A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of NBL-012 in Healthy Chinese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Clinically significant changes from baseline in 12-lead electrocardiogram (ECG) examination will be recorded as AEs at each visit time point.
研究概览
简要总结
This is a phase 1, randomized, double-blind, placebo-controlled, sequential cohort study to evaluate the safety, tolerability and pharmacokinetics (PK) of NBL-012 as single ascending doses (SAD) administered subcutaneously to healthy Chinese subjects.
详细描述
This is a phase 1, randomized, double-blind, placebo-controlled, sequential cohort study to evaluate the safety, tolerability and pharmacokinetics of NBL-012 administered subcutaneously as single ascending doses (SAD) to healthy Chinese subjects. Six dose cohorts will be intended for enrollment. The first dose will be sentinel group which will consist of 2 subjects, both of whom will receive active NBL-012. For subsequent dose cohorts, subjects will be given a single escalating SC dose of NBL-01
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
- •Healthy male and/or female subjects between the ages of 18 and 45 years (inclusive) at screening.
- •Body Mass Index (BMI) of 18 to 26 kg/m2 (inclusive), body weight for male ≥50 kg and for female≥45 kg.
- •Good general health defined as no clinically significant abnormalities identified by a detailed medical history (thoracic and abdominal examination, nervous and mental system examination, etc.), full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG,
排除标准
- •Participated in any drug or medical device clinical trial within 3 months before screening
- •Pregnant or nursing (lactating) women who have a positive blood/urine pregnancy test.
- •Females of child-bearing potential (defined as all females physiologically capable of becoming pregnant) and males who are unwilling or unable to use effective contraception during the study and until the end of study visit (more than 15 weeks after drug administration), or subjects with a plan to give birth wi
研究组 & 干预措施
NBL-012 Injection
Two subjects will be enrolled in the initial dose. 8 out of 10 healthy subjects will be randomized to receive a single dose of NBL-012 Injection for subsequent dose cohorts
干预措施: NBL-012 Injection (Drug)
Placebo
2 out of 10 healthy subjects will be randomized to receive a single dose of placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Clinically significant changes from baseline in 12-lead electrocardiogram (ECG) examination will be recorded as AEs at each visit time point.
时间窗: Up to Day 113 from screening
ECG monitoring includes P-R, QT and QTc intervals in ms.
Clinically significant changes from baseline in blood biochemistry test will be recorded as AEs at each visit time point.
时间窗: Up to Day 113 from screening
Blood biochemistry test includes alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase and glutamyltranspeptidase in U/L.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
时间窗: Up to Day 113 from screening
Number of participants with treatment-related adverse events will be assessed by CTCAE v5.0. The AEs will be summarized according to the system organ class (SOC) and preferred term (PT), including the number and percentage of participants who had AEs.
Clinically significant changes from baseline in physical examination will be recorded as AEs at each visit time point.
时间窗: Up to Day 113 from screening
Physical examination includes general conditions, skin, neck, chest, spine, limbs, nervous system, and lymphatic system.
Clinically significant changes from baseline in vital signs examination will be recorded as AEs at each visit time point.
时间窗: Up to Day 113 from screening
Vital signs monitoring includes systolic blood pressure and diastolic blood pressure in mmHg.
Clinically significant changes from baseline in routine blood test will be recorded as AEs at each visit time point.
时间窗: Up to Day 113 from screening
Routine blood test includes white blood cell count, platelet, neutrophilic granulocyte count, lymphocyte count and monocyte count in 10\^9 /L.
Clinically significant changes from baseline in routine urine test will be recorded as AEs at each visit time point.
时间窗: Up to Day 113 from screening
Routine urine test includes glucose and protein in mg/dL.
次要结局
- Time to achieve maximum plasma concentration (Tmax) of NBL-012 injection(Pre-dose and multiple timepoints up to 113 days post-dose)
- Apparent volume of Distribution(Vz/F) of NBL-012 injection(Pre-dose and multiple timepoints up to 113 days post-dose)
- Half-life(t1/2) of NBL-012 injection(Pre-dose and multiple timepoints up to 113 days post-dose)
- Peak plasma concentration (Cmax) of NBL-012 injection(Pre-dose and multiple timepoints up to 113 days post-dose)
- Area under the plasma concentration versus time curve (AUC) of NBL-012 injection(Pre-dose and multiple timepoints up to 113 days post-dose)
- Apparent clearance(CL/F) of NBL-012 injection(Pre-dose and multiple timepoints up to 113 days post-dose)
- The incidence of Anti-drug antibody (ADA)(Pre-dose and multiple timepoints up to 113 days post-dose)
- Free IL-23 concentration in Serum.(Pre-dose and multiple timepoints up to 113 days post-dose)