NL-OMON49980已完成不适用
Randomized, placebo-controlled multiple dose study to evaluate the effect of hydroxychloroquine on the general immuno-competence in young and elderly healthy male volunteers - Effect of hydroxychloroquine treatment on the general immuno-competence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
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 99（—）
入选标准
- •1. Signed informed consent prior to any study-mandated procedure
- •2. Healthy male subjects, 18 to 30 years or 65 to 75 years of age, inclusive at
- •3. Body mass index (BMI) between 18 and 32 kg/m2, inclusive, and with a minimum
- •weight of 50 kg.
- •4. Has the ability to communicate well with the Investigator in the Dutch
- •language and willing to comply with the study restrictions.
排除标准
- •1. Known hypersensitivity reaction to chloroquine, hydroxychloroquine or
- •4-aminoquinolines;
- •2. Evidence of any active or chronic disease or condition that could interfere
- •with, or for which the treatment of might interfere with, the conduct of the
- •study, or that would pose an unacceptable risk to the subject in the opinion of
- •the investigator, following a detailed medical history (including a known
- •history of long QT syndrome, known history of retinal disease, G6PD deficiency,
- •porphyria, psoriasis, myasthenia gravis, liver disease, diabetes mellitus type
- •I and II, existing hearing loss and current or previous history of a relevant
- •psychiatric disorder i.e. major depressive disorder, bipolar disorder,
- •schizophrenia or another psychotic disorder or current of previous suicidality
- •irrespective of an associated psychiatric disorder);
- •3. Clinically significant abnormalities, as judged by the investigator, in
- •laboratory test results (including hepatic and renal panels, complete blood
- •count, chemistry panel and urinalysis). In the case of uncertain or
- •questionable results, tests performed during screening may be repeated before
- •randomization to confirm eligibility or judged to be clinically irrelevant for
- •healthy subjects;
- •4. Signs or symptoms of any active infection within two weeks prior to first
- •5. Positive SARS-CoV-2 qPCR test pre-dose.
- •6. Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab),
- •or human immunodeficiency virus antibody (HIV Ab) at screening;
- •7. Systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and
- •diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg and
- •considered to be of clinical relevance by the investigator;
- •8. Abnormal findings in the resting ECG, including but not limited to QTcF> 450
- •9. Use of any medications (prescription or over-the-counter [OTC]), within 14
- •days of study drug administration, or less than 5 half-lives (whichever is
- •longer). Exceptions will only be made if the rationale is clearly documented by
- •the investigator;
- •10. Participation in an investigational drug study (last dosing of previous
- •study was within 90 days prior to first dosing of this study);
- •11. History of abuse of addictive substances (alcohol, illegal substances) or
- •current use of more than 14 units alcohol per week, drug abuse, or regular user
- •of sedatives, hypnotics, tranquillizers, or any other addictive agent and
- •unable to abstain from alcohol use from at least 24 hours before every visit;
- •12. Positive test for drugs of abuse at screening or pre-dose. Drugs test may
- •be repeated;
- •13. Smoker of more than 10 cigarettes per week prior to screening or who use
- •tobacco products equivalent to more than 10 cigarettes per week and unable to
- •abstain from smoking from at least 7 days before first dosing until the last
- •return visit (day 10);
- •14. Any confirmed significant allergic reactions (urticaria or anaphylaxis)
- •against any drug, or multiple drug allergies (non-active hay fever is
- •acceptable);
- •15. Loss or donation of blood over 500 mL within three months prior to
- •screening or intention to donate blood or blood products during the study;
- •16. Any known factor, condition, or disease that might interfere with treatment
- •compliance, study conduct or interpretation of the results such as drug or <
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