This trial is conducted in Europe. The aim of this trial is to describe the safety and tolerability of single intravenous (i.v.) and subcutaneous (s.c.) doses of NNC0215-0384 in subjects with active rheumatoid arthritis (RA) on background methotrexate (MTX) treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
I.v.(intravenous) dose-escalation. Highest dose planned for i.v. administration is 10 mg/kg
Administered i.v.(intravenous) or s.c. (subcutaneous, under the skin).
The s.c. (subcutaneous, under the skin) part will not start until at least two i.v. dose levels have been evaluated for safety and pharmacokinetics. Highest dose planned for s.c. administration is 4 mg/kg
Novo Nordisk Investigational Site
Berlin, Germany
Incidence of adverse events (AEs)
Time frame: Up to 10 weeks after trial product administration
I.v. administration: AUC, Area under the curve
Time frame: Up to 10 weeks after drug administration
I.v. administration: terminal half-life (t½)
Time frame: Up to 10 weeks after drug administration
S.c. administration: AUC, Area under the curve
Time frame: Up to 10 weeks after drug administration
S.c. administration: terminal half-life (t½)
Time frame: Up to 10 weeks after drug administration
Maximum level and duration of full C5a receptor (C5aR) occupancy by NNC0215-0384 on neutrophils
Time frame: Up to 10 weeks after drug administration
Maximum and minimum levels of relevant serum and plasma biomarkers related to NNC0215-0384 safety, efficacy or mechanism of action (MoA)
Time frame: Up to 10 weeks after drug administration
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