Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of a Single Ascending Dose (SAD) of CAN106 Administered Intravenously (IV) in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Incidence of subjects with dose-limiting toxicity (DLTs)
研究概览
简要总结
This is a single site, single dose escalation study in healthy subject with CAN106. The study is to assess the safety and tolerability of single escalating doses of CAN106; to characterize the PK and PD profile of CAN106; and to evaluate the immunogenicity of CAN106 injection.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be able to understand and provide informed consent.
- •Males or females, between 21 and 45 years of age, inclusive;
- •Body mass index must be within the range of 18.5 to 32.0 kg/m2;
- •12-lead electrocardiogram (ECG) within normal limits with no clinically significant abnormalities in the opinion of the Investigator；
- •Systolic blood pressure ≤140 mmHg and a diastolic blood pressure of ≤ 90 mmHg after 5 minutes with supine rest；
- •non-pregnancy
- •meningococcal vaccinations for at least 2 weeks before dosing
排除标准
- •Disease or conditions interfere with participating the trial
- •Active serious mental illness or psychiatric disorder
- •clinically relevant abnormal test results in hepatic function
- •unacceptable CBC lab test
- •asymptomatic complement deficiency
- •Any other clinical safety laboratory test
- •HIV, HBV, HCV positive
- •Alcohol and drug abuse
研究组 & 干预措施
Single Ascending Dose (SAD)
In the SAD arm subjects will be sequentially included in one of up to six cohorts (dose levels). Additional subjects may be added in any cohort if necessary.
干预措施: CAN106 (Drug)
placebo
In the SAD arm subjects will be sequentially included in one of up to six cohorts (dose levels). In higher dose levels, subjects will be randomized to receive the treatment or placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of subjects with dose-limiting toxicity (DLTs)
时间窗: 6-months after dosing
TEAEs will be categorized as per the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria. a DLT is defined as one subject with a Grade 3 AE or higher, that are assessed as drug-related by the site investigator.
Incidence of adverse events (AEs)
时间窗: 6-months after dosing
An AE is defined as any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Incidence of severe adverse events (SAEs)
时间窗: 6-months after dosing
Any untoward medical occurrence that at any dose: * Results in death, * Is life-threatening, * Requires inpatient hospitalization or prolongation of existing hospitalization, * Results in persistent or significant disability/incapacity, or * Is a congenital anomaly/birth defect. (ICH E6 (R2))
次要结局
- PK parameters - tmax(6-months after dosing)
- PK parameters-Cmax(6-months after dosing)
- PK parameters - AUC0-t(6-months after dosing)
- PK parameters - t1/2(6-months after dosing)
- PD endpoints-free C5(6-months after dosing)
- Immunogenicity(6-months after dosing)
- PD endpoints-CH50(6-months after dosing)
- PD endpoints-total C5(6-months after dosing)