First in Human Single Ascending Dose Study of MOR107

Alan Richardson

Status and phase: Terminated; Phase 1

Conditions: Safety

Treatments: Other: Low sodium diet; Drug: Placebo; Drug: MOR107

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03067363

MOR107-C001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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24 participants in 11 patient groups, including a placebo group

Part 1, MOR107 Dose level 1

Experimental group

Description:

MOR107, single subcutaneous injection

Treatment:

Drug: MOR107

Part 1, MOR107 Dose level 2

Experimental group

Description:

MOR107, single subcutaneous injection

Treatment:

Drug: MOR107

Part 1, MOR107 Dose level 3

Experimental group

Description:

MOR107, single subcutaneous injection

Treatment:

Drug: MOR107

Part 1, MOR107 Dose level 4

Experimental group

Description:

MOR107, single subcutaneous injection

Treatment:

Drug: MOR107

Part 1, MOR107 Dose level 5

Experimental group

Description:

MOR107, single subcutaneous injection

Treatment:

Drug: MOR107

Part 1, MOR107 Dose level 6

Experimental group

Description:

MOR107, single subcutaneous injection

Treatment:

Drug: MOR107

Part 1, Placebo

Placebo Comparator group

Description:

Placebo, single subcutaneous injection

Treatment:

Drug: Placebo

Part 2: MOR107 low dose

Experimental group

Description:

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

Treatment:

Other: Low sodium diet

Drug: MOR107

Part 2: MOR107 medium dose

Experimental group

Description:

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

Treatment:

Other: Low sodium diet

Drug: MOR107

Part 2: MOR107 high dose

Experimental group

Description:

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

Treatment:

Other: Low sodium diet

Drug: MOR107

Part 2: Placebo

Placebo Comparator group

Description:

Placebo single subcutaneous injection and low sodium diet for 6 days before dosing and 2 days after dosing

Treatment:

Other: Low sodium diet

Drug: Placebo