First in Human Study to Compare Safety Between Intravenous Bolus Versus Infusion of ApTOLL

Summary

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.

Timeline

Start

2022-04-25

Primary completion

2022-06-24

Completion

2022-06-24

Publications

• 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.
• 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.
• 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.

Drugs

Indications