NL-OMON51504已完成不适用
Double-blind, placebo-controlled phase 1 trial of nizaracianine administered in three divided doses to healthy volunteers - A phase 1 study of divided doses of nizaracianine in healthy volunteers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
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. Subject is 18-55 years old at screening (inclusive).
- •2. Subject is able and willing to comply with study procedures.
- •3. Subject is in good general health, according to the investigator*s judgement
- •based on vital signs, medical history, physical examination, and laboratory
- •tests performed.
- •4. Body mass index between 18-32 kg/m2 (inclusive) and with a minimum body
- •weight of 50 kg at screening.
- •5. An estimated GFR >= 90.
- •6. Female subjects need to be surgically sterile, post-menopausal or
- •pre-menopausal with a negative urine pregnancy test at screening and before
- •administration of nizaracianine. Pre-menopausal female subjects who are not
- •surgically sterile have to agree to use an effective method of contraception.
- •7. Subject*s screening ECG and clinical laboratory test results are within
- •normal limits, or if any are outside of normal limits they are considered to be
- •clinically insignificant.
- •8. Subject has negative test results for drug and alcohol screening.
- •9. Written informed consent must be given prior to any study activities,
- •according to ICH/GCP and national/local regulations.
排除标准
- •1. (A history of) any clinically significant medical condition or
- •abnormalities, as judged by the investigator, in physical examination,
- •laboratory test results (including chemistry panel with hepatic and renal
- •panels, complete blood count, and urine dipstick) or electrocardiography (ECG)
- •at screening. In the case of uncertain or questionable results, tests performed
- •during screening may be repeated to confirm eligibility or judged by the
- •investigator to be clinically irrelevant for healthy subjects.
- •2. Female subjects that are lactating or pregnant.
- •3. The subject has a positive screening test for hepatitis B, hepatitis C, and
- •human immunodeficiency virus.
- •4. Use of any prescription medication and any other substance that in the
- •opinion of the investigators may influence the outcome of the study within 7
- •days prior to study drug administrations, or less than five half-lives
- •(whichever is longer, and during the course of the study).
- •5. Previous inclusion in this study.
- •6. Participation in a clinical trial within 3 months or 5 half-lives, whichever
- •7. Use of alcohol during the 24 hours prior to screening and/or an
- •unwillingness to abstain from alcohol consumption during the stay at the
- •clinical unit, and for at least 24 hours prior to each study visit;
- •8. Positive urine drug screen or alcohol test at screening and/or at first
- •9. History of anaphylactic reactions to a prescription drug, over-the-counter
- •drug, or herbal supplement.
- •10. Prior organ transplant.
- •11. Signs of moderate or severe symptoms of prostate hypertrophy
- •12. Loss or donation of blood over 500 mL within four months prior to
- •13. Any other condition that in the opinion of the investigator would
- •complicate or compromise the study or the well-being of the subject.
- •14. History of AV blocks or any type of AV block on the ECG at the screening
- •15. History of syncope
研究者
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