| Trial ID: | L2950 |
| Source ID: | NCT00976729
|
| Associated Drug: |
Nox-E36
|
| Title: |
NOX-E36 First-in-Human (FIH) Study
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Inflammatory Diseases|Type 2 Diabetes Mellitus|Systemic Lupus Erythematosus
|
| Interventions: |
DRUG: NOX-E36|DRUG: NOX-E36|DRUG: Placebo
|
| Outcome Measures: |
Primary: Safety and tolerability of NOX-E36 by means of adverse events, vital signs, laboratory parameters, 12-lead ECG and immunogenicity assessment, throughout the entire study | Secondary: Pharmacokinetic parameters in plasma and urine, throughout the entire study|Pharmacodynamic profile, throughout the entire study
|
| Sponsor/Collaborators: |
Sponsor: TME Pharma AG
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
72
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2009-05
|
| Completion Date: |
2009-12
|
| Results First Posted: |
|
| Last Update Posted: |
2013-02-13
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT00976729
|
