Assessment of Safety, Tolerability and Pharmacokinetics of Single Ascending Subcutaneous Doses of MOR107 in Healthy Male Subjects and Pharmacodynamics in Healthy Male Subjects on a Low Sodium Diet

Alan Richardson1 个研究点分布在 1 个国家目标入组 24 人开始时间: 2017年2月16日最近更新: 2018年2月7日

适应症

干预措施

试验速览

阶段: 1 期
状态: 终止
发起方
入组人数: 24
试验地点: 1
主要终点: Incidence of treatment-emergent adverse events (safety and tolerability)

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 the first in human study of MOR107. It is a 2 part, single centre, double-blind, randomised, placebo-controlled study in healthy male subjects. Part 1 is a single ascending dose study, and Part 2 is a parallel group, dose range finding study in healthy male subjects on a low sodium diet.

详细描述

MOR107 is an angiotensin 2 receptor (AT2R) agonist with the potential to treat a wide range of diseases through activation of the protective arm of the renin-angiotensin system.

In this study MOR107 will be administered to humans for the first time.

The study will enroll healthy male subjects and is split into two sequential parts, both of which have a single centre, double-blind, randomised, placebo-controlled design.

Part 1 will evaluate the safety, tolerability and pharmacokinetics (PK) of single ascending doses of MOR107.

Part 2 will evaluate the pharmacodynamics, safety, tolerability and PK of three different doses of MOR107 in healthy male subjects who will be fed a low sodium diet in order to increase AT2R expression.

研究设计

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

入排标准

年龄范围: 18 Years 至 45 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Healthy males
•Age 18 to 45 years of age
•Body mass index of 18.0 to 32.0 kg/m2
•For Part 2, subjects must have at least a 25% reduction in 24 hour urinary sodium excretion on Day -2 compared with admission

排除标准

•Subjects who have received any IMP in a clinical research study within the previous three months
•Regular alcohol consumption >21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
•Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening/admission
•Current smokers of e-cigarettes and nicotine replacement products and those who have smoked these products within the last 12 months
•Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator
•Positive drugs of abuse test result
•Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
•History of psychiatric disorder, cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease as judged by the investigator
•Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients

研究组 & 干预措施

Part 2: MOR107 high dose

Experimental

MOR107 high dose single subcutaneous injection and low sodium diet for 6 days before dosing and 2 days after dosing

干预措施: Low sodium diet (Other)