NCT01208506View on ClinicalTrials.gov

First-in-Man Trial of NNC114-0005 in Healthy Subjects and Subjects With Rheumatoid Arthritis

PHASE1CompletedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

September 30, 2010

Primary Completion Date

February 29, 2012

Study Completion Date

February 29, 2012

Conditions
InflammationRheumatoid ArthritisHealthy
Interventions
DRUG

NNC0114-0000-0005

A single dose of NNC0114-0000-0005 administered i.v. (into the vein) in healthy subjects.

DRUG

NNC0114-0000-0005

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.

DRUG

NNC0114-0000-0005

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.

DRUG

NNC0114-0000-0005

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.

DRUG

NNC0114-0000-0005

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.

DRUG

placebo

A single dose of NNC0114-0000-0005 placebo.

Trial Locations (1)

10117

Novo Nordisk Investigational Site, Berlin

Sponsors

Lead Sponsor

Novo Nordisk A/S
All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY