Evaluating the safety and pharmacokinetics of IMT504 in healthy volunteers

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

This study is testing a new drug called IMT504 in healthy adults to see if it's safe and how the body processes it.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ministry of Public Health of the Province of La Rioja (Government)
• Locations: 1 site (Buenos Aires)
• Trial ID: NCT06312423 on ClinicalTrials.gov

What this trial studies

This phase 1 open-label dose-escalation study aims to assess the safety and pharmacokinetics of IMT504, a phosphorothioate oligonucleotide that acts as an immunomodulator and tissue repair inducer, in healthy adult volunteers. The study will include 12 participants divided into three groups, with each group receiving varying doses of the drug administered subcutaneously. The first group will receive a single dose, while the second and third groups will receive multiple doses over several days, contingent on the absence of toxicity. The primary focus is to ensure the safety of the drug and understand how it is processed in the body.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 years or older who meet specific health criteria and are willing to comply with study protocols.

Not a fit: Patients with significant health issues or those who do not meet the eligibility criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new treatments that enhance tissue repair and modulate immune responses.

How similar studies have performed: While this approach is novel, similar studies involving immunomodulators have shown promise in other contexts.

Eligibility criteria

Inclusion Criteria:

1. Male or female participants aged 18 years or older.
2. With the capacity and willingness to comply with the prohibitions and restrictions specified in the protocol.
3. In female volunteers of childbearing potential, negative pregnancy test at the beginning of the study and commitment to using a contraceptive method from the date of consent signing until 3 months after the study is completed.
4. Capable of reading and understanding all the features of the study.
5. Negative PCR (Polymerase Chain reaction) for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2 ) virus;
6. Laboratory analysis without clinically significant variations within the 30 days prior to receiving the first dose of the investigational drug.
7. Negative serologies for hepatitis B virus (surface antigens \[HBsAg\] and antibodies against the core of hepatitis B virus \[AntiHBc\]), hepatitis C virus (AntiHCV), and human immunodeficiency virus (HIV).
8. Electrocardiogram (ECG) without evidence of acute or chronic significant pathologies.
9. Chest X-ray without significant pathological findings.
10. Capable of providing their signed and dated informed consent by the study volunteer and the authorized physician.

Exclusion Criteria:

1. Having participated in a research study within the 60 days prior to the start of the study.
2. Having a history of known allergies or a history of anaphylaxis or any other serious adverse reaction to any known drug or excipient.
3. History of alcoholism or substance abuse that would prevent compliance with the protocol characteristics.
4. Acute infectious disease at the time of enrollment or temperature ≥38.0°C in the 24 hours prior to the scheduled study vaccination.
5. Any laboratory abnormality with a severity grade \>1 according to the Common Toxicity Criteria (CTC version 5 - November 2017).
6. Body Mass Index (BMI) greater than 35 kg/m2.
7. History of any active chronic disease.
8. Having received an investigational drug (including drugs related to COVID-19 prophylaxis or sepsis) or used an invasive investigational medical device in the 30 days prior to the start of the study.
9. Ongoing pregnancy or planned pregnancy within 3 months after administration of the investigational treatment, or lactation period.
10. Having undergone a surgical procedure requiring hospitalization in the 12 weeks prior to the start of the study, or not fully recovered from the surgery requiring hospitalization, or having a scheduled surgery requiring hospitalization during the expected study participation period or within 3 months after administration of the investigational treatment.

Where this trial is running

Buenos Aires

• CENTRO DE INVESTIGACIÓN PARA ESTUDIOS DE FARMACOLOGÍA CLÍNICA DE FASE1 EN POBLACIÓN ADULTA y DE BIOEQUIVALENCIA. Sanatorio Nuestra Señora del Pilar — Buenos Aires, Argentina (Recruiting)

Study contacts

• Principal investigator: Eduardo Pirotzky, Doctor — Centro Nuestra Señora del Pilar
• Study coordinator: Ricardo A Lopez, Doctor

Conditions Immune System; INMUNOMODULATOR; OLIGONUCLEOTIDE; CYTOKINES