SAD study of subcutaneous MOR107 in healthy male subjects (QCL117531)
Research type
Research Study
Full 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
IRAS ID
215208
Contact name
Axel Mescheder
Contact email
Sponsor organisation
LanthioPep B.V.
Eudract number
2016-003701-34
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 4 months, 20 days
Research summary
The Sponsor is developing the study drug, MOR107, for the potential treatment of diseases where tissue surrounding organs in the body become scarred. This includes diabetic nephropathy which is a term to describe damage to the kidneys which is caused by diabetes.
The study will try to identify the safety and how well tolerated the study drug is after a single dose is injected under the skin in healthy male subjects. The study will also try to identify the pharmacodynamics (PD - the impact of the drug on the body) of the study drug after a single dose is injected under the skin in healthy male subjects on a low salt (sodium) diet.
The study will consist of 2 parts involving up to 112 healthy male subjects. In Part 1, up to 80 subjects will receive a single dose of either 1 µg, 10 µg, 100 µg, 1 mg, 10 mg, 100 mg MOR107 or matching placebo. In Part 2 up to 32 subjects will receive a single dose of MOR107 or matching placebo. The doses of MOR107 given in Part 2 will be decided after Part 1 is completed. Samples of blood and urine will be taken throughout the study to look at the concentrations of MOR107 in the body.
REC name
Wales REC 1
REC reference
16/WA/0366
Date of REC Opinion
14 Dec 2016
REC opinion
Further Information Favourable Opinion