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The general aim of the study is to determinate safety, tolerability and early pharmacokinetics of cardiotrophin.1 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiotrophin-1 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| recombinant human cardiotrophin-1 | Drug | Single dose intravenous administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events as a Measure of Safety and Tolerability | Evaluate the tolerability and safety of single dose intravenous administration | single dose administration (baseline) and 1 post-treatment follow up week |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic and Pharmacodynamic parameters | Obtain pharmacokinetic parameters before and after CT-1 single dose administration. Analyze surrogated biological markers associated with CT-1 administration | single adminsitration (baseline) and 1 week of follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Belén Sádaba, MD | Clínica Universidad de Pamplona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hosp. Universitario Puerta de Hierro de Majadahonda | Madrid | Spain | ||||
| Clínica Universidad de Navarra |
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| Label | URL |
|---|---|
| Treatment of murine fulminant hepatitis with genetically engineered endothelial progenitor cells. | View source |
| \[Obesity, inflammation and insulin resistance: role of gp 130 receptor ligands\]. | View source |
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| Placebo |
| Other |
Single dose intravenous administration |
|
| Pamplona |
| Spain |