Back to resultsFirst-in-Man Trial of NNC114-0005 in Healthy Subjects and Subjects With Rheumatoid Arthritis
Primary Purpose
Inflammation, Rheumatoid Arthritis, Healthy
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
NNC0114-0000-0005
NNC0114-0000-0005
NNC0114-0000-0005
NNC0114-0000-0005
NNC0114-0000-0005
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Inflammation
Eligibility Criteria
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
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Dose level 1
Dose level 2
Dose level 3
Dose level 4
Dose level 5
Dose level 6
Dose level 7
Dose level 8
Arm Description
Outcomes
Primary Outcome Measures
Incidence of adverse events
Secondary Outcome Measures
Area under the serum concentration-time curve
Maximum level of free IL-21 and maximum level of bound IL-21 in peripheral blood
Change in Disease Activity Score 28 (DAS28)-C-reactive protein (CRP) in subjects with RA
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01208506
Brief Title
First-in-Man Trial of NNC114-0005 in Healthy Subjects and Subjects With Rheumatoid Arthritis
Official Title
First Human Dose Trial of NNC0114-0000-0005 in Healthy Subjects and Subjects With Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Rheumatoid Arthritis, Healthy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose level 1
Arm Type
Experimental
Arm Title
Dose level 2
Arm Type
Experimental
Arm Title
Dose level 3
Arm Type
Experimental
Arm Title
Dose level 4
Arm Type
Experimental
Arm Title
Dose level 5
Arm Type
Experimental
Arm Title
Dose level 6
Arm Type
Experimental
Arm Title
Dose level 7
Arm Type
Experimental
Arm Title
Dose level 8
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
NNC0114-0000-0005
Intervention Description
A single dose of NNC0114-0000-0005 administered i.v. (into the vein) in healthy subjects.
Intervention Type
Drug
Intervention Name(s)
NNC0114-0000-0005
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
NNC0114-0000-0005
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
NNC0114-0000-0005
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
NNC0114-0000-0005
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
A single dose of NNC0114-0000-0005 placebo.
Primary Outcome Measure Information:
Title
Incidence of adverse events
Time Frame
at least 12 weeks after dose administration
Secondary Outcome Measure Information:
Title
Area under the serum concentration-time curve
Time Frame
at least 12 weeks after dose administration
Title
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
Title
Change in Disease Activity Score 28 (DAS28)-C-reactive protein (CRP) in subjects with RA
Time Frame
at least 12 weeks after dose administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
12. IPD Sharing Statement
Citations:
Citation
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
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
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First-in-Man Trial of NNC114-0005 in Healthy Subjects and Subjects With Rheumatoid Arthritis
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