NOX-E36 First-in-Human (FIH) Study

Launched by TME PHARMA AG · Sep 11, 2009

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy male and female subjects
• • Body mass index (BMI) between 19.0 and 29.0 kg/m2 inclusive
• • Body weight between 50 and 100 kg inclusive
• • Creatinine clearance of greater than 80 mL/min
• Exclusion Criteria:
• • Male and female subjects who are not or whose partners are not willing to use appropriate contraception methods
• • Intake of any prescribed systemic or topical medication within 14 days prior to dosing
• • Intake of any non-prescribed systemic or topical medication (including herbal remedies) within 7 days prior to dosing (with the exception of vitamin/mineral supplements)
• • Supine blood pressure and supine pulse rate higher than 140/90 mmHg and 100 beats per minute (bpm), respectively, or lower than 90/50 mmHg and 40 bpm, respectively, as confirmed by a repeat assessment
• • History of any clinically significant neurological, dermatological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological or other major disorders