ACTRN12616001040459已完成1 期
A Phase 1, Randomized, Double Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KZR-616 in Healthy Subjects
Clinical Network Services0 个研究点目标入组 128 人开始时间: 2016年8月4日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 128
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1. Normal healthy volunteers, age at screening 18 to 65 years, inclusive.
- •2. Subjects must be in good general health, with no significant medical history, have no clinically significant abnormalities on physical examination at screening, and/or before administration of the initial dose of study drug.
- •3. Subjects must weigh more than or equal to 50 kg and have a Body Mass Index between 20 and 29 kg/m2 Inclusive.
- •4. Subjects must have clinical laboratory values less than 1.5 x upper limit of normal (ULN) as specified by the testing laboratory, unless deemed not clinically significant by the Investigator.
- •5. Must agree to abstain from alcohol intake 48 hours before administration of study agent and during the inpatient period of the study.
- •6. Negative urine drug screen /alcohol breath test at screening and Day -1.
- •7. Subjects must have the ability and willingness to attend the necessary visits to the study centre.
- •8. Written informed consent signed prior to entry into the study.
- •9. Subjects using highly effective, double barrier contraception (both male and female partners) during the study and for 90 days following the last dose of KZR-616
- •Double barrier contraception is defined as a condom AND one other form of the following:
- •-Birth control pills (The Pill)
- •-Depot or injectable birth control
- •-IUD (Intrauterine Device)
- •-Birth Control Patch (e.g., Othro Evra)
- •-NuvaRing, Registered Trademark
- •-Documented evidence of surgical sterilization at least 6 months prior to screening visit. i.e., tubal ligation or hysterectomy for women or vasectomy for men.
- •Males must not donate sperm for at least 90 days post-dose of the last study treatment. Male partners of female subjects and female partners of male subjects must also use contraception, if they are of childbearing potential.
- •Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1.
- •Females not of childbearing potential must be post-menopausal (defined as cessation of regular menstrual periods for at least 12 months), confirmed by follicle stimulating hormone (FSH) level greater than 40 mIU/mL.
- •Rhythm methods will not be considered as highly effective methods of birth control. Subject abstinence for the duration of the study and 90 days after the dose of KZR-616 is acceptable.
排除标准
- •1. Positive testing for human immunodeficiency virus (HIV),hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).
- •2. Have any underlying physical or psychological medical condition that, in the opinion of the investigator, would make it unlikely that the subject will complete the study
- •3. Have evidence of any chronic medical condition (e.g., hypertension, elevated cholesterol/triglycerides, asthma, or diabetes).
- •4. Use of any prescription or over-the counter medication (with the exception of paracetamol and oral contraceptives) within 7 days of randomization.
- •5. Any clinically significant laboratory abnormality.
- •6. Absolute neutrophil count less than 1500/microliter.
- •7. Aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 1.5 x ULN unless not clinically significant (NCS) by investigator discretion.
- •8. History or presence of alcoholism or drug abuse within the 2 years prior to the first study drug administration.
- •9. Blood donation or significant blood loss within 60 days prior to the first study drug administration.
- •10. Plasma donation within 7 days prior to the first study drug administration.
- •11. Administration of investigational product (IP) in another trial within 30 days prior to the first study drug administration.
- •12. Females who are pregnant or lactating.
- •13. Surgery within the past three months prior to the first study drug administration determined by the PI to be clinically relevant.
- •14. Failure to satisfy the PI of fitness to participate for any other reason.
- •15. Active infection (diagnosed or suspected) or history of recurrent infections.
- •16. Serious local infection or systemic infection within 3 months requiring antibiotic treatment.
- •17. Any acute illness within 30 days prior to Day 1.
- •18. Known or suspected hypersensitivity to polysorbate 80 (PS-80, also known as (aka) Tween 80)
研究者
相似试验
尚未招募
1 期
A study to evaluate the Safety and Pharmacokinetics (Pharmacokintecus, the measure of how the human body processes a substance) of ETX0282 when administered orally to healthy participants.ACTRN12618000350224INC Research/ Inventiv Health116
已完成
不适用
A Phase 1, Randomized, Double-blind, Placebo-Controlled, Single- and Multiple-Dose Escalation Study Evaluating Safety and Pharmacokinetics of VX-440 Alone and in Combination with VX-661/Ivacaftor, and Bioavailability and Food Effect of VX-440 in Healthy Adult Subjects10038686cystic fibrosisNL-OMON43882Vertex Pharmaceuticals120
招募中
1 期
A First-in-Human Study of SGB-9768 in Healthy VolunteersComplement-mediated DiseasesInflammatory and Immune System - Other inflammatory or immune system disordersACTRN12624000054516Sanegene Bio New Zealand Ltd36
已完成
不适用
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics of Minocin® (minocycline) for Injection in Healthy Adult SubjectsAcinetobacter infectionsNL-OMON45336Medicines Company60
招募中
1 期
First in human clinical trial to study the safety, tolerability, absorption, distribution, metabolism, elimination, and biochemical and physiological effects of PDP-117 along with food effect when administered as single and multiple oral doses at escalating dose levels in healthy human subjects.CTRI/2022/02/040223Indian Council of Medical Research