This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetic (the effect of the body on the investigated drug), pharmacodynamic biomarkers (biomarkers related to anti-IL-21 expected mode of action) and signs of clinical efficacy of increasing single doses, at 9 i.v. (into the vein) dose levels in Healthy Subjects , at 3 i.v. dose levels in subjects with rheumatoid arthritis (RA) and at 3 s.c. dose levels in Healthy Subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
64
A single dose of NNC0114-0000-0005 administered i.v. (into the vein) in healthy subjects.
A single dose of NNC0114-0000-0005 administered i.v. (into the vein) in healthy subjects. Based on safety data, a single dose of NNC0114-0000-0005 may be administered i.v. (into the vein) in subjects with RA. In addition a single dose of NNC0114-0000-0005 administered s.c. (under the skin) in healthy subjects.
A single dose of NNC0114-0000-0005 administered i.v. (into the vein) in healthy subjects. In addition a single dose of NNC0114-0000-0005 may be administered s.c. (under the skin) in healthy subjects based on safety data.
Novo Nordisk Investigational Site
Berlin, Germany
Incidence of adverse events
Time frame: at least 12 weeks after dose administration
Area under the serum concentration-time curve
Time frame: at least 12 weeks after dose administration
Maximum level of free IL-21 and maximum level of bound IL-21 in peripheral blood
Time frame: at least 12 weeks after dose administration
Change in Disease Activity Score 28 (DAS28)-C-reactive protein (CRP) in subjects with RA
Time frame: at least 12 weeks after dose administration
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A single dose of NNC0114-0000-0005 administered i.v. (into the vein) in healthy subjects. Based on safety data, a single dose of NNC0114-0000-0005 may be administered i.v. (into the vein) in subjects with RA. In addition a single dose of NNC0114-0000-0005 may be administered s.c. (under the skin) in healthy subjects based on safety data.
A single dose of NNC0114-0000-0005 administered i.v. (into the vein) in healthy subjects. Based on safety data, a single dose of NNC0114-0000-0005 may be administered i.v. (into the vein) in subjects with RA.
A single dose of NNC0114-0000-0005 placebo.