NCT05569720

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

First in Human Clinical Trial to Compare Safety and Tolerability Between Intravenous Infusions and Bolus Intravenous Inhection of ApTOLL in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: aptaTargets S.L. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Stroke

Interventions

Type	Name	Description
DRUG	ApTOLL	ApTOLL will be administered as follows: * Day 1: a dose of 0.1mg/kg will be administered intravenously as a slow infusion. * Day 2: a dose of 0.1mg/kg will be administered intravenously as single bolus injection. * Day 3: a dose of 0.2mg/kg will be administered intravenously as single bolus injection.

Timeline

• Start date: 2022-04-25
• Primary completion: 2022-06-24
• Completion: 2022-06-24
• First posted: 2022-10-06
• Last updated: 2022-10-06

Locations

1 site across 1 country: Spain