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First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NOX-H94

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ClinicalTrials.gov Identifier: NCT01372137
Recruitment Status : Completed
First Posted : June 13, 2011
Last Update Posted : January 25, 2016
Sponsor:
Information provided by (Responsible Party):
TME Pharma AG

Study Description
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Brief Summary:
This is the first clinical trial with NOX-H94. The purpose of this clinical trial is to identify a safe and efficacious treatment regimen for the clinical development of NOX-H94 in patients with anemia of chronic disease (inflammation).

Condition or disease Intervention/treatment Phase
Anemia Chronic Diseases Inflammation Drug: NOX-H94 Other: Glucose 5% Phase 1

Detailed Description:

NOX H94 is a pegylated Spiegelmer that specifically binds to human hepcidin, thereby antagonizing its role in hemostasis, and is therefore indicated for use in anemia of inflammation. Human hepcidin has emerged as the central regulatory molecule of systemic iron homeostasis. Hepcidin expression in hepatocytes is regulated by multiple, in particular opposing signals, including systemic iron availability, hepatic iron stores, erythropoietic activity, hypoxia, and inflammatory states. These different signals are integrated transcriptionally. In chronic inflammation, such as occurs in rheumatoid arthritis, chronic kidney disease or cancer, elevated hepcidin levels have been measured and may be a key factor leading to anemia in these patients.

NOX-H94 is therefore indicated for treatment of patients with an anemia of inflammation, which is characterized by increased intracellular iron stores, increased serum ferritin concentrations and reduced sensitivity to treatment with erythropoiesis stimulating agents (ESAs), due to the limited availability of serum iron. Antagonism of hepcidin by NOX-H94 therefore leads to elevated levels of iron and transferrin saturation in the peripheral blood and could supply iron for erythropoiesis thereby correcting the anemia.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NOX-H94
Study Start Date : July 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: NOX-H94
Group A: single 15 minutes IV infusion of 0.3 mg/kg NOX-H94 Group B: single 15 minutes IV infusion of 0.6 mg/kg NOX-H94 Group C: single 15 minutes IV infusion of 1.2 mg/kg NOX-H94 Group D: single 15 minutes IV infusion of 2.4 mg/kg NOX-H94 Group E: single 15 minutes IV infusion of 4.8 mg/kg NOX-H94 Group F: single / repeated SC injection of NOX-H94 over a treatment period of 2 weeks Group G: multiple doses of NOX-H94 as a 15 minutes IV infusion over a treatment period of 2 weeks Group H: multiple doses of NOX-H94 as a 15 minutes IV infusion over a treatment period of 2 weeks
 Drug: NOX-H94
Dosage form: NOX-H94 25 mg (oligonucleotide basis) Solution for Injection Strength: 14.6 mg NOX-H94 / mL Dose: 0.3 - 4.8 mg/kg single dose Route: IV infusion over 15 minutes / SC administration
Other Name: lexaptepid pegol
Placebo Comparator: Glucose 5%
Group A to Group H get NOX-H94 or Placebo
 Other: Glucose 5%
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: 0 to 90 days ]

Secondary Outcome Measures :
  1. drug plasma concentrations [ Time Frame: 0 to 29 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Male subjects or female subjects of non-childbearing potential (Groups A to E), male subjects (groups F to H)
  • Age 18-65 years
  • Healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram, and clinical laboratory parameters
  • Males willing to use 2 means of contraceptive methods for at least 2 months after the final examination

Exclusion Criteria:

  1. Anemia predominantly caused by other factors than chronic disease.
  2. Iron overload or disturbances in utilization of iron.
  3. Intravenous iron treatment or blood transfusion within 4 weeks prior to screening visit.
  4. Erythropoietin treatment within 4 weeks prior to screening visit.
  5. Intake of Intravenous iron, Blood transfusions, Erythropoietin during their trial participation.
  6. Resting supine pulse rate < 40 or > 100 beats / min.

  7. Resting supine blood pressure:

    Systolic blood pressure < 90 or > 160 mmHg Diastolic blood pressure < 40 or > 100 mmHg.

  8. History or presence of confirmed orthostatic hypotension defined.
  9. Positive test of HIV type 1/2 antibodies, HBs antigen, HBc antibodies, HCV antibodies.
  10. Participation in another clinical trial during the last 3 months before starting this trial.
  11. Positive test for drugs of abuse.
  12. Diseases or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
  13. Marked repolarization abnormality.
  14. Current bronchial asthma, childhood asthma which has been resolved is allowed.
  15. Definite or suspected history of drug allergy or hypersensitivity or intolerance to PEG
  16. Regular intake of over 14 units of alcohol per week for women and 21 units for men.

  17. Not able to abstain from consumption of:

    • Caffeine containing beverages or food (tea, coffee, cola, chocolate, etc.)
    • Quinine containing beverages or food (bitter lemon, tonic water)
    • Grapefruit juice (sweet or sour)
    • Poppy seeds containing beverages or food
  18. Subjects who have donated any blood, plasma or platelets in the month prior to screening
  19. History of seizures or at risk
  20. Known or suspected of not being able to comply with the trial protocol and/or clinical unit restrictions.
  21. History of or presence of clinically significant diseases other than the underlying disease.
  22. Surgery or trauma with significant blood loss within the last 2 months before administration of study drug.

28. History of increased bleeding risk.

Contacts and Locations
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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): NCT01372137


Locations
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United Kingdom
HMR
London, United Kingdom, NW10 7EW
Sponsors and Collaborators
TME Pharma AG
Investigators
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Study Director: Riecke Kai, MD TME Pharma AG
More Information
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Study Data/Documents: Manuscript  This link exits the ClinicalTrials.gov site
Identifier: doi: 10.1111/bph.13433

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: TME Pharma AG
ClinicalTrials.gov Identifier: NCT01372137    
Other Study ID Numbers: SNOXH94C001
2011-000705-46 ( EudraCT Number )
First Posted: June 13, 2011    Key Record Dates
Last Update Posted: January 25, 2016
Last Verified: June 2014
Keywords provided by TME Pharma AG:
NOX-H94
Hepcidin
Anemia
Inflammation
Additional relevant MeSH terms:
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Inflammation
Chronic Disease
Pathologic Processes
Disease Attributes