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

NCT05569720 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2022-10-06

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Centro para el Desarrollo Tecnológico Industrial

    collaborator UNKNOWN

  • aptaTargets S.L.

    lead INDUSTRY

Principal Investigators

  • Macarena Hernández, PhD · aptaTargets S.L.

  • Dolores Ochoa, MD, PhD · Hospital Universitario La Princesa

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-25
Primary Completion
2022-06-24
Completion
2022-06-24

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05569720 on ClinicalTrials.gov