Phase Ia, Randomized Double-Blinded, Placebo-Controlled Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered CUG252 Following a Single Dose Administration in Normal Health Volunteers.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Cugene Inc.
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number and percentage of subjects with Treatment Emergent Adverse Events
研究概览
简要总结
The intent of this study is to evaluate the safety and tolerability of single escalating subcutaneous doses of CUG252 in healthy adult subjects.
详细描述
This is a Phase Ia study of CUG252, comprising a randomized, double-blind, placebo-controlled, single ascending dose in healthy adult subjects.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-smoking adult healthy male and female, aged 18 to 65 years (inclusive), at the time of consent with a body mass index (BMI) between 18.0 and 32.0 kg/m2 (inclusive), at Screening.
- •Healthy as determined by medical history, physical examination, vital signs, clinical laboratory safety tests, ECG, and chest X-ray
排除标准
- •Active bacterial, viral, fungal infection or known inflammatory process, infection or antibiotic treatment
- •Laboratory test results outside the local reference range and deemed clinically significant
- •History of chronic medications, immunosuppressant or steroids
- •History of malignant neoplasm
- •History of relevant atopy
- •History of hypersensitivity to biologic agents or any of the excipients in the formulation.
- •Excessive xanthine consumption
- •History of drug or alcohol addiction or dependence within 1 year
- •Positive of a tuberculosis test or a history of tuberculosis
- •Abnormal blood pressure and/or ECG parameters
- •Any prescribed medications within 28 days or nonprescription drugs within 7 days
- •Previously received aldesleukin or any other IL-2 derivative
研究组 & 干预措施
CUG252
Participants will be randomized in a 3:1 ratio to CUG252 or placebo. CUG252 or placebo will be administered at a single ascending dose in healthy volunteers.
干预措施: CUG252 (Drug)
Placebo
Participants will be randomized in a 3:1 ratio to CUG252 or placebo. CUG252 or placebo will be administered at a single ascending dose in healthy volunteers.
干预措施: Placebo (Drug)
结局指标
主要结局
Number and percentage of subjects with Treatment Emergent Adverse Events
时间窗: Up to 10 weeks
To evaluate the safety and tolerability of subcutaneous injections of CUG252 in healthy subjects.
次要结局
- Pharmacokinetics profile of CUG252 (AUC)(Up to 10 weeks)
- Pharmacokinetics profile of CUG252 (Cmax)(Up to 10 weeks)
- Pharmacokinetics profile of CUG252 (Tmax)(Up to 10 weeks)
- Pharmacokinetics profile of CUG252 (t1/2)(Up to 10 weeks)
- Change in the number and percentages of immune cells(Up to 10 weeks)
- Immunogenicity of CUG252(Up to 10 weeks)