NL-OMON53439招募中不适用
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE- AND MULTIPLE ASCENDING DOSE TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF LEO 158968 IN HEALTHY SUBJECTS - Investigating safety of LEO 158968 in healthy volunteers
eo Pharma0 个研究点目标入组 120 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Age: 18 to 60 years, inclusive, at screening
- •Sex: Male or female
- •Body mass index: 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening
- •Health status: In good health as judged by the Investigator based on medical
- •history, physical examination, electrocardiogram (ECG), hematology,
- •biochemistry, and urinalysis.
排除标准
- •1. Male subjects sexually active with a woman of childbearing potential who are
- •not willing to use a barrier method of contraception (eg, condom) from the time
- •of first dose of investigational medicinal product (IMP) until 16 weeks after
- •the last dose, in conjunction with this female partner using a highly effective
- •form of contraception.
- •2. Female subjects who are pregnant, lactating, or planning to become pregnant
- •during the time of the trial.
- •3. Subjects with any surgical or medical condition which might significantly
- •alter the absorption, distribution, metabolism, or excretion of any drug.
- •4. Positive polymerase chain reaction (PCR) test for COVID-19 at Day -1, or
- •contact with COVID-19 positive (or suspected) persons within 14 days prior to
- •first dose.
- •5. ECG with QT-interval corrected for heart rate (QTc) using Fridericia*s
- •formula (QTcF) >450 msec for men, >460 msec for women, confirmed by repeat
- •measurement at screening.
- •6. Treatment with any prescribed or nonprescribed systemic or topical
- •medication within 7 days prior to the first dose of IMP (excluding paracetamol;
- •including herbal remedies), unless, in the opinion of the Investigator and the
- •Sponsor, the medication will not interfere with the trial procedures or
- •compromise safety.
研究者
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