NCT06312423

Safety and Pharmacokinetics of IMT504, an Immunomodulator and Tissue Repair Inducer

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Ministry of Public Health of the Province of La Rioja · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Immune System

Interventions

Type	Name	Description
DRUG	Oligonucleotides, Phosphorothioate	Group 1: 20 mg/day single dose Group 2: 20 mg/day for 3 days Group 3: 20 mg/day for 5 days

Timeline

• Start date: 2024-02-23
• Primary completion: 2024-08-30
• Completion: 2024-12-30
• First posted: 2024-03-15
• Last updated: 2024-03-15

Locations

1 site across 1 country: Argentina