A Phase 1 Placebo-and Active-Controlled Crossover Study of the Potential for Cardiac Repolarization Effects Following Single Dose of ABBV-CLS-7262 in Healthy Subjects

Calico Life Sciences LLC1 个研究点分布在 1 个国家目标入组 72 人开始时间: 2024年3月14日最近更新: 2024年7月1日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Calico Life Sciences LLC
入组人数: 72
试验地点: 1
主要终点: To evaluate the effect of ABBV-CLS-7262 on the QTc interval in healthy adult subjects

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, blinded, placebo and active-controlled, 4-period, crossover design thorough QT/QTc (TQT) study to evaluate the effect of ABBV-CLS-7262 on cardiac repolarization in healthy adult subjects.

详细描述

This is a randomized, blinded, placebo and active-controlled, 4-period, crossover study. The study will be double-blinded for ABBV-CLS-7262 (dose 1 or dose 2) and placebo regimens and open-label for moxifloxacin. 72 subjects are planned to be enrolled.

All subjects will receive a single oral dose of 4 different study treatments over 4 separate treatment periods, each separated by a washout period.

On Day 1 of each period, subjects will receive either ABBV-CLS-7262 dose 1, ABBV-CLS-7262 dose 2, placebo, or moxifloxacin 400 mg.

In each period, cardiodynamic ECGs will be collected pre-dose and for 24 hours post-dose and PK blood samples will be collected pre-dose and for 48 hours post-dose. Safety will be monitored throughout the study by repeated clinical and laboratory evaluations.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Basic Science
盲法: Double (Participant, Investigator)

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

•Adult volunteers in general good health.
•Must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures.
•Individuals between 18 and 55 years of age inclusive at the time of screening.
•Body Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 kg/m2
•All male subjects who are sexually active and not surgically sterilized must agree to use an acceptable contraceptive method. Additionally, male subjects must agree to not donate sperm during the study until 30 days after the final dose of study drug.
•All female subjects who are sexually active and of childbearing potential must agree to use a highly effective contraceptive method. Additionally, female subjects must agree to not donate eggs during the study and for 30 days after the final dose of study drug.

排除标准

•Subject who, in the opinion of the investigator, is incapable of completing study-required visits and procedures
•Pregnant or breastfeeding.
•Treatment with any other investigational treatment within 30 days