NCT01370902

Safety and Tolerability of NNC0141-0000-0100 in Subjects With Rheumatoid Arthritis

A Randomised, Double-blind, Placebo-controlled, Single-dose and Multiple-dose, Dose-escalation Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0141-0000-0100 in Subjects With Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Innate Pharma · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This trial is conducted in Europe. The aim of this dose-escalating trial is to assess the safety, tolerability, pharmacokinetics (the rate at which the body eliminates the trial drug) and pharmacodynamics (the effect of the investigated drug on the body) of single and repeated doses of NNC141-0100 in subjects with Rheumatoid Arthritis.

Conditions

• Inflammation
• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	NNC 0141-0000-0100	Single dose administered subcutaneously (under the skin), up to six dose levels. Progression to next dose will be based on safety evaluation. Initiation of the MD s.c. phase will depend on the results from the SD i.v. cohorts as well as the first two dose cohorts of the SD s.c. part
DRUG	placebo	Single dose administered subcutaneously (under the skin) as a comparator at all dose levels
DRUG	NNC 0141-0000-0100	Multiple doses administered subcutaneously (under the skin) at 4 different occasions with a dosing interval of two weeks, at five different dose levels.
DRUG	placebo	Multiple doses administered subcutaneously (under the skin) as a comparator at all dose levels
DRUG	NNC 0141-0000-0100	Single dose administered intravenously (into a vein), up to nine dose levels. Progression to next dose will be based on safety evaluation. Initiation of the SD s.c. phase will depend on the results from the first three dose cohorts of the SD i.v. part
DRUG	placebo	Single dose administered intravenously (into a vein), as a comparator at all dose levels

Timeline

• Start date: 2011-05-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2011-06-10
• Last updated: 2014-12-23

Locations

1 site across 1 country: Germany