A Phase 1, Randomized, Placebo-Controlled Single Ascending Dose Participant- and Investigator-Blind Study to Investigate the Safety, Tolerability, and Pharmacokinetics of UCB5285 in Healthy Study Participants
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Incidence of Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of single ascending doses of UCB5285 in healthy study participants, including healthy Japanese study participants
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- •For study participants of Japanese origin: study participant who is born in Japan and of Japanese descent as evidenced in appearance and verbal confirmation of familial heritage with all 4 grandparents and both parents born in Japan and has not had a significant change in lifestyle or diet since leaving Japan
- •For all study participants:
- •Study participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent
- •Study participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- •Body weight within 40 kilograms (kg) to 110 kg and body mass index (BMI) within the range of 18 kilograms per meter square (kg/m2) to 30 kg/m2 (inclusive)
排除标准
- •Study participant has a history or presence of any medical or psychiatric condition, physical examination finding, laboratory test result, electrocardiogram (ECG), or vital sign that, in the opinion of the investigator, could significantly alter the absorption, or elimination of drugs; constitute a risk when taking the study intervention; or interfere with the interpretation of data
- •Study participant has a recent history (within 6 months of Screening) or currently active clinically significant bacterial, fungal, endoparasite, or viral infection.
- •Study participant has a significant allergy to humanized monoclonal antibody (mAbs)
研究组 & 干预措施
Cohort 1
Participants randomized to this arm will receive a single dose of UCB5285 (Dose 1) or placebo via Route of Administration 1.
干预措施: Placebo (Other)
Cohort 1
Participants randomized to this arm will receive a single dose of UCB5285 (Dose 1) or placebo via Route of Administration 1.
干预措施: UCB5285 (Drug)
Cohort 4
Participants randomized to this arm will receive a single dose of UCB5285 (Dose 4) or placebo via Route of Administration 1.
干预措施: UCB5285 (Drug)
Cohort 2
Participants randomized to this arm will receive a single dose of UCB5285 (Dose 2) or placebo via Route of Administration 1.
干预措施: UCB5285 (Drug)
Cohort 2
Participants randomized to this arm will receive a single dose of UCB5285 (Dose 2) or placebo via Route of Administration 1.
干预措施: Placebo (Other)
Cohort 3
Participants randomized to this arm will receive a single dose of UCB5285 (Dose 3) or placebo via Route of Administration 1.
干预措施: UCB5285 (Drug)
Cohort 3
Participants randomized to this arm will receive a single dose of UCB5285 (Dose 3) or placebo via Route of Administration 1.
干预措施: Placebo (Other)
Cohort 4
Participants randomized to this arm will receive a single dose of UCB5285 (Dose 4) or placebo via Route of Administration 1.
干预措施: Placebo (Other)
Cohort 5
Participants randomized to this arm will receive a single dose of UCB5285 (Dose 4) or placebo Route of Administration 2.
干预措施: UCB5285 (Drug)
Cohort 5
Participants randomized to this arm will receive a single dose of UCB5285 (Dose 4) or placebo Route of Administration 2.
干预措施: Placebo (Other)
Cohort 6
Participants randomized to this arm will receive a single dose of UCB5285 (Dose 5) or placebo via Route of Administration 1.
干预措施: UCB5285 (Drug)
Cohort 6
Participants randomized to this arm will receive a single dose of UCB5285 (Dose 5) or placebo via Route of Administration 1.
干预措施: Placebo (Other)
Cohort 8
Participants randomized to this arm will receive a single dose of UCB5285 (Dose 6) or placebo via Route of Administration 1.
干预措施: UCB5285 (Drug)
Cohort 7
Participants randomized to this arm will receive a single dose of UCB5285 (Dose 5) or placebo via Route of Administration 2.
干预措施: UCB5285 (Drug)
Cohort 7
Participants randomized to this arm will receive a single dose of UCB5285 (Dose 5) or placebo via Route of Administration 2.
干预措施: Placebo (Other)
Cohort 8
Participants randomized to this arm will receive a single dose of UCB5285 (Dose 6) or placebo via Route of Administration 1.
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events (TEAEs)
时间窗: From Day 1 to the End Of Study (up to Day 161)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment emergent adverse events (TEAEs) are adverse events that are not present prior to the pharmaceutical product administration or an already present event that worsens either in intensity or frequency.
Incidence of Treatment-Emergent Serious Adverse Events (SAEs)
时间窗: From Day 1 to the End Of Study (up to Day 161)
An SAE is defined as any untoward medical occurrence that, at any dose, meets 1 or more of the criteria listed: * Results in death * Is life-threatening * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect * Other important medical events which based on medical or scientific judgement may jeopardize the patients or may require medical or surgical intervention to prevent any of the above.
次要结局
- Maximum Observed Serum Concentration (Cmax) of UCB5285(From Day 1 (Predose) at predefined time points up to Day 161)
- Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC) of UCB5285(From Day 1 (Predose) at predefined time points up to Day 161)
- Area Under the Serum Concentration-Time Curve from Time Zero to the Time of Last Detectable Concentration (AUC0-t) of UCB5285(From Day 1 (Predose) at predefined time points up to Day 161)