First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NOX-H94
Anemia, Chronic Diseases, Inflammation
About this trial
This is an interventional treatment trial for Anemia focused on measuring NOX-H94, Hepcidin, Anemia, Inflammation
Eligibility 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:
- Anemia predominantly caused by other factors than chronic disease.
- Iron overload or disturbances in utilization of iron.
- Intravenous iron treatment or blood transfusion within 4 weeks prior to screening visit.
- Erythropoietin treatment within 4 weeks prior to screening visit.
- Intake of Intravenous iron, Blood transfusions, Erythropoietin during their trial participation.
- Resting supine pulse rate < 40 or > 100 beats / min.
Resting supine blood pressure:
Systolic blood pressure < 90 or > 160 mmHg Diastolic blood pressure < 40 or > 100 mmHg.
- History or presence of confirmed orthostatic hypotension defined.
- Positive test of HIV type 1/2 antibodies, HBs antigen, HBc antibodies, HCV antibodies.
- Participation in another clinical trial during the last 3 months before starting this trial.
- Positive test for drugs of abuse.
- Diseases or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- Marked repolarization abnormality.
- Current bronchial asthma, childhood asthma which has been resolved is allowed.
- Definite or suspected history of drug allergy or hypersensitivity or intolerance to PEG
- Regular intake of over 14 units of alcohol per week for women and 21 units for men.
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
- Subjects who have donated any blood, plasma or platelets in the month prior to screening
- History of seizures or at risk
- Known or suspected of not being able to comply with the trial protocol and/or clinical unit restrictions.
- History of or presence of clinically significant diseases other than the underlying disease.
- Surgery or trauma with significant blood loss within the last 2 months before administration of study drug.
28. History of increased bleeding risk.
Sites / Locations
- HMR
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
NOX-H94
Glucose 5%
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
Group A to Group H get NOX-H94 or Placebo