A Subject-Blind, Investigator-Blind, Randomized, Placebo-Controlled, First-in-Human Study to Evaluate Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Intravenous Doses of UCB0107 in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- The incidence of Adverse Events (AEs) during the study
研究概览
简要总结
The purpose of the study is to evaluate the safety and tolerability of single ascending doses of UCB0107 administered by intravenous (iv) infusion in healthy male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject is male, >= 18 and <= 75 years of age
- •Subject has a body mass index (BMI) >= 18.0 and < 30.0 kg/m^2, with a body weight of at least 50 kg and maximum 100 kg
- •Subject is in good physical and mental health
- •Subject has clinical laboratory test results within the reference ranges of the laboratory
- •Subject's electrocardiogram (ECG) is considered "normal," or "abnormal" but clinically non-significant (as interpreted by the investigator)
- •Male subject confirms that, during the study period and for a period of 6 months or 5 half-lives of the investigational medicinal product (IMP) (whichever is longer), when having sexual intercourse with a woman of childbearing potential, a method of efficient contraception will be used, including a barrier AND an additional highly effective contraceptive method by the female partner
排除标准
- •Subject is an employee or direct relative of an employee of the contract research organization (CRO) or UCB
- •Subject has previously been assigned to treatment in this study or in another study of the medication under investigation in this study
- •Subject is considered to be a vulnerable participant
- •Subject has had major surgery (including joint surgery) within 6 months prior to Screening, or has planned surgery within 6 months after study treatment
- •Subject has an active infection (eg, sepsis, pneumonia, abscess) or has had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 4 weeks before the first dose of IMP
研究组 & 干预措施
UCB0107
Subjects randomized to this arm will receive UCB0107. This arm will consist of a maximum of 7 cohorts. The dose for cohort 1 will be fixed, proposed doses for cohorts 2,3,4,5,6 and 7 may be adapted based upon recommendation by the Safety Review Group.
干预措施: UCB0107 (Drug)
Placebo
Subjects randomized to this arm will receive matching Placebo to UCB0107. This arm will consist of a maximum of 7 cohorts.
干预措施: Placebo (Other)
结局指标
主要结局
The incidence of Adverse Events (AEs) during the study
时间窗: During the study from Visit 1 up to the Safety Follow-Up Visit (Week 20)
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
次要结局
- The terminal half-life (t½) of UCB0107 in serum(Pharmacokinetic samples will be taken at pre-defined time points throughout study completion (up to Week 20))
- CSF/serum ratio of antibody concentrations(Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20))
- The time to maximum concentration (tmax) for UCB0107 in serum and cerebrospinal fluid(Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20))
- The Maximum concentration (Cmax) for UCB0107 in serum and cerebrospinal fluid(Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20))
- The area under the concentration-time curve from time 0 to time t, the time of the last quantifiable concentration (AUC(0-t)) in serum and cerebrospinal fluid(Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20))
- The volume of distribution (Vz) for UCB0107 in serum(Pharmacokinetic samples will be taken at pre-defined time points throughout study completion (up to Week 20))
- The total Clearance (CL) for UCB0107 in serum(Pharmacokinetic samples will be taken at pre-defined time points throughout study completion (up to Week 20))
- The area under the concentration-time curve from time 0 to infinity (AUC) in serum and cerebrospinal fluid(Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20))