NL-OMON52916已完成不适用
A Phase 1 Pharmacology Study of the Dual MDMX/MDM2 Inhibitor, ALRN-6924, in Healthy Volunteers. - CS0351-200052 Aileron
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
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
- •Is healthy, defined as being free from clinically significant (and clinically
- •relevant per Principal Investigator) illness or disease as determined by their
- •medical history, medical assessment, physical examination, clinical laboratory
- •tests, and 12-lead ECG obtained during Screening and predose on Day 1.
- •Is male or female, aged 18-65 years, inclusive, at the time of informed consent
- •(except for cohorts of subjects undergoing scalp biopsy who will be females
- •aged 18-60 years).
- •Has a BMI ranging between 18.0 and 30.0 kg/m2, inclusive, at Screening.
- •Has negative urine drug and cotinine screen results at Screening and predose on
排除标准
- •Has resting systolic blood pressure <=90 or >=140 mmHg and a resting diastolic
- •blood pressure <=51 or >=90 mmHg at Screening.
- •Has resting pulse <=50 or >=100 bpm at Screening.
- •Has QTc intervals corrected for heart rate via the Fridericia method (QTcF)
- •>450 msec (males) and >480 msec (females) at Screening.
- •Is pregnant or a nursing female.
研究者
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