Trials / Completed
CompletedNCT00976729
NOX-E36 First-in-Human (FIH) Study
NOX-E36 - A Phase I, Double-Blind, Placebo Controlled, Single Intravenous and Subcutaneous Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 72 (actual)
- Sponsor
- TME Pharma AG · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
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 subcutaneous (SC) doses to healthy male and female subjects. This information, together with the pharmacokinetic and pharmacodynamic data, will help establish the doses, dosage regimen and route of administration suitable for multiple dose administration to healthy volunteers, followed by the studies in the patient population.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NOX-E36 | single ascending IV doses, ranging from 0.03 mg/kg to 2.0 mg/kg |
| DRUG | NOX-E36 | single SC doses, at safe and tolerable dose level |
| DRUG | Placebo |
Timeline
- Start date
- 2009-05-01
- Primary completion
- 2009-12-01
- Completion
- 2009-12-01
- First posted
- 2009-09-14
- Last updated
- 2013-02-13
Source: ClinicalTrials.gov record NCT00976729. Inclusion in this directory is not an endorsement.