ACTRN12619001529134尚未招募1 期
A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Single Dose, Dose-Escalation and Food-Effect Study to Assess the Safety, Tolerability, and Pharmacokinetics of INCB099280 When Administered Orally to Healthy Adult Participants
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 72
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 55 Years（—）
- 性别
- All
入选标准
- •1. Male or female healthy adult participants aged 18 to 55 years
- •2. BMI between 18.0 and 30.0 kg/m2, inclusive. Participants with a BMI up to 32.0 kg/m2 may be enrolled with the sponsor’s approval.
- •3. Willingness to avoid pregnancy or fathering children.
排除标准
- •1.History of uncontrolled or unstable cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening.
- •2.History or presence of an abnormal ECG before initial dose administration that, in the investigator's opinion, is clinically significant. QTcF interval > 450 milliseconds, QRS interval > 120 milliseconds, and PR interval > 220 milliseconds
- •3.Current or recent (within 3 months of screening) clinically significant gastrointestinal disease or surgery (including cholecystectomy) that could affect the absorption of study drug except that appendectomy will be allowed.
- •4.Donation of blood to a blood bank or in a clinical study (except a screening visit) within 4 weeks of screening (within 2 weeks for plasma only).
- •5.History of alcoholism within 3 months of screening.
- •6.Positive urine, blood, or breath test for ethanol or positive urine or serum screen for drugs of abuse that are not otherwise explained by permitted concomitant medications or diet.
- •7.Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug with another investigational medication or current enrollment in another investigational drug protocol.
- •8.History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) deemed clinically relevant by the investigator.
- •9.Use of tobacco- or nicotine-containing products within 1 months of screening.
- •10.Women who are pregnant or breastfeeding.
研究者
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