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

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ClinicalTrials.gov Identifier: NCT01208506
Recruitment Status : Completed
First Posted : September 24, 2010
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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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.

Condition or disease Intervention/treatment Phase
Inflammation Rheumatoid Arthritis Healthy Drug: NNC0114-0000-0005 Drug: placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: First Human Dose Trial of NNC0114-0000-0005 in Healthy Subjects and Subjects With Rheumatoid Arthritis
Study Start Date : September 2010
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose level 1 Drug: NNC0114-0000-0005
A single dose of NNC0114-0000-0005 administered i.v. (into the vein) in healthy subjects.

Drug: placebo
A single dose of NNC0114-0000-0005 placebo.
Experimental: Dose level 2 Drug: NNC0114-0000-0005
A single dose of NNC0114-0000-0005 administered i.v. (into the vein) in healthy subjects.

Drug: placebo
A single dose of NNC0114-0000-0005 placebo.
Experimental: Dose level 3 Drug: NNC0114-0000-0005
A single dose of NNC0114-0000-0005 administered i.v. (into the vein) in healthy subjects.

Drug: placebo
A single dose of NNC0114-0000-0005 placebo.
Experimental: Dose level 4 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: placebo
A single dose of NNC0114-0000-0005 placebo.
Experimental: Dose level 5 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: placebo
A single dose of NNC0114-0000-0005 placebo.
Experimental: Dose level 6 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: placebo
A single dose of NNC0114-0000-0005 placebo.
Experimental: Dose level 7 Drug: NNC0114-0000-0005
A single dose of NNC0114-0000-0005 administered i.v. (into the vein) in healthy subjects.

Drug: placebo
A single dose of NNC0114-0000-0005 placebo.
Experimental: Dose level 8 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.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: at least 12 weeks after dose administration ]

Secondary Outcome Measures :
  1. Area under the serum concentration-time curve [ Time Frame: at least 12 weeks after dose administration ]
  2. 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 ]
  3. Change in Disease Activity Score 28 (DAS28)-C-reactive protein (CRP) in subjects with RA [ Time Frame: at least 12 weeks after dose administration ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01208506


Locations
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Germany
Novo Nordisk Investigational Site
Berlin, Germany, 10117
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

Publications of Results:
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

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01208506    
Other Study ID Numbers: NN8828-3837
2010-018347-33 ( EudraCT Number )
U1111-1116-2585 ( Other Identifier: WHO )
First Posted: September 24, 2010    Key Record Dates
Last Update Posted: February 8, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Inflammation
Joint Diseases
Musculoskeletal Diseases
 Pathologic Processes
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases