Safety Clinical Trial
Official title:
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
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.
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.
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