NCT03375606终止1 期
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous CSL730 in Healthy Caucasian and Japanese Subjects
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- CSL Behring
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Percentage of subjects with adverse events overall, and by causality and severity
研究概览
简要总结
To assess the safety and tolerability of ascending doses of CSL730 after a single intravenous (IV) infusion in healthy Caucasian and Japanese subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males or females (postmenopausal or surgically sterile only) aged ≥ 20 to ≤ 55 years and of Caucasian or Japanese descent
排除标准
- •Evidence of a clinically significant medical condition, disorder, or disease as judged by Investigator and / or study Medical Monitor.
- •History of asthma (with the exception of childhood asthma that has resolved), chronic obstructive pulmonary disease, or recurrent or current respiratory infections; splenectomy; or recurrent or current gastrointestinal infections.
- •Evidence of active or latent tuberculosis.
- •Known or suspected hypersensitivity to the IP, to any excipients of the IP, humanized monoclonal antibodies, or Fc fusion protein therapeutics.
- •History, or current diagnosis, of substance use disorder.
- •Any abnormal clinical laboratory values deemed clinically significant by the Investigator and / or study Medical Monitor.
- •Positive serology test result for human immunodeficiency virus antibody, hepatitis virus B surface antigen or hepatitis virus C antibody at Screening.
- •Donation or loss of ≥ 480 mL of whole blood within 2 months or donation of plasma within 14 days before Day -
- •Plans to participate in another investigational drug study while enrolled in this study, or has participated in any other investigational drug study in which they were known to have been administered a monoclonal antibody or biological IP within 4 months, any other investigational drug study within 60 days or > 3 investigational drug studies within 12 months before IP administration.
研究组 & 干预措施
CSL730
Experimental
干预措施: CSL730 (Biological)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Percentage of subjects with adverse events overall, and by causality and severity
时间窗: Up to 8 weeks after infusion
次要结局
- Area under the concentration-time curve from time 0 extrapolated to time infinity (AUC0-inf) of CSL730 in serum(Before study drug infusion and up to 56 days after the start of the infusion.)
- Area under the concentration-time curve from time 0 to the last collection time (AUC0-last) of CSL730 in serum(Before study drug infusion and up to 56 days after the start of the infusion.)
- Number of subjects with anti-CSL730 antibodies in serum(Before study drug infusion and up to 56 days after the start of the infusion.)
- Maximum observed concentration (Cmax) of CSL730 in serum(Before study drug infusion and up to 56 days after the start of the infusion.)
- Time of maximum observed concentration (Tmax) of CSL730 in serum(Before study drug infusion and up to 56 days after the start of the infusion.)
- Terminal elimination half-life (T1/2) of CSL730 in serum(Before study drug infusion and up to 56 days after the start of the infusion.)
- Total systemic clearance (CL) of CSL730 in serum(Before study drug infusion and up to 56 days after the start of the infusion.)
- Volume of distribution during the elimination phase (Vz) of CSL730 in serum(Before study drug infusion and up to 56 days after the start of the infusion.)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Safety, Tolerability and Pharmacokinetics of CSL112 in Healthy VolunteersHealthyNCT01129661CSL Limited57
已完成
1 期
A Study to Test the Safety, Pharmacokinetics, and Efficacy of UCB9741 in Healthy Study Participants and in Study Participants With Atopic DermatitisAtopic DermatitisNCT04643457UCB Biopharma SRL107
已完成
1 期
A Safety Study of LY2886721 Single Doses in Healthy SubjectsAlzheimer's DiseaseNCT01133405Eli Lilly and Company40
已完成
1 期
Safety and Pharmacodynamcis of SELA-070 Nicotine Vaccine in SmokersSmoking CessationNCT03148925Selecta Biosciences, Inc.72
已完成
1 期
Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SP-8008StrokeAcute Coronary SyndromeNCT04770194Shin Poong Pharmaceutical Co. Ltd.48