Status:
COMPLETED
NOX-E36 First-in-Human (FIH) Study
Lead Sponsor:
TME Pharma AG
Conditions:
Chronic Inflammatory Diseases
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
This is the first time NOX-E36 will be administered to man. The principal aim of this study is to obtain safety and tolerability data when NOX-E36 is administered by single intravenous (IV) and subcut...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00976729
Start Date
May 1 2009
End Date
December 1 2009
Last Update
February 13 2013
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