- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01208506
First-in-Man Trial of NNC114-0005 in Healthy Subjects and Subjects With Rheumatoid Arthritis
February 6, 2017 updated by: Novo Nordisk A/S
First Human Dose Trial of NNC0114-0000-0005 in Healthy Subjects and Subjects With Rheumatoid Arthritis
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Berlin, Germany, 10117
- Novo Nordisk Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dose level 1
|
A single dose of NNC0114-0000-0005 administered i.v.
(into the vein) in healthy subjects.
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.
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.
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.
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.
A single dose of NNC0114-0000-0005 placebo.
|
Experimental: Dose level 2
|
A single dose of NNC0114-0000-0005 administered i.v.
(into the vein) in healthy subjects.
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.
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.
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.
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.
A single dose of NNC0114-0000-0005 placebo.
|
Experimental: Dose level 3
|
A single dose of NNC0114-0000-0005 administered i.v.
(into the vein) in healthy subjects.
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.
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.
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.
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.
A single dose of NNC0114-0000-0005 placebo.
|
Experimental: Dose level 4
|
A single dose of NNC0114-0000-0005 administered i.v.
(into the vein) in healthy subjects.
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.
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.
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.
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.
A single dose of NNC0114-0000-0005 placebo.
|
Experimental: Dose level 5
|
A single dose of NNC0114-0000-0005 administered i.v.
(into the vein) in healthy subjects.
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.
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.
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.
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.
A single dose of NNC0114-0000-0005 placebo.
|
Experimental: Dose level 6
|
A single dose of NNC0114-0000-0005 administered i.v.
(into the vein) in healthy subjects.
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.
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.
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.
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.
A single dose of NNC0114-0000-0005 placebo.
|
Experimental: Dose level 7
|
A single dose of NNC0114-0000-0005 administered i.v.
(into the vein) in healthy subjects.
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.
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.
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.
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.
A single dose of NNC0114-0000-0005 placebo.
|
Experimental: Dose level 8
|
A single dose of NNC0114-0000-0005 administered i.v.
(into the vein) in healthy subjects.
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.
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.
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.
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.
A single dose of NNC0114-0000-0005 placebo.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of adverse events
Time Frame: at least 12 weeks after dose administration
|
at least 12 weeks after dose administration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the serum concentration-time curve
Time Frame: at least 12 weeks after dose administration
|
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
|
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
|
at least 12 weeks after dose administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
February 1, 2012
Study Completion (Actual)
February 1, 2012
Study Registration Dates
First Submitted
September 23, 2010
First Submitted That Met QC Criteria
September 23, 2010
First Posted (Estimate)
September 24, 2010
Study Record Updates
Last Update Posted (Estimate)
February 8, 2017
Last Update Submitted That Met QC Criteria
February 6, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN8828-3837
- 2010-018347-33 (EudraCT Number)
- U1111-1116-2585 (Other Identifier: WHO)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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