ACTRN12624001003561尚未招募1 期
A Phase 1a/b, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of BJT-628 in Healthy Volunteers and in Subjects with Chronic Hepatitis B Infection, Including Subjects with Chronic Hepatitis D Infection.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 80
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
- Randomised controlled trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 60 Years（—）
- 性别
- All
入选标准
- •1. 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
- •2. Male and female adults.
- •Phase 1a (Healthy Volunteers)
- •3. 18 to 60 years of age, inclusive
- •4. Body mass index (BMI) 18 to 35 kg/m2, inclusive
- •5. In good health, in the judgment of the Investigator
排除标准
- •1. Pregnant or lactating females
- •2. Male or female subjects of childbearing potential unwilling to comply with contraception requirements during the study.
- •3. History or presence of central neurological or peripheral neuropathy disease from physical examination
- •4. Family history of peripheral neuropathy
- •5. History of or current migraine headaches
- •6. Diabetes
- •7. Treatment with a different investigational drug other than BJT-628, a biological agent or device within 4 weeks or 5 half-lives of Day 1, whichever is longer
- •8. Clinically significant medical history of:
- •a) Cardiac diseases (e.g., myocardial infarctions, stroke, arrhythmia, heart failure, and coronary heart disease),
- •b) Autoimmune diseases (e.g., lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, sarcoidosis, moderate or severe psoriasis, thyroiditis), or
- •c) Malignancies within 3 years. Malignancy that has been successfully surgically resection and considered cured would not exclude the subject
- •d) Severe psychiatric disease, especially depression, characterized by a suicide attempt, hospitalization for psychiatric disease, or a period of disability as a result of psychiatric disease
- •e) Liver diseases (not including the disease(s) under evaluation), such as nonalcoholic steatohepatitis (NASH), alcohol-associated hepatitis, cholestatic liver disease, other viral (e.g., HAV or HCV) or non-viral hepatitis that has the potential to impact interpretation of data. Exceptions to this criterion for CHB and CHD subjects include fatty liver without any signs of steatohepatitis or past HCV infection that was successfully treated greater than or equal to 6 months prior to Screening
- •9. History of hypersensitivity to any of the components in the BJT-628 formulation
- •10. History of excess alcohol consumption within one year of Screening, defined as weekly intake of greater than or equal to 14 drinks per week (average of greater than or equal to 2 drinks per day)
- •11. History of drug abuse/addiction within one year of Screening (except cannabis)
- •12. 12-lead electrocardiogram (ECG) with a corrected QTc interval >450 msec for males and >470 msec for females or <340 msec (Fridericia’s correction)
- •13. Donated or lost >500 mL of blood within 60 days prior to Study Day 1
- •14. Unwillingness to comply with study procedures, including follow up, as specified by this protocol, or unwillingness to cooperate fully with the Investigator
- •15. Have any 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
- •16. PHQ-9 questionnaire (administered by appropriately trained site staff) score greater than equal to 10
- •17. Serious or severe chronic conditions requiring frequent medical intervention or continuous pharmacologic management
- •18. Medical or social conditions that would potentially interfere with the subject’s ability to comply with study visits
- •19. History of severe drug hypersensitivity or severe allergic reaction
- •20. Positive HBsAg, hepatitis C virus (HCV) antibody (Ab), or human immunodeficiency virus (HIV) Ab
- •21. Sustained supine systolic blood pressure (BP) of >150 or <90 mm Hg or supine diastolic BP of >95 or <50 mm Hg at Screening. The average of 2 assessments of BP will be used to exclude a subject
- •22. Resting pulse rate at Screening of >100 or <45 beats per minute
- •23. Positive drug test
研究者
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