A Randomized, Double-Blind, Placebo-Controlled, Phase 1, Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Food Effect of THB335 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of Participants with Treatment-Related Adverse Events
研究概览
简要总结
This study is a double blind, randomized, placebo-controlled, Phase 1 study in three parts: single ascending doses and food effect (Part 1), multiple ascending doses (Part 2) and Relative Bioavailability of Two Formulations (Part 3).
详细描述
THB335 is a highly potent and selective inhibitor of the receptor tyrosine kinase KIT that is expressed on mast cells.
The study will evaluate the safety, pharmacokinetics, pharmacodynamics, and food effect profile of THB335 administered orally in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In good health, determined by no clinically significant findings from medical history, 12 lead electrocardiogram (ECG), vital sign measurements, and clinical laboratory evaluations
- •Males or females, of any race, between 18 and 65 years of age, inclusive.
- •Participants must understand the nature of the study and must provide signed and dated written informed consent in accordance with local regulations before the conduct of any study related procedures
- •Body weight of ≥ 50.0 kg for men and ≥ 45.0 kg for women and Body Mass Index (BMI) of 17.5-32.0 kg/m2 (inclusive) at Screening
排除标准
- •Significant history or clinical manifestation of cancer or any metabolic, allergic, dermatological, hepatic, biliary, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
- •Vaccinated within 14 days prior to Day -1 or intention to receive vaccination during the study
- •A positive urine drug screen/alcohol breath test
- •The participant currently smokes, vapes, or uses nicotine-containing products.
研究组 & 干预措施
THB335 fasted and fed
Single dose of THB335 fasted and then fed
干预措施: THB335 fasted/fed (Drug)
Multiple dose placebo
14 days of multiple doses of placebo capsule
干预措施: Multiple dose placebo (Drug)
THB335 single dose
Single dose of THB335 fasted
干预措施: THB335 single dose (Drug)
THB335 multiple dose
14 days of multiple ascending doses of THB335
干预措施: THB335 multiple dose (Drug)
Single dose placebo
Single dose of placebo capsule, fasted
干预措施: Single dose placebo (Drug)
Fasted and fed placebo
Single dose of placebo capsule fasted and then fed
干预措施: Placebo fasted/fed (Drug)
结局指标
主要结局
Number of Participants with Treatment-Related Adverse Events
时间窗: Part 1 Day 1 through Day 9 (end of study), and Part 2 Day 1 through Day 29 (end of study)
次要结局
- Maximum observed plasma concentration (Cmax)(Part 1, and Part 2 on Day 1. Part 2 on Day 14)
- Area under the plasma concentration-time curve (AUC)(Part 1, and Part 2 on Day 1. Part 2 on Day 14)
- Time to Cmax (Tmax)(Part 1, and Part 2 on Day 1. Part 2 on Day 14)