NL-OMON51837已完成不适用
First-in-human, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects of Apta-1. - First in human study of Apta-1
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aptahem AB
- 入组人数
- 72
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. Has the ability to communicate well with the Investigator in the Dutch
- •language and is willing and able to comply with all study procedures and give
- •written informed consent prior to any study-mandated procedure.
- •2. Healthy male and female subjects,18 to 55 years of age, inclusive, at
- •3. Body mass index (BMI) between 18 and 30 kg/m2 and with a weight between 50
- •and 100 kg, both inclusive, at screening.
- •4. Female subjects of childbearing potential and male subjects who have sexual
- •intercourse with a woman of childbearing potential must be willing to practice
- •effective contraception (see paragraph 4.5.1.) during the study and be willing
- •and able to continue contraception for respectively at least 180 days (females)
- •and 90 days (males) after their last dose of study treatment.
- •Women of childbearing potential are defined as all women physiologically
- •capable of becoming pregnant, unless they meet one of the following conditions:
- •Post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 weeks
- •after surgical bilateral oophorectomy with or without hysterectomy;
- •Post-hysterectomy.
排除标准
- •1. Evidence of any active or chronic disease or condition (e.g. history of
- •sepsis, cardiovascular disease, syncope or malignancy) 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, physical examination,
- •vital signs (systolic and diastolic blood pressure, pulse rate, body
- •temperature) and 12-lead electrocardiogram (ECG)). Minor deviations from the
- •normal range may be accepted, if judged by the Investigator to have no clinical
- •2. 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.
- •3. Hemorrhagic diathesis (e.g. nose bleeds, mucosal bleedings, easy bruising,
- •gastrointestinal bleeding, menorrhagia), as judged by the investigator.
- •4. Use of any prescription or OTC medications, antibiotics, NSAIDs (such as
- •ibuprofen), aspirin, anti-platelet therapy, anti-coagulation therapy,
- •prophylactic and therapeutic LMWH or un-fractioned heparin within 4 weeks, or 5
- •half-lives (whichever is longer), prior to first IMP administration. Exception
- •for prescription contraceptives.
- •5. Any active or ongoing chronic inflammatory or infectious disease including
- •periodontitis except for common viral or fungal skin infections such as plantar
- •warts or athlete*s foot.
- •Additional criteria for part B:
- •1. Previous participation in a systemic (i.v./inhaled) LPS challenge trial or
- •prior exposure to systemic endotoxin within a year before LPS administration in
- •this study.
- •2. Significant risk or history of cardiac failure, overfilling and/or
- •developing edema.
- •3. Estimated glomerular filtration rate (eGFR) of <90mL/min/1.73m2.
研究者
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