First-in-human study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of NOX-H94
- Conditions
- MedDRA - LLT 10002272 (Anämie / Anemia)D63Anaemia in chronic diseases classified elsewhere
- Registration Number
- DRKS00003102
- Lead Sponsor
- OXXON Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 64
Groups A to G (healthy subjects):
Healthy Male subjects or healthy female subjects of non-childbearing potential (Groups A to E), healthy male subjects (groups F to H); Age 18-65 years; Males willing to use 2 means of contraceptive methods for at least 2 months after the final examination
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; 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, Positive alcohol breath test; Diseases or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs; Current bronchial asthma; Definite or suspected history of drug allergy or hypersensitivity or intolerance to PEG, Subjects who have donated any blood, plasma or platelets in the month prior to screening, Pregnant or breastfeeding women; History of seizures or at risk; 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 the following medication during their trial participation (from screening until final examination): Intravenous iron, Blood transfusions, Erythropoietin.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the safety and tolerability of ascending single and multiple doses of NOX-H94 in healthy subjects
- Secondary Outcome Measures
Name Time Method 1) To determine the single and multiple dose pharmacokinetics of NOX-H94 in healthy subjects and patients with anemia; 2)To assess the single and multiple dose pharmacodynamic response of NOX-H94 in healthy subjects and patients with anemia<br>