NL-OMON34384已完成不适用
A Phase I, Single-Centre, Randomized, Double-Blind, Placebo Controlled, Multiple Dose Study to Evaluate the Effect of tedalinab on ECG parameters, CNS Function and Pain Perception in Healthy Subjects. - Phase I study to evaluate effects of tedalinab
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
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
- •Male, 18-65 years (inclusive);
- •Body weight >=60kg;
- •Physical examination and laboratory safety evaluations within normal range for age;
- •Willing to participate and provide written informed consent.
排除标准
- •Allergy to tedalinab or any excipients;
- •Subjects who have participated in an investigational drug study within 90 days prior to the dosing day;
- •Hepatitis B, C or HIV infection;
- •Subjects who have lost or donated >350 ml of blood within 12 weeks prior to the (first) dosing day;
- •Subjects with clinically significant laboratory abnormalities;
- •Subjects with an abnormal ECG at Screening or pre-dose, defined as:
- •o PR > 210 ms, or QRS complex > 120 ms, or QTc > 450 ms;
- •o Any cardiac conduction abnormalities;
- •o Any known structural abnormalities;
- •o Any clinically significant ST/T wave abnormalities;
- •o Any atrial or ventricular arrhythmias which are of clinical significance and may have an impact on the safety of the subject or the conduct of the study as judged by the PI;
- •Subjects with a history of additional risk factors for torsade de pointes, e.g. a personal or family history of Long QT Syndrome;
- •Subjects with a supine systolic blood pressure >160 mmHg or a supine diastolic blood pressure >90 mmHg;
- •Subjects with a Body Mass Index (BMI) <18.0 or >29.0 kg/m2;
- •Subjects who smoke (subjects will have to be non-smokers for at least 6 months preceding Screening);
- •Subjects who have used prescription medication within 2 weeks prior to the first dosing day;
- •Subjects who have used non-prescription medication, including aspirin, paracetamol, homeopathic medicines, vitamins, and herbal and dietary supplements within 96 hours pre-dose;
- •Subjects with a presence or a history of clinically relevant conditions in the gastrointestinal, hepatic, renal, urogenital, metabolic, endocrine or central and peripheral nervous systems;
- •Subjects with active presence or history of alcoholism or drug addiction;
- •Subjects who are considered unsuitable to participate in the study for any reason in the opinion of the PI.
研究者
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