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First in Human Clinical Trial of ApTOLL in Healthy Volunteers

NCT04742062 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2022-03-17

No results posted yet for this study

Summary

This is a Phase I, first-in-human, dose ascending, randomized, placebo-controlled clinical study to assess the tolerability and pharmacokinetics of ApTOLL in healthy volunteers. ApTOLL is an aptamer able to antagonize TLR4 receptor and, therefore, to reduce the inflammatory response.

Conditions

Interventions

DRUG

ApTOLL

ApTOLL is a Toll-like receptor 4 (TLR4) antagonist, a receptor that is involved in innate immune responses but also responds to tissue damage, and therefore it is directly involved in a large number of diseases where the inflammatoryy response is involved. ApTOLL has demonstrated specific binding to human TLR4 as well as a TLR4 antagonistic effect, reducing inflammation and improving outcome after different disease models.

OTHER

Placebo

100 mL 0.9% Sodium Chloride solution

Sponsors & Collaborators

  • Ministry of Science and Innovation, Spain

    collaborator OTHER_GOV

  • Anagram

    collaborator UNKNOWN

  • aptaTargets S.L.

    lead INDUSTRY

Principal Investigators

  • Dolores Ochoa, MD, PhD · Clinical Trials Unit. Hospital Universitario La Princesa

  • Macarena Hernández, PhD · aptaTargets S.L.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2019-07-18
Primary Completion
2020-02-27
Completion
2020-03-20

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 NCT04742062 on ClinicalTrials.gov