NL-OMON31095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 325568 Administered to Healthy Volunteers - Antisense glucagon receptor in healthy volunteers
ISIS Pharmaceuticals0 个研究点目标入组 56 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
- 56
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 subjects of either gender aged between 18-65 years
- •2. Females must be non-pregnant and non-lactating, and either
- •surgically sterile (hysterectomy, oophrectomy, or tubal ligation) or postmenopausal.
- •Males must be surgically sterile, abstinent or if engaged in sexual
- •relations of child-bearing potential, subject or partner must be using an acceptable
- •contraceptive method during the trial and for 9 weeks after the last dose of study
- •3. Give written informed consent to participate in study and availability for all study
- •requirements
- •4. Fasting plasma glucose <= the upper limit of the laboratory*s reference range
- •5. HbA1C <= ULN
- •6. BMI < 30 kg/m2
排除标准
- •1. Clinically significant abnormalities in medical history or physical examination
- •2. Abnormalities on laboratory examination (ALT > ULN, AST > ULN, bilirubin >
- •ULN, creatinine > ULN, urine protein positive by urine dipstick, platelets < lower
- •limit of normal and any other clinically significant laboratory findings)
- •3. History of clinically significant abnormalities in coagulation parameters
- •4. Positive test result for HIV, hepatitis B virus, and/or hepatitis C virus
- •5. Active infection requiring antiviral or antimicrobial therapy
- •6. Subjects on chronic or acute prescription medication may be permitted after
- •discussion with the Isis Medical Monitor.
- •7. Malignancy (with the exception of basal or squamous cell carcinoma of the skin if
- •adequately treated and no recurrence for > 1 year)
- •8. Any other concurrent condition which, in the opinion of the Investigator, would
- •preclude participation in this study or interfere with compliance
- •9. History of alcohol or drug abuse
- •10. Undergoing or have undergone treatment with another investigational drug,
- •biologic agent or device within 90 days prior to Screening.
- •11. Blood donation within three months of screening
研究者
相似试验
招募中
不适用
A Phase 1, Placebo-Controlled, Double-Blind, Dose-Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of a Single Intravenous Dose of Getagozumab in Healthy VolunteersACTRN12618000121268Gmax Biopharm Australia Pty Ltd.32
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 Volunteersdisorder with hyperglycemia10018424Diabetes MellitusNL-OMON35464ISIS Pharmaceuticals103
已完成
1 期
A Phase 1, Double-Blind, Randomized, Placebo-controlled, Single Ascending Dose Study of Flecainide Acetate Inhalation Solution to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy VolunteersRecent Onset Paroxsymal Atrial FibrillationCardiovascular - Other cardiovascular diseasesACTRN12616001156471InCarda Therapeutics Australia44
已完成
1 期
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of FlecIH-101 Versus Placebo in Healthy VolunteersCardiovascular - Other cardiovascular diseasesParoxysmal atrial fibrillationACTRN12618001239257InCarda Therapeutics Australia, Pty, Ltd22
已完成
1 期
An interventional study to evaluate the Safety and Pharmacokinetics (PK, the measure of how the human body processes a substance) of ETX2514 when administered intravenously (IV, directly into the bloodstream through a vein in the arm) to healthy participants.ACTRN12616000995471INCResearch Australia Pty Ltd124