First in Human Single Ascending Dose Study of MOR107

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03067363
• Other study ID #: MOR107-C001
• Status: Terminated
• Phase: Phase 1
• First received: February 21, 2017
• Last updated: February 6, 2018
• Start date: February 16, 2017
• Est. completion date: March 23, 2017

Study information

• Verified date: February 2018
• Source: LanthioPep BV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: March 23, 2017
• Est. primary completion date: March 23, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Safety

Intervention

Drug:
• MOR107
MOR107 solution for injection
• 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

Locations

Country	Name	City	State
United Kingdom	Quotient Clinical	Nottingham	Nottinghamshire

Sponsors (2)

Lead Sponsor	Collaborator
Alan Richardson	Quotient Clinical

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events (safety and tolerability)	Reporting of adverse events, physical examination, injection site assessment, vital signs, ECG, and clinical chemistry, haematology and urinalysis	Up to 10 days post-dose
Secondary	Time from dosing at which the maximum MOR107 concentration was observed (Tmax)	Plasma PK parameter	Up to 48 hours post-dose
Secondary	Maximum observed MOR107 concentration (Cmax)	Plasma PK parameter	Up to 48 hours post-dose
Secondary	Concentration of MOR107 at 12 hours post-dose (C12)	Plasma PK parameter	12 hours post-dose
Secondary	Concentration of MOR107 at 24 hours post-dose (C24)	Plasma PK parameter	24 hours post-dose
Secondary	Area under the curve from 0 time to last measurable MOR107 concentration (AUC0-t)	Plasma PK parameter	Up to 48 hours post-dose
Secondary	Area under the curve from 0 time to infinity for MOR107 (AUC0-inf)	Plasma PK parameter	Up to 48 hours post-dose
Secondary	Percentage of AUC(0-inf) for MOR107 extrapolated beyond last measured time point (AUC%extrap)	Plasma PK parameter	Up to 48 hours post-dose
Secondary	Slope of the apparent elimination phase for MOR107 (Lambda-z)	Plasma PK parameter	Up to 48 hours post-dose
Secondary	Apparent elimination half-life for MOR107 (T-half)	Plasma PK parameter	Up 48 hours post-dose
Secondary	MOR107 Cmax normalised for dose (Cmax/D)	Plasma PK parameter	Up to 48 hours post-dose
Secondary	MOR107 AUC(0-t) normalised for dose (AUC[0-t]/D)	Plasma PK parameter	Up to 48 hours post-dose
Secondary	MOR107 AUC(0-inf) normalised for dose (AUC[0-inf]/D)	Plasma PK parameter	Up to 48 hours post-dose
Secondary	Amount of MOR107 excreted in the urine over a specified period of time after dosing (Ae)	Urine PK parameter	Up to 48 hours post-dose
Secondary	Cumulative amount of MOR107 excreted in the urine (CumAe)	Urine PK parameter	Up to 48 hours post-dose
Secondary	Amount of MOR107 excreted in the urine over a specified period of time after dosing, expressed as a percentage of the administered dose (Ae%)	Urine PK parameter	Up to 48 hours post-dose
Secondary	Cumulative amount of MOR107 excreted in the urine, expressed as a percentage of the administered dose (CumAe%)	Urine PK parameter	Up to 48 hours post-dose
Secondary	Renal clearance: the apparent volume of plasma cleared per unit time via renal elimination (CLr)	Urine PK parameter	Up to 48 hours post-dose