NL-OMON20057尚未招募不适用
Extension of the randomized, double-blind, placebo-controlled single ascending dose study to assess the safety and tolerability of AP30663 in healthy subjects.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 32
研究概览
简要总结
.A.
研究设计
- 研究类型
- Interventional
入排标准
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 screening.
- •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 pre-dose.
- •12. Routine smoker or history of nicotine abuse (average of >5 cigarettes per day for >3 months).
- •13. Excess in xanthine consumption (more than eight cups of coffee or equivalent per day) or unwilling or unable to abstain from xanthine consumption during the stay at CHDR.
- •14. Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any
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