NL-OMON54972已完成不适用
Phase 1 Dose Escalation Study Assessing the Safety and Pharmacokinetics of PTC518 in Healthy Subjects - CS0349-200101 PTC518
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. For Part 1, Part 2, Part 4, and Part 5: Healthy male or female subjects aged
- •from 18 to 65 years old, inclusive, at Screening. For Part 3: healthy male of
- •female subjects aged 50 to 65 years old, inclusive, at Screening.
- •2. Subjects must understand the nature of the study and must provide signed and
- •dated written informed consent before the conduct of any study-related
- •procedures.
- •3. Body Mass Index (BMI) of >=18.5 kg/m2 and <=30.0 kg/m2 with a body weight
- •>=50.0 kg for male subjects and a body weight >=45.0 kg for female subjects at
- •4. Healthy as determined by the Investigator, based upon a medical evaluation
- •including medical history, physical examination, laboratory test results, ECG
- •recording (e.g. QTcF <= 450 msec for males and QTcF <= 470 ms for females) and
- •vital signs. Out of range values can be repeated once.
- •5. Male subjects and female subjects of childbearing potential must be willing
- •to use 2 methods of birth control for the duration of the study and for 30 days
- •after the last dosing.
排除标准
- •1. Subjects that participated in any drug or device clinical investigation
- •within 60 days prior to Screening or who anticipate participating in any drug
- •or device clinical investigation within the duration of this study.
- •2. Prior or ongoing medical condition (e.g., concomitant illness, psychiatric
- •condition), medical history, physical findings that, in the Investigator*s
- •opinion, could adversely affect the safety of the subject or could impair the
- •assessment of study results.
- •3. An abnormal general neurological examination.
- •4. Presence of any clinically significant abnormality during Screening.
- •5. Any psychological, emotional problems, any disorders or resultant therapy
- •that is likely to invalidate informed consent or limit the ability of the
- •subject to comply with the protocol requirements.
研究者
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