ACTRN12623000075684已完成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 1 conducted in Healthy Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
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
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •Cohort A (Healthy Volunteers)
- •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, age 18 to 55 years
- •BMI 18 to 35 kg/m2
- •Females: Non-pregnant and non-lactating; surgically sterile (e.g., tubal ligation, hysterectomy, bilateral salpingectomy, bilateral oophorectomy), post-menopausal (defined as 12 months of spontaneous amenorrhea in females less than 55 years of age or, in females less than or equal to 55 years, 12 months of spontaneous amenorrhea without an alternative medical cause and FSH levels in the postmenopausal range for the laboratory involved) or, if engaged in sexual relations of child-bearing 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 childbearing 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.
- •In good health, in the judgement of investigator
排除标准
- •Cohort A (Healthy Volunteers)
- •Serious or severe chronic conditions requiring frequent medical intervention or continuous pharmacologic management
- •Medical or social conditions that would potentially interfere with the subject’s ability to comply with the study visits
- •History of severe drug hypersensitivity or severe allergic reaction
- •History of or current excess alcohol consumption within 1 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)
- •Significant drug abuse/addiction within 1 year of Screening (excluding cannabis), or a
- •positive urine drug screen (except cannabis)
- •Positive HBsAg, hepatitis C virus (HCV) antibody (Ab), or human immunodeficiency
- •virus (HIV) Ab
- •12-lead electrocardiogram (ECG) showing the following: having a corrected QTc interval greater than 450 msec for males and greater than 470 msec for females or less than 340 msec (Fridericia’s correction)
- •Sustained supine systolic blood pressure (BP) of greater than 150 or less than90 mm Hg or supine diastolic BP of greater than 95 or less than50 mm Hg at Screening. The average of 2 assessments of BP will be used to exclude a subject
- •Resting pulse rate at Screening of greater than 100 or less than 45.
- •Donated or lost greater than 500 mL of blood within 60 days prior to enrollment into this study
- •Active infection or febrile illness less than or equal to 14 days prior to Study Day 1
- •Use of prescription or over-the-counter medications or herbal supplements less than or equal to 14 days prior to Study Day 1 or anticipated use during the 12 weeks post dosing
- •Any clinically significant screening laboratory values outside of the normal limits
- •Treatment with another investigational drug, biological agent, or device within 4 weeks of Screening or 5 half-lives of the investigational drug, whichever is longer
研究者
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