First in Human Single Ascending Dose Study of MOR107

NCT03067363 | Terminated Phase 1

• 1 other identifier: MOR107-C001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Safety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Time from dosing at which the maximum MOR107 concentration was observed (Tmax)

  Up to 48 hours post-dose

• Maximum observed MOR107 concentration (Cmax)

  Up to 48 hours post-dose

• Concentration of MOR107 at 12 hours post-dose (C12)

  12 hours post-dose

• Concentration of MOR107 at 24 hours post-dose (C24)

  24 hours post-dose

• Area under the curve from 0 time to last measurable MOR107 concentration (AUC0-t)

  Up to 48 hours post-dose

Study Arms (11)

Part 1, MOR107 Dose level 1

EXPERIMENTAL

MOR107, single subcutaneous injection

Drug: MOR107

Part 1, MOR107 Dose level 2

EXPERIMENTAL

MOR107, single subcutaneous injection

Drug: MOR107

Part 1, MOR107 Dose level 3

EXPERIMENTAL

MOR107, single subcutaneous injection

Drug: MOR107

Part 1, MOR107 Dose level 4

EXPERIMENTAL

MOR107, single subcutaneous injection

Drug: MOR107

Part 1, MOR107 Dose level 5

EXPERIMENTAL

MOR107, single subcutaneous injection

Drug: MOR107

Part 1, MOR107 Dose level 6

EXPERIMENTAL

MOR107, single subcutaneous injection

Drug: MOR107

Part 1, Placebo

PLACEBO COMPARATOR

Placebo, single subcutaneous injection

Drug: Placebo

Part 2: MOR107 low dose

EXPERIMENTAL

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

Drug: MOR107; Other: Low sodium diet

Part 2: MOR107 medium dose

EXPERIMENTAL

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

Drug: MOR107; Other: Low sodium diet

Part 2: MOR107 high dose

EXPERIMENTAL

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

Drug: MOR107; Other: Low sodium diet

Part 2: Placebo

PLACEBO COMPARATOR

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

Drug: Placebo; Other: Low sodium diet

Interventions

MOR107 DRUG

MOR107 solution for injection

Also known as: LP2-3

Part 1, MOR107 Dose level 1; Part 1, MOR107 Dose level 2; Part 1, MOR107 Dose level 3; Part 1, MOR107 Dose level 4; Part 1, MOR107 Dose level 5; Part 1, MOR107 Dose level 6; Part 2: MOR107 high dose; Part 2: MOR107 low dose; Part 2: MOR107 medium dose

Placebo DRUG

Solution for injection manufactured to match MOR107 solution for injection

Also known as: Placebo (for MOR107)

Part 1, Placebo; Part 2: Placebo

Low sodium diet OTHER

Diet designed to restrict sodium intake to 40 mmol/day

Part 2: MOR107 high dose; Part 2: MOR107 low dose; Part 2: MOR107 medium dose; Part 2: Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males
• Age 18 to 45 years of age
• Body mass index of 18.0 to 32.0 kg/m2
• For Part 2, subjects must have at least a 25% reduction in 24 hour urinary sodium excretion on Day -2 compared with admission

You may not qualify if:

• Subjects who have received any IMP in a clinical research study within the previous three months
• Regular alcohol consumption \>21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
• 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
• Current smokers of e-cigarettes and nicotine replacement products and those who have smoked these products within the last 12 months
• Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator
• Positive drugs of abuse test result
• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
• History of psychiatric disorder, cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease as judged by the investigator
• Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients

Sponsors & Collaborators

• Alan Richardson: lead
• Quotient Clinical: collaborator

Study Sites (1)

Quotient Clinical

Nottingham, Nottinghamshire, NG11 6JS, United Kingdom

Location

MeSH Terms

Interventions

Diet, Sodium-Restricted

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Axel Mescheder, MD

  LanthioPep BV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Project Manager

Model Details: Part 1: single ascending doses Part 2: parallel group

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: March 1, 2017
• Study Start: February 16, 2017
• Primary Completion: March 23, 2017
• Study Completion: March 23, 2017
• Last Updated: February 7, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)