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First in Human Single Ascending Dose Study of MOR107

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ClinicalTrials.gov Identifier: NCT03067363
Recruitment Status : Terminated (Part 1 completed successfully. Part 2 not conducted.)
First Posted : March 1, 2017
Last Update Posted : February 7, 2018
Sponsor:
Collaborator:
Quotient Clinical
Information provided by (Responsible Party):
Alan Richardson, LanthioPep BV

Tracking Information
First Submitted Date  ICMJE February 21, 2017
First Posted Date  ICMJE March 1, 2017
Last Update Posted Date February 7, 2018
Actual Study Start Date  ICMJE February 16, 2017
Actual Primary Completion Date March 23, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2017)
Incidence of treatment-emergent adverse events (safety and tolerability) [ Time Frame: Up to 10 days post-dose ]
Reporting of adverse events, physical examination, injection site assessment, vital signs, ECG, and clinical chemistry, haematology and urinalysis
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03067363 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2017)
  • Time from dosing at which the maximum MOR107 concentration was observed (Tmax) [ Time Frame: Up to 48 hours post-dose ]
    Plasma PK parameter
  • Maximum observed MOR107 concentration (Cmax) [ Time Frame: Up to 48 hours post-dose ]
    Plasma PK parameter
  • Concentration of MOR107 at 12 hours post-dose (C12) [ Time Frame: 12 hours post-dose ]
    Plasma PK parameter
  • Concentration of MOR107 at 24 hours post-dose (C24) [ Time Frame: 24 hours post-dose ]
    Plasma PK parameter
  • Area under the curve from 0 time to last measurable MOR107 concentration (AUC0-t) [ Time Frame: Up to 48 hours post-dose ]
    Plasma PK parameter
  • Area under the curve from 0 time to infinity for MOR107 (AUC0-inf) [ Time Frame: Up to 48 hours post-dose ]
    Plasma PK parameter
  • Percentage of AUC(0-inf) for MOR107 extrapolated beyond last measured time point (AUC%extrap) [ Time Frame: Up to 48 hours post-dose ]
    Plasma PK parameter
  • Slope of the apparent elimination phase for MOR107 (Lambda-z) [ Time Frame: Up to 48 hours post-dose ]
    Plasma PK parameter
  • Apparent elimination half-life for MOR107 (T-half) [ Time Frame: Up 48 hours post-dose ]
    Plasma PK parameter
  • MOR107 Cmax normalised for dose (Cmax/D) [ Time Frame: Up to 48 hours post-dose ]
    Plasma PK parameter
  • MOR107 AUC(0-t) normalised for dose (AUC[0-t]/D) [ Time Frame: Up to 48 hours post-dose ]
    Plasma PK parameter
  • MOR107 AUC(0-inf) normalised for dose (AUC[0-inf]/D) [ Time Frame: Up to 48 hours post-dose ]
    Plasma PK parameter
  • Amount of MOR107 excreted in the urine over a specified period of time after dosing (Ae) [ Time Frame: Up to 48 hours post-dose ]
    Urine PK parameter
  • Cumulative amount of MOR107 excreted in the urine (CumAe) [ Time Frame: Up to 48 hours post-dose ]
    Urine PK parameter
  • Amount of MOR107 excreted in the urine over a specified period of time after dosing, expressed as a percentage of the administered dose (Ae%) [ Time Frame: Up to 48 hours post-dose ]
    Urine PK parameter
  • Cumulative amount of MOR107 excreted in the urine, expressed as a percentage of the administered dose (CumAe%) [ Time Frame: Up to 48 hours post-dose ]
    Urine PK parameter
  • Renal clearance: the apparent volume of plasma cleared per unit time via renal elimination (CLr) [ Time Frame: Up to 48 hours post-dose ]
    Urine PK parameter
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE First in Human Single Ascending Dose Study of MOR107
Official Title  ICMJE 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
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.
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Part 1: single ascending doses Part 2: parallel group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Safety
Intervention  ICMJE
  • Drug: MOR107
    MOR107 solution for injection
    Other Name: LP2-3
  • Drug: Placebo
    Solution for injection manufactured to match MOR107 solution for injection
    Other Name: Placebo (for MOR107)
  • Other: Low sodium diet
    Diet designed to restrict sodium intake to 40 mmol/day
Study Arms  ICMJE
  • Experimental: Part 1, MOR107 Dose level 1
    MOR107, single subcutaneous injection
    Intervention: Drug: MOR107
  • Experimental: Part 1, MOR107 Dose level 2
    MOR107, single subcutaneous injection
    Intervention: Drug: MOR107
  • Experimental: Part 1, MOR107 Dose level 3
    MOR107, single subcutaneous injection
    Intervention: Drug: MOR107
  • Experimental: Part 1, MOR107 Dose level 4
    MOR107, single subcutaneous injection
    Intervention: Drug: MOR107
  • Experimental: Part 1, MOR107 Dose level 5
    MOR107, single subcutaneous injection
    Intervention: Drug: MOR107
  • Experimental: Part 1, MOR107 Dose level 6
    MOR107, single subcutaneous injection
    Intervention: Drug: MOR107
  • Placebo Comparator: Part 1, Placebo
    Placebo, single subcutaneous injection
    Intervention: Drug: Placebo
  • Experimental: Part 2: MOR107 low dose
    MOR107 low dose single subcutaneous injection and low sodium diet for 6 days before dosing and 2 days after dosing
    Interventions:
    • Drug: MOR107
    • Other: Low sodium diet
  • Experimental: Part 2: MOR107 medium dose
    MOR107 medium dose single subcutaneous injection and low sodium diet for 6 days before dosing and 2 days after dosing
    Interventions:
    • Drug: MOR107
    • Other: Low sodium diet
  • Experimental: Part 2: MOR107 high dose
    MOR107 high dose single subcutaneous injection and low sodium diet for 6 days before dosing and 2 days after dosing
    Interventions:
    • Drug: MOR107
    • Other: Low sodium diet
  • Placebo Comparator: Part 2: Placebo
    Placebo single subcutaneous injection and low sodium diet for 6 days before dosing and 2 days after dosing
    Interventions:
    • Drug: Placebo
    • Other: Low sodium diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 6, 2018)
24
Original Estimated Enrollment  ICMJE
 (submitted: February 24, 2017)
72
Actual Study Completion Date  ICMJE March 23, 2017
Actual Primary Completion Date March 23, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03067363
Other Study ID Numbers  ICMJE MOR107-C001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Alan Richardson, LanthioPep BV
Study Sponsor  ICMJE Alan Richardson
Collaborators  ICMJE Quotient Clinical
Investigators  ICMJE
Study Director: Axel Mescheder, MD LanthioPep BV
PRS Account LanthioPep BV
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP