A Randomized, Single-blinded, Placebo Controlled, Single Ascending Dose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of KJ103 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- AE
研究概览
简要总结
This is a randomized, single-blinded, placebo controlled, single ascending dose phase I study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) and immunogenicity of KJ103 in healthy subjects.
详细描述
This single ascending dose (SAD), randomized, single-blinded, placebo controlled study is the first study and it is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of KJ103 in healthy subjects after a single intravenous dose. It will include up to 34 healthy subjects in up to five dose groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Male or female between the ages of 18 and 55 years, inclusive.
- •Male body weight ≥50kg, female body weight ≥45kg, body mass index (BMI) within 18 kg/m2to 35 kg/m2, inclusively.
- •Immunoglobulin (IgG) levels at screening is within the normal range.
- •Considered "healthy" by the investigator. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, as well as a complete physical examination including vital signs, 12-lead ECG, hematology, biochemistry, and urinalysis.
排除标准
- •History of or diagnosis at screening of any clinically significant immunodeficiency including but not limited to immunoglobulin A deficiency.
- •History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease.
- •Any clinically significant illness in the 28 days prior to the first study drug administration.
- •Any history of tuberculosis.
- •Positive screening results to HIV Ag/Ab combo, syphilus, hepatitis A, hepatitis B surface antigen or hepatitis C virus tests.
- •Positive test result for alcohol and/or drugs of abuse at screening or prior to the first drug administration.
- •Current use of tobacco or nicotine-containing products exceeding 10 cigarettes per day or equivalent.
- •Received an investigational drug (or was using an investigational device at the time) within 30 days prior to screening, or at least 5 times the respective elimination half-life (if known), whichever is longer.
- •Female who is lactating.
- •Female who is pregnant according to the pregnancy test at screening or prior to the first study drug administration.
研究组 & 干预措施
KJ103 dose group 1
KJ103 single dose
干预措施: KJ103 (Drug)
KJ103 dose group 2
KJ103 single dose
干预措施: KJ103 (Drug)
KJ103 dose group 3
KJ103 single dose
干预措施: KJ103 (Drug)
KJ103 dose group 4
KJ103 single dose
干预措施: KJ103 (Drug)
KJ103 dose group 5
KJ103 single dose
干预措施: KJ103 (Drug)
Matching placebo for each dose group
placebo, single dose
干预措施: Placebo (Drug)
结局指标
主要结局
AE
时间窗: Day 1 through Day 14
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational drug
次要结局
- Cmax(Up to 144 hours postdose)
- Tmax(Up to 144 hours postdose)
- t½(Up to 144 hours postdose)
- AUC0-inf(Up to 144 hours postdose)
- IgG level(Day 1 through Day 63)