NL-OMON49415已完成不适用
Extension of the randomized, double-blind, placebo-controlled single ascending dose study to assess the safety and tolerability of AP30663 in healthy subjects. - Extension of the single ascending dose study of AP30663.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
研究概览
简要总结
Trial ended prematurely
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 45 years of age, inclusive.
- •3. Healthy volunteer part only: Body mass index (BMI) between 18 and 30 kg/m2,
- •inclusive and a body weight between 50 and 100 kg, inclusive at screening.
- •4. All male volunteers must practice effective contraception during the study
- •and be willing and able to continue contraception for at least 90 days after
- •their last dose of study treatment.
- •5. 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. Evidence (following a detailed medical history, physical examination, vital
- •signs, 12-lead ECG and clinical laboratory parameters) of any active or chronic
- •disease or condition that could interfere with, or for which the treatment
- •might interfere with, the conduct of the study, or that would pose an
- •unacceptable risk to the subject in the opinion of the investigator.
- •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). Minor deviations of laboratory values
- •from the normal range may be accepted, if judged by the Investigator or
- •medically qualified designee as not clinically significant. 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. Positive Hepatitis B surface antigen (HBsAg), Hepatitis B antibodies,
- •Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV
- •Ab) at screening.
- •4. 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 at
- •5. Abnormal findings in the resting ECG at screening defined as:
- •- QTcF> 450 or < 300 msec
- •- Notable resting bradycardia (HR < 45 bpm)
- •- Notable resting tachycardia (HR > 100 bpm)
- •- Personal or family history of congenital long QT syndrome or sudden death;
- •- ECG with QRS and/or T wave judged to be unfavorable for a consistently
- •accurate QT measurement (e.g., neuromuscular artefact that cannot be readily
- •eliminated, arrhythmias, indistinct QRS onset, low amplitude T wave, merged T-
- •and U-waves, prominent U waves);
- •- Evidence of a sustained atrial or ventricular arrhythmia, either by anamnesis
- •or by Holter or telemetric observation.
- •- Pre-excitation (Wolff-Parkinson-White syndrome)
- •- PR interval >220 ms
- •6. Use of any medications (prescription or over-the-counter (OTC)), within 14
- •days of investigational product administration, or less than 5 half-lives
- •(whichever is longer). Exceptions are paracetamol (up to 4 g/day) and ibuprofen
- •(up to 1g/day). Other exceptions will only be made if the rationale is clearly
- •documented by the investigator.
- •7. Use of any vitamin, mineral, herbal, and dietary supplements within 7 days
- •of investigational product administration, or less than 5 half-lives (whichever
- •is longer). Exceptions will only be made if the rationale is clearly documented
- •by the investigator.
- •8. Participation in an investigational product or device study within 3 months
- •prior to first dosing, or >4 studies in the year prior to study participation.
- •9. History of abuse of addictive substances (alcohol, illegal substances) or
- •use of more than 21 units alcohol per week within 3 months prior to screening,
- •drug abuse, or regular user of sedatives, hypnotics, tranquillizers, or any
- •other addictive agent.
- •10. Positive test for drugs of abuse at screening or pre-dose.
- •11. Alcohol will not be allowed from at least 24 hours before screening or
- •12. Routine smoker or history of nicotine abuse (average of >5 cigarettes per
- •day for >3 months).
- 另有 1 项未显示
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