ACTRN12612001033831已完成1 期
A single-blind, placebo-controlled, single dose, safety and pharmacokinetic study of 3 ascending doses of SANGUINATE in 3 cohorts of healthy volunteers
Prolong Pharmaceuticals0 个研究点目标入组 24 人开始时间: 2012年9月26日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- All
入选标准
- •1. Able to provide written Informed Consent
- •2. Male or female healthy volunteers
- •3. Age > 18 years and < 45 years;
- •4. Body Mass Index > 20 and < 30 kg/m2.
- •5. In good general health with no clinically significant illness seen on physical examination or ongoing medical history, as determined by the Investigator;
- •6. Documented 12-lead ECG with no clinically significant abnormalities, as determined by the Investigator
- •7. No clinically significant abnormalities in screening or Day 0 laboratory tests, as determined by the Investigator
- •8. Female subjects of reproductive potential must have a negative serum pregnancy (beta-HCG) test at screening and a negative urine pregnancy test at Day 0 prior to dosing. Female subjects must also be non-lactating
- •9. Adequate venous access and can receive intravenous infusions
排除标准
- •1. If female, pregnant or lactating;
- •2. Any history of significant cardiac, renal, neurologic, metabolic, pulmonary, gastrointestinal, chronic hepatic disease or any other disease which in the judgment of the Investigator would interfere with the study or confound the results;
- •3. History of allergy or major allergic reaction considered to be clinically significant by the Investigator;
- •4. Screening or Day 0 clinical laboratory test result(s) determined to be clinically significant by the Investigator
- •5. Screening or Day 0 laboratory values for Troponin I > 0.31 ng/mL
- •6. Screening or Day 0 laboratory values for amylase or lipase > 1.1 x upper limit of normal
- •7. Physical examination or 12-lead ECG result(s) considered to be clinically significant by the Investigator
- •8. Donated blood within 60 days of screening or otherwise experienced blood loss of >250 mL within the same period;
- •9. Known to be allergic to any of the test product(s) or any components in the test product(s)
- •10. Intending to begin new concomitant drug therapy or over-the-counter medication anytime from screening to the time of administration of study drug
- •11. Received or intending to receive a vaccination in the two weeks prior to dosing, or anytime during study participation;
- •12. Received treatment with a drug that has not received regulatory approval for an indication during the 60 days preceding study enrollment
- •13. History of drug and/or alcohol dependence within past 12 months, and/or positive results on drug of abuse or alcohol tests
- •14. Screening laboratory result indicating HIV-positivity, or previously diagnosed with AIDS, AIDS related complex, or other immunodeficiency
- •15. Screening laboratory result indicating serologic positivity for hepatitis C antibodies or hepatitis B surface antigens, unless explained by a documented vaccination
- •16. Has taken any regular, prescribed, or over-the-counter medication with the exception of acetaminophen (maximum 2g/day), multi-vitamins, or hormonal birth control in the 2 weeks prior to dosing (other medication may only be taken with the specific approval of the Investigator in consultation
- •with the Medical Monitor)
- •17. Receiving any significant concomitant therapies
- •18. Malignancy within the last 5 years, with the exception of successfully treated basal cell carcinoma and carcinoma in situ uteri
- •19. Unable to comply with study attendance, protocol procedures or other study requirements
- •20. Any condition that, in the opinion of the investigator, might interfere with study objectives.
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