A Single-center, Randomized, Double-Blind, Placebo-Controlled Phase 1 Single Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity Characteristics of 9MW3011 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Adverse Event(including serious adverse event)
研究概览
简要总结
The objectives of the study are to evaluate the safety , tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single ascending intravenous (IV) doses of 9MW3011 in Chinese healthy volunteers.
详细描述
The single ascending dose(SAD) study will comprise 6 dose cohorts of 8 healthy volunteers each. In each cohort, subjects will be randomized in a 6:2 ratio to receive 9MW3011 or placebo via intravenous infusion.
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
- Double (Participant, Investigator)
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
- •Male or female subjects aged 18 to 65 years (including 18 and 65 years).
- •Weight≥50.0 kg for males, or weight≥45.0 kg for females, and body mass index (BMI) in the range of 19.0 ~ 26.0 kg/m2 (including cut-off value).
- •Being judged by the investigator to be eligible based on medical history, physical examination, laboratory tests and test related items of inspection or no clinically significant mild abnormalities.
- •Volunteered to participate in this clinical trial, capable of giving written informed consent.
排除标准
- •Nervous/mental, respiratory system, cardiovascular system, digestive system, blood and lymphatic system, endocrine system, skeletal and muscular system , immune system, urinary system diseases , or a family history of severe systemic diseases (including cardiovascular system, digestive system, urinary system, etc.), may affect the health status of the subjects or any other diseases and physiological conditions that may affect the results of the study , judged by the investigator.
- •Currently suffering from iron deficiency/Iron deficiency anemia, taking iron supplements and complicated with other diseases related to abnormal iron metabolism.
- •Subjects who have a history of allergies to monoclonal antibodies or any drug components; those who have a history of allergies to excipients of 9MW
- •Subjects who have lost blood or donated blood ≥200mL within 3 months before screening, or those who plan to donate blood within 3 months.
- •Positive for hepatitis B virus surface antigen and/or hepatitis B virus e antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or treponema pallidum antibody.
- •Subjects who is inappropriate to participate in the trial due to any reasons as determined by the investigator.
研究组 & 干预措施
9MW3011 Dose 2
Ascending IV doses administered per protocol
干预措施: 9MW3011 (Drug)
9MW3011 Dose 5
Ascending IV doses administered per protocol
干预措施: 9MW3011 (Drug)
9MW3011 Dose 1
Ascending IV doses administered per protocol
干预措施: 9MW3011 (Drug)
9MW3011 Dose 1
Ascending IV doses administered per protocol
干预措施: 9MW3011 placebo (Drug)
9MW3011 Dose 2
Ascending IV doses administered per protocol
干预措施: 9MW3011 placebo (Drug)
9MW3011 Dose 3
Ascending IV doses administered per protocol
干预措施: 9MW3011 (Drug)
9MW3011 Dose 3
Ascending IV doses administered per protocol
干预措施: 9MW3011 placebo (Drug)
9MW3011 Dose 4
Ascending IV doses administered per protocol
干预措施: 9MW3011 (Drug)
9MW3011 Dose 4
Ascending IV doses administered per protocol
干预措施: 9MW3011 placebo (Drug)
9MW3011 Dose 5
Ascending IV doses administered per protocol
干预措施: 9MW3011 placebo (Drug)
9MW3011 Dose 6
Ascending IV doses administered per protocol
干预措施: 9MW3011 (Drug)
9MW3011 Dose 6
Ascending IV doses administered per protocol
干预措施: 9MW3011 placebo (Drug)
结局指标
主要结局
Adverse Event(including serious adverse event)
时间窗: up to day 99
The incidence of AEs and SAEs from treatment until the last scheduled follow-up visit
次要结局
- Number of subjects with abnormal vital signs(up to day 99)
- Number of subjects with abnormal clinically significant results from physical examination(up to day 99)
- Number of subjects with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters(up to day 99)
- Number of subjects with abnormal clinically significant clinical laboratory results(up to day 99)
- Cmax(up to day 85)
- AUC0-t(up to day 85)
- AUC0-∞(up to day 85)
- Tmax(up to day 85)
- λz(up to day 85)
- t1/2z(up to day 85)
- Vz(up to day 85)
- CL(up to day 85)
- MRT(up to day 85)
- Pharmacodynamic(PD)parameters-hepcidin(up to day 85)
- PD parameters-serum iron(up to day 85)
- PD parameters-TSAT(up to day 85)
- Anti-drug antibodies(ADA)(up to day 85)