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

NCT01370902 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2014-12-23

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Innate Pharma

    lead INDUSTRY

Principal Investigators

  • Renaud Buffet · Innate Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Germany

Study Locations

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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 NCT01370902 on ClinicalTrials.gov