NCT03001544Unknown1 期
Phase 1 Single-ascending Dose-escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Anti-alpha2-antiplasmin (α2AP) Monoclonal Antibody TS23 in Healthy Human Volunteers
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 24
- 主要终点
- Number and severity of adverse events post-dose
研究概览
简要总结
This study is designed to determine the safety, pharmacokinetics and pharmacodynamics of a single intravenous dose of TS23 in healthy adults.
详细描述
This is a first-in-human, Phase 1 study of the safety, pharmacokinetics and pharmacodynamics of TS23 in healthy male volunteers.TS23 is a monoclonal antibody that inactivates alpha 2-antiplasmin. Four dose cohorts of six subjects will be studied in a single ascending dose trial at one clinical center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Able to provide written informed consent
- •Healthy males age 18 years to 60 years of age
- •Body mass index ≥ 20 and ≤ 33 kg/m squared
排除标准
- •Known allergies or hypersensitivities to blood products or derivatives or therapeutic proteins or product excipients or components of CHO cells
- •Current alcohol or drug abuse or history of alcohol or drug abuse
- •Participation in any trial with an investigational drug within 90 days prior to dosing
- •Blood donation of more than 500 mL of blood within 90 days prior to dosing
- •Any history of a bleeding or thrombotic disorder
- •Any history of significant cardiac, pulmonary, renal, hepatic, neurologic, or immunologic disorder
- •Over-the-counter medications, dietary supplements and herbal products (except a daily vitamin) within 14 days of drug administration or during the study
- •No prescription medication for at least 14 days or 5-half-lives, whichever is longer, prior to study drug administration.
- •Use of anticoagulants, fibrinolytic agents or non-steroidal anti-inflammatory medicines (except aspirin doses of 82 mg per day or less) for 2 weeks prior to and during the study
- •Known hereditary fructosemia (due to sorbitol in the formulation)
- •Any previous or current monoclonal antibody therapy
- •History of trauma or surgery within the past 60 days or planned surgery within 30 days
- •Abnormal baseline laboratory values or any laboratory values deemed clinically significant by the Investigator
- •Recent history of head trauma in last 30 days prior to receiving TS23
- •Unwillingness or inability to avoid contact sports or other activities with more than a small risk of head or facial trauma within 30 days of receiving TS23
- •History of or risk of falls (e.g., due to dementia, frailty, etc.)
- •Sexually active subjects must agree to use a reliable method of birth control (abstinence, condoms, vasectomy) and to not donate sperm for 3 months after receiving TS23
结局指标
主要结局
Number and severity of adverse events post-dose
时间窗: 10 weeks
To count the number and assess the severity of treatment emergent adverse events within 10 weeks post dose
次要结局
- Coagulation (fibrinogen, PT, aPTT)(10 weeks)
- Anti-drug antibody(16 weeks)
- D-dimer(10 weeks)
- alpha2-antiplasmin activity(10 weeks)
- Pharmacokinetic parameter, maximum concentration of TS23(10 weeks)
- Pharmacokinetic parameter, half-life of TS23(10 weeks)
研究者
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