CompletedNCT01208506Updated Feb 8, 2017

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

A Phase 1 interventional study of NNC0114-0000-0005 and NNC0114-0000-0005 in Inflammation, Rheumatoid Arthritis and Healthy, sponsored by Novo Nordisk A/S. Completed at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-02-08.

Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 64
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study summary

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.

Conditions studied

Inflammation
Rheumatoid Arthritis
Healthy

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In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 64 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

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Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 101 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

For all subjects the following applies:
Male subjects, if not sterilized, must be using two acceptable methods of contraception (e.g., spermicidal gel plus condom) for the entire duration of the trial corresponding to up to three months following trial drug administration. Male subjects must also agree to refrain from sperm donation from screening (trial start) until 120 days beyond trial drug administration
For healthy subjects (HS) the following additional criteria applies:
Male subjects, aged between 18 and 60 years (both inclusive) and in good health, as determined by past medical history, physical examination, vital signs, (electrocardiogram) ECG, and laboratory tests at screening (trial start)
For subjects with rheumatoid arthritis (RA) the following additional criteria applies:
Diagnosed with RA at least 3 months prior to trial drug administration
Active RA, characterised by a Disease Activity Score 28 (DAS28)-C-reactive protein (CRP) greater than 3.2
Effective methods of contraception
Male and female subjects aged greater and equal to 18 and greater and equal to 75 years
Females must be post-menopausal or surgically sterile (post-menopausal for at least 1 year). If female of child-bearing potential must be willing to use highly effective method of birth control during the trial until their final visit
Methotrexate treatment (MTX) treatment for at least 12 weeks at a stable dose (dose at least 7.5 mg/week and maximum 25 mg/week inclusive) for at least 4 weeks prior to trial product administration
Concomitant medication according to specific list

Exclusion criteria

Exclusion Criteria:

For all subjects the following applies:
Body mass index (BMI) between 20.0-38.0 kg/m2 (both inclusive)
Females with a positive pregnancy test
History of regular alcohol consumption exceeding 14 drinks per week for females or 21 drinks per week for men
Donation or loss of at least 400 mL of blood within 8 weeks prior to trial product administration
For healthy subjects (HS) the following additional criteria applies:
Body weight greater than 110.0 kg
For subjects with rheumatoid arthritis (RA) the following additional criteria applies:
Chronic inflammatory autoimmune disease other than RA (except secondary Sjögren's syndrome or stable hypothyroidism)
History of or current inflammatory joint disease other than RA such as gout (crystal proven), psoriatic arthritis, juvenile idiopathic arthritis, current reactive arthritis or Lyme disease

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single group
Masking: Double (Participant, Investigator)
Enrollment: 64 participants (actual)

Study arms

Experimental
Dose level 1
Drug: NNC0114-0000-0005 · Drug: placebo
Experimental
Dose level 2
Drug: NNC0114-0000-0005 · Drug: placebo
Experimental
Dose level 3
Drug: NNC0114-0000-0005 · Drug: placebo
Experimental
Dose level 4
Drug: NNC0114-0000-0005 · Drug: placebo
Experimental
Dose level 5
Drug: NNC0114-0000-0005 · Drug: placebo
Experimental
Dose level 6
Drug: NNC0114-0000-0005 · Drug: placebo
Experimental
Dose level 7
Drug: NNC0114-0000-0005 · Drug: placebo
Experimental
Dose level 8
Drug: NNC0114-0000-0005 · Drug: placebo

Interventions

DrugNNC0114-0000-0005
A single dose of NNC0114-0000-0005 administered i.v. (into the vein) in healthy subjects.
DrugNNC0114-0000-0005
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.
DrugNNC0114-0000-0005
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.
DrugNNC0114-0000-0005
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.
DrugNNC0114-0000-0005
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.
Drugplacebo
A single dose of NNC0114-0000-0005 placebo.

What researchers measure

Primary outcomes

Incidence of adverse events
Time frame: at least 12 weeks after dose administration

Secondary outcomes

Area under the serum concentration-time curve
Time frame: at least 12 weeks after dose administration
Maximum level of free IL-21 and maximum level of bound IL-21 in peripheral blood
Time frame: at least 12 weeks after dose administration
Change in Disease Activity Score 28 (DAS28)-C-reactive protein (CRP) in subjects with RA
Time frame: at least 12 weeks after dose administration

Study locations

1 site

Novo Nordisk Investigational Site
Berlin, 10117, Germany

References and documents

Publications

First in human study with recombinant anti-IL-21 monoclonal antibody in healthy subjects and patients with rheumatoid arthritis. Arthritis and Rheumatism 2012; 64 (10 (supplement)): Abstract 1279

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01208506
Lead sponsor: Novo Nordisk A/S
Responsible party: Sponsor
First posted: Sep 24, 2010
Start date: Sep 2010
Primary completion: Feb 2012
Completion: Feb 2012
Last update: Feb 8, 2017

Study contacts

Global Clinical Registry (GCR, 1452)

study director · Novo Nordisk A/S

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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