ISRCTN90049550进行中（未招募）1 期
A randomized, double-blind, placebo-controlled Phase I study of single and multiple ascending doses of IMSB301 in healthy subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 64
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
- 性别
- All
入选标准
- •1. Healthy male or female subjects between 18 and 55 years of age, inclusive
- •2. Signed informed consent and mental capability to understand the informed consent
- •3. Body mass index (BMI) between 18 and 33 kg/m2, inclusive, and a total body weight >45 kg for females and >50 kg for males
- •4. Unremarkable physical exam, normal vitals, and all laboratory values must be within normal limits or any abnormalities deemed not clinically significant by the Investigator at screening
- •5. Electrocardiogram (ECG) without evidence of clinically meaningful conduction abnormalities or active ischemia as determined by the Investigator
- •6. Negative test for drugs of abuse or alcohol at screening and Day -1
- •7. Women of childbearing potential (defined as a female who has experienced menarche and who has not undergone successful surgical sterilization [hysterectomy, bilateral salpingectomy, or bilateral oophorectomy]) or is not postmenopausal (defined as amenorrhea for at least 12 consecutive months with an appropriate clinical profile at the appropriate age, eg, greater than 45 years) must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day -1
- •8. Male and female subjects with reproductive potential must agree to use highly effective contraception throughout the study and for at least 3 months after the last study drug dose
- •9. Subjects must be willing and able to comply with scheduled visits, all sample collections, and other trial procedures
排除标准
- •1. Resting 12-lead ECG showing confirmed prolongation of corrected QT (QTc) (Fridericia’s correction) interval (QTc interval >470 for females and >450 for males)
- •2. Ongoing illness including, but not limited to, congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, clinically significant hypertension, or psychiatric illness/social situations that in the opinion of the Investigator would limit compliance with study requirements.
- •3. Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
- •4. Have any of the following infectious risks:
- •4.1. Evidence of active infection during screening or Day -1 that in the opinion of the Investigator would pose an unacceptable risk for participating in the study
- •4.2. Symptomatic herpes zoster infection within 12 weeks prior to the screening period
- •4.3. Positive hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or tuberculosis (TB) test at screening
- •4.4. Household contact with a person with active TB and did not receive appropriate and documented prophylaxis for TB
- •5. Blood or plasma donation within 30 days prior to Day -1.
- •6. Any clinically significant illness in the 30 days prior to Day -1.
- •7. Receipt of an investigational drug within 30 days or five half-lives of the drug (whichever is longer) prior to Day -1.
- •8. Use of nicotine products within six months prior to screening.
- •9. Use of prescription drugs except hormonal contraception, or over-the-counter medication including paracetamol, within two weeks of Day -1
- •10. Prior receipt of investigational product in this trial.
- •11. Female subjects who are breastfeeding or who have a positive pregnancy test at screening or Day -1.
- •12. History of any condition that might impair the subject’s ability to understand or comply with the requirements of the study or to provide informed consent.
- •13. Receipt of a vaccination within 3 weeks prior to Day -1.
- •14. Consumption of any foods or beverages known to modulate CYP enzymes activity (eg, St. John’s wort, grapefruit or grapefruit juice, pomelo juice, star fruit, or Seville [blood] orange products) within 72 hours prior to admission to the study site and throughout the study.
研究者
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