First in Human Single Ascending Dose Study of MOR107

• Status: Terminated
• Trial end date: 2017-03-23
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alan Richardson
• Collaborator: Quotient Clinical

Criteria

Key Inclusion Criteria:

1. Healthy males

2. Age 18 to 45 years of age

3. Body mass index of 18.0 to 32.0 kg/m2

4. For Part 2, subjects must have at least a 25% reduction in 24 hour urinary sodium excretion on Day -2 compared with admission

Key Exclusion Criteria:

1. Subjects who have received any IMP in a clinical research study within the previous three months

2. Regular alcohol consumption >21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)

3. 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

4. Current smokers of e-cigarettes and nicotine replacement products and those who have smoked these products within the last 12 months

5. Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator

6. Positive drugs of abuse test result

7. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results

8. History of psychiatric disorder, cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease as judged by the investigator

9. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients