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First in Human Single Ascending Dose Study of MOR107

NCT03067363 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-02-07

No results posted yet for this study

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

Interventions

DRUG

MOR107

MOR107 solution for injection

DRUG

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

Sponsors & Collaborators

  • Quotient Clinical

    collaborator OTHER

  • Alan Richardson

    lead INDUSTRY

Principal Investigators

  • Axel Mescheder, MD · LanthioPep BV

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-16
Primary Completion
2017-03-23
Completion
2017-03-23

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03067363 on ClinicalTrials.gov