A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, First-In-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of AK119 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent AEs
研究概览
简要总结
This is a first-in-human (FIH), Phase 1, single-center, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, PK and immunogenicity of AK119, a humanized monoclonal antibody targeting the CD73. The study will consist of 4 cohorts of healthy subjects. Eight subjects will be enrolled per cohort, randomized in a 3:1 ratio to receive a single dose of either the active drug AK119 (N=6) or matching placebo (N=2). Approximately 32 subjects (24 receiving active drug and 8 receiving placebo) will participate in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must meet ALL the following inclusion criteria (as applicable) to be eligible for participation in this study:
- •Adults between 18 and 55 years of age, inclusive, at screening.
- •Must have a calculated body mass index (BMI, weight [kg]/height [m2]) within 18.0 to 30.0 kg/m2 (inclusive) at screening, and a total body weight ≥50 kg for men or ≥45 kg for women at screening and Day -1 before randomization.
- •Must, in the opinion of the Investigator, be in good general health based upon medical history, physical examination (including vital signs), and 12-lead ECG; and clinical laboratory tests (up to 1 repeat permitted) must fall within the clinical laboratory"s reference normal ranges.
排除标准
- •Subjects who meet ANY of the following exclusion criteria will not be enrolled in this study
- •Have a history of latent or active granulomatous infection, including histoplasmosis, candidiasis, or coccidioidomycosis prior to screening, or a history of any other infectious disease within 4 weeks prior to screening that, in the opinion of the Investigator, affects the subject"s ability to participate in the study.
- •Have a history of multiple drug allergies or a known allergy or hypersensitivity to any biologic therapy at screening that is important in the opinion of the Investigator.
- •Have a known allergy or reaction to any component of the AK119 formulation.
- •Have any known malignancy or have a history of malignancy within the previous 5 years.
- •Have a 12-lead ECG demonstrating QTcF interval > 450 msec for male subjects and >470 msec for female subjects at screening and Day -1 from average of 3 ECGs obtained after 5 minutes of supine rest.
- •Blood pressure (BP) >150 mmHg (systolic) or > 95 mmHg (diastolic) at screening and Day -1, following at least 5 minutes of supine rest.
- •Have had a live vaccination within 12 weeks prior to the study dosing or intend to have a live vaccination during the course of the study or have participated in a vaccine clinical study within 12 weeks prior to the study dosing.
研究组 & 干预措施
AK119
Single dose of AK119 is administered via intravenous infusion to healthy subjects.
干预措施: AK119 (Drug)
Placebo
Single dose of placebo is administered via intravenous infusion to healthy subjects.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of treatment-emergent AEs
时间窗: From signing of informed consent till end of study (approximately 64 days postdose)
次要结局
- Maximum serum concentration (Cmax) of AK119(From baseline till end of study (approximately 64 days postdose))
- Area under the concentration-time curve (AUC) of serum concentration of AK119(From baseline till end of study (approximately 64 days postdose))
- Percentage of subjects who develop detectable anti-drug antibodies (ADAs)(From baseline till end of study (approximately 64 days postdose))