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A Study to Test Safety, Tolerability, and the Way the Body Absorbs, Distributes, and Gets Rid of a Study Drug Called MOR106, in Healthy Subjects and in Patients With Moderate to Severe Atopic Dermatitis

NCT03689829 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2020-03-18

No results posted yet for this study

Summary

The clinical study consists of three parts:

* Part 1 with healthy volunteers.
* Part 2 and Part 3 including subjects with moderate to severe atopic dermatitis (a skin disease).

For Part 1 the main goal of the study is to compare the safety, tolerability, and exposure of administration of the test drug via an injection in a skin layer just under the surface (subcutaneous), to administration of the test drug into the vein (intravenous).

For Part 2 and Part 3 the main goal of the study is to assess the safety and tolerability of administration of the test drug via an injection in a skin layer just under the surface (subcutaneous) during 12 weeks of treatment.

Conditions

Interventions

DRUG

MOR106

The active pharmaceutical drug substance of MOR106 is a human immunoglobulin gamma-1 (IgG1) monoclonal antibody that binds with a high apparent affinity to human interleukin-17C (IL-17C).

DRUG

Placebo

Corresponding placebo s.c. injections.

Sponsors & Collaborators

  • Galapagos NV

    lead INDUSTRY

Principal Investigators

  • Helen Timmis, MB CHB · Galapagos NV

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-13
Primary Completion
2020-03-02
Completion
2020-03-02

Countries

  • Germany
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT03689829 on ClinicalTrials.gov