NCT02045472已完成1 期
Double-Blind, Placebo-Controlled, Dose-Escalation Phase 1 Study in Healthy Volunteers to Evaluate the Safety and Pharmacokinetics of a Human Monoclonal Antibody (VIS410) to Influenza Type A Hemagglutinin
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Safety assessment
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability, immunogenicity and pharmacokinetics of single escalating doses of VIS410 in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
- •Body mass index between 18 and 33 kg/m2, inclusive
- •Normal labs
- •Volunteers agree to use acceptable contraceptive measures
排除标准
- •Prior receipt of antibody or biologic therapy
- •History of cancer, heart disease, diabetes, respiratory condition (eg asthma), autoimmune disorder, blood dyscrasias
- •Any chronic condition requiring daily prescription or over the counter medication
- •History of a previous severe allergic reaction
- •Drug or alcohol abuse within previous 12 months
- •Positive serology for human immunodeficiency virus (HIV) antibody, hepatitis C virus (HCV) antibody or hepatitis B surface antigen (HBsAg)
- •Positive pregnancy test
- •Breast feeding
- •Positive drug or alcohol test at screening or check-in
- •Receipt of licensed vaccine (within 30 days) or other investigational product within 30 days or 5 half-lives, whichever is longer, before study product administration
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo administered as a single infusion
干预措施: Placebo (Drug)
VIS410
Experimental
VIS410 administered as a single infusion with ascending dose-escalation ranging from 2 to 50 mg/kg
干预措施: VIS410 (Drug)
结局指标
主要结局
Safety assessment
时间窗: 120 days post-infusion
Incidence of adverse events
次要结局
- Pharmacokinetic analysis(56 days post-infusion)
- Immunogenicity(120 days post-infusion)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Safety Study of TTP4000 in Subjects With Alzheimer's DiseaseAlzheimer's DiseaseNCT01548430vTv Therapeutics8
已完成
2 期
Efficacy and Safety of CDP6038 in Patients With Rheumatoid Arthritis With an Unsuccessful Response to Anti-Tumor Necrosis Factor (Anti-TNF) TherapyRheumatoid ArthritisNCT01242488UCB Pharma221
已完成
1 期
A Clinical Study to Investigate How Safe and Tolerable the Study Drug MT-2990 is and How MT-2990 is Taken up by the Body in Healthy VolunteersHealthyNCT03156738Mitsubishi Tanabe Pharma Corporation40
已完成
1 期
A Randomized, Double-blind, Placebo-controlled Study to Assess Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamic Response of Repeated Intravenous Infusions of BAN2401 in Subjects With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's DiseaseAlzheimer's DiseaseNCT02094729Eisai Co., Ltd.26
已完成
1 期
A Clinical Study of AK101 in Subjects With Moderate to Severe Plaque PsoriasisPlaque PsoriasisNCT04172233Akeso96