NCT01955603View on ClinicalTrials.gov

A Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0215-0384 Administered to Subjects With Moderate to Severe Rheumatoid Arthritis

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

September 30, 2013

Primary Completion Date

October 31, 2014

Study Completion Date

October 31, 2014

Conditions
InflammationRheumatoid Arthritis
Interventions
DRUG

NNC0215-0384

A total of seven once-weekly doses of NNC0215-0384 or placebo will be administered subcutaneously (s.c., under the skin) at one of three ascending dose levels. Each cohort will consist of eight subjects randomised to either active (6 subjects) or placebo (2 subjects) treatment. Each subject will participate in one cohort only. Dose-escalation to the next dose level will be initiated when the safety data has been evaluated and if considered safe.

DRUG

placebo

Placebo administered corresponding to NNC0215-0384 treatment

Trial Locations (4)

13353

Berlin

119435

Moscow

H1027

Budapest

31-637

Krakow

Sponsors

Lead Sponsor

Novo Nordisk A/S
All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY

NCT01955603 - A Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0215-0384 Administered to Subjects With Moderate to Severe Rheumatoid Arthritis | Biotech Hunter | Biotech Hunter