First-in-human study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of NOX-H94 - SNOXH94C001

OXXON Pharma AG0 sites64 target enrollmentJune 8, 2011

Overview

No summary available.

Registry

who.int

Start Date

June 8, 2011

End Date

March 7, 2012

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

OXXON Pharma AG

•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.