A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single IV Infusion of SHR-1906 in Healthy Subjects

Guangdong Hengrui Pharmaceutical Co., Ltd1 个研究点分布在 1 个国家目标入组 72 人开始时间: 2021年8月10日最近更新: 2023年2月16日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 72
试验地点: 1
主要终点: Adverse events

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 study is a phase 1 single dose escalation study of SHR-1906 in healthy subjects. The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of SHR-1906 in healthy subjects.

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 55 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial, and provides written informed consent, be able to comply with all the requirements and able to complete the study.
•Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form.
•Total body weight ≥ 45 kg.
•No clinically significant abnormalities in medical history, general physical examination, vital signs, laboratory tests (hematology, urinalysis, blood chemistry, coagulation function and thyroid function) and ECG at the investigator's discretion during screening and baseline
•Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods

排除标准

•History of serious cardiovascular, liver, kidney, digestive tract, psychiatric, hematology, metabolic disorders, primary immunodeficiency disease or acquired immune deficiency syndrome, or organ transplantation.
•Severe infections, injuries or major surgeries (as determined by the investigator) within 6 months prior to screening, or plan to do any surgery during the trial.
•Positive testing for human immunodeficiency virus (HIV-Ab), or hepatitis B surface antigen (HBsAg), or TP-Ab , or hepatitis C antibodies (HCV-Ab).
•Screening/baseline systolic blood pressure (BP) ≥140 mmHg or ≤90 mmHg; diastolic BP ≥90 mmHg or <60 mmHg on a single measurement
•Positive urine drug screening at baseline;
•Use of any medicine within 1 monthes (including any prescription, or over-the-counter medicine, herbal remedy or nutritional supplement, except for vitamins and occasional use of acetaminophen with recommended dose), or within 5 half-lives of any drugs whichever is longer prior to dosing, or plan to use any medicine during the trial.
•Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening or within 5 half-lives of any drugs during screening visit, or in the follow-up period of a clinical study whichever is longer (according to the date of signed consent form) which is defined as having consented and used other investigational drugs (including placebo) or trial medical devices.
•Blood donation or loss of ≥ 400 mL of blood within 1 months; or received blood or blood products within 2 months prior to screening.
•Any other circumstances that, in the investigator's judgment, may increase the risk associated with the subject's participation in and completion of the study or could preclude the evaluation of the subject's response.
•Researchers and relevant staff of the research center or other persons directly involved in the implementation of the program.