorizations required by local law and can comply with all study requirements
- •Male or female adults between 18 and 70 years of age
- •BMI 18-40 kg/m2
- •Chronic HBV infection greater than or equal to 6 months (e.g., positive for serum HBsAg greater than or equal to 6 months)
- •Plasma HBV DNA less than 100 IU/ml at Screening
- •On nucleos(t)ide analogs
- •Qualitative HBsAg level criteria at Screening by Cohort/group:
- •- Cohort D and F: greater than or equal to 10 IU/ml
- •Females: Non-pregnant and non-lactating; surgically sterile, post-menopausal or, if engaged in sexual relations of childbearing potential, subject is using an acceptable contraceptive method from the time of signing the informed consent form until at least 12 weeks after the last dose of Study Drug.
- •Males: Surgically sterile or if engaged in sexual relations with a female of child-bearing potential, subject is utilizing an acceptable contraceptive method during treatment with Study Drug and for at least 12 weeks after the last dose of Study Drug. Agree not to donate sperm for at least 12 weeks after the last dose of Study Drug.
- •Must have quantifiable serum HDV RNA levels at screening
排除标准
- •Evidence of cirrhosis
- •History of decompensated liver disease as evidenced by ascites, hepatic encephalopathy, and/or gastric or esophageal varices
- •History of liver disease other than Hepatitis B (i.e., NASH, alcohol associated hepatitis, cholestatic liver disease, etc.)
- •Chronic hepatitis C virus (HCV) infection; subjects with past HCV RNA infection that was successfully treated must be HCV RNA negative and at least 24 weeks post treatment.
- •Received solid organ or bone marrow transplant
- •Currently taking, or took within 1 month of Screening, any immunosuppressing drugs (e.g., prednisone). If the subject received a short course, the situation may be discussed with the Medical Monitor, or designee
- •Clinically significant abnormalities aside from chronic HBV infection in medical history (e.g., previous acute coronary syndrome within 6 months of Screening, major surgery within 3 months of Screening, uncontrolled diabetes) or physical examination
- •History of bleeding diathesis or coagulopathy
- •History of, or suspected presence of vasculitis
- •History of extrahepatic disorders possibly related to HBV immune complexes (e.g., glomerulonephritis, polyarteritis nodosa)
- •Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated
- •Treatment with a different investigational drug other than BJT-778, biological agent, or device within 4 weeks of screening or 5 half-lives of Study Drug, whichever is longer.
- •History of drug abuse/addiction within 6 months (except cannabis) of Screening or positive urine drug Screen (excluding physician-prescribed drugs and cannabis)
- •Unwillingness to comply with study procedures, including follow-up, as specified by this protocol, or unwillingness to cooperate fully with the Investigator
- •Have any other conditions (medical, social, psychiatric, or other), which in the opinion of the Investigator would make the subject unsuitable for inclusion or could interfere with the subject participating in or completing the study.
研究者
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