MedDRA - LLT 10002272 (Anämie / Anemia) D63
Conditions
Interventions
Group 1: Group A:
healthy subjects will be included in a double blind, placebo controlled, single ascending IV dose design with NOX-H94 (0,3 mg/kg).
Group 2: Group B:
healthy subjects will be include
Sponsors
NOXXON Pharma AG
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: Resting supine pulse rate = 100 beats / min; Resting supine blood pressure: Systolic blood pressure = 160 mmHg Diastolic blood pressure = 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the safety and tolerability of ascending single and multiple doses of NOX-H94 in healthy subjects | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Contacts
Public ContactLuciana Summo
NOXXON Pharma AG
Outcome results
None listed