NL-OMON43465已完成不适用
A phase 1, randomized, double blind, placebo-controlled, single ascending dose study to assess safety, tolerability and pharmacokinetics of cRGD-ZW800-1 intravenous injection in healthy volunteers - A phase 1 study of cRGD-ZW800-1 in healthy volunteers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. The subject is 18-65 years old at screening.
- •2. The subject is able and willing to comply with study procedures, and signed and dated informed consent is obtained before any study-related procedure is performed.
- •3. Female subjects need to be either surgically sterile, post-menopausal or pre-menopausal with a negative urine pregnancy test at screening and just before administration of cRGD-ZW800-1. Pre-menopausal female subjects who are not surgically sterile should also employ an effective method of birth control for at least 90 days post dosing when it consists of a hormonal contraceptive method or IUD. For other contraceptive methods premenopausal females who are not surgically sterile have to agree to use an effective method of contraception.
- •4. The subject*s body weight is <=90 kg and the body mass index is <=30 kg/m2.
- •5. The subject has a normal or clinically acceptable medical history, physical examination, and vital signs findings at screening (within 21 days before administration of study drug).
- •6. The 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.
- •7. The subject has negative screening test results for hepatitis B, hepatitis C, and human immunodeficiency virus.
- •8. The subject has negative test results for drug and alcohol screening.
- •9. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
- •10. Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
排除标准
- •1. Female subjects that are lactating or pregnant.
- •2. Unacceptable known diagnoses or diseases at baseline, e.g., known cardiovascular or pulmonary disease, renal or liver dysfunction, ECG or laboratory abnormalities, etc.
- •3. Use of prescription drugs, with the exception of contraceptive drugs.
- •4. Previous inclusion in this study.
- •5. Participation in a clinical trial within 90 days of screening or more than 4 times in the previous year.
- •6. History of anaphylactic reactions.
研究者
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