ACTRN12626000933358招募中1 期
Phase 1 Dose Escalation Study Assessing the Safety, Pharmacokinetics, and Pharmacodynamics of PTC612 in Adult Volunteers - Part 1 (Single Ascending Dose) and Part 3 (Multiple Ascending Dose)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 56
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
- Randomized
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Participant must be between 18 to 65 years of age.
- •Be generally healthy, as determined by medical history, physical examination, blood and urine tests, heart test (ECG), and vital signs.
- •Body mass index BMI greater than 18.5 and less than or equal to 32.0 kilograms per square meter with a body weight of at least 50.0 kilograms for males or at least 45.0 kilograms for females at screening.
- •Have read, understood, and signed the informed consent form.
- •Be willing and able to attend all study visits and follow all study instructions and restrictions.
- •Be willing to stop most medications, supplements, and herbal products before the study, as required by the study doctor.
- •Be willing to avoid alcohol, nicotine products, caffeine, certain foods (including grapefruit and poppy seeds), and strenuous exercise for specified periods before and during the study.
- •Have negative screening tests for alcohol, drugs of abuse, and nicotine.
- •Must have negative pregnancy tests if able to become pregnant.
- •Must agree to use reliable contraception or abstain from sexual activity during the study and for a short time after the last dose.
- •Must not donate eggs during the study and shortly after.
- •Must agree to use barrier contraception if sexually active with women who could become pregnant.
- •Must not donate sperm during the study and for a period after the last dose.
- •For study parts requiring food before dosing, Participants must be willing and able to consume the entire high-fat high-calorie or standard meal in the designated timeframe.
排除标准
- •Have taken part in another clinical trial involving a drug or medical device within the last 30 days or plan to take part in another trial during this study.
- •Have any current or past medical or mental health condition that the study doctor believes could affect safety or interfere with study results.
- •Had a fever or symptoms of a viral or bacterial infection within 7 days before screening.
- •Have had cancer within the last 5 years, unless it was surgically removed and considered cured.
- •Have a history of severe allergic reactions or serious drug allergies.
- •Have any clinically significant abnormal findings at screening, including abnormal liver test results.
- •Have abnormal liver blood test results above accepted limits at screening.
- •Have a history of tuberculosis or a positive tuberculosis test at screening.
- •Have psychological or emotional conditions that may affect informed consent or ability to follow study requirements.
- •Are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.
- •Have donated whole blood within the last 3 months, plasma within the last 2 weeks, or platelets within the last 6 weeks.
- •Have consumed alcohol within 48 hours before screening or study check in visits.
- •Have a history of alcohol abuse within the last 2 years.
- •Have evidence of active hepatitis B, hepatitis C, or human immunodeficiency virus infection at screening.
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