Safety, Tolerability, and Pharmacokinetics of MG-ZG122 in a Single Subcutaneous Injection in Chinese Healthy Adult Subjects: a Single-center, Randomized, Double-blind, Placebo-controlled, Dose-increasing Phase I Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Tolerability and Safety Analysis
研究概览
简要总结
To determine the safety and tolerability of MG-ZG122 in Chinese healthy adult subjects
详细描述
Main purpose: To determine the safety and tolerability of MG-ZG122 humanized monoclonal antibody injection (MG-ZG122 for short) in Chinese healthy adult subjects.
Secondary objective: To study the pharmacokinetic (PK) characteristics of MG-ZG122 in healthy Chinese adult volunteers, and to provide a basis for the design of clinical trial protocols for subsequent clinical trials; To evaluate the immunogenicity of MG-ZG122 in Chinese healthy adult volunteers; Preliminary exploration of the efficacy of MG-ZG122 in Chinese healthy adult subjects Impact of Biomarkers in Physiology (PD).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subjects signed the ICF before the study and fully understood the research content, process and possible adverse reactions; voluntarily participated in the study and were able to complete the study according to the program requirements.
- •Chinese healthy adult subjects aged 18-65 years (including the boundary value) , both male and female;
- •Male volunteers weighing ≥50 kg; women weighing ≥40 kg; body mass index (BMI) within the range of 19.0-26.0 kg/m2 (including boundary values; BMI=weight kg/height 2 m2);
排除标准
- •Patients with acute or subacute infection (such as fever, cough, urgency, dysuria, abdominal pain, diarrhea and skin infection wounds, etc.) within 2 weeks before screening, or acute or chronic infection within 4 weeks before screening history, and receiving systemic anti-infective treatment;
- •Those who have a history of tuberculosis infection in the past;
- •The results of physical examination, vital sign measurement, laboratory examination, electrocardiogram, chest X-ray, etc. are abnormal and have clinical significance;
- •Those who are known to be allergic to monoclonal antibody drugs or excipients of MG-ZG122 injection, or food allergies judged by the investigator to be unsuitable to participate in the researcher;
- •Those who have been vaccinated within 1 month before screening or plan to be vaccinated during the study;
- •Those who have used any prescription drugs within 2 weeks before administration, those who have used non-prescription drugs or traditional Chinese medicines within 1 week before administration, or those who are expected to use prescription drugs, non-prescription drugs and traditional Chinese medicines during the study period;
- •Those who have received any research non-biological agents within 5 half-lives (if known) or within 3 months (whichever is longer) before administration, or have participated in other clinical trials or plan to participate in other clinical trials during the study period. clinical trial subjects;
- •Those who have special requirements for diet or cannot accept a unified diet;
- •Women who are lactating and pregnant, or female volunteers of childbearing age have a positive serum pregnancy test;
研究组 & 干预措施
MG-ZG122 first dose group
4 cases in the 52.5 mg dose group (2 cases of placebo, 2 cases of experimental drug)
干预措施: MG-ZG122 Humanized Monoclonal Antibody Injection (Drug)
MG-ZG122 first dose group
4 cases in the 52.5 mg dose group (2 cases of placebo, 2 cases of experimental drug)
干预措施: Placebo (Drug)
MG-ZG122 second dose group
10 cases in the 105 mg dose group (2 cases of placebo, 8 cases of experimental drug)
干预措施: MG-ZG122 Humanized Monoclonal Antibody Injection (Drug)
MG-ZG122 second dose group
10 cases in the 105 mg dose group (2 cases of placebo, 8 cases of experimental drug)
干预措施: Placebo (Drug)
MG-ZG122 third dose group
10 cases in the 210 mg dose group (2 cases of placebo, 8 cases of experimental drug)
干预措施: MG-ZG122 Humanized Monoclonal Antibody Injection (Drug)
MG-ZG122 third dose group
10 cases in the 210 mg dose group (2 cases of placebo, 8 cases of experimental drug)
干预措施: Placebo (Drug)
MG-ZG122 forth dose group
10 cases in the 420 mg dose group (2 cases of placebo, 8 cases of experimental drug)
干预措施: MG-ZG122 Humanized Monoclonal Antibody Injection (Drug)
MG-ZG122 forth dose group
10 cases in the 420 mg dose group (2 cases of placebo, 8 cases of experimental drug)
干预措施: Placebo (Drug)
结局指标
主要结局
Tolerability and Safety Analysis
时间窗: up to 127 days
Evaluate for dose escalation for study termination criteria or achievement of MTD
次要结局
- Pharmacokinetic Analysis of Cmax(127 days)
- Pharmacokinetic Analysis of Tmax(127 days)
- Pharmacokinetic Analysis of AUC0-t(127 days)
- Pharmacokinetic Analysis of t1/2(127 days)
- Pharmacodynamic Biomarker Analysis of immunoglobulin E(127 days)
- Pharmacodynamic Biomarker Analysis of the number of eosinophils in peripheral blood(127 days)
- Immunogenicity ADA(127 days)
- Neutralizing Antibody (Nab)(127 days)
- Pharmacokinetic Analysis of AUC0-∞(127 days)
- Pharmacodynamic Biomarker Analysis of serum interleukin-5(127 days)