A Randomized Phase 1 Dose-Escalation Study in Healthy Volunteers and Subjects on Aspirin With Stable Coronary Artery Disease to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous RUC-4

CeleCor Therapeutics1 个研究点分布在 1 个国家目标入组 44 人开始时间: 2019年2月18日最近更新: 2024年8月27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: 44
试验地点: 1
主要终点: Platelet Inhibition

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 designed to assess tolerability of the weight-adjusted dose of RUC-4 (mg/kg) required to achieve 80% or more inhibition of the initial slope of platelet aggregation to 20 µM ADP by Light Transmission Aggregometry (LTA) within 15 minutes of SC administration of RUC-4 with return toward baseline values within 4 hours in healthy volunteers and subjects on aspirin with stable coronary artery disease (CAD). In the Dose Expansion Part, VerifyNow PRUTest will be used to measure platelet aggregation in addition to LTA.

Since the goal of RUC-4 therapy is to achieve maximal antiplatelet therapy as rapidly as possible, first the tolerability of the weight-adjusted dose (mg/kg) that inhibits ADP-induced platelet aggregation by 80% or more in 5 of 6 healthy volunteers will be identified. A similar dose escalation will be subsequently performed in subjects with CAD who are taking aspirin. To facilitate administration using a single weight-adjusted (mg/kg) dose for a defined group of subjects weighing between 55 and 120 kg, the study will also evaluate the safety and biologic effect on platelet aggregation of the weight adjusted (mg/kg) dose when administered to subjects with weights at either end of this range.

详细描述

Part 1 Dose Escalation:

Drug: RUC-4 0.05 mg/kg (Cohort 1) Drug: RUC-4 0.075 mg/kg (Cohort 2) Drug: Placebo (Cohorts 1-2)

Part 2 Dose Escalation Drug: RUC-4 (Cohort 1-3 doses to be defined) Placebo (Cohorts 1-3)

Part 2 Dose Expansion Drug: RUC-4 (dose to be defined, 1 Cohort) Drug: Placebo (1Cohort)

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, Care Provider, Investigator)

盲法说明

The first 2 subjects in each dose cohort receive RUC-4 in a single- blind manner (only the subjects will blinded to treatment assignment), prior to randomizing the remaining 5 subjects to either RUC 4 (n = 4) or placebo (n = 1) in a double-blind manner.

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

未提供

排除标准

未提供

研究组 & 干预措施

Part 1 Cohort 2

Experimental

Cohort 2: 0.075 mg/kg RUC-4/placebo 7 subjects will be enrolled: 6 subjects will receive a single subcutaneous dose of RUC-4 and 1 subject will receive matched placebo.