A Phase 1a Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Oral MORF-057 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration (Cmax) of MORF-057 in a fed state
研究概览
简要总结
Phase 1a randomized, double-blind, placebo-controlled study to evaluate single and multiple ascending doses of MORF-057 in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 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
- •Healthy male and female subjects between 18 to 65 years old with a body mass index between 18 and 32 kg/m2
- •Determined to be medically healthy by the Investigator.
- •Use of acceptable methods of contraceptives.
- •Ability to provide written informed consent and to understand and comply with the requirements of the study.
排除标准
- •History of any malignancy, except basal or squamous cell carcinoma of the skin that resolved or in remission prior to Screening.
- •Abnormal laboratory values at Screening.
- •Any clinically significant major diseases.
- •Female who is pregnant or breastfeeding, or planning to become pregnant during the course of the study.
- •Unwilling or unable to comply with the requirements of the protocol.
研究组 & 干预措施
MORF-057
SAD: Subjects will be assigned to one of five planned dose cohorts and receive single doses of MORF-057.
Food Effect: Subjects will receive single dose administration of MORF-057 in fed and fasted states.
MAD: Subjects will be assigned to one of three planned dose cohorts and receive multiple doses of MORF-057.
干预措施: MORF-057 (Drug)
Placebo for MORF-057
SAD: Subjects will be assigned to one of five planned dose cohorts and receive single doses of placebo.
MAD: Subjects will be assigned to one of three planned dose cohorts and receive multiple doses of placebo.
干预措施: Placebo for MORF-057 (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax) of MORF-057 in a fed state
时间窗: Day -1 to Day 28
Cmax (Food Effect cohort)
Time to Reach Cmax (Tmax) of MORF-057 in a fed state
时间窗: Day -1 to Day 28
Tmax (Food Effect cohort)
Incidence of adverse events and safety signals observed during single and multiple ascending doses of MORF-057 administered orally to healthy adult subjects
时间窗: Day -1 to Day 28
Subject incidence of adverse events and serious adverse events
次要结局
- Time to Reach Cmax (Tmax) during single and multiple ascending doses of MORF-057(Day -1 to Day 28)
- Incidence of adverse events and safety signals observed during single dose of MORF-057 administered after a meal to healthy subjects.(Day -1 to Day 28)
- Maximum Plasma Concentration (Cmax) during single and multiple ascending doses of MORF-057(Day -1 to Day 28)