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| Name | Class |
|---|---|
| German Federal Ministry of Education and Research | OTHER_GOV |
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This is the first time NOX-A12 will be administered to man. The principal aim of this study is to obtain safety and tolerability data when NOX-A12 is administered by single intravenous (IV) doses to healthy male and female subjects. This information, together with the pharmacokinetic and pharmacodynamic data, will help establish the doses and dosage regimen of administration suitable for subsequent studies in the patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.05 mg/kg NOX-A12 | Experimental |
| |
| 0.15 mg/kg NOX-A12 | Experimental |
| |
| 0.45 mg/kg NOX-A12 | Experimental |
| |
| 1.35 mg/kg NOX-A12 | Experimental |
| |
| 2.7 mg/kg NOX-A12 | Experimental |
| |
| 5.4 mg/kg NOX-A12 | Experimental |
| |
| 10.8 mg/kg NOX-A12 | Experimental |
| |
| 5.4 mg/kg NOX-A12 plus apheresis | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NOX-A12 | Drug | single ascending IV doses, ranging from 0.05 mg/kg to 10.8 mg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of NOX-A12 by means of adverse events, vital signs, laboratory parameters, 12-lead ECG and immunogenicity assessment | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters in plasma and urine | 1 month | |
| Pharmacodynamic profile | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Zeitler, MD | TME Pharma AG | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scope Life Sciences GmbH | Hamburg | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30957581 | Derived | Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19. |
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| ID | Term |
|---|---|
| C587878 | NOX-A12 |
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|
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| NOX-A12 | Drug | single IV dose, at efficacious dose level |
|
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