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

PHASE1CompletedINTERVENTIONAL
Enrollment

92

Participants

Timeline

Start Date

May 31, 2011

Primary Completion Date

March 31, 2014

Study Completion Date

March 31, 2014

Conditions
InflammationRheumatoid Arthritis
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

Trial Locations (1)

13353

Berlin

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Innate Pharma

INDUSTRY

NCT01370902 - Safety and Tolerability of NNC0141-0000-0100 in Subjects With Rheumatoid Arthritis | Biotech Hunter | Biotech Hunter