Randomized, Double-blind, Placebo-controlled, Phase Ib Clinical Trial of Safety and Pharmacokinetics of VM-1500 After Multiple Oral Administration in Healthy Volunteers

Viriom1 个研究点分布在 1 个国家目标入组 36 人开始时间: 2012年7月最近更新: 2015年7月3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: 36
试验地点: 1
主要终点: Safety and tolerability of VM-1500 after multiple oral administration in adult healthy subjects based on analysis of AEs and laboratory values.

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

The purpose of the study to assess safety and tolerability of VM-1500 and to determine main pharmacokinetic parameters of VM-1500 after multiple oral administration in adult healthy subjects.

详细描述

This is a randomized, double-blind, placebo-controlled, phase Ib study in healthy volunteers with dose escalation to identify the optimal dosing schedule of VM-1500.

A total of 36 subjects will be treated with the VM-1500 or placebo for 14 days with further follow-up for four weeks. Subjects will be randomized into 3 cohorts with 3:1 drug/placebo ratio:

Cohort 1 (n=12): 10 mg VM-1500 for 9 volunteers, Placebo for 3 volunteers; Cohort 2 (n=12): 20 mg VM-1500 for 9 volunteers, Placebo for 3 volunteers; Cohort 3 (n=12): 30 mg VM-1500 for 9 volunteers, Placebo for 3 volunteers; Decision to escalate to the next (higher) dose will be made by the Independent Safety Review Board (ISRB), established specifically for this study. ISRB will base its decision on both the safety data obtained during drug administration in each cohort and analysis of clinical and lab data obtained within the course of the study.

Study time lines:

Screening period - up to 30 days
Treatment period - 14 days dosing (Day 1-14)
2 hospitalizations: Day 1-3, Day 13-15
28 PK samples in plasma: Day1 - predose, 0,25; 0,5; 1; 1,5; 2; 3; 4; 8; 12 hours Day 3, Day 5, Day 7, Day 9, Day 11, Day 13 - before dosing Day 14 (feed condition) - before dosing, 0,5; 1; 2; 4; 8; 12h Day 16, Day 23, Day 30, Day 37, Day 44 PK in blood cells - Day 1 (predose, 4h, 8h), Day 3, 5,7, 9, 11, 13, 14
Post treatment follow-up period 30 days.

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 50 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Provided signed written informed consent;
•Healthy male subjects, 18-50 years of age;
•Use of adequate and reliable forms of contraception during the study and 3 months after discontinuation of study medication.
•ICF signed prior to any study-related procedure.

排除标准

•HIV, hepatitis B, C antibodies in plasma;
•Clinical relevant laboratory abnormalities;
•Active tobacco, alcohol or drug abuse;
•Anticipated non-compliance with the protocol;
•Patients who have taken any investigational drug 3 months prior to the start of the study;
•Plasma donorship, surgery 12 weeks prior to the start of the study;
•Current significant gastrointestinal, renal, liver, bronchopulmonary, biliary, neurological, cardiovascular, oncologic, allergic, or ophthalmologic diseases, including history of cataracts/lens opacities.