First Human Dose Trial of NNC0114-0000-0005 in Healthy Subjects and Subjects With Rheumatoid Arthritis

NCT01208506 Phase 1 COMPLETED

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.

Details

Lead sponsor	Novo Nordisk A/S
Phase	Phase 1
Status	COMPLETED
Enrolment	64
Start date	2010-09
Completion	2012-02

Conditions

• Inflammation
• Rheumatoid Arthritis
• Healthy

Interventions

• NNC0114-0000-0005
• NNC0114-0000-0005
• NNC0114-0000-0005
• NNC0114-0000-0005
• NNC0114-0000-0005
• placebo

Primary outcomes

• Incidence of adverse events — at least 12 weeks after dose administration

Countries

Germany