NCT05480579已完成1 期
A Dose Escalation Phase I Clinical Study to Evaluate the Tolerability and Safety of a Single Intravenous Injection IBI311 in Healthy Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Incidence, relatedness and severity of all adverse events, treatment emergent adverse events and serious adverse events
研究概览
简要总结
It is designed for Multi-center, double-masked, randomized, placebo- control study with dose escalation phase I trial to evaluate the safety, tolerability, PK and immunogenicity profiles of a single intravenous injection of IBI311 in healthy volunteers.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing and able to sign informed consent form and comply with visit and study procedures per protocol.
- •Male or female subjects with age of 18~45 yrs.
- •Female subjects of childbearing age or male subjects with childbearing age female partner agree to take effective contraceptive measures from the screening period to 120 days after the end of treatment.
排除标准
- •Have a history of or any evidence of chronic diseases of liver, kidney, cardiovascular, nervous/mental, digestive tract, respiratory, urinary and endocrine systems.
- •Have received prior treatment with another anti-IGF-1R monoclonal antibody.
- •History of drug, alcohol, or chemical abuse within 6 months prior to screening.
- •History of positive HIV antibody, HCV antibody, Syphilis check, HBV positive during screening period.
- •Receipt of a live vaccine within 180 days prior to screening or expected to receive live vaccine during study period.
- •History of recurrent significant infection or history of recurrent bacterial infections.
- •Must not have a history of tinnitus or hearing impairment.
- •Must not have received an investigational agent for any condition within 90 days.
- •Female volunteers must not be pregnant or lactating.
结局指标
主要结局
Incidence, relatedness and severity of all adverse events, treatment emergent adverse events and serious adverse events
时间窗: Up to 16 weeks
次要结局
- half-life (t1/2)(Up to 16 weeks.)
- maximum concentration (Cmax）(Up to 16 weeks.)
- area under the curve (AUC)(Up to 16 weeks.)
- the incidence of ADA(Up to 16 weeks)
研究者
研究点 (1)
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