NCT03067363

First in Human Single Ascending Dose Study of MOR107

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Alan Richardson · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Safety

Interventions

Type	Name	Description
DRUG	MOR107	MOR107 solution for injection
DRUG	Placebo	Solution for injection manufactured to match MOR107 solution for injection
OTHER	Low sodium diet	Diet designed to restrict sodium intake to 40 mmol/day

Timeline

• Start date: 2017-02-16
• Primary completion: 2017-03-23
• Completion: 2017-03-23
• First posted: 2017-03-01
• Last updated: 2018-02-07

Locations

1 site across 1 country: United Kingdom