First-in-Man Trial of NNC114-0005 in Healthy Subjects and Subjects With Rheumatoid Arthritis
First Human Dose Trial of NNC0114-0000-0005 in Healthy Subjects and Subjects With Rheumatoid Arthritis
3 other identifiers
interventional
64
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 23, 2010
CompletedFirst Posted
Study publicly available on registry
September 24, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedFebruary 8, 2017
February 1, 2017
1.4 years
September 23, 2010
February 6, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of adverse events
at least 12 weeks after dose administration
Secondary Outcomes (3)
Area under the serum concentration-time curve
at least 12 weeks after dose administration
Maximum level of free IL-21 and maximum level of bound IL-21 in peripheral blood
at least 12 weeks after dose administration
Change in Disease Activity Score 28 (DAS28)-C-reactive protein (CRP) in subjects with RA
at least 12 weeks after dose administration
Study Arms (8)
Dose level 1
EXPERIMENTALDose level 2
EXPERIMENTALDose level 3
EXPERIMENTALDose level 4
EXPERIMENTALDose level 5
EXPERIMENTALDose level 6
EXPERIMENTALDose level 7
EXPERIMENTALDose level 8
EXPERIMENTALInterventions
A single dose of NNC0114-0000-0005 administered i.v. (into the vein) in healthy subjects.
A single dose of NNC0114-0000-0005 placebo.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Berlin, 10117, Germany
Related Publications (1)
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
RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2010
First Posted
September 24, 2010
Study Start
September 1, 2010
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
February 8, 2017
Record last verified: 2017-02