A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Pharmacodynamic Characteristics of a Single Dose of GR2301 Injection in Healthy Adult Subjects in China.

Genrix (Shanghai) Biopharmaceutical Co., Ltd.1 个研究点分布在 1 个国家目标入组 36 人开始时间: 2025年10月10日最近更新: 2025年9月24日

干预措施

试验速览

阶段: 1 期
状态: 尚未招募
发起方: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
入组人数: 36
试验地点: 1
主要终点: Adverse events (AEs)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a randomized, double-blind, placebo-controlled Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary pharmacodynamic characteristics of GR2301 injection in healthy adult subjects in China.The GR2301 injection dosage will be gradually increased. All healthy subjects will receive a single subcutaneous injection. Following administration, subjects will be followed for at least 16 weeks ± 7 days.

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: Triple (Participant, Investigator, Outcomes Assessor)

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

•BMI 19.0-28.0 kg/m², with male subjects weighing ≥50.0 kg and female subjects weighing ≥45.0 kg；
•Understand and comply with the requirements of the clinical protocol, voluntarily participate in the clinical trial, and sign the informed consent form.

排除标准

•A history of past or current conditions involving the nervous system, cardiovascular system, urinary system, digestive system, respiratory system, endocrine system, metabolic system, or other clearly documented medical conditions, which the investigator deems may pose a risk to the subject's safety or interfere with the conduct, progress, or completion of the trial.
•History of drug use or substance abuse, or positive urine drug screening prior to enrollment.
•Pregnant and breastfeeding women.