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| Name | Class |
|---|---|
| Centro para el Desarrollo Tecnológico Industrial | UNKNOWN |
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The main objective of the study is to assess the tolerability and safety of ApTOLL administration when comparing intravenous infusion vs. bolus intravenous injection, in healthy volunteers. Pharmacokinetic profile of ApTOLL will be also analysed as secondary objective of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ApTOLL treatment | Experimental | Volunteers will receive a dose of ApTOLL of 0.1mg/kg administered intravenously as slow infusion one day and as a single bolus intravenous injection the second day. In a third and last admission day, volunteers will receive a dose of ApTOLL of 0.2mg/kg administered as a single bolus intravenous injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ApTOLL | Drug | ApTOLL will be administered as follows:
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | To evaluate the safety and tolerability between different ways of ApTOLL administration: intravenous infusion versus bolus intravenous injection, and pharmacokinetic characteristics of ApTOLL in healthy volunteers after single dose administration in fasting conditions. | day 1 to day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Macarena Hernández, PhD | aptaTargets S.L. | Study Director |
| Dolores Ochoa, MD, PhD | Hospital Universitario La Princesa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology Department. Hospital Universitario de La Princesa | Madrid | 28006 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35402075 | Background | Hernandez-Jimenez M, Martin-Vilchez S, Ochoa D, Mejia-Abril G, Roman M, Camargo-Mamani P, Luquero-Bueno S, Jilma B, Moro MA, Fernandez G, Pineiro D, Ribo M, Gonzalez VM, Lizasoain I, Abad-Santos F. First-in-human phase I clinical trial of a TLR4-binding DNA aptamer, ApTOLL: Safety and pharmacokinetics in healthy volunteers. Mol Ther Nucleic Acids. 2022 Mar 9;28:124-135. doi: 10.1016/j.omtn.2022.03.005. eCollection 2022 Jun 14. | |
| 29910175 |
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We have not planned this point yet
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000722692 | TLR4 antagonist ApTOLL |
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|
| Background |
| Fernandez G, Moraga A, Cuartero MI, Garcia-Culebras A, Pena-Martinez C, Pradillo JM, Hernandez-Jimenez M, Sacristan S, Ayuso MI, Gonzalo-Gobernado R, Fernandez-Lopez D, Martin ME, Moro MA, Gonzalez VM, Lizasoain I. TLR4-Binding DNA Aptamers Show a Protective Effect against Acute Stroke in Animal Models. Mol Ther. 2018 Aug 1;26(8):2047-2059. doi: 10.1016/j.ymthe.2018.05.019. Epub 2018 Jun 15. |
| 39897575 | Derived | Hernandez-Jimenez M, Martin-Vilchez S, Mejia-Abril G, Roman M, Luquero-Bueno S, Pineiro D, Ribo M, Abad-Santos F, Ochoa D. Clinical trial to compare safety and tolerability between intravenous infusion and bolus intravenous injection of ApTOLL in healthy volunteers. Mol Ther Nucleic Acids. 2024 Dec 21;36(1):102435. doi: 10.1016/j.omtn.2024.102435. eCollection 2025 Mar 11. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |