NL-OMON44238
已完成
不适用
A First-in-Human Randomized, Placebo-controlled, Double-blind, Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses of LTI-291 in Healthy Subjects - Single Ascending Dose study of LTI-291
ysosomal Therapeutics Incorperated.0 个研究点目标入组 40 人待定
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- GBA-Associated Parkinson's Disease
- 发起方
- ysosomal Therapeutics Incorperated.
- 入组人数
- 40
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Signed informed consent prior to any study\-mandated procedure.
- •2\. Healthy male or female subjects of non\-childbearing potential (defined as postmenopausal with amenorrhea for at least 12 months) or permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy); or otherwise be incapable of pregnancy, 18 to 65 years of age (inclusive) at screening.
- •3\. Body mass index (BMI) between 18 and 32 kg/m2, inclusive, and with a minimum weight of 50 kg at screening.
- •4\. All males must practice effective contraception and abstain from sperm donation during the study and be willing and able to continue contraception and abstain from sperm donation 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 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, physical examination, vital signs (systolic and diastolic blood pressure, pulse rate, body temperature), 12\-lead electrocardiogram (ECG), and clinical laboratory parameters (hematology, blood chemistry, and urinalysis)). Minor deviations of laboratory values from the normal range may be accepted, if judged by the Investigator to have no clinical relevance.
- •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\. 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 150 or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 95 or less than 50 mm Hg at screening or baseline.
- •5\. Abnormal findings in the resting ECG at screening defined as:
- •a. QTcF \> 450 msec for males or \> 470 msec for females;
- •b. Notable resting bradycardia (HR \< 40 bpm) or tachycardia (HR \> 100 bpm);
- •c. QRS \> 120 msec;
- •d. Personal or family history of congenital long QT syndrome or sudden death;
- •e. 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);
结局指标
主要结局
未指定
相似试验
已完成
1 期
A study to assess the safety and tolerability of ACI-3024 and how the drug affects and interacts with the bodyISRCTN18150742AC Immune (Switzerland)80
进行中（未招募）
1 期
Testing the safety and effects of a new study drug (GCG-06) in adult subjects (GCG-06 - first doses in human)ObesityNutritional, Metabolic, EndocrineISRCTN69500549Imperial College London54
进行中（未招募）
1 期
A study to test the safety and effectiveness of bacteria called Bifidobacterium breve in adults with asthmaEUCTR2018-003242-16-GB4D pharma plc90
已完成
不适用
A First-in-Human, randomized, double-blind, placebo-controlled ascending dose study to assess safety, tolerability, pharmacokinetics and pharmacodynamics of STR-324 in healthy subjects.PainNL-OMON46459Stragen France78
招募中
1 期
A Double-Blind, Placebo-Controlled, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZE50 0134 in Healthy VolunteersChronic lymphocytic leukemia (CLL)Cancer - Leukaemia - Chronic leukaemiaACTRN12624000093583Eilean Therapeutics AU Pty Ltd (A subsidiary of Eilean Therapeutics LLC)40