A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetic Study of Escalating Single and Multiple Doses of CVN424 in Healthy Subjects

Cerevance Beta, Inc.1 个研究点分布在 1 个国家目标入组 64 人开始时间: 2018年9月18日最近更新: 2019年7月23日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Cerevance Beta, Inc.
入组人数: 64
试验地点: 1
主要终点: Evaluation of 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 is a phase 1, randomized, double-blind, placebo-controlled, single- and multiple-dose ascending study in healthy subjects.

详细描述

Part 1: Single-Dose Regimen and Fasted-Fed Crossover - For the single-dose regimen, approximately 40 healthy male and female subjects will be enrolled in 1 of 5 single dose cohorts (designated as S1 through S5, respectively) in an ascending fashion.

Part 2: Multiple-Dose Regimen

For the multiple-dose regimen, approximately 24 healthy male and female subjects age 18 to 50 years old will be enrolled in 1 of the 3 multiple-dose cohorts (designated as M1 through M3, respectively) in an ascending fashion.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Sequential
主要目的: Other
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 50 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•In the opinion of the Investigator, the subject is capable of understanding and complying with protocol requirements.
•The subject signs and dates a written informed consent form (ICF) and any required privacy authorization prior to the initiation of any study procedures.
•Subject is a healthy male or female adult who is 18 to 50 years of age inclusive at the time of ICF and study drug dosing.
•Subject weighs at least 45 kg (99 lbs) and has a BMI between 18.0 and 30.0 kg/m2, inclusive at Screening.
•A male subject who is nonsterilized and sexually active with a female partner of childbearing potential* agrees to use adequate contraception* from signing of the ICF throughout the duration of the study and for 12 weeks after last dose.
•A female subject with no childbearing potential, defined as the subject has been surgically sterilized (hysterectomy, bilateral oophorectomy or tubal ligation) or who are postmenopausal (defined as continuous amenorrhea of at least 2 years and FSH>40 IU/L).

排除标准

•Subjects have a known hypersensitivity to any component of the formulation of CVN
•Subjects have evidence of CS neurologic, cardiovascular, pulmonary, hepatic, hematopoietic disease, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, serious allergy, allergic skin rash, psychiatric disorder, or other abnormality that may impact the ability of the subject to participate or potentially confound the study results.
•There is any finding in the subject's medical history, physical examination, or safety laboratory tests giving reasonable suspicion of a condition that might interfere with the conduct or interpretation of the study.

研究组 & 干预措施

Single Ascending Dose

Active Comparator

The planned dose levels will be 1, 5, 25, 75, and 225 mg CVN424 and matching placebo.

干预措施: CVN424 (Drug)

Single Ascending Dose

Active Comparator

The planned dose levels will be 1, 5, 25, 75, and 225 mg CVN424 and matching placebo.

干预措施: Placebo (Drug)

Multiple Ascending Dose

Active Comparator

The planned dose levels will be 25, 75, and 150 mg CVN424 and matching placebo.

干预措施: CVN424 (Drug)

Multiple Ascending Dose

Active Comparator

The planned dose levels will be 25, 75, and 150 mg CVN424 and matching placebo.

干预措施: Placebo (Drug)