Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SOBI002 Following Subcutaneous and Intravenous Administration. A Double-blind, Placebo-controlled, Randomized Within Dose Cohort, Single and Repeated Dose-escalation Study in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To assess the safety and tolerability of SOBI002 in healthy volunteers following single and repeated adminstration
研究概览
简要总结
The main purpose of this study is to assess the safety and tolerability of SOBI002 in healthy volunteers following single and repeated administration.
详细描述
This is a double-blind, placebo-controlled, randomized within dose cohort single and repeated dose study with sequential dose escalation.
Eligible volunteers will be divided into dose cohorts and for each cohort, a new panel of 8 volunteers will be randomized to receive either SOBI002 (n=6) or placebo (n=2). SOBI002 will either be administered subcutaneously or intravenously.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Females of non-childbearing potential or males
- •18 to 45 years of age
- •Judged by the Principal Investigator to be healthy on the basis of medical history and a pre-study physical examination including 12-lead electrocardiogram (ECG), 24-hour Holter ECG, vital signs and blood and urine laboratory assessments.
排除标准
- •Females of childbearing potential
- •Clinically significant disease
- •Clinically significant abnormal laboratory, ECG, vital signs or other safety findings as determined by medical history, physical examination or other evaluations conducted at screening or on admission.
研究组 & 干预措施
SOBI002
Single and repeated administration of different doses of test product
干预措施: SOBI002 (Drug)
placebo
Single and repeated administration of placebo comparator
干预措施: Placebo (Drug)
结局指标
主要结局
To assess the safety and tolerability of SOBI002 in healthy volunteers following single and repeated adminstration
时间窗: Up to 13 weeks
Safety will be evaluated by assessing all Adverse Events, vital signs, 12-lead ECGs, urine samples for determination of urinalysis variables and blood samples for determination of hematology, biochemistry and coagulation variables.
次要结局
- Assessment of pharmacodynamics by assessing the inhibition of SOBI002 on hemolytic activity(Up to 13 weeks)
- Assessment of the immungenicity of SOBI002 by measuring the occurence of anti-drug antibodies(Up to 13 weeks)
- Assessment of pharmacokinetics of SOBI002 through analysis of serum samples(Up to 13 weeks)