ACTRN12615000614594已完成1 期
A Phase 1, Single-Center, Open-label Study to Evaluate the Pharmacokinetics of PRN1008 in Healthy Male and Female Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
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
- Open (masking not used)
入排标准
- 年龄范围
- 40 Years 至 75 Years（—）
- 性别
- All
入选标准
- •*Healthy adult male or non-pregnant non-lactating females, 40 to 75 years of age (inclusive) at the time of screening.
- •*Body mass index (BMI) equal to or greater than 18 and equal to or less than 35 (kg/m2) (inclusive) and a minimum body weight of 45 kg.
- •*Able to participate and comply with all study procedures and restrictions, and willing to provide written informed consent to participate in the study.
- •*Negative urine drug/alcohol testing at screening and check-in (Day -1).
排除标准
- •*Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).
- •*History or presence of alcoholism or drug abuse within the 2 years prior to the first study drug administration.
- •*History of any significant (as determined by the Investigator) drug-related allergic reactions such as, anaphylaxis, Stevens-Johnson syndrome, urticaria or multiple drug allergies.
- •*Blood donation or significant blood loss within 30 days prior to screening.
- •*Plasma donation within 14 days prior to the first study drug administration.
- •*Participation in another clinical trial of a drug or device whereby the last investigational drug/device administration is within 30 days prior to the first study drug administration or 5 half-lives, whichever is longer.
- •*Surgery within the past three months prior to the first study drug administration determined by the PI to be clinically relevant.
- •*Personal or family history of prolonged QT syndrome or family history of sudden death.
- •*QTcF greater than 450 msec (males) or greater than 470 msec (females) or less than 300 msec at screening or baseline visit, unless deemed clinically insignificant by the Investigator.
- •*Seated resting systolic blood pressure (SBP) greater than 150 or less than 90 mm Hg, or diastolic blood pressure greater than 95 or less than 50 mm Hg.
- •*History or presence of any other medical condition that makes the participant unsuitable for the study in the opinion of the Investigator.
研究者
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