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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
92
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
Single dose administered subcutaneously (under the skin) as a comparator at all dose levels
Multiple doses administered subcutaneously (under the skin) at 4 different occasions with a dosing interval of two weeks, at five different dose levels.
Unnamed facility
Berlin, Germany
Incidence of adverse events
Time frame: from trial product administration to week 12
Antibodies against NNC141-0100
Time frame: from trial product administration until final visit (week 12 or longer if applicable)
Area under the serum concentration-time curve - SD trial part
Time frame: from trial product administration until final visit (week 12 or longer if applicable)
Terminal half-life (t½) - SD trial part
Time frame: from trial product administration until final visit (week 12 or longer if applicable)
Terminal half-life (t½) - MD trial part
Time frame: from trial product administration until final visit (week 12 or longer if applicable)
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Multiple doses administered subcutaneously (under the skin) as a comparator at all dose levels
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
Single dose administered intravenously (into a vein), as a comparator at all dose levels