NL-OMON47937已完成不适用
A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IW-6463 when Administered to Healthy Volunteers as Single Ascending Doses with a Food Interaction Cohort, and as Multiple Ascending Doses - IW 6463 in healthy subjects as a SAD, MAD and Food interaction
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 138
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
- •1. Signed an ICF before any study-specific procedures are performed.
- •2. Age is *18 and <65 years at the Screening Visit.
- •3. Body mass index is *18.5 and <32 kg/m2 at the Screening Visit.
- •4. Ambulatory, in good health and no clinically significant findings on a
- •physical examination,
- •12-lead ECG, alcohol breathalyzer, and clinical laboratory tests (ie, serum
- •hematology, coagulation, urine drug screen, and urinalysis) after signing the
- •ICF but before
- •receiving the dose of study drug.
- •5. Screening results are negative for the hepatitis panel (hepatitis B surface
- •antigen [HBsAg],
- •the antihepatitis C virus [HCV]), and the human immunodeficiency virus (HIV)
排除标准
- •1. Participated in any clinical study or treated with any investigational drug
- •or device within 28 days prior to Screening.
- •2. Clinically significant manifestation of metabolic; hepatic; renal;
- •hematological; pulmonary; cardiovascular; gastrointestinal; endocrinological;
- •musculoskeletal; dermatological; urogenital; eye, ear, nose, and/or throat;
- •psychiatric (including history of clinical depression or suicidal ideation, any
- •cognitive impairment or dementia); or neurological disorder that, in
- •the opinion of the Investigator, precludes the subject from participating in
- •3. Lymphoma, leukemia, or any malignancy within the past 5 years. Exception:
- •Basal cell or squamous epithelial carcinomas of the skin that have been
- •resected with no evidence of
- •metastatic disease for 3 years.
- •4. Clinically significant hypersensitivity or allergy to any of the inactive
- •ingredients contained in the active or placebo drug products.
- •5. Active alcoholism or drug addiction during the 12 months before the
- •Screening Visit or has a positive urine drug screen or alcohol test (see
- •Section 8.1.7.2) at the Screening Visit or at
- •Check-in to the Study Center.
- •6. 12-lead ECG at the Screening Visit demonstrating severe bradycardia (HR <40
- •beats per minute) or average QT interval corrected for HR using Fridericia*s
- •formula (QTcF) *450 msec for men or *470 msec for women.
- •7. Family history of short QT syndrome or long QT syndrome.
- •8. Elevated levels (ie, >1.5× the upper limit of normal as defined by the
- •laboratory) at the Screening Visit or at Check-in of alanine aminotransferase,
- •aspartate aminotransferase, or
- •creatinine.
研究者
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