A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Intravenous Administration of SHR-1707 in Healthy Young Adult and Elderly Subjects

Atridia Pty Ltd.1 个研究点分布在 1 个国家目标入组 50 人开始时间: 2021年2月23日最近更新: 2022年7月12日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Atridia Pty Ltd.
入组人数: 50
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

A randomized, double-blind, placebo-controlled, single dose escalation phase 1 study to access the Pharmacokinetics and Pharmacodynamics of Single Intravenous Administration of SHR-1707

详细描述

The study will consist of two parts: Subjects will be randomized to receive SHR-1707 as reflected by the guiding principle for the dose esclation/expansion phase. Each dose group includes a screening period, a baseline period, an observational period, and a safety follow-up period.

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: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 —（Adult, Older 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, voluntarily participate in the trial,
•Male or female aged between 18 years and 45 years (inclusive) at the date of signed consent form in Part 1 and aged between 55 years and 80 years (inclusive) in Part 2
•Total body weight of 45~100 kg (inclusive), with a body mass index (BMI) of 19~32 kg/m2 (inclusive) at screening and baseline
•Subjects with good general health, no clinically significant abnormalities, or have underlying disease which is believed to have minimal impact on the study treatment in elderly subjects
•WOCBP agree to take effective contraceptive methods

排除标准

•Severe injuries or surgeries within 6 months before screening
•ALT, or AST or total bilirubin level <1.5x upper limit of normal range (ULN) at screening or baseline visits
•QTcF > 450msec (Male), QTcF > 470msec (Female) in 12-lead ECG test during screening and baseline
•Known history or suspected of being allergic to the study drug.
•Use of any medicine within 14 days (including any prescription, or over-the-counter medicine, herbal remedy or nutritional supplement, except for vitamins and acetaminophen with recommended dose [The dose of acetaminophen should be less than 2g/day, and no more than 3 days for continuous use]), or within 5 half-lives
•Live (attenuated) vaccination within 1 month before screening
•Blood donation or loss of more than 400 mL of blood within 3 months; or received blood transfusion within 3 months before screening.
•History of alcohol abuse in the past 12 months of screening
•History of illicit or prescription drug abuse or addiction within 12 months of screening
•More than 5 cigarettes daily for 12 months before screening
•Participation in clinical trials of other investigational drugs (include placebo) or medical devices within 3 months prior to screening
•Researchers and relevant staff of the research center or other persons directly involved in the implementation of the program

研究组 & 干预措施

SHR-1707 Dose level 3 (Elderly subjects)

Experimental

SHR-1707 or placebo is administered intravenous to Elderly subjects

干预措施: Placebo (Drug)