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Safety and Pharmacokinetics of IMT504, an Immunomodulator and Tissue Repair Inducer — ECDA000/02  

Immune System Clinical Trial

Official title:
Phase 1 Open-label Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of IMT504 Phosphorothioate Oligonucleotide, an Immunomodulator and Tissue Repair Inducer, in Healthy Volunteers

Clinical Trial Summary

Phase 1 open-label dose-escalation study to evaluate the safety and pharmacokinetics of IMT504 Phosphorothioate Oligonucleotide, an immunomodulator and tissue repair inducer, in healthy volunteers.

Clinical Trial Description

This is a phase 1 open-label dose-escalation study to evaluate the safety and pharmacokinetics of IMT504 Phosphorothioate Oligonucleotide, an immunomodulator and tissue repair inducer, in healthy volunteers. A total of 12 adult volunteers of both sexes will be included, who will be progressively incorporated into 3 groups of 4 volunteers each. The first group will be administered subcutaneously with a single dose of 20 mg of IMT504. The second group will receive 3 doses (20 mg daily for 3 days) and then, if no toxicity is detected, the last group will be administered 5 daily doses of 20 mg/d. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06312423
Study type Interventional
Source Ministry of Public Health of the Province of La Rioja
Contact Ricardo A Lopez, Doctor
Phone 5491133016577
Email ralopez.new@gmail.com
Status Recruiting
Phase Phase 1
Start date February 23, 2024
Completion date December 30, 2024
View Details
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