NCT03689829

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

A Parallel-design Phase 1 Study to Assess Safety, Tolerability and Pharmacokinetics/Exposure Following Different Single Dose Levels of MOR106 (Administered Subcutaneously or Intravenously) in Healthy Male Subjects (Randomized, Open-label), and in Subjects With Moderate to Severe Atopic Dermatitis (Randomized, Placebo-controlled, Double-blind, Repeated Subcutaneous Dosing Over 12 Weeks)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

• Healthy
• Atopic Dermatitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-08-13
• Primary completion: 2020-03-02
• Completion: 2020-03-02
• First posted: 2018-09-28
• Last updated: 2020-03-18

Locations

15 sites across 4 countries: Germany, Spain, Ukraine, United Kingdom