ACTRN12618000805279已完成1 期
A phase 1, randomized, double-blind, placebo-controlled study to evaluate the pharmacokinetics, safety, and tolerability of CSL112 in healthy Japanese and Caucasian subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- CSL Limited
- 入组人数
- 52
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
- 20 Years 至 54 Years（—）
- 性别
- All
入选标准
- •Healthy (determined by a comprehensive clinical assessment) male or female adult Japanese or Caucasian subjects with a body weight of >= 45 kg to <= 95 kg and a body mass index of >= 18.0 to <= 29.9 kg/m2. Japanese subjects must be of Japanese descent (ie, born in Japan with 2 Japanese biologic parents and 4 Japanese biologic grandparents) and have not lived outside of Japan for >= 10 successive years. Caucasian subjects must have origins in any of the original peoples of Europe, the Middle East, or North Africa.
排除标准
- •1. Evidence of a clinically significant medical condition, disorder or disease.
- •2. Evidence of hepatobiliary disease.
- •3. Any clinically significant abnormalities in hematology, biochemistry, or urinalysis as judged by the Investigator and / or study Medical Monitor at Screening and / or Day -1.
- •4. Sustained and / or symptomatic hypotension (systolic blood pressure < 90 mmHg).
- •5. Any major illness requiring hospitalization within the 30 days before the Screening Visit or planned hospitalization at any time during the study.
- •6. Known history of soy bean or peanut allergies, hypersensitivity to the investigational product, or to any excipients of the investigational product or placebo (albumin), or IgA deficiency or antibodies to IgA.
- •7. A positive result for HAV antibody, HBV surface antigen, HCV antibody, or HIV -1 and / or 2 antibodies at Screening.
- •8. Evidence or history of substance or alcohol abuse or a positive drug test or alcohol breath test at Screening or Day -1.
- •9. Smokers, those who have smoked or used tobacco products within 6 months before Screening
- •10. Plans to participate in another investigational drug study while enrolled in this study or has participated in any investigational drug study within 30 days (or 5 half-lives, whichever is longer) or more than 3 investigational drug studies within the 12 months before Day 1.
- •11. Clinically significant abnormalities in vital signs or physical examination at Screening or Day -1 as judged by Investigator and / or Sponsor.
- •12. A mean QTcF > 450 ms for male subjects or > 470 ms for female subjects at Screening.
- •13. Subjects who have been a recipient of an organ transplant.
研究者
相似试验
已完成
不适用
A phase 1, randomized, double-blind, placebo-controlled, single-dose escalation, multiple-dose escalation, and food effect study of RPT193 in healthy subjects and patients with moderate to severe atopic dermatitisasthmaatopische dermatitisAtopic dermititisNL-OMON49945RAPT Therapeutics, Inc.76
已完成
不适用
A phase 1, randomized, double-blind, placebo-controlled study evaluating the pharmacokinetics of capsule and tablet formulations of VX-150, including the effects of food and milk, the relative bioavailability of the tablet formulation, and the drug-drug interaction between VX-150 and Midazolam, in healthy adultspijnpainNL-OMON45544Vertex Pharmaceuticals Incorporated40
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-150 including an assessment of the effect of food on the pharmacokinetics of VX-150 in healthy adult subjects.Pijn.Pain.NL-OMON41908Vertex Pharmaceuticals Incorporated96
已完成
不适用
A phase 1, randomized, double-blind, placebo-controlled, safety, tolerability, pharmacokinetic and biomarker study of multiple ascending doses of ESB1609 in healthy volunteers.Niemann-Pick C disease (NPC)1002766410013317NL-OMON55239ESCAPE Bio, Inc.32
已完成
1 期
A phase 1, randomized, double-blind, placebo-controlled, sequential-panel, ascending single-dose study to evaluate the safety, tolerability, and pharmacokinetics of intravenous CMX-020 in healthy male and female subjectsPain ControlAnaesthesiology - Pain managementACTRN12617001583336Cytometix Inc48