First in Human, Randomized, Blinded, Placebo-Controlled Single Ascending Dose and Multiple Dose Study of MAR002 in Healthy Men
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Number of participants with TEAEs (treatment-emergent adverse events)
研究概览
简要总结
Evaluate the safety and tolerability of subcutaneous (SC) administration of MAR002 in healthy men
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Willingness to provide written informed consent
- •Age 18 to 40
- •Weight 55 to 95 kg
- •Body mass index (BMI) 18 to 30 kg/m2
- •Healthy men
排除标准
- •History of hypersensitivity to monoclonal antibodies or study drug
- •Participation in any other investigational drug study
- •History of cancer
- •Recent acute illness
- •Positive test for HIV, hepatitis B/C
- •History of substance abuse or nicotine use
- •Recent blood donation
- •History of pituitary disorder
- •Any condition that prevents the participant from complying with study procedures
研究组 & 干预措施
Dose A MAR002
Subcutaneous injection
干预措施: MAR002 (Drug)
Dose A MAR002
Subcutaneous injection
干预措施: Placebo (Drug)
Dose B MAR002
Cohort 2 receiving single Dose B
干预措施: MAR002 (Drug)
Dose B MAR002
Cohort 2 receiving single Dose B
干预措施: Placebo (Drug)
Dose C MAR002
Cohort 3 receiving single Dose C
干预措施: MAR002 (Drug)
Dose C MAR002
Cohort 3 receiving single Dose C
干预措施: Placebo (Drug)
Dose D MAR002
Cohort 4 receiving single Dose D
干预措施: MAR002 (Drug)
Dose D MAR002
Cohort 4 receiving single Dose D
干预措施: Placebo (Drug)
Dose E MAR002
Cohort 5 receiving single Dose E
干预措施: MAR002 (Drug)
Dose E MAR002
Cohort 5 receiving single Dose E
干预措施: Placebo (Drug)
Dose F MAR002
Cohort 6 receiving multiple Dose F
干预措施: MAR002 (Drug)
Dose F MAR002
Cohort 6 receiving multiple Dose F
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with TEAEs (treatment-emergent adverse events)
时间窗: From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6.
To evaluate the safety and tolerability of subcutaneous (SC) administration of MAR002 in healthy men
次要结局
- PK Parameters -- Cmax(From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6.)
- PK Parameters - Tmax(From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6.)
- PK Parameters - AUC(From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6.)
- PK Parameters - Half Life(From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6.)
- PK Parameters - Clearance(From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6.)
- PK Parameters - MRT(From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6.)