NL-OMON45352已完成不适用
A phase I, randomized, placebo-controlled, double blind, first time in human, escalating single-dose study to evaluate the safety, tolerability pharmacokinetics and pharmacodynamics of Neu-P12 in healthy male volunteers - Neu-P12 (CS0270)
QPS Netherlands B.V.0 个研究点目标入组 32 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
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
- •1. Subjects have signed the informed consent form prior to any study related activity.
- •2. Subjects are healthy male volunteers between 18 and 55 years of age at the screening (inclusive).
- •3. Subject has a BMI * 18.0 kg/m and * 30.0 kg/m2 at the screening.
- •4. Subject can stay in the study center for 3 nights.
- •5. Subject is appropriate for the study in the judgement of the investigator, based on physical examination, laboratory tests, and subject*s interview.
- •6. Subject has a high probability for compliance with and completion of the study.
- •7. Male subjects must agree to either abstain from sexual intercourse or use a condom with spermicide during the duration of the study until 90 days after their last dose in the study.
- •8. Subjects are non-smoker for at least 6 months.
- •9. Subject must have skin type 1 or 2 according to Fitzpatrick Skin Typing Test. (not applicable for cohort 1).
排除标准
- •1. Subject shows clinically significant abnormalities in physical examination or vital signs, according to the investigator*s judgement.
- •2. Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic seizures) abnormalities or diseases.
- •3. Has a history of significant and/or severe allergies.
- •4. Had major surgery, donated or lost 1 unit of blood or plasma (approximately 500 mL) within 4 weeks prior to the pretrial (screening) visit.
- •5. Has participated in another investigational trial within 90 days prior to the first intake of the IMP of this study.
- •6. Subject has an abnormal laboratory result judged by the investigator as being clinically significant.
- •7. Subject has used any prescription drug or herbal medicine within 14 days, OTC or vitamin supplements within 7 days prior to Day 1.
- •8. Subject has tattoos on the skin areas to be exposed with UV radiation (not for cohort 1).
- •9. Standard liver function tests including ALT, AST, alkaline phosphatase, gamma-glutamyl transferase, lactate dehydrogenase and bilirubin (total and direct) do not exceed the upper limit of normal for the local laboratory during screening and day -1.
- •10. Subject has a positive urinary drug screen (incl. amphetamine, barbiturates, benzodiazepines, cocaine, marijuana, methadone, methamphetamine, morphine, phencyclidine, and tricyclic antidepressants).
- •11. History of abuse of alcohol or drugs in the last 2 years (alcohol >23 units/week).
- •12. Subject has a positive test for HIV antibody, HBsAg, or HCV antibody.
- •13. Subject has a QTc (Bazet) prolongation greater than or equal to 450 ms.
- •14. Subject has ECG with one or more of the following criteria (a single repeat is allowed for eligibility determination, at screening and day -1):
- •Pulse rate <45 and >100 bpm
- •PR Interval <110 and >200 msec
- •QRS duration <70 and >120 msec
- •15. Subject is unwilling or unable to adhere to any specific protocol restriction as mentioned in Section 8.3.3 of this protocol.
- •16. Male subject who plans to father a child during the course of the study.
研究者
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