First Human Dose Trial of NNC0215-0384 in Subjects With Rheumatoid Arthritis

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

June 4, 2012

Primary Completion Date

June 17, 2013

Study Completion Date

June 17, 2013

Conditions
InflammationRheumatoid Arthritis
Interventions
DRUG

NNC0215-0384

I.v.(intravenous) dose-escalation. Highest dose planned for i.v. administration is 10 mg/kg

DRUG

placebo

Administered i.v.(intravenous) or s.c. (subcutaneous, under the skin).

DRUG

NNC0215-0384

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

Trial Locations (1)

10117

Novo Nordisk Investigational Site, Berlin

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY

NCT01611688 - First Human Dose Trial of NNC0215-0384 in Subjects With Rheumatoid Arthritis | Biotech Hunter | Biotech Hunter