NL-OMON35464已完成不适用
A Phase 1, Double Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ISIS 388626 Administered to Healthy Volunteers - Phase 1 Study with Single and Multiple Doses of ISIS 388626
ISIS Pharmaceuticals0 个研究点目标入组 103 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 103
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. Healthy volunteers aged between 18 to 65 years
- •2. Male or female gender although females must be post-menopausal or surgically sterile (hysterectomy, oophrectomy or tubal ligation).
- •3. Give written informed consent to participate in the study and availability for all study requirements
- •4. Fasting plasma glucose <= the upper limit of the laboratory*s reference range (ULN)
- •5. HbA1c <= ULN
- •6. BMI < 30 kg/m2
排除标准
- •1. Pregnant women, nursing mothers or women of childbearing potential
- •2. Presence of any of the following conditions:
- •a. Clinically significant abnormalities in medical history or physical examination
- •b. Clinically significant abnormalities in laboratory examination. (ALT > ULN, AST > ULN, bilirubin > ULN, creatinine > ULN, urine protein positive by dipstick, platelets < lower limit of normal and any other clinical significant laboratory findings)
- •c. Clinically significant abnormalities in coagulation parameters
- •d. Positive test result for HIV, hepatitis B virus, and/or hepatitis C virus
- •e. Active infection requiring antiviral or antimicrobial therapy
- •f. Subjects on chronic or acute prescription medication may be permitted after discussion with the Isis Medical Monitor.
- •g. Malignancy (with the exception of basal or squamous cell carcinoma of the skin if adequately treated and no recurrence for > 1 year)
- •h. Any other concurrent condition which, in the opinion of the Investigator, would preclude participation in this study or interfere with compliance
- •3. History of alcohol or drug abuse
- •4. Undergoing or have undergone treatment with another investigational drug, biologic agent or device within 90 days prior to Screening.
- •5. Blood donation within three months of Screening
研究者
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